News

Increasing Diversity in Clinical Trials

The FDA issued guidance in November aimed at enhancing diversity and encouraging inclusivity in medical research, specifically in the development of medical products. FDA Commissioner Stephan M. Hahn, M.D., wrote that “in order to promote public health, it is important that people who are in clinical trials represent the populations likely to use the potential medical product.”

Last week, the industry trade group PhRMA issued voluntary guidelines to members aimed at enhancing racial and ethnic diversity among clinical trial participants. Those guidelines go into effect in April 2021.

The FDA guidance discusses:

1. broadening eligibility criteria and avoiding unnecessary exclusions for clinical trials;
2. developing eligibility criteria and improving trial recruitment so that the participants enrolled in trials will better reflect the population most likely to use the drug, if the drug is approved, while maintaining safety and effectiveness standards; and
3. applying the recommendations for broadening eligibility criteria to clinical trials of drugs intended to treat rare diseases or conditions.

The final FDA guidance addresses demographic diversity as well as non-demographic diversity, including people with co-morbidities, disabilities and wider weight ranges. Broadening inclusion eligibility for clinical trials impacts protocol design and methodological approaches.

The PhRMA guidelines specifically focus on outreach to communities of color to reduce health disparities. Activities include outreach and education, as well as the reduction of barriers to participation.

Exclusion and eligibility criteria necessarily balances risk of adverse events against the potential benefit of the research. Pregnant women, people with chronic or severe kidney disease, or complex medical conditions are often excluded from clinical trials due to risk. However, the FDA cautions against excluding certain populations out of habit or template, rather than based on strong clinical or scientific justification. Both sets of guidelines encourage broadening eligibility criteria to increase diversity when scientifically and clinically appropriate.

The FDA guidance addresses the logistics of participation and offers strategies for minimizing the burden on enrollees. For example, certain populations may find it difficult to visit research sites frequently. Researchers and sponsors are encouraged to consider alternative methods of engaging with participants, including phone or virtual visits, email, social media and digital devices.

Investigators and sponsors are encouraged to adopt enrollment and retention practices that enhance inclusiveness. Engaging patient advocacy groups in the design of protocols; increasing outreach and education through community organizations; expanding research sites to ethnic or underserved neighborhoods; hosting frequent recruitment events; and developing recruitment materials in multiple languages are just some of the suggestions.

While both the FDA and PhRMA address sponsored clinical trials, it can also influence investigator-initiated trials.

Broadening eligibility criteria and adopting more-inclusive enrollment practices should improve the quality of studies by ensuring that the study population is more representative of the population that will use the medical product if it is approved.

Critical Considerations for Remote Clinical Trials

Even as research centers and academic institutions re-open after shutdowns due to COVID-19, many researchers are looking at ways to use remote technologies in their clinical trials. In South Carolina, for example, nicotine addiction researchers[1] are examining how to enroll smokers in their studies. They are evaluating e-consents, online surveys and questionnaires, as well as smartphone-enabled devices.

Patient Enrollment

Historically, patient enrollment in clinical research has been a significant challenge. According to research by the National Institutes of Health, 80 percent of clinical trials fail to reach their enrollment goals within the prescribed timelines. Some sites fail to recruit a single participant.

Social media is a promising way to recruit potential research subjects. With its current ubiquity, social media enables researchers to reach broad populations and target subjects based on personal information. They can also reach physicians and other clinical practitioners to inform them of new trials.

However, there are important risks to manage, including privacy and transparency. Researchers who join online patient communities — for example, those focused on a particular diagnosis — should be clear of their role.

Learn more about Social Media and Research Recruitment in this webinar: Citi Program course informed consent and clinical investigations a focus on the process

Electronic Consents

Obtaining informed consent via electronic methods involves more than just video conferencing technology. E-consents require an adjustment in processes, which can be an adjustment for research coordinators or others obtaining consent. Proper training on process is critical to ensure informed consent is obtained appropriately and the rights and welfare of human subjects are continually protected.

Implementing e-consent also requires assurance that the technology platforms are in compliance with FDA requirements for electronic signatures. Institutions must consider issues such as privacy and data security.

Learn more about remote informed consent: https://www.brany.com/telehealth-clinical-research-and-informed-consent/

Virtual Patient Visits and Wearables

Investigators who are writing protocols must consider opportunities for virtual patient visits that will minimize exposure to clinical environments such as hospitals and clinics. The use of telemedicine technologies has exploded in 2020, as clinicians worked to maintain continuity of care during lockdown.

One critical element to consider for virtual patient visits is to include them in the budget. Recent news reports[2] about insurance coverage of telemedicine visits demonstrate some shifts in reimbursement.

To monitor patients’ vital signs and other data in real-time, some investigators are turning to mobile apps and wearable devices. The use of these technologies presents challenges with regard to privacy. Many of these devices and third-party apps have their own user agreements that require careful review, as they may be in conflict with certain privacy requirements or the terms of use may need to be explained to patients during the informed consent process.

COVID-19 presented many challenges to clinical researchers. But it also offered many opportunities to revolutionize how investigators think about writing protocols, and how patients can enroll and participate in them. The landscape continues to shift rapidly, and requires careful monitoring to ensure both compliance and patient protection.

[1] https://www.news-medical.net/news/20200930/Researchers-explore-remote-methods-for-conducting-smoking-cessation-clinical-trials.aspx

[2] https://www.statnews.com/2020/09/29/united-healthcare-anthem-telemedicine-coverage-insurers/

How COVID-19 Has Impact Clinical Trial Budgeting

As COVID-19 swept across the United States earlier this year, many research centers found themselves pausing or stopping clinical trials and shifting their work from an office or clinic to their homes. Clinical research staff pivoted their focus to support the COVID-19 response, or to launch critical studies focusing on COVID-19.

As some research staff return to campus, research sites are reviewing their study budgets and making important adjustments. We have outlined some of the key areas that may have clinical trial budget impacts.

Remote Monitoring

Without the ability to visit campuses in person, sponsors must conduct monitoring visits virtually and remotely. It may seem like this is less time consuming and convenient. In fact, it may take more time and coordination to prepare medical records to review remotely from the research site perspective.

Study coordinators must collaborate with their institution’s IT teams to develop HIPAA-compliant remote access for sponsor or CRO study monitors. Within each institution, there may be many security steps that must be achieved prior to granting access to external parties. It can even be more complicated when there is a lot of staff turnover; monitors can change frequently during the research study lifecycle. In some cases, research staff might not have the proper equipment at home to access and/or transmit records. Research staff may have to print or scan medical records, then redact them and send them securely to the monitor.

Research sites should have their staff carefully track time spent on the extra steps and be sure to account for added time and effort in their budgets. Under pre-COVID circumstances, sponsors often provided arguments for not covering monitoring visits as it was considered a part of doing business. However, in the case of remote monitoring, coordinators and/or analysts should have a conversation about including the extra staff time and effort in the budget. This should include the time and effort of the IT department.

Telemedicine and Its Limits

For the sake of patient safety and whenever possible, office visits have shifted to virtual visits over the phone or videoconferencing. For patients in clinical trials, it could include engaging with the attending investigator, or a consultation with a nurse or coordinator. It is important to keep track of who participated in the virtual visit and to consider negotiating virtual visits as an item to be invoiced to the sponsor if the visit is not already covered as part of the sponsor’s budget. Keep in mind the time and effort of IT, or cost of HIPAA-compliant telecommunications technology to establish secure communication pathways among the patient, the investigator and research staff, for the purpose of the research study. If you are using online meeting platforms, such as Zoom or Microsoft Teams, there are costs associated with these applications as well.

Home Visits

In some cases, the protocol may call for a specific procedure such as IV drug administration. In this case, a visiting nurse or a contracted home health service may have to visit the patient’s home. The need for such a service should be identified and the logistics should be discussed with the sponsor. Budgets should include these visits as well as any costs for contracting and coordinating home health services.

COVID-19 Safety Measures

In some institutions, on-site staff are undergoing frequent COVID testing, sometimes twice a week. They also have had to stock up on personal protective equipment (PPE). As sites return to meeting study participants in person the use of PPE may increase. Consider including costs for some PPE supplies in your study budget when in person visits are required.

Careful Coordination

Many research coordinators shifted their focus to COVID-19-related projects. Many of them are now turning their attention back to research that had been put on hold, or on emerging new research projects.

Institutions have a mix of staff working at home and working in clinical environments. Administrators are encouraging more virtual meetings and contactless interfaces. This leads to a higher reliance on IT’s involvement in research to provide secure networks and communication. This, also, may mean a higher level of coordination with pharmacies, radiologists, and other clinical staff.

The return to campus and the restart of many trials requires a close look at budget to evaluate if there are any anticipated COVID-19 impacts, even if the study is not specific to the pandemic.

Investigators Face Challenges in Writing Research Protocols in the Age of Remote Working

While some research institutions are slowly re-opening their campuses, many investigators and their staff are still working remotely from home, at least part time. This has had a significant impact on both industry sponsored and investigator initiated clinical trials. Learn how to continue protocol writing even when working remotely. https://bit.ly/2QoW1NW

Telehealth, Clinical Research and Informed Consent

By most any measure, one of the biggest impacts that COVID-19 has had on the practice of medicine is the shift toward more telemedicine visits. Although the practice of delivering health services over the phone or the Internet has been around for some time, it wasn’t until the pandemic forced communities to close that clinical practices started to explore the use of technologies to continue monitoring patients remotely.

The global health crisis has forced both health care providers and regulatory agencies to pivot toward digital health services. Clinical research is no exception. Many clinical research studies were put on hold in the early days and weeks of the pandemic in the United States. Researchers and their staff were deployed to support COVID-19 efforts. Regulatory agencies had to adapt guidelines for HIPAA and other issues for the new environment. Health insurers developed policies for telemedicine and reimbursement.

Although clinical research in COVID-19 still seems to dominate at research institutions, protocols not related to COVID-19 are starting to return. Studies that were paused are also being resumed, albeit slowly and cautiously. Each institution has to assess risk based on local risk factors and patient populations. For studies that are primarily computational, or do not require in-person interventions, telemedicine may continue to dominate.

For research professionals, one critical issue is the process for consenting, or re-consenting, patients. For studies that were paused, investigators may need to re-consent patients due to necessary changes in the protocol. Participants may have to confirm their willingness to continue their participation in a trial.

These and other issues require consideration of the process of obtaining consent. Research coordinators, while familiar with the protocols, may need to adapt to the method of consent and how they explain the studies to patients via these technologies. The 2018 regulatory changes to consent forms that require a concise summary may be helpful in helping to communicate with potential participants. The remote consenting process may require more dialogue with the patient to ensure understanding.

These new processes can be an adjustment for research coordinators or others obtaining consent. Proper training on process is critical to ensure informed consents are conducted appropriately and continue to protect human subjects.

CITI Program, a division of BRANY, is hosting a webinar on informed consent on September 30, 2020 at 2PM EST.

Lessons Learned (so far) in COVID-19

Even as communities start the process of evaluating re-opening, many experts believe that a new normal will be with us for a long time. Physical distancing, face masks and ubiquitous alcohol gel will be part of daily life. The risk of recurrence spikes also looms ahead and threatens a return to stricter “stay at home” orders. Health care and higher education institutions continue to evaluate risks and will likely continue to encourage employees, including IRB and research administration staff, to work from home in order to maintain physical distancing. Research office staff have made incredibly quick adjustments in real time as the pandemic made its way through the United States.

In assisting our partners and clients make rapid changes, we learned some lessons we believe will help research institutions be more resilient in the months and even years to come.

Prepare for the unexpected

Disaster planning and business continuity are required for organizations receiving National Institutes of Health (NIH) funding. But even non-NIH funded research institutions should have robust business continuity plans in place. The elements of a disaster plan include issues such as data security and protecting human subjects.

Leverage technology

Many organizations scrambled to get their staff up and running from impromptu home offices. From installing and learning video conference platforms to having documentation securely available online, many research professionals quickly adapted to new ways of working and collaborating despite the learning curve.

Research institutions and investigators should consider building in these technologies as a part of their daily operations:

• Web-based collaborative protocol-writing tools
• Electronic Research Protocol Management Systems and Clinical Trial Management Systems
• Online training for research staff, particularly for operations and regulatory compliance
• Secure online meeting/video conferencing applications
• Secure cloud-based document storage for regulatory materials and other essential documents

Build in flexibility

Many research institutions pivoted their resources toward COVID-19 research efforts. This means that internal resources are unavailable for ongoing work or pending projects. Being able to shift that work to external resources, including IRBs, allows for flexibility to respond quickly as situations evolve.

External IRB partners should offer processes and procedures for running IRB meetings virtually in compliance with regulatory requirements. They should also hold frequent meetings, with the ability to hold ad-hoc meetings as needed.

Other functions can be outsourced to strategic partners, particularly when rapid turnarounds are required. These include the development and management of study budgets, coverage analysis, and clinical trial agreement support.

Select the right partners

The historic scope of impact on the research community at every level demonstrates weaknesses in every system, including partnerships. As with any disaster, communication is often the first thing to fail. Tightly synchronized communication with responsive partners who act as an extension of the research team can be the difference between an inconvenience and a very costly mistake.

Research institutions have demonstrated great resilience in their response to COVID-19, and have continued to focus on human subject protection throughout their efforts. There is talk of a “new normal” in the aftermath of the pandemic. These lessons learned can help institutions retain the integrity of their research while remaining responsive to what may be a long-standing landscape in the months or years to come.

Chart Review Studies During and After a Pandemic

The current global pandemic combined with electronic medical records and data visualization technologies have resulted in unprecedented advances in real-time tracking of SARS-CoV-2, the virus that causes COVID-19, across countries, states and local communities. As the situation evolves, there will be ample opportunity and increased need for both retrospective and prospective COVID-19 research studies that involve the review of medical records.

The rapidly evolving situation in this global pandemic requires investigators to design and write protocols quickly for IRB review. A guided protocol-writing experience, as with ProtocolBuilder, streamlines the process, ensures regulatory and institutional compliance, and facilitates collaboration among researchers.

In medical record review studies, also called a “chart reviews,” a researcher may collect and analyze information that was originally collected for a different purpose, also referred to as a secondary use of data. It often involves the collection of data from medical records in order to evaluate possible relationships between different variables and specific outcomes measures. An investigator may assess biomedical, treatment or demographic variables by reviewing various elements of a medical record. These may include lab results, physician or summary notes, admission and discharge summaries, etc.

Chart review studies can also be designed to collect prospective data, meaning the patient data does not exist at the time the protocol is submitted to the IRB for initial review. While many chart review protocols may qualify for a determination of exempt status from the IRB or expedited IRB review due to the minimal risk to research subjects, these studies are still subject to IRB review and HIPAA privacy protections. A guided and structured protocol-writing experience can accelerate the process while enhancing compliance, supporting collaboration, and saving time.

A chart review study protocol will generally include the following key elements:

• A synopsis — includes the objectives and high-level summary of the study elements, including a study flow chart
• Introduction and background — includes the protocol statement of compliance
• Rationale — includes the problem statement, risks and benefits
• Literature review — a synthesis of the current literature to establish the relevance of the problem and description of the literature that supports the need for the study
• Research design and methods — includes the study population and duration of the study. For chart reviews, a date range that indicates the timeframe for which records will be queried (e.g., a review of all ER visits between 1/1/2020 and 7/1/2020)
• Data collection and handling — includes a plan for maintaining subject confidentiality and privacy, how data will be collected and stored
• Statistical analysis plan — how the data will be analyzed to achieve the objectives

Chart review protocols are emerging as an important methodology in understanding COVID-19. Given the rapidly-developing nature of the global pandemic, the need for prompt writing and review of these protocols is critical to the ongoing effort to understand the situation.

ProtocolBuilder, a cloud-based research protocol-writing tool, can help improve the quality and consistency of clinical research protocols to make internal and IRB review processes more efficient.

Further Resources

ProtocolBuilder
https://protocolbuilderpro.com/

Research Study Design
https://about.citiprogram.org/en/series/research-study-design/

Research and HIPAA Privacy Protections (part of Comprehensive CIP Course for Advanced Learners)
https://about.citiprogram.org/en/course/comprehensive-cip-course-for-advanced-learner

BRANY’s IRB and Clinical Trial Services teams stand ready to support institutions and sponsors through COVID-19

Research institutions may need to transfer some or all of their clinical trials as they adjust operations in response to the coronavirus pandemic.

BRANY, a national organization that provides IRB review and clinical trial start-up services, announced today that its team of experts is standing ready to support institutions impacted by COVID-19.

Extraordinary measures, from “shelter in place orders” to ramping down non-essential services, have significantly disrupted IRB and clinical trial research operations. Front line health care providers are focusing their time and energy on myriad patient care issues. Clinicians who may have served on IRBs have necessarily shifted their focus to patient care. Meanwhile, research professionals, such as clinical research coordinators, are working from home, sometimes without the appropriate set-up or resources.

“Research institutions, hospitals and academic medical centers across the United States are all deeply impacted by the ongoing COVID-19 pandemic,” says Paddy Mullen, chief executive officer of BRANY. “We are a national company, owned by four academic medical centers in New York. Our deep expertise and knowledge of IRB and clinical trial start-up operations at academic medical centers, health systems, and hospitals, puts BRANY in a unique position to offer IRB and clinical trials support services that can be seamlessly incorporated into an organization’s day-to-day research operations.”

At this time, when staffing and resources for research oversight may be sparse, BRANY offers a seamless, integrated model of support. This may be particularly needed when research administrators may be pulled away from research oversight to tend to other organizational priorities. BRANY can support any institution, even those in a hardship situation, to help their IRB and Clinical Trial Offices remain compliant with regulations and institutional requirements.

“Several institutions are implementing investigator-initiated trials focusing on COVID-19,” says Ms. Mullen. “These urgently-needed protocols require swift IRB review, and we are positioned to provide that. We can also alleviate the burden of maintaining existing trials while resources are being redirected to COVID-19 trials.”

BRANY offers a wide range of research support services. Some organizations may need to temporarily transfer IRB oversight of some or all of their trials to ensure the protection of human subjects during this crisis. BRANY IRB is prepared to act as an IRB partner and assume IRB oversight. BRANY offers rapid clinical trial start-up services, including IRB review, budget development and negotiation, clinical trial agreement negotiation, and coverage analysis. BRANY also provides web-based technology solutions including SMART, a clinical trial management system, and Protocol Builder, a clinical protocol-writing application.

BRANY’s other divisions, CITI Program and the HRP Consulting Group, are also offering consulting, training and staffing support services to institutions facing a myriad of COVID-19 related concerns.

To discuss how BRANY can support an institution’s research needs, please contact Carmela Shabazz, Director, Corporate Development & Operations Support at 516-470-6979.

BRANY

BRANY is a national organization providing a continuum of research and compliance support services to investigators, hospitals, universities and academic medical centers. BRANY was founded in 1998 by four nationally-ranked academic medical centers: NYU School of Medicine, Montefiore Medical Center, Icahn School of Medicine at Mount Sinai, and Northwell Health. BRANY IRB was the first IRB in New York to be accredited by AAHRPP in 2006.

Preparing for COVID-19 Impacts on Research Institutions

The rapidly evolving federal, state and local policies regarding COVID-19 are impacting every walk of life in the United States and around the world. Companies, as well as academic and government researchers, have pivoted their focus on vaccines and possible treatments for the novel coronavirus.

Health and research institutions are trying to keep up with rapidly changing policies and procedures, while still providing patient care in real time. Resources at medical facilities are being activated and redirected to respond to the increase in testing and treating patients.

Research institutions and sponsors are evaluating protocols to determine which ones may be paused, altered, or continued. A phase three clinical trial investigating a diabetes drug has been put on hold in order to protect patients and workers, according to the sponsor.[1] Some universities have issued “urgent ramp-down of on-site, in-person research activities”[2] or are downright “suspending all non-critical on-campus research activities.”[3] Investigators are encouraged to check with their institutions’ research offices and sponsors for the latest information regarding trials in which they are involved.

Institutions must address several critical issues as they develop their policies, but the most important is the health and safety of patients and staff. Institutional review boards, research offices, laboratories and environmental health and safety committees must work together to provide guidance to investigators and research teams. These are some of the considerations in developing a policy:

• Flexibility — The situation is changing rapidly, as are federal, state and local mandates regarding the mobility of the public. In communicating with staff, it is important that they recognize and acknowledge the fluidity of the situation, and that policies may be revised in response.
• Continuity plans — Policies should consider continuity or contingency plans to protect the integrity of ongoing research. In some cases, disaster plans can be consulted for guidance in this situation.
• Communication with patients — Investigators and research offices will need a plan for communicating with patients and human subjects. Some institutions are waiving IRB review of these urgent communications.
• Reporting study deviations — IRBs will likely require reporting of study deviations, or have modified policies for doing so. Check with your IRB.
• Remote work contingencies — With many non-critical staff working from home, policies should address the use of video conferencing for IRB and other meetings, remote access and security of HIPAA-protected data, and so on.
• Telemedicine — Researchers may want to consider the use of telemedicine technologies to conduct study visits.

The rapidly changing landscape, the urgency and scale of response, and the impact on health care institutions is making this an unprecedented situation for everyone. Protecting the physical and emotional health of workers and patients should be at the center of our attention as we navigate uncharted territory.

Below are some resources for investigators who are conducting NIH-funded research:

National Institutes of Health

https://grants.nih.gov/grants/natural_disasters/corona-virus.htm

Global Impact on Clinical Trials

https://www.engage.hoganlovells.com/knowledgeservices/news/the-global-impact-of-covid-19-on-clinical-trials-and-countermeasure-development

[1] https://www.fiercebiotech.com/biotech/covid-19-outbreak-prompts-provention-to-pause-diabetes-trial

[2] https://provost.columbia.edu/news/covid-19-and-urgent-research-tasks

[3] https://drexel.edu/research/resources/coronavirus-preparedness-information/on-campus-research-activities-status-change/

Reporting Changes to Research and Reportable Events due to COVID-19

BRANY IRB is monitoring the COVID-19 epidemic and has been notified that organizations conducting research have implemented guidelines to ensure the health and safety of employees, visitors, patients and research participants. In some cases, such guidelines may impact a research team’s ability to carry out study procedures and visits as required. We recognize that this might result in protocol deviations, as well as the need for protocol amendments.

Be sure to follow your organization’s requirements in response to the COVID-19 epidemic.

Regulations require the IRB to follow written procedures to ensure prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject.

If you need to make a change in order to eliminate apparent immediate hazards to the subject, this can be done prior to BRANY IRB review and approval. Such safety-related changes may include procedures to minimize potential exposure to COVID-19, or to continue medically necessary study interventions. BRANY IRB policy requires you report such changes within 5 days. Changes may be reported in the form of a protocol amendment, letter, memo, or other document containing sufficient detail for the IRB to assess the risk associated with the change. BRANY IRB is available to promptly review such changes prior to implementation as well.

BRANY IRB defines a protocol deviation as any temporary alteration/modification to the IRB-approved protocol. The protocol may include the detailed protocol, protocol summary, consent form, recruitment materials, questionnaires, and any other information relating to the research study. Deviations can be major (affect subject safety, rights, welfare, or data integrity) or minor (do not affect subject safety, rights, welfare, or data integrity).

Examples of minor deviations may include use of telemedicine and other modifications to minimize in-person visits when feasible, changes to study visit schedules, or a decision to temporarily pause enrollment of new participants. Minor protocol deviations should be reported in aggregate to BRANY IRB at continuing review or with notification of study closure, using the Minor Deviation Log. Please review the Information Sheet for Researchers – Reportable Events for more information.

BRANY IRB encourages researchers to consider the potential benefit of study participation versus the risk of potential exposure to COVID-19, and act accordingly. Researchers should also confer with study sponsors in all cases.

If you have any questions, please contact a BRANY IRB representative.

Taking Advantage of NIH Funding Increases for Investigator-Initiated Clinical Research Requires Thoughtful Protocol Writing

Earlier this year, the National Institutes of Health (NIH) announced the approval of a budget appropriation bill for funding through September 2020. In it, the NIH receives $41.68 billion in funding, an increase of $2.6 billion from FY 2019. For NIH, the new budget appropriation includes $500 million for the All of Us precision medicine study and a $25 million increase for HIV/AIDS research. It also included a $350 million increase for targeted Alzheimer’s research, $50 million to support pediatric cancer research, and $212.5 million to increase funding for adult cancer research.

The 2020 appropriation includes grant funding for both early stage and clinical research. One of the challenges in grant submission related to clinical research is developing a well thought out clinical trial protocol that can meet both scientific and regulatory requirements. Some investigators, particularly ones earlier in their career, may feel daunted by the process of writing a protocol.

Having an easy-to-follow, step-by-step protocol-writing tool can promote adherence to regulations and streamline the institutional review processes. Many institutions have developed protocol writing templates for investigators. Unfortunately, many of them are basic word processing documents and can be unwieldy and long, frustrating protocol writers. A cloud-based, guided experience can assist both seasoned protocol writers and those new to protocol writing, such as medical residents.

Physician investigators and medical residents are not the only ones who may benefit from such a tool. Doctoral students in nursing, physical therapy and other allied health fields are discovering that to complete certification in their fields, they must participate in clinical research.

Additionally, a cloud-based protocol writing system allows closer collaboration with co-investigators or research advisors. By engaging collaborators early in the protocol-writing process, investigators benefit from the shared ‘creative thinking’ that is critical to scientific development.

As institutions, including medical centers, support residents and early career investigators, they may wish to consider a more robust solution than Word templates. In identifying and selecting a tool, they should consider the following questions:

• Does the tool allow easy collaboration with mentors or co-investigators?
• Is it a guided experience, offering assistance and education throughout the process?
• Can it be customized to suit the requirements of the individual institution?
• Does it maintain an audit trail of changes?

These and other critical questions can help institutions evaluate the best protocol-writing tools. By supporting investigators in medicine and allied health fields, institutions can realize the benefits of clearly-articulated protocols. This, in turn, may help increase opportunities for developing well thought-out investigator-initiated clinical protocols that can help strengthen a grant submission.

Interested in protocol-writing tools? Check out Protocol Builder by BRANY.

Challenges and questions remain as the one year anniversary of the implementation of the Revised Common Rule approaches

One year has passed since the implementation of the Revised Common Rule, and many challenges and questions remain. While IRBs wait for promised guidance to materialize, we are left to interpret various aspects of the rule ourselves. This has resulted in variability across IRBs in how the new requirements are interpreted and operationalized.

Variability in the Key Information Summary

A significant area of confusion and variability relates to informed consent. The Revised Rule requires that “informed consent must begin with a concise and focused presentation of key information that is most likely to assist a prospective subject or legally authorized representative (LAR) in understanding the reasons why one might or might not want to participate in the research.”

Overall the response to the requirement for the Key Information section has been positive among IRB members since it provides an opportunity to highlight the most important information. However, significant challenges remain. IRBs have come up with a wide variety of approaches to meet this new requirement, ranging from brief paragraphs to lengthier, organized tables of information.

In our experience, industry sponsors have also not uniformly grasped the intent of this section, which is meant to be concise. Sponsor representatives often cut and paste long, complicated sections of risk language from the main body of the consent document (often multiple pages worth). This creates complex key information sections, resulting in more work for those who prepare consent documents, and more back and forth with sponsors.

Broad Consent Poses More Questions

Some additional informed consent issues that have been problematic relate to the provision of “clinically relevant research results” and under what circumstances they should be provided back to subjects, the statement regarding future use of research specimens, and the required element regarding whole genome sequencing.

Although the broad consent option was intended to give researchers better options for obtaining consent to use information and specimens for research, the fatal flaw seems to be the requirement to track refusals. Given the final rule’s definition of what was identifiable, and the removal of the concept that all biospecimens are identifiable, the need for a mechanism such as broad consent was diminished. As a result it seems that institutions are not utilizing the new broad consent option.

Institutions, particularly large medical centers with multiple facilities, still need guidance on how to operationalize the mechanism of broad consent. How far does the refusal to broad consent have to be tracked? What if an individual visited multiple facilities and gave conflicting answers to the request for broad consent? What if an individual changes their mind? Broad consent does not appear to be a great option for most research institutions at this point.

Navigating the Transition

For IRBs that have not transitioned studies that were approved prior to January 21, 2019 to the Revised Rule, another challenge is having two sets of rules to follow, as some studies fall under the pre-2018 requirements, and others under the 2018 requirements. An additional complicating factor is the lack of harmonization with FDA regulations. For many, their systems had to be customized to allow for labelling of studies so it is clear which regulations are applicable to a particular study. IRB reviewers also need to be particularly cognizant as they review multiple studies for one meeting, as there is no one set of rules to follow.

The transition to the revised Common Rule has been challenging to a community that worked under rules that remained largely unchanged for several decades. While the changes were definitely needed, and welcomed by most, there will be growing pains. As exemplified by some of the scenarios above, some areas will need to be refined as we gain experience in applying the new rules. While we patiently wait for guidance and harmonization, IRBs continue to do a magnificent job of sharing best practices among each other. At the end of the day IRBs seek to protect the rights and welfare of research participants, despite any hurdles that come along.

Asentral IRB Joins BRANY IRB (Biomedical Research Alliance of New York)

For Immediate Release
17 December 2019

Asentral, Inc. Institutional Review Board (IRB), based near the biotech hubs of Boston and Cambridge, Massachusetts, is joining BRANY, company officials announced today. BRANY will provide its full suite of IRB services to Asentral’s current clients.

“Asentral was founded by research professionals with deep research experience, and has been instrumental as a central IRB for sponsors for over 16 years,” said Raffaella Hart, Vice President, IRB and IBC Services at BRANY. “We are a natural fit with our cultures and dedication to human subject protection, as well as a delivering a high standard of service to clients.”

“We are thrilled to become part of the BRANY family,” said Asentral CEO Richard Clunie, who will remain on the team.  “In addition to BRANY’s expertise in IRB review, our clients will receive additional benefits, such as the use of IRBManager, an online tool for managing IRB submissions and accessing documents.”

This agreement reflects BRANY’s continued interest in providing the highest level of ethical IRB services to individual researchers, academic institutions, hospital systems, and industry sponsors, including medical device companies.

About BRANY
BRANY was founded over 21 years ago and is owned by four leading academic medical centers: Icahn School of Medicine at Mount Sinai, NYU School of Medicine, Montefiore Medical Center and Northwell Health. BRANY is a national company providing research support services including IRB/IBC review, clinical study support services, HRPP consulting and research compliance training.

The Critical Issues Sites Need to Track During a Clinical Trial – Part Three – Enrollment

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful tracking ensures your research organization remains compliant and that your site is compensated properly for the study.

Follow our series on the key critical issues you need to track throughout a clinical trial.

Part Three — Enrollment

One of the most pressing reasons why clinical trials are delayed is low enrollment. According to a Tufts University study, nearly half of clinical trials do not meet their participant enrollment goals.

Many of these challenges need to be addressed before a site determines that they will participate in a clinical trial. A realistic assessment, or feasibility study, of a site’s enrollment potential can minimize the risk of low enrollment later. The assessment may include an evaluation of your patient population, community demographics, prevalence of the disease being studied, and so on.

Enrollment and Sponsor Billing

Accurate enrollment tracking is directly tied to the ability to invoice study sponsors, which has an impact on cash flow for your site.

Typically sites provide data to study sponsors in real time when they enroll participants and when participants complete study visits and procedures throughout the course of their participation in the study. Sites should also be tracking their enrollment information internally at least monthly, and comparing  the actual number of participants enrolled against what was originally estimated. Regular tracking allows a site to notify the study sponsor of possible problem areas early in the process, when enrollments seem to be falling behind original targets.  If other sites are experiencing difficulty meeting enrollment targets an intervention, such as a protocol amendment, may be necessary. Coaching on recruitment techniques could also be helpful.

Include “Screen Failures”

The number of enrolled study participants is not the only critical metric. Sites should also track the number patients who go through the screening process, but for some reason are not qualified to participate in the study. These are called “screen failures.” Often sponsors will include a certain amount of reimbursement in the study budget for screen failures, Therefore it is important to track and invoice sponsors in accordance with the study budget.

Additionally, a high number of screen failures can signal an issue with the protocol’s inclusion and exclusion (eligibility) criteria. A screening log that includes information about the reason for exclusion can be important in a “root cause analysis” if enrollment goals are not being met.

Retention

Not only is it important to track initial enrollment, but sites need to monitor retention, or when a patient drops out of a study for any reason. Dropout rates can have implications for analysis. Having an “early warning” system in place to identify high dropout rates gives sites the opportunity to mitigate the problem.

Tracking the study procedures for participants who may terminate from the study early is also important. Sites should be paid for all study procedures performed up to the point of termination.

Besides the budget implications, a site can gain critical insights in tracking detailed enrollment data, which can then aid them in making future decisions about participating in trials. These “lessons learned” can assist a site in being more successful in future clinical trials.

The Critical Issues You Need to Track During a Clinical Trial

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful monitoring ensures your research institution remains compliant and that your site is compensated properly for the study.

Follow our series on the key critical issues you need to track throughout a clinical trial.

Part Two — Budgeting and Maximizing Revenue

Research sites that have a clear process for clinical trial budgeting as well as billing and collections can ensure their research efforts are feasible and sustainable.

An initial process that thoroughly accounts for every expense related to the clinical trial will result in a thoughtful budget that supports site resources. In addition to completing a Coverage Analysis to determine research procedures from standard of care procedures, research coordinators should consider costs that may be “hidden” or less obvious such as protocol specific training, or time needed for site initiation and monitoring visits. A detailed budgeting process up front will make tracking study activity and expenses much easier. Besides the expenses related to patient visits, budgets should include line items that cover time and effort of the investigator, the coordinator, and other research personnel for the various administrative tasks necessary to effectively carryout the requirements of the study. These administrative tasks can include:

• Screening for eligible participants
• Responding to sponsor queries
• Reviewing safety reports
• Preparation of regulatory documents or maintaining the regulatory binder

Throughout the study, it is important to track not only visits and procedures, but also items for which you need to invoice the study sponsor or CRO. Invoiceable fees can include procedures done outside the study visits, such additional scans, lab tests, or unscheduled visits. If patients are reimbursed for travel or other expenses, these should also be tracked.

To ensure research billing and collections are maximized it is essential to have strong systems in place to track all study visits and procedures completed throughout the study and record all the activity in comprehensive invoices. It is also important to track study payments and accounts receivables. Reconciling payments received from the sponsor/CRO to the study budget and to the actual study activities completed is critical. If you do not receive payment for all study activity your cash flow and profitability are impacted.

Careful tracking of all study activity, billable expenses, and sponsor/CRO payments help ensure that your site will have positive cash flow and cover its costs related to operating clinical trials.

The Critical Issues Sites Need to Track During a Clinical Trial

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful tracking ensures your research organization remains compliant and that your site is compensated properly for the study.

Follow our series on the key critical issues you need to track throughout a clinical trial.

Part One — Protocol amendments

This is likely one of the most common and time-consuming of the issues that require tracking. A Tufts University study found that over half of sponsored studies have at least one significant amendment.

Protocol amendments are inevitable, and some trials undergo multiple amendments throughout their duration. But some revisions are so significant it could feel like starting all over again.

There are generally two kinds of protocol amendments — administrative updates and substantive protocol revisions. Administrative changes are typically minor, and may involve grammar, wordsmithing, punctuation or small editorial changes. Significant amendments are any changes that may impact the safety of participants, and can include any change to the design of the protocol, including:

• Change to the dosing or duration of participant exposure to a drug
• Change to the design of the protocol, such as the inclusion or exclusion criteria or the addition of treatment arms
• Addition of new tests or procedures

IRB review and approval is required in order to carry out the visits and procedures that are part of the amended protocol. IRBs often require the following information when submitting an amendment:

• A description of the differences between the original protocol and the amendment
• Revisions to the informed consent, if applicable
• Revisions to any marketing or patient recruitment materials

Informed consent

Protocol amendments can impact patient recruitment efforts. In fact, some protocol amendments may also affect a site’s ability to enroll if there are significant changes to inclusion or exclusion criteria. Often the consent form must also be revised to reflect the changes to the protocol. Patients may need to be re-consented with the updated, IRB approved version of the consent form so they can be made aware of changes in protocol procedures.

Budget impacts

Depending on the scope of the protocol amendment, your research site should review the study budget, as the necessary procedures may have changed or new procedures and visits may have been added. In our experience, amendments have an impact in roughly half of all study budgets. A full review of the budget, and possibly a revised Medicare Coverage Analysis, may be necessary.

Create a checklist

The more you prepare and plan for protocol amendments, the smoother the process to implement the amended protocol. The use of a checklist or systematic approach will ensure that no steps are overlooked.

Whenever there is a protocol amendment, clinical research coordinators should make sure they update the following:

• IRB/IEC and other regulatory submissions
• Informed consent documents, including oral consent scripts
• Marketing, advertising or recruitment materials
• Sponsor contract, particularly if there is an impact to the budget, and coverage analysis, if applicable

Studies have shown that protocol amendments can impact the cost and duration of clinical trials. But with some careful preparation, clinical research coordinators can ensure a smooth administration of the changes.

News Release – BRANY Names Michael Belotto as Chairperson for Social-Behavioral IRB

NEWS RELEASE

BRANY (brany.com) has announced that Michael Belotto, PhD, MPH, CCRC, CCRA, will serve as chairperson for their social-behavioral IRB. The SBER IRB is comprised of a multidisciplinary group of experts in social and behavioral research, as well as human subject protection.

“Dr. Belotto has been a great contributor to BRANY IRB’s success over the past 20 years,” says Raffaella Hart, MS, CIP, Vice President, IRB and IBC Services for BRANY. “In serving as an IRB member and Quality Assurance auditor, he has been dedicated to ensuring that investigators conduct research in compliance with federal regulations and ethical guidelines. Researchers and research participants will be well-served with Michael serving as the Chairman of BRANY SBER IRB.”

BRANY started the SBER IRB in 2016 in response to an unmet need identified by social, behavioral, and education researchers. Common feedback from this group of researchers centered on the fact that most IRB processes and procedures were rooted in biomedical research which often did not align with the needs of social and behavioral researchers. The issues in social-behavioral research are distinct from biomedical research in a variety of critical ways, and need the review of experts in the relevant fields. Research protocols can include graduate student dissertations, research outside the U.S., as well as focus groups.

Dr. Belotto serves as a research compliance expert responsible for auditing sites to ensure investigators’ compliance with FDA regulations and ethical guidelines. He will continue to serve as a member of BRANY IRB in addition to chairing the SBER IRB.

Dr. Belotto worked as a paramedic in the New York City Emergency Medical Service 9-1-1 system for 10 years, with 7 years of experience in Hospital Administration.

Dr. Belotto is a graduate of New York Medical College where he completed a Master’s in Public Health with a concentration in epidemiology. He completed his doctorate in Public Health at Walden University.

The SBER IRB is part of BRANY’s Connected IRB model, which helps maintain an ongoing connection among investigators, institutions and the IRB, by promoting communication with key stakeholders. This includes email alerts for investigators and research coordinators as well as specific alerts for critical concerns such as unanticipated problems involving risks to subjects or others.

The Revised Common Rule and New “Concise Summary” Requirements

Our own Linda Reuter offers thoughts on how to meet new ‘concise summary’ requirements on informed consent for clinical trials. https://bit.ly/2JUQ8o3

New CITI Program Courses and Webinar Help Researchers and Institutions Meet Regulatory Requirements

(Miami, FL) — The Collaborative Institutional Training Initiative (CITI Program), a division of BRANY, has announced new online courses and webinars designed to help research professionals understand and comply with regulatory requirements for clinical trials.

The three courses and webinars address critical regulatory requirements:

• Transitioning research to the Revised Common Rule
• Protocol registration and disclosure on ClinicalTrials.gov
• The role of principal investigators in meeting regulatory requirements

Transitioning Research to the Revised Common Rule: The What, How, and Why, a webinar that outlines considerations and challenges for transitioning pre-existing research to the revised Common Rule, as well as required documentation and tips for IRB review, is offered to both institutions and individual learners.

Designed for research professionals, including investigators, institutional review boards and research staff, the webinar reviews pre-2018 and 2018 versions of the Common Rule, including factors an organization may want to consider when deciding whether to transition a pre-existing study (or studies) to comply with the revised Common Rule, and strategies for the management and communication of transition decisions.

The webinar is presented by Karen Christianson, RN, BSN, a principal with HRP Consulting Group.

Recently published research demonstrates that many research institutions are not prepared to meet current requirements for registering and reporting clinical trials. A new course addresses this gap.

Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov, an innovative video-enhanced course, guides learners through critical parts of the regulations and provides a step-by-step guide to data entry. This course can help organizations/investigators clearly understand protocol registration requirements to avoid the risk of significant civil monetary penalties or loss of NIH grant funding due to non-compliance with protocol registration and results reporting.

Biomedical PI focuses on key topics essential to the biomedical investigator’s role and responsibilities in conducting a clinical investigation of a product regulated by the U.S. Food and Drug Administration (FDA). This role-based course covers supervision, delegation, management, reports, and communication for investigators.

These courses, along with dozens of others available at CITIprogram.org, train investigators and research professionals to understand and meet research ethics standards and compliance requirements.

About CITI Program

The Collaborative Institutional Training Initiative (CITI Program), a division of BRANY, is dedicated to promoting the public’s trust in the research enterprise by providing high quality, peer-reviewed, web-based educational courses in research, ethics, regulatory oversight, responsible conduct of research, research administration, and other topics pertinent to the interests of member organizations and individual learners.

Is This the Right Study for Your Research Site? Five Questions You Should Ask Before Agreeing to be an Investigator

Clinical investigators often have multiple opportunities to participate in sponsored clinical trials. In addition to the professional satisfaction of being at the forefront of therapeutic development, clinical trials present an ability for physicians to offer patients alternatives to treatments they may otherwise be unable to access.

While study sites may receive compensation for time and resources invested in starting up and running a clinical trial, it is important to recognize exactly how much of an investment is required of study sites to be successful. Additionally, sites may invest time and resources only to discover that the trial is delayed or terminated due to issues of enrollment and other challenges.

Clinical trial delays may suffer from a variety of root causes, but participant enrollment is often cited as one of the most significant. Investigators must be realistic about their practice’s ability to recruit and enroll participants within the prescribed timelines. The ability to meet sponsors’ expectations is essential in maintaining positive relationships, which can lead to future opportunities.

Assuming the research has scientific merit and is ethical, investigators need to be realistic about their capacity before deciding to join a clinical trial. By carefully reviewing the proposal from the sponsor, and balancing the requirements of the protocol and expectations of the sponsor against the capacity of the practice, investigators can increase their chance of starting and running a successful trial.

Before agreeing to participate in a particular study, these are five questions every investigator should answer.

Do I have sufficient staffing available to execute the trial within the timelines set by the sponsor/CRO, in compliance with the protocol, and in accordance with regulatory requirements?

As studies become more complex, the time and resources necessary to start up and run clinical trials increase. It is important for investigators to have a conversation with their clinical trial staff about their workload. You may need to consider adding capacity by outsourcing administrative processes to supplement your existing staff resources.

Do I have the appropriate and sufficient patient population from which to draw participants?

Carefully review the inclusion and exclusion criteria in the protocol. If possible, run a query through your EMR to see the approximate number of potential patients that might be eligible to participate. If you do not have sufficient patients in your practice, how will you expand your enrollment efforts to the broader community?

Do I have other ongoing studies that may compete for enrollees among the same patient population?

With each clinical trial in a particular therapeutic area, your pool of potential enrollees may decrease. Carefully review your current clinical trial commitments to ensure you are not spread too thinly across a narrow patient population.

Do I have the infrastructure to support this study?

If you add staff to help with the trial, you should consider space issues. (Of course, if you have outsourced administrative duties, this is not a consideration.) Additionally, you should think about drug storage, archive space, space for documentation files, and equipment.  Study monitors also need a desk or conference room when they are on-site monitoring the trial. Finally, what is your institution’s laboratory and pharmacy capacity?

Do I have the necessary credentials and expertise to conduct this trial?

Ensure that your certifications, such as Good Clinical Practice (GCP), etc., are up to date. Be prepared to provide evidence of your clinical expertise in the specialties or therapeutic areas of the study.

Investigators should agree to take on new research projects only when they can carry out the research in an ethical manner in full compliance with all regulatory requirements, as well as meet the expectations of the study sponsor. A realistic assessment of personal, practice and institutional capacity will help ensure that you are participating in appropriate trials.

Four Essentials for Clinical Trial Enrollment

Clinical trial enrollment continues to be one of the most vexing challenges for research institutions and sponsors. Despite one quarter of sponsors’ clinical trial budgets being allocated to enrolling participants, half of research sites enroll only one or no patients in studies. Recruiting a diverse patient population is an even bigger challenge, with ethnic minorities, women and the elderly often underrepresented in clinical research.

Typically a contract between an investigator and the sponsor will outline the number of participants to be enrolled. The inability to enroll the required number of patients can have serious implications for the study’s success. Eighty percent of clinical trials fail to finish on time^[1] and 85 percent fail to retain enrollees, leading to canceled trials. Not meeting enrollment targets can dampen the relationship between the investigator and the sponsor and perhaps diminish future opportunities for the research site.

The vast majority of patients are willing to enroll, if only they know it’s an option. Eight-five percent of patients were either unaware or unsure that they could enroll in a trial, according to a Harris Interactive Survey of cancer patients. But 75 percent of these patients said they would have been willing to enroll had they known it was possible.

Sponsors are turning to artificial intelligence, machine learning and other technologies to provide detailed predictive analytics in an effort to improve recruitment. These technologies can comb through thousands of electronic medical records and other demographic data, and cross-reference criteria from hundreds of available trials. Microsoft just announced a chatbot designed to match patients to trials.

Sponsors must continue to work closely with research sites to coordinate the most effective methods of finding and enrolling patients, however. Even with new technologies, research coordinators and investigators play the most important roles in the successful recruitment and retention of clinical trial participants. By nurturing relationships in patient communities, a human-centered approach can yield demonstrably improved results.

Budget for recruitment. Recruitment and enrollment takes the time of the research coordinator and other staff—time that needs to be accounted for in the study budget if the research institution is to avoid working at a loss. When budgeting, consider the entire process of patient recruitment, not just the advertising budget, to ensure an accurate assessment of resources used.

Collaborate with colleagues. Investigators and research coordinators should network and collaborate with their colleagues in other specialties, and leverage these relationships to encourage patient referrals to clinical trials. Many clinical trials cross over different specialties. For example, a study may encompass both cardiology and endocrinology for heart disease and diabetes. Creating a network, even an informal one, to share ideas and proactively discuss clinical trials with their patients will raise awareness.

Understand the compliance issues. Compliance issues impact patient enrollment in a variety of ways. For example, if you will be reviewing medical records to identify potential research participants, you may need a partial HIPAA waiver for recruitment purposes from the IRB to share information.

Compliance also impacts any traditional advertising and marketing. Sponsors may sometimes run larger national awareness campaigns for certain clinical trials, but for others it’s often up to the investigators to reach out within their own community through traditional advertising methods. This can include newspapers, radio and local cable television. It can be as simple as distributing flyers in places where potential participants may see them. Whatever media you use, the IRB needs to review the material before it is released. Physician-to-physician letters may not require IRB review so check your IRB’s policies in advance. Consider advertising a step in your recruitment plan.

Monitor progress. In the course of running a busy clinical practice, it may be easy to let your recruitment efforts slip. At the beginning of the trial, schedule regular “touch base” meetings with your team to learn what you are doing to recruit participants and how successful those efforts are. If an activity is not yielding results, you can replace it with something else and not waste unnecessary time and effort.

Technologies are moving rapidly in artificial intelligence and machine learning. Staying abreast of these developments and trends can keep you ahead of the curve and aware of opportunities for your practice. However, personal relationships and human contacts are still an essential part of the patient recruitment toolkit.

^[1] Clinical Leaders

Reconciling Your Clinical Trial Protocol Start-Up Costs and Budget

As clinical trials protocols have grown more complex and more disparate teams are working on different elements of executing them, there is a potential for incongruency between the protocol requirements and the budget. It is critical to engage the stakeholders that will have a part in carrying out the research in the budgeting process. All departments must ensure their costs related to facilitating the research will be addressed in the study budget. Failing to include key stakeholders in the process can lead to financial losses or a lack of commitment from stakeholders that are critical to successfully achieving the established goals for the study.

Even if a site is diligent about including ongoing costs such as the procedures associated with each patient visit, pharmacy costs, and radiology costs, some of the start-up costs may be overlooked. These are some of the key areas of risk in developing a budget.

Administrative start-up

Before a study even starts, research sites will incur certain expenses related to site selection activities, and training staff on the study protocol. Even items such gaining access to the sponsor’s web based portal can require the support of IT to adjust system configurations that permit access to such portals.

It may seem minor, but the time and effort it takes to develop a budget should actually be in the budget. In fact, other activities required for start-up, such as meetings with other departments and coordinating the start-up paperwork, should also be part of the overall administrative budget.

Consent Forms

The preparation and review of consent forms is also a cost often overlooked.

For example, a research site may need to translate consent forms into different languages (depending on the community it serves) for non-English speaking participants.

Screening costs

Not every patient is qualified to participate in a clinical trial, so there are screening costs. Your site may have to screen several people for each person who actually gets into the trial. These are called “screen failures,” and they take time and effort.

Training

In addition to ongoing training of staff, certain protocols may require specific additional training to ensure compliance or appropriate recruitment of patients.

Other department costs

Does your clinical or research lab, or pharmacy, have start-up costs to prepare for the initiation of this clinical trial? Investigators should understand the implications for other departments on whom she is dependent for the successful launch of the trial. Other costs to consider in the budget for other departments are annual maintenance fees and close out fees.

IRB

The research coordinator needs to prepare documents for IRB review. Even if your site uses a local IRB, those fees should be included. You may also want to include an annual or quarterly fee to cover staff time for management and maintenance of the research project and submission to the IRB for continuing review approval.

It is critical that an investigator or research coordinator understands all the tasks and procedures that impact the execution of research protocol and develops a complete and accurate budget. The sponsor’s template budget will not generally include all the budget elements, especially those related to administrative start-up, which may not be obvious. Carefully review all protocol related costs, discuss the protocol with key stakeholders, and be prepared to negotiate with the study sponsor to secure the fees needed to cover the study costs.

Burnout Among Research Coordinators — Warning Signs and How to Avoid Them

Let’s face it. Every job has its challenges. However, burnout seems to be at an all-time epidemic level. A recent report from Harvard University highlighted physician burnout as a public health crisis. A keyword search for “preventing burnout” yields 15 million results in Google. In the United States, problems associated with burnout are estimated to cost more than $120 billion a year.

Burnout is typically defined as a response to prolonged stress. Key signs are emotional exhaustion, cynicism or detachment, and feeling ineffective. The results can include a feeling of isolation, irritability, and even frequent illness and absenteeism. One study indicates that up to eight percent of annual healthcare costs are associated with and may be attributable to how U.S. companies manage their work forces.

Research coordinators, too, face burnout that may be resulting in high turnover rates, low enrolling studies, disrupting workflows and even delaying the start of clinical trials. Certainly at many institutions, risk factors are in place for research coordinators to experience burnout — increased workloads, few opportunities to learn, lack of feedback and limited autonomy.

There are thousands of articles and blog posts about preventing burnout, often putting the impetus on the individual. Many articles cheerily extol professionals to “find life work balance,” eat a balanced diet, exercise or get some sleep. Preventing burnout is not the sole responsibility of the individual to self-manage. There is a vast database of scientific research on workplace predictors of employee burnout. The reality is that organizational culture is a primary driving cause of burnout.

Here are some steps your organization can implement to reduce the risk of burnout and increase motivation and engagement among research staff.

• Offer ongoing professional training. The field of clinical research is constantly shifting, with the regulatory landscape increasingly complex. Professional training increases competence, which improves performance.
• Look for opportunities to provide autonomy. With training, research coordinators can have the appropriate knowledge and confidence to manage some workplace decisions. This is especially the case in places with high workload and emotionally demanding clients, such as patients. And while research coordinators are often extremely independent in their work style, researchers must remain diligent in keeping lines of communication open and regularly meeting with their research team.
• Provide feedback. Researchers and clinicians are busy, also, dealing with their own job stresses. Despite this, clinical research coordinators and other research staff benefit from receiving constructive feedback, including explicitly expressed appreciation from senior leaders.
• Be realistic about workload. Every job has its times of increased demands. But if daily workload transforms into a chronic overload, there can be serious implications. Leveraging outsourced solutions can ease some of the pressure when overload situations arise. Partnering with outsourcing service providers that can work as an extension of your institution, can complement the internal staff responsibilities.

Given the negative impact of burnout on individuals’ well-being and workplace performance, it is critical that organizations seek proactive ways to create cultures that support and engage their staff.

Aligning Timelines for Better Coordination

Increased complexity of launching and running research protocols means different teams are contributing their expertise to ensure human subject protection, accurate budgets and successful patient recruitment. It also means that, with so many disparate groups involved, the risk of delays increases.

One significant contributor to delays in study start-up is the lack of a common understanding for the overall timeline. Each group may know what it is responsible for, but may not be aware how its actions impacts others. An IRB approval can be in place for months while another team still wrestles with the budget or contract with the sponsor. This disconnection can lead to lengthy study start up times and put an institution at a disadvantage in achieving success in its research programs

These are a few best practice tips for keeping everyone on track:

1. Appoint a quarterback. Even if your institution does not have a centralized approach to study start-up, it’s critical that at least one person is responsible for setting the calendar, communicating with different teams and setting expectations. This requires having a general understanding of the processes of different committees, such as the pharmacy or radiation safety committee.
2. Create a master calendar. Developing and sharing a master calendar, including dependencies, is a fundamental pillar of successful project management. This should include the schedule of all committee meetings. This kind of “big picture” calendar helps identify if there are risks to the schedule. Ideally key stakeholders in the start up process (Investigator, Coordinator, CRO, Sponsor) will collectively decide on a timeline consistent with industry expectations. Do we want to say suggest a completion date goal and share it w the sponsor?
3. Have regularly scheduled check-in meetings. Depending on the volume of your studies, this can be a weekly meeting with representatives of each of the teams or committees to discuss the status of each and identify risks of delay. This gives everyone an opportunity to understand the impact of one team on the whole. As an added bonus, this kind of collaboration across teams can encourage creative problem solving to get past hurdles.
4. Schedule regular email updates. Yes, we have too much email. But a weekly, perhaps every Monday morning, email to everyone on each of the teams that outlines what is critical that week, will keep everyone on track. This builds transparency to the process and creates accountability.
5. Coordinate with the sponsor. There are times when a sponsor is unaware that a research site has reached a particular timeline milestone, which can impact their ability to provide needed information. Sponsor processes also need to be connected to the timeline.

The two most important factors in ensuring on-time clinical study start-up are transparent communication and team accountability. These coordinated best practices can help to ensure a successful, on-time program.

Are Staffing Challenges Affecting Your Institution’s Research Profile?

Many institutions still struggle to recruit and retain the best talent for these challenging positions. A changing regulatory landscape, increasingly complex protocols and a litany of deadlines all contribute to a stressful environment for these employees. Additionally, salaries have remained largely stagnant, creating a general sense of disengagement.

Staff turnover can lead to interruption in workflow and management, often creating delays for study start-ups. With study coordinators often the primary contact with CROs, regulatory agencies and sponsors, the disruption and inconsistency in communication can have a negative impact on the relationship with these important stakeholders.

“We have seen situations at institutions in which an entire study was put on hold because a coordinator departed and there was no one to continue the work,” says Jill Filipelli, BRANY’s Clinical Trials Activation Team, Operations Manager, “This created quite a bit of consternation and frustration from the sponsor.” These institutions are at risk of losing future opportunities as selected study sites.

High turnover can be expensive for employers. A study published by the Society for Human Research Management showed that replacing an employee can cost up to 50 to 60 percent of the employee’s annual salary. If you add the cost to onboard and train a new coordinator in procedures and protocols, the cost of recruiting a new employee can be significant. Investing in retaining experienced talent can save in long-term costs associated with turnover.

Studies have shown that salary alone is not the key factor in retaining staff. According to a 2012 Centerwatch study, study coordinators are looking to advance their careers through professional training and promotions. Providing opportunities for education and training is a cornerstone to a successful staff retention strategy. Ongoing mentoring of CRCs can also encourage more engagement and job satisfaction.

Investing in the development of clinical research staff can yield results well beyond mitigating the hassle of hiring new employees. Having a consistent team also ensures consistency and smoother workflow to ensure the successful start-up and management of clinical research programs. This, in turn, stabilizes and improves relationships with CROs and sponsors when they are identifying research sites.

The Revised Common Rule and Informed Consent: Public Posting

Public Posting

An important provision in the Revised Common Rule is the requirement to post, to a publicly-available federal Web site, a copy of an IRB-approved version of the consent form that was used for enrollment purposes for each clinical trial conducted or supported by a federal department or agency. The Office for Human Research Protections (OHRP) has identified two publicly available federal websites that will satisfy the consent form posting requirement in the revised Common Rule: http://ClinicalTrials.gov and a docket folder on http://Regulations.gov. It is possible that additional sites may be identified in the future.

The consent form will need to have an up-front concise and focused presentation of the key information as required by 46.116(a)(5).

The specific requirement is that an IRB-approved consent form that was used for enrollment purposes be posted. There is no requirement to post multiple forms for multicenter studies, or for a study that has separate consent forms for different subject groups (e.g., adults versus pediatric participants). Also, for consent forms that underwent revision over the course of the study, the final rule does not stipulate that the posted document be the most recently approved version.

The posting can take place any time after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. Information that should not be made available on a federal website, as determined by the federal department or agency supporting or conducting the clinical trial, can be redacted.

The purpose of the new provision is to increase transparency, which some feel will lead to improved consent form quality. The commentary to the Final Rule, describes how having  an easily accessible repository of such forms freely available for analysis and public discussion will foster public discussion and  create multiple opportunities for improving these forms, and thereby improve one of the most important aspects of our human subjects protections system.

For More On The Revised Common Rule and Informed Consent, see our previous article on Consent Waivers

The Revised Common Rule and Informed Consent: Consent Waivers

The Revised Common Rule Compliance Dates and Transition Provision Draft Guidance

The Department of Health & Human Services (HHS) has released The Revised Common Rule Compliance Dates and Transition Provision Draft Guidance. In it, you will find information about transitioning studies to the Revised Common Rule, and answers to frequently asked questions. Our team at BRANY has been closely monitoring the guidance from regulatory agencies and is prepared to help our clients in this transition period.

https://www.regulations.gov/document?D=HHS-OPHS-2019-0001-0001

The Revised Common Rule and Informed Consent: Consent Waivers

The Revised Common Rule has a few important changes regarding consent waivers.

Under the revised Common Rule, broad consent is provided as an alternative to the informed consent requirements for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. If an individual was asked and refused to provide broad consent, the IRB is prohibited from waiving informed consent at a later date for the use of the subject’s identifiable private information or identifiable biospecimens in a secondary study. This means that this information must be tracked. This may be complicated, particularly for larger health care institutions and systems, and therefore the broad consent mechanism may not be widely utilized.

Of note is that the use of the individual’s materials in a nonidentifiable manner in secondary research continues to be permissible, even if there was a refusal to broad consent, since this particular use would not otherwise require a waiver of informed consent since the activity does not constitute research with human subjects.

The Revised Common Rule also adds a new waiver criterion. In order to waiver or alter consent, the IRB must find and document the following:

• The research involves no more than minimal risk to subjects;
• The waiver or alteration will not adversely affect the rights and welfare of the subjects;
• The research could not practicably be carried out without the requested waiver or alteration;
• (New as of January 21, 2019) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; and
• Whenever appropriate, the subjects or legally authorized representative will be provided with additional pertinent information after participation

The term “practicably” has not been clarified in the revised rule.

In the case of recruitment and screening of research subjects, the pre-2018 rule required an IRB to determine that informed consent can be waived under the .116(d) criteria before investigators could record identifiable private information for the purpose of identifying and contacting prospective subjects for a research study. Although not considered a “waiver,” under the new rule, an IRB can approve an investigator’s proposal to obtain information directly from a prospective subject, or to obtain already collected identifiable information or identifiable biospecimens by accessing records or stored biospecimens, for purposes of screening, recruiting, or eligibility assessment, without the informed consent of the prospective subjects.

The Revised Common Rule’s section on waivers or alterations of consent can be complicated, so it is important for research professionals, researchers and IRBs to review the changes and the exceptions.

For More On The Revised Common Rule and Informed Consent, see our previous article on Broad Consent

The Revised Common Rule and Informed Consent: Broad Consent

The Revised Common Rule and Informed Consent: Broad Consent

While the industry waits for additional guidance on the Revised Common Rule, there are some aspects that are worth taking note now. This is a series of blog posts that address various important changes for research professionals to keep in mind as they implement the Revised Common Rule.

BLOG POST #2 — Broad Consent

One of the significant changes in the Revised Common Rule is the introduction of Broad Consent., a new type of consent intended to serve as a substitute for traditional informed consent in certain circumstances. “Broad Consent” is a very specific term in the revised regulations used to describe a regulatory pathway, and is different from the concept of obtaining consent for future use of information or specimens under the prior regulations.

The new regulations also provide two new exempt categories for the storage, maintenance and research use involving identifiable private information or identifiable biospecimens when broad consent has been obtained.

Broad consent may prove to be problematic, particularly for large medical centers or health care systems, due to the documentation requirements. The regulations stipulate that an IRB cannot waive consent for storage, maintenance, or secondary research use of the identifiable information or identifiable biospecimens if an individual was previously asked to provide broad consent and refused.  Such tracking requirements may make broad consent very difficult to implement, and may limit its usefulness.

A Broad Consent Form must contain certain elements in order to be valid. The following elements are unique to broad consent, and must be included:

• A general description of the types of research that may be conducted with the information or biospecimens that a reasonable person would need to make a determination
• A description of the identifiable information or biospecimens that might be used in research, whether sharing might occur, and the types of institutions or investigators that might conduct such research
• A description of the period of time allowed that the information or biospecimen would be stored and maintained or used for research purposes (may be indefinite)
• Statement that the subject or LAR will not be provided details about specific research studies that might be conducted using the information or biospecimens including the purposes of the research and that they might have chosen not to consent to some of those specific research studies
• Results may not be disclosed to subjects
• Contact information for questions about rights and storage and use of the information and specimens, and whom to contact if the event of a research-related harm

These elements are required in every broad consent document, and cannot be waived.

For More On The Revised Common Rule and Informed Consent, see our previous article on Concise Summary

The Revised Common Rule and Informed Consent: Concise Summary

The Revised Common Rule and Informed Consent: Concise Summary

While the industry waits for additional guidance on the Revised Common Rule, there are some aspects that are worth taking note now. This is a series of posts that address various important changes for research professionals to keep in mind as they implement the Revised Common Rule.

Concise Summary

Consent forms must facilitate comprehension by providing information that a “reasonable person” would understand in order to make an informed decision about whether or not to participate in a clinical research protocol. This includes a brief summary that is concise, focused and includes the key information about the research.

So far there has been very little guidance on the length or specific required content of the summary. It likely depends on the study itself, as well as the patient population that is being asked to participate. This will allow for flexibility in what is included in the summary.

The summary can refer to information included later in the consent, which provides the full context of a study, including its risks and benefits. Generally speaking, these five factors will most likely assist a “reasonable person” in making a decision about study participation:

• The fact that consent is being sought for research and that participation is voluntary
• The purposes of the research, the time commitment that will be expected, and the main procedures
• The most common risks or discomforts to the prospective subject
• Benefits to subject or others that are reasonably expected
• Alternative procedures or courses of treatment, if any, that might be advantageous
• Any significant costs that will be incurred

These new guidelines apply to all federally supported studies, and may also apply to other studies depending on how each institution applies the requirements of 45 CFR 46 across the board to all studies.

It will be important to note in the summary that the key information that is presented up front does not include all of the information related to the study.   Potential subjects will need to be advised that in order to have all the details about the study and their participation in it, they will need to refer to the full consent form and also discuss any questions or concerns with the study doctor during the consent process.

Career Series: Late Career

Experienced Research Professionals Should Consider Mentoring the Next Generation

Approximately 10,000 baby boomers will turn 65 every day between now and 2030, according to a study by the Pew Research Center. The field of clinical research is no exception to this enormous wave of research leaders reaching retirement age and exiting the profession.

As senior research professionals turn toward their retirement, now may be a good time to consider how they may leave a legacy. Mentoring can enrich the work lives of both mentor and mentee through sharing of knowledge, skills, insights and wisdom. The profession also benefits by developing emerging leaders to take on new responsibilities. Mastering how to navigate through the regulatory landscape that governs research is difficult, and having the chance to learn from those that have mastered this field will make a huge difference to the future of the industry.

Developing a dedicated pipeline of leaders

According to Price Waterhouse Coopers, millennials will make up over half of the workforce by 2020. There is an enormous opportunity to demonstrate the importance of the research mission and how its benefits to society can lead to a career of meaningful work. These two areas are important to the next generation of workers, according to several surveys.

But how does one become a mentor? Beyond being a teacher or advisor, a strong mentor also understands the interpersonal part of the relationship based on an understanding of the mentee, and a willingness to invest emotionally in a mentee’s growth and development.

Demonstrate curiosity

Rather than focusing on teaching or dispensing advice, it’s useful for the mentor to listen, ask questions and demonstrate a curiosity about what motivates the mentee. Sometimes it can be more meaningful and a stronger learning experience if the mentee is guided to his or her own answers to questions.

Lead by example

Being a role model — by demonstrating the skills and emotional intelligence necessary to be a successful research professional — can teach important lessons in navigating an institution or the profession.

Identify goals

A strong mentor will nudge a mentee into reaching for goals beyond the status quo. Having a clear understanding for a mentees strengths and capabilities can help a mentor understand the person’s potential.

Succession planning

Being a mentor can be part of developing a formal succession plan in order to fill the open leadership positions with passionate and talented workers. Such planning should include providing ample training opportunities.

With a few guidelines, a mentor and mentee can both benefit from a rich relationship.

Data Analysis Methods for Qualitative Research: Managing the Challenges of Coding, Interrater Reliability, and Thematic Analysis

The peer-reviewed journal The Qualitative Report has published an article by Michael Belotto, Director of the BRANY Institute of Research Education, entitled “Data Analysis Methods for Qualitative Research: Managing the Challenges of Coding, Interrater Reliability, and Thematic Analysis.”

(LINK: https://nsuworks.nova.edu/tqr/vol23/iss11/2/)

“While … text books explain the general philosophies of the interpretive tradition and its theoretical groundings, I found few published studies where authors actually explained the details pertaining to exactly how they arrived at their findings,” says Mr. Belotto. In the article he shares the sources of information that he has found and the methods that he has used to address these challenges. He also discuss issues of trustworthiness and how matters of objectivity and reliability can be addressed within the naturalistic paradigm.

This is a must-read for anyone interested in the details of qualitative research and analysis.

Career Series: Mid-Career

Career Transitions: Becoming a Clinical Research Nurse

This is part two of a three-part series on research careers.

By mid-career, nurses are sometimes looking for new challenges. However, not all nurses are interested in pursuing careers in administration. One path to consider is in clinical research.

Nurses play an essential role in the success of clinical research. Although a principal investigator (PI) has ultimate responsibility for any clinical research study, it is often a nurse who does a significant amount of the coordination and execution of the study. From recruiting and screening participants to collecting data, a nurse can play a pivotal role in human subject protection and compliance.

There are a number of ways that a nurse can become involved in research. A staff nurse may encounter an inpatient or outpatient who happens to be enrolled in a clinical study. At hospitals that are striving for or maintaining their Magnet status from the American Nurses’ Credentialing Center, nurses may be involved in research directly. At academic medical centers, where advanced nurse practitioners work closely with clinicians who are also investigators on research studies. Nurses can also serve as investigators or sub-investigators on research studies.

Such is the case with Radica Palmer, RN, a nurse practitioner at Northwell Health. Her role as a clinic nurse has evolved over the years, and has excelled in a leadership role in research for her department. Ms. Palmer’s experience brings a unique perspective to the research programs in which she is involved.

“Having clinical knowledge offers a great advantage to the PI,” says Ms. Palmer. “The nurse can gather valuable information from patients and share it with the investigator, who can then make important clinical decisions.” Working closely with and mentoring study coordinators, a research nurse is a valuable asset to the clinical research team. A research nurse is also able to develop relationships with patients, which opens up communication and is beneficial to the study as well as the patients.

The relationship that nurses cultivate with patients or study participants is extremely important. Participants may feel more comfortable speaking to a nurse, and this can lead to their providing more details about their health or involvement in the trial. These nuances can have a material impact on the trial and might not always come up during a clinical visit with the physician.

For nurses who are interested in advancing their career into research, there are a few requirements that will prepare them to play this role. Understanding the clinical trial process is essential. First, he or she should take courses in Human Subjects Research (HSR) and Good Clinical Practice (GCP). Depending on their interest, nurses may also explore courses in institutional review board administration, compliance or regulatory topics.

As clinical trials increase in complexity, nurses who are interested in expanding their careers have many opportunities to further their careers in research. Nurses who are interested in exploring a career in research can consider some of these online courses:

Human Subject Research

HSR provides foundational training in human subjects research and includes the historical development of human subject protections, ethical issues, and current regulatory and guidance information.

https://about.citiprogram.org/en/series/human-subjects-research-hsr/?h=HSR

Good Clinical Practice

GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials of drugs, biologics, and devices.

https://about.citiprogram.org/en/series/good-clinical-practice-gcp/

Clinical Research Coordinator

This course focuses on the operational and regulatory elements needed for the ethical conduct of clinical research.

https://about.citiprogram.org/en/series/clinical-research-coordinator-crc/

Career Series: Early Career

How to Attract and Keep the Best Research Coordinators

This is part of a series on career development for research professionals.

One of the most challenging responsibilities for an investigator is the recruitment and retention of talented staff, particularly research coordinators. Nationwide, there is a high turnover rate among research coordinators. This disruption in staffing can lead to delays in conducting research, from missing deadlines to entire studies being stalled.

Investigators recruit research coordinators from a variety of sources. Sometimes the role of study coordinator is viewed as an entry-level position, and those individuals hired to fill the role can be new to the workforce, and may have little experience. Many may be so-called Millennials, recently out of college.

Millennials, generally speaking, were born between 1980 and 2000. They are considered one of the most educated generations of our times. Their numbers are huge, surpassing those of the baby boomers. Much has been studied and written about their attitudes toward work and career growth.

Millennials in the workplace can be dedicated and creative, and eager to make a significant contribution to your research site. To retain this young talent and minimize the risk of study disruption due to turnover consider the following tips:

Respect the balance between work and personal life.

Unlike Baby Boomers, younger workers tend to integrate their work and personal life in a more fluid way. They prefer not to have a distinct separation between the typical eight-hour work day and their personal interests. That said, they tend to be more protective of their personal time.

Practically speaking, this means they prefer more flexibility in their work day. They may be willing to work later in the day, or evenings, as long as they can take some time during the day to run errands or do other things.

Provide opportunities for learning and professional development.

Millennial workers are easily bored and need to feel they are growing and expanding their knowledge. Invest in their professional growth by offering access to online courses — either focused on research or on specific skills. This will keep them engaged.

Think beyond salary.

While millennial workers understand the important of earning an income, a high salary is not the primary driver for work place happiness. Beyond a salary, consider offering flexible work hours, additional days off, or opportunities for telecommuting.

Avoid isolating millennial workers.

The work of a research coordinator can be solitary, with them working independently from others in the office. It requires a fair amount of entrepreneurship and independence. However, Millennials are usually motivated by dynamic, cross-functional positions. They also seek jobs that allow them to be in contact with and learn from interesting people, interacting with other professionals and teams.

If your millennial research coordinator reports directly to you, it is important to honor your time together to discuss projects or studies. Ensure they can participate in office meetings so they can gain an appreciation for how their work might be connected to other activities in the office.

Provide a constant feedback loop.

For Baby Boomers, performance feedback had traditionally formal review process tied to promotion and compensations, conducted at specific times. For Millennials, feedback is informal and is expected throughout the work week.

Give them a sense of purpose.

Millennials are inspired by a vision or purpose, not by a list of tasks. Millennials, in general, will not be content to simply complete forms and file documents. They are looking for meaning in their work. Remind them of the importance of their work in human subject protection. Keep them in the loop about the value of clinical research at your research site — the impact on medical knowledge in general and on patients specifically.

Leverage their knowledge of social networks.

The world of Facebook, Twitter, Instagram and Snapchat is a daily part of their lives. They will not react well to feeling disconnected, even at work. In fact, research shows that over half of Millennials would turn down a job that denies them access to social networks.

Their adept use of social network sites can help gain insights that may help you improve your study participant recruitment, as well.

In general, they key driver for Millennial job satisfaction is a sense of connection and purpose. A lack of connectivity makes them feel isolated, and they are likely to move on to other opportunities. A fully engaged Millennial research coordinator can, however, be a dynamic part of your research team.

Gene Therapy Research — Is Your Institution Ready?

Recent news about approved immunotherapy and gene therapies has generated excitement around the possibilities of treating difficult diseases. Organizations have increased funding in this area, including a recently announced $1.3 million grant in funding by the Alliance for Cancer Gene Therapy for research in gliobastoma, sarcoma and ovarian cancer.

The increased attention and funding means that more research institutions may enter this exciting field of research. However, institutions may not be fully aware of the specific NIH guidelines and requirements for gene transfer research in addition to IRB review. An institution that receives NIH funding or conducts NIH funded recombinant DNA research is required to follow the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (“NIH Guidelines”). Even if the funding source is a private entity, it is still advised that institutions comply with the NIH Guidelines to ensure the safety of research teams and the communities they serve.

The NIH Guidelines define human gene transfer as the deliberate transfer into human research participants of either:

• Recombinant nucleic acid molecules
• DNA or RNA derived from recombinant nucleic acid molecules
• Synthetic nucleic acid molecules, or
• DNA or RNA derived from synthetic nucleic acid molecules that meet certain criteria

An institution that engages in gene transfer must establish an institutional biosafety committee (IBC). This committee can be administered either internally (by the institution), or by an experienced external group. The IBC must have at least five members, two of whom must not be affiliated with the institution. The role of the IBC is distinct from the role of an Institutional Review Board (IRB). The IRB’s focus is on protecting the rights and welfare of research participants, whereas the IBC assesses the containment levels, facilities, procedures, practices, and training and expertise of personnel involved in recombinant or synthetic nucleic acid molecule research.

Research involving recombinant or synthetic nucleic acid molecules requires IBC review because additional safety measures are needed. The risk assessment for these agents must be done by qualified experts experienced in biosafety guidelines, including physical and biological containment requirements. Those conducting this research need to understand and identify the biosafety level of the particular investigational agent — level one being the lowest level and level four being the highest. Each level has specific parameters that must be met with relation to precautions needed, such as containment levels, staff training requirements, and the experience required of those handling the agent.

Risk is assessed by evaluating the following:

• Staff training — are they trained in handling the agents according to guidelines and standard operating procedures?
• Protocol — does the protocol outline how the agents are handled, including waste precautions and decontamination procedures?
• Recordkeeping — how are records documented and kept?
• Procedures — how and where is the agent or drug constituted?
• Community safety — what mitigation steps are in place to protect the community?

While the prospect and promise of human gene transfer research is exciting, institutions and researchers must understand the requirements when working with these investigational agents.

When research involving recombinant DNA is NIH funded or conducted at a site that receives NIH funding, failure to comply with the NIH Guidelines could risk that funding or result in additional requirements by NIH for the conduct of such research. Leveraging an external team of experts fluent in biosafety, the NIH Guidelines, and IBC administration can provide an immediate framework for an institution to build upon that will ensure the safety of local research teams and the surrounding communities in an ethical and efficient way.

Survey Results

Last year we asked research staff and managers to tell us about their staff training needs. We want to thank those who took the time to complete the questionnaire. The results are in and here is what we learned.

• The majority of those who responded to the survey either have limited or no funding for training and education activities.
• Over one-third of respondents said online courses, including webinars, were made available to research support staff. Additionally, respondents said online courses and webinars either are or would be the most useful to staff.
• Frequency of training is variable, with most institutions reporting either annual or quarterly.
• Content needs also varied, but 45% of respondents said regulatory training, such as good clinical practices, regulations and IRB management, was their biggest need. Respondents also said they needed training in strategies to effectively execute clinical research studies.

Training for research staff is critical to ensure awareness of ethics involved in human subjects research, and to stay abreast of regulatory and compliance issues related to clinical research. This is true not only for onboarding new clinical research staff, but also for continuing education and professional development of experienced professionals.

Unfortunately, with the majority of respondents suggesting they do not receive adequate training, institutions may be missing an opportunity to optimize their workforce, and may be putting institutions at risk of non-compliance when their staff are not properly trained.

Many research professionals, from research coordinators to new investigators, may be eligible to take CITI Program’s online courses through their institutions’ subscription. Check with your research office to find out if they are organizational subscribers.

Resources

Learn more about organizational subscriptions: https://about.citiprogram.org/en/organizational-subscriptions

Learn more about online training for clinical research coordinators through CITI. We offer both basic and advanced courses. https://about.citiprogram.org/en/series/clinical-research-coordinator-crc/

Do you know the difference between odds and probability?

It’s once again time to get ready for the National Football League (NFL) Super Bowl, and the odds-makers are making their forecasts. Many an office worker is looking to join the fun by participating in office pools to see if, this year, they get lucky.

One person, however, is raising his eyebrows as people make their selection. Seth Schwartz, PhD, a faculty member at the University of Miami and the author of the CITI Program’s Fundamentals of Biostatistics, an online statistics course.

“It’s probably the most common challenge for students taking a statistics course — understanding the difference between odds and probability,” he says. “If you bet on your team to win and you have 3:1 odds, what does that mean?”

What are the odds?

It doesn’t mean that your team is three times more likely to win. What it means is that if you have 3:1 odds, from an infinite set of possible games, your team will win one game for every three games it loses. In this case, you are facing odds against your team winning.

Probability, on the other hand, is described in percentages. For example, a 50 percent probability that a coin will land on tails.

You would have to do some calculations to measure the probability of your team winning based on the odds, or the other way around. Of course, there is no way to know for sure what the true odds are. But odds are set to determine the payout of the gamble — the higher the risk, the higher the reward if you win.

“Probability and odds both are terms that describe the likelihood of an event occurring. But they are not mathematically equivalent,” says Schwartz.

Still confused?

If you are planning to take a college course in statistics and feel you need to be better prepared, consider the online statistics class that we developed. Or, if you’re in any industry that requires research — medicine, marketing, or bookie — this go-at-your-own-pace online course may be a perfect introduction to statistics.

Learn more about the Fundamentals of Biostatistics.

What We Learned At PRIM&R This Year

Representatives from BRANY, CITI, Protocol Builder, and HPR Consulting are all still abuzz about the great conference hosted by PRIM&R this year. We have returned to our work newly energized and inspired and  have spent the past couple weeks back in our offices talking about what we learned and would like to share these reflections with you.

Confirmation that proposed changes to the effective date for the revised Common Rule continues to elude us.

When federal agencies released the revised Common Rule, research professionals were left with many questions. Not the least of these was, “when will we really have to implement this”?  The Department of Health and Human Services has been delayed in providing guidance to help the research community prepare for compliance.

Research professionals are still preparing to implement the new rules to the best of their understanding, even though there has been a request for a one-year delay on the effective date. Despite the request for delay, there are potentially three burden-reducing provisions that could be implemented during the delay period and it is still unclear which are included. Also, it’s important to note that the request for delay has not been granted, and is going through its process of review and consideration.

We will continue to monitor this situation closely.

Patients and their advocates are taking science and research into their own hands.

Patient advocacy is not a new phenomenon, but the use of social media has given patients and their advocates powerful new tools in nudging researchers to address their needs.

Using readily available technology, wearable devices, and social media, patients are crowdsourcing and collecting data about themselves and compelling researchers to take action to help them. Patients and their advocates are challenging traditional methods used to design research studies and recruit research subjects.

For many patients, this is literally a matter of life and death. Patients with debilitating and deadly diseases, such as ALS, have little patience for clinical trial start-up delays and bureaucracy. This so-called “democratization of research” will continue to have a significant impact on research, subjects, and human subject protection.

Ethics sometimes trump regulatory compliance.

Lifetime Achievement Award Recipient Ruth Macklin implored attendees to remember their humanity in implementing regulatory compliance measures. Regulations are critically important, of course, but the driving mandate is to protect human subjects in research. This should always be the priority over checking a proverbial box in a compliance checklist. Research professionals should understand ethics and context, and apply regulations accordingly.

Informed consent continues to be a challenge.

Developing useful consent forms has always been a challenge for research professionals tasked with human subject protection. Even with the implementation of new technologies, such as digital consents and the use of videos, it is still a challenge to ensure consumers understand the risks and benefits of participating in clinical research. Research professionals must still be sure to account for participants’ literacy, and consider using shorter, simpler words, and verbiage in their consent process.

Pervasive data may be more powerful than big data.

We have all heard plenty about the power of big data — the collection, processing, and analysis of massive volumes of data points. But data scientists alerted conference attendees to the importance and impact of pervasive data, which add context to big data. It is collected via many channels beyond the electronic medical record or genomic database. It can include personal, social, behavioral, economic, geographic, political or any other information and it’s disturbingly easy to access.

With social media, wearable and connected home devices, and data collected by giants such as Facebook, Google, and Amazon, the lines between medical and social data can easily blur.

The current ethics framework is ill-prepared to address the tsunami of pervasive data and how it can be used. Even the revised Common Rule struggles to address this type of data science in research. Yet, while consumers will freely reveal intimate details about themselves in social media and are willing to allow big online companies to amass this information about them, they are still generally protective when it comes to their personal medical information.

The conference opened significant and important dialogue about these critical issues that are facing us. While there are no easy answers, we welcomed the opportunity to interact with our colleagues around the country. We will continue to monitor and report our understanding of these issues, and we hope to see you at next year’s PRIM&R conference!

BRANY protocol launch showcases paradigm shift in behavioral and social sciences research

Please read the attached Centerwatch Article to learn how social, educational and behavioral research is distinct from biomedical research when it comes to writing study protocols.  cww2131_BRANY

Protocol Builder Launches Protocol Template for Social-Behavioral – Educational Research

BRANY announced today the release of a new research protocol template specifically designed to address the unique needs of social-behavioral-education researchers, as part of Protocol Builder®, a secure, cloud-based protocol writing application.

“Social and behavioral research is distinct from biomedical research,” says Jeffrey Cohen, PhD, a principal with HRP Consulting Group, also a division of BRANY. “The process of writing a protocol can be more subtle than an interventional drug study, for example.”

“Although historically many social behavior researchers have not developed full protocols for their research prior to submitting to an IRB, many institutions are now requesting social behavioral protocol development templates as research in this area continues to grow,” says Kimberly Irvine, Executive Vice President and Chief Operating Office for BRANY. BRANY now also has a social behavioral IRB as part of its comprehensive IRB service offering. This new template is a response to our customers’ requests for a tool that provides them with a more comprehensive approach to protocol development for social and behavioral research.

The specially-designed template provides a guided, step-by-step protocol-writing process for investigators who specialize in psychology, nursing, education and other disciplines that are focused on behavioral and social functioning. It is one of several standard and customizable templates offered through Protocol Builder®, including the new NIH IND/IDE template.

Protocol Builder® is currently in use at leading academic medical centers and universities as a tool to foster compliance with institutional protocol writing standards among their investigators, including residents and fellows.

Protocol Builder® is a division of BRANY, the leading provider of research support services to hospitals, academic medical centers and investigators. In addition to Protocol Builder®, BRANY offers a wide array of services designed to improve research efficiency and quality. These include IRB, human subject protection consulting and continuing education.

BRANY IRB Services

BRANY IRB, AAHRPP-accredited since 2006, has been providing high quality, customer service oriented IRB services to client for more than 18 years. BRANY IRB specializes in , single IRB (sIRB) for multi-site research, and SBER IRB review by a committee with expertise specific to social, behavioral and education research.   BRANY’s “Connected IRB” model has provided institutions with a customized solution that results in high quality human subject protection oversight, as well as efficiency for industry sponsored and investigator initiated research.

HRP Consulting

Through its consulting division, the HRP Consulting Group, BRANY provides institutions human subject protection and research compliance consulting services.

CITI Program

The Collaborative Institutional Training Initiative (CITI Program) at the University of Miami, also part of BRANY, is the leading provider of online research ethics education courses and materials. CITI’s web-based training materials serve millions of learners at academic institutions, government agencies, and commercial organizations in the U.S. and around the world. CITI Program now offers the CTSA created GCP – Social and Behavioral Research Best Practices for Clinical Research course.*  This course introduces GCP principles and discusses how they apply to clinical trials using behavioral interventions and social science research.

How BRANY IRB Can Help Your Institution Meet the NIH’s Policy for sIRBs

The National Institutes of Health (NIH) Policy on the use of a Single Institutional Review Board of Record (sIRB) for Multi-Site Research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a sIRB to conduct the required ethical review for the Protection of Human Subjects.

As an experienced provider of sIRB services, BRANY’s AAHRPP accredited IRB can help institutions and researchers by performing a comprehensive and ethical review of research protocols in accordance with applicable regulations and the NIH’s sIRB policy, including:

• Conducting IRB review of the protocol and inform consent forms for all participating sites
• Facilitating IRB Authorization Agreements for sites
• Serving as Privacy Board when requested by participating site
• As applicable, coordinating with participating sites the process for reviewing and reporting conflicts of interest disclosed by site personnel
• Maintaining records of IRB proceedings as required by applicable regulations
• Pertinent documents are available to Lead Institutions and participating sites 24/7 via IRBManager (BRANY IRB’s secure, electronic IRB management system)
• NIH’s sIRB policy includes requirements for facilitating communication between participating sites and the sIRB. BRANY IRB can configure notifications and customize communication workflows regarding sIRB reviews and determinations to participating sites’ needs (e.g., notifications to institutional designees in addition to researchers).
• Reporting to participating sites, and regulatory agencies as applicable, any unanticipated problems, serious/continuing non-compliance, or suspensions/terminations of IRB approval.

BRANY IRB’s model for the last 19-years has emulated that of a “single IRB” for multisite research, and we have worked diligently over the years to design and customize specific processes to keep researchers, institutions and key personnel at various sites connected to all pertinent research matters throughout the course of a research study. We are eager to partner with organizations to create customized single IRB solutions that result in high quality human subject protection, while also adding operational efficiencies to your research.

To learn more about how investigators and institutions can work with sIRBs, please contact Carmela Houston-Henry.

Top Four Reasons Your Research Contract May Be Delayed

The process of launching a clinical trial can be daunting for an inexperienced researcher and his or her team. From carefully reviewing a research protocol to navigating the IRB process, the researcher and team must ensure certain steps are followed to comply with federal and state regulations, as well as their own institutions’ policies and procedures.

One important element in launching the clinical trial is developing and negotiating a clinical trial agreement and budget with the sponsor. This critical step ensures that that the costs of carrying out the trial are covered.

Karen Roth, BRANY’s legal counsel, shares some of the common pitfalls that investigators encounter, which are common causes of delays.

Sponsor reporting of safety issues — Federal regulations require sponsors to submit safety reports to the FDA and participating investigators conducting studies with any investigational drug. For institutions using AAHRP-certified IRBs, such as BRANY IRB, there is a requirement to demonstrate how adverse events are reported.

“When BRANY is negotiating contracts with sponsors on behalf of institutions, we request language that goes beyond what is required under the law,” says Ms. Roth. The sponsor continues to receive data, even if the study has ended. “We require that our sponsors provide information regarding safety data that might impact the health of former subjects for at least two years after the termination of the study.”

Indemnification — An indemnification clause in a research contract is basically a promise by the sponsor to defend the investigator and the institution and to cover financial losses if there is patient harm or illness as a result of the trial.

“With the exception of institution’s potential negligence, we try to negotiate as broad an indemnification as possible,” says Ms. Roth. “Because the product belongs to the sponsor and the protocol is written by the sponsor, we want to ensure the institution is indemnified for claims arising from the study. It will be the responsibility of the researcher, however, to ensure that the protocol is followed to the letter.”

Subject injury — This is similar to indemnification, but it covers the cost of diagnosing and treating a patient who may have suffered harm or injury as a result of the trial. Since some injuries may be latent, it is important to have this provision survive the agreement indefinitely.

“It is our expectation that the sponsor will pay for diagnosis and treatment of a study injury without the institution having to seek reimbursement from insurance,” says Ms. Roth. “Our subjects are volunteers. We cannot expect them to rely on private insurance, which may be limited, to pay for research expenses.  In addition, we make every effort to ensure that subjects will not need to incur the legal fees associated with a formal legal claim in order to have their medical expenses covered.”

Intellectual Property — Sponsors expect to own intellectual property developed as a result of the studies they fund.  This expectation can conflict with the mission of the institution to conduct its own research and develop its own intellectual property.  We work with sponsors and institutions to clearly define the ownership rights of each party.  Investigators who conduct their own research should keep such projects completely separate from industry sponsored projects.  It is inappropriate for an investigator to use study data or specimens from an industry sponsored study for investigator initiated research.

“In no case should an investigator use a sample taken from a patient during previous sponsored studies,” says Ms. Roth. This needs to be clarified and articulated in the contract.

Study contracts exist to protect the interests of sponsors, investigators and patients. But there are common pitfalls that often require careful legal review and experienced negotiation to ensure the important elements are in place — even if it means a slight delay on the start of the trial.

Social and Behavioral Health Research and the IRB

What are the challenges for IRBs reviewing social and behavioral health research protocols? Learn more in our white paper.  Social and Behavioral Health Research and the IRB

SBER IRB Featured on Centerwatch

Our new social-behavioral research IRB was featured on Centerwatch.

Please click on this link to read the article.  Centerwatch SBER IRB Article November 2016

New Final Common Rule Published

Final revisions to the Common Rule were published January 19, 2017. Our colleagues at HRP Consulting Group have assembled a summary of the changes. Please click here to read them =>  summary of the changes

End of year Checklist for Research Professionals

As 2016 winds down we start to look ahead and prepare for the new year. With the elections over, much has been said about what a new administration may mean to pending research legislation, the regulatory landscape, or research funding. Even without a crystal ball, there are several things that a research professional can do now to prepare for the year ahead.

Review and update Standard Operating Procedures (SOPs)

While study site SOPs are not specifically required in FDA regulations, guidelines suggest that they help ensure clinical research sites follow federal regulations, ICH, GCP and institutional policies. SOPs can include provisions for research subject screening and recruitment, data management, adverse events reporting, and more.

BRANY recommends an annual review of SOPs to ensure policy-based regulations are up-to-date.

Additionally, staff should be trained on the SOPs, and the training should be documented. Before calendars get too busy, schedule refresher training for research staff to ensure competency and compliance.

Update Training

Institutions vary in their requirements for human subject protection training for investigators or research professionals. However, requirements may come from funding agencies or collaborating institutions. Other training may also be required, including HIPAA compliance, conflict of interest, biosafety, and IRB refresher courses. Additionally, the completion of annual continuing education courses may be required in order to meet professional development and/or certification maintenance requirements.

Click here to see a menu of CITI Programs courses approved for CMEs and CEUs as well as CITI’s new courses

https://www.citiprogram.org/index.cfm?pageID=887

Update Essential Documents (Curriculum Vitae, License Information, Lab Certificates)

For long-term studies, it’s important to review and update investigator CVs and licenses in the regulatory binder. Review investigators’ medical licenses and update the documentation if they have expired.

The FDA has been clear in its guidance that IRBs “must review the qualifications of clinical investigators who conduct FDA-regulated research.” Even if the members of the IRB are familiar with the investigator’s background, many sponsors will require updated CVs to ensure the investigators are “qualified by training and experience as appropriate experts.”

While your CLIA or other lab certification may not come up at the end of a calendar year, it is important to ensure your certification is up to date and note on the calendar when it is time to renew. CLIA certification is effective for two years.

Monitor your Delegation of Authority Log

If you add a new investigator to a trial, or hire a new research coordinator, you must document the addition of any key personnel in your Delegation of Authority Log. This information must also be submitted to the IRB.

With busy schedules, it can be tempting to wait for monitors to flag concerns. But it’s important to be proactive. Conducting a spot check every six months and a more detailed annual audit may protect you from panicked scrambling in the days before an announced FDA visit. Also, if an inspector finds an issue with one clinical trial, the investigation may extend to your other trials. And that is the kind of headline-making news you want to avoid.

Prepare for Accreditation Renewal

Whether you are an AAHRPP-accredited site or have accreditation from another organization, you will likely be required to prepare an annual report or possibly prepare for re-accreditation. Annual reports for AAHRPP serve to notify the organization of any changes that might impact the organization’s Human Subject Protection Program, including changes to the organization, resources or programs.

Amid the end-of-year holiday parties and a general sense of relief that the year is winding down, there is still much left to do to prepare for the new year.

Year-end can also be a time when organizations assess what resources they have and how efficiently they are being utilized.  In our experience the work patterns in research ebb and flow.  At times organizations may need additional staffing support, but lack the ability to bring on additional staff.  More and more organizations are looking to supplement their staff needs with outsourced services.  When tasks like contract negotiation, budget development, coverage analysis preparation, regulatory document prep and IRB submissions can be outsourced, the staff on site then have more time to focus on carrying out the study, and recruiting and retaining patients in clinical trials.

What is your institution or research team doing to prepare for the new year? Do you have any New Year’s resolutions for how you will be more efficient or how you will stay on top of regulatory or compliance requirements?

Share your story with us!

BRANY Announces Launch of a new IRB Focusing on Social, Behavioral and Educational Research

Focused IRB offers specific expertise in social and behavioral sciences, including:

• Qualitative Research

• Nursing Research (Magnet Designated)

• Quality of Life Research

• Evidence based research

 (Lake Success, NY) — BRANY announced today the launch of a new IRB focusing on social, behavioral and educational research (SBER).

“The aim of BRANY’s SBER IRB is to offer social, behavioral, and educational researchers an IRB review process that aligns with their research needs,” says Jeffrey Cohen, PhD, senior advisor with HRP Consulting, a division of BRANY. “For years, these researchers have been asked to conform to IRB review processes built to support biomedical research. BRANY’s SBER IRB offers a solution designed to streamline the IRB review of social, behavioral, and educational research, while ensuring the research is sound and ethical.”

BRANY has assembled a group of experts who are well versed at identifying and evaluating the psychological and social risks that are often associated with SBER, such as:

• Questionnaires about illegal behaviors which may damage subjects’ reputations or raise legal concerns
• Collecting information from subjects about activities that may place them at risk of harm or legal action
• Compromising a subject’s confidentiality, possibly jeopardizing employment and/or insurance coverage
• Research involving deception
• Providing subjects with unwelcome and disturbing information about themselves
• Research that involves use of questions and/or procedures that can cause stress or embarrassment

This unique Institutional Review Board offers a wide range of expertise from nurses, epidemiologists, psychologists and social workers. The service is available immediately.

For more information please contact Carmela Houston-Henry at choustonhen@brany.com or 516-470-6979.

ABOUT BRANY

The Biomedical Research Alliance of New York (BRANY) is a national organization that provides support services to sponsors and investigators involved in research in a wide variety of therapeutic areas, medical devices, biologic, and diagnostic trials.  Staffed by multi-disciplinary experts, with a robust network of more than 200 academic based investigators, BRANY is able to offer its partners a turnkey solution for expedited site identification and 60-day study start-up. More information at www.brany.com.

Feds Announce Requirements Aimed at Providing more information about clinical trials to the public

Feds Announce Requirements Aimed at Providing more information about clinical trials to the public

The US Department of Health and Human Services (HHS) recently announced a final rule, which outlines new requirements for registering and recording certain clinical trials on its ClinicalTrials.gov website. At the same time, the National Institutes of Health (NIH) issued a policy for registering and submitting summary results for all NIH-funded trials.

“Access to more information about clinical trials is good for patients, the public and science,” said NIH Director Francis S. Collins, M.D., Ph.D. “The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health.”

Important elements of the final rule include:

• Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information
• Expanding the scope of trials for which summary results information must be submitted
• Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov
• Requiring additional types of adverse event information
• Providing a list of potential legal consequences for non-compliance

Read the news here.

https://www.nih.gov/news-events/news-releases/hhs-takes-steps-provide-more-information-about-clinical-trials-public

FOCUS: Kris Michael Mahadeo, MD

Pediatric hematologist-oncologist Kris Michael Mahadeo, MD., has been with Children’s Hospital at Montefiore (CHAM) in New York for two years. He was previously at University of Southern California, Keck School of Medicine and Children’s Hospital in Los Angeles.  Like many other specialists in pediatric cancer, he credits the low mortality rate among children with cancer to the long history of clinical trials in this area.

“Despite not having any new drugs in pediatric cancer for quite some time, we have seen cure rates of 70 to 90 percent,” he says. “Clinical research has been paramount to any success we have had.”

Dr. Mahadeo primarily works in underserved communities, which can pose particular challenges in enrolling and retaining patients. “Due to the time sensitivity of enrolling pediatric patients in clinical trials, we have to be creative and figure out how to help these families,” he says. “Often families don’t have the resources to make appointments on a regular basis.” He and his colleagues work closely with partner groups to ensure the resources are available to ensure successful enrollment.

Because of the unique challenges he faces as a practicing physician with a desire to also serve as principal investigator for clinical trials, Dr Mahadeo and his colleagues rely on BRANY to facilitate industry-sponsored clinical trials that they feel are important to have available to their patients. Once Dr. Mahadeo receives the regulatory packet, he has the BRANY team organize and develop the budget and contract, prepare materials for IRB review, and handle the clinical trial billing and collection process.

“Having BRANY take care of the administrative tasks associated with running clinical trials allows me to focus on working with patients and their families. I find that when families understand the legacy of people who have enrolled before them, and the benefit it has to all pediatric cancer patients, they are more inclined to participate.”

Congratulations to our Top Ten Clinical Trial Enrollers

BRANY recently completed an analysis to assess how principal investigators are enrolling in active clinical trials. The ten investigators listed below, along with their research teams, consistently enrolled subjects in their ongoing clinical trials, hitting their recruitment goal at an average of 70 percent or higher.  We were impressed with these statistics and wanted to acknowledge their accomplishments.

• James Tauras, MD – Montefiore Medical Center
• Michael Schulder, MD – Northwell Health
• Winona Tse, MD – Icahn School of Medicine at Mount Sinai
• Jacqueline Barrientos, MD – Northwell Health
• Richard Furie, MD – Northwell Health
• Kevin Ferrick, MD – Montefiore Medical Center
• Suchitra Acharya, MD – Cohen Children’s Hospital
• Sanjay Goel, MD – Montefiore Medical Center
• David Bernstein, MD – Northwell Health
• Robert Grossberg, MD – Montefiore Medical Center

Recruitment rates of 70 percent or better are impressive especially when you consider that one of the biggest challenges facing principal investigators is the enrollment of participants. According to some reports, nearly half of research sites under-enroll study volunteers. With eligibility requirements increasing or growing more complex, this problem is likely to continue.

What can researchers do to have a successful experience? Here are some tips:

• Select trials that are truly suited for your practice and patient population
• Ensure staff are trained and engaged in achieving the goals for the clinical trial
• Bring awareness to patients and their families of the important role clinical trials play not only in the management of their disease/condition, but also the positive effects for our society.

Frequently asked questions about BRANY’s Acquisition of CITI

In May 2016, BRANY (Biomedical Research Alliance of NY), a national organization providing support services to research institutions and investigators in a wide variety of therapeutic areas, medical devices, biologic and diagnostic trials, announced its acquisition of the Collaborative Institutional Training Initiative Program (CITI).

The link below will bring you to frequently asked questions about the acquisition.

https://support.citiprogram.org/customer/portal/articles/2477581-citi-program-a-division-of-brany—faq

If you have any additional questions, please contact us at 516.470.6900.

NIH’s Final Policy on Single Institutional Review Boards Has Widespread Implications for Research Institutions

The NIH has released its final policy on the use of central IRBs for multi-site research. Starting May 2017, in multi-site studies in the United States involving non-exempt human subjects research funded by the National Institutes of Health (NIH), research institutions will be expected to use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects at 45 CFR Part 46. Limited exceptions to the rule are provided, primarily to accommodate prohibitions established by federal, tribal, or state laws, regulations, or policies.

As stated by NIH, the goal of the policy is to “enhance and streamline the IRB review process in the context of multisite research so that research can proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections. The shift in workload away from conducting redundant reviews is also expected to allow IRBs to concentrate more time and attention on the review of single site protocols, thereby enhancing research oversight.”

Institutions applying for grants to fund multi-site research will need to submit a plan describing the use of an sIRB that will be selected to serve as the IRB of record for all study sites. The policy outlines several other administrative responsibilities for the institution (applicant).

Participating sites also have specific responsibilities. For example, they are responsible for meeting other regulatory obligations, such as obtaining informed consent, overseeing the implementation of the approved protocol, and reporting unanticipated problems and study progress to the sIRB.

Thousands of investigators, patient advocacy groups, institutions and others filed comments with the agency during the public comment period. Some commenters expressed concerns that the proposed policy does not recognize the time and effort needed to identify and establish a single IRB of record, including negotiating and executing authorization agreements and standard operating procedures, conducting study initiation meetings, creating account activities, and modifying information technology (IT) systems.

HRP is prepared to help institutions comply with the new policy

HRP has helped institutions to establish and implement procedures to comply with regulations, policies, and accreditation standards and to ensure appropriate local oversight of research and protection of human subjects. Despite relying on an sIRB, organizations still hold overall responsibility for the oversight and conduct of the research. HRP can partner with you to develop reliance agreements that meet the needs of all parties and to develop internal processes to ensure that all organizational responsibilities are fulfilled while streamlining the process. HRP’s expertise includes:

• Development of customized policies, procedures, forms and checklists
• Evaluation and development of human research protection programs (HRPPs), policies, and processes
• Evaluation and development of IRB policies and processes
• Training and education

BRANY offers a “Connected IRB”

BRANY offers an AAHRPP-accredited IRB to institutions. BRANY IRB’s experience with a wide variety of institutions and sponsors has led to the development of the unique “Connected IRB” model. Understanding that institutions need to remain connected to the research conducted throughout their organization, BRANY includes in its processes the mechanisms to keep key institutional personnel apprised of all pertinent research matters throughout the course of a clinical research study.

This policy represents a significant shift in how protocol reviews are conducted for federally funded research. Institutions needing assistance in this transition can rely on their partners at HRP Consulting and at BRANY.

FDA Releases Draft Guidance for Medicare Coverage of Investigational Devices

The FDA recently released a draft guidance policy categorizing investigational device exemption (IDE) devices. The guidance was developed to assist the Centers for Medicare & Medicaid Services (CMS) in determining whether or not an IDE device should be covered (reimbursed) by CMS. The guidance has significant implications for research sites and investigators who are responsible for developing research budgets.

In 2013, CMS published a final rule that, among other things, categorized devices based on risk.

• Category A devices are those “…for which ‘absolute risk’ of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective.”
• Category B devices are those “…for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type.”

CMS uses FDA’s category definitions in evaluating whether or not an IDE device receives Medicare coverage. Medicare may cover an investigational device and routine care services provided in an FDA-approved Category B IDE study if CMS determines prior to the submission of the first related claim that the Medicare coverage IDE study criteria are met. Medicare may cover only routine care items and services furnished in an FDA-approved Category A IDE study, but not the device itself if CMS determines that Medicare coverage IDE study criteria are met. In other words, Medicare cannot cover device expenses for studies that FDA has categorized as Category A.

Since then, the FDA has received a number of IDEs which do not easily fit into the two main categories or any of the eight sub-categories. These often refer to early feasibility studies, or EFS, which evaluate early stage devices in a small population. These can be new devices or approved devices that have been modified for a new use and may pose significant risk.

Once the FDA determines that the sponsor has provided enough information justifying a clinical trial, it will use the suggested criteria to assign a device to a CMS Category A or B when the IDE is approved or approved with conditions.

Category A

FDA intends to consider a device to be in Category A if one or more of the following criteria are met, and if available data on the proposed device or its intended use do not resolve questions of safety and effectiveness.

• No Premarket Approval (PMA), 510(k) clearance or de novo request has been granted for the proposed device.
• The proposed device has different characteristics compared to a legally marketed device.
• The proposed device is being studied for a new indication or new intended use

The FDA intends to consider a device Category B if one or more of the above criteria are met and additional non-clinical and/or clinical data on the proposed device resolve questions of safety and effectiveness.

FDA categorizes IDE devices based on whether available data demonstrate that initial questions of safety and effectiveness have been resolved. The guidance document describes the criteria that will be used to help determine the appropriate category for a device to be studied. It also describes when it is appropriate to change the device category from Category A to Category B.

It is important for research professionals to understand these categories in order to make the correct determination of whether or not to bill insurance for the device. Additionally, clinical trial coordinators need to be prepared to obtain CMS, or a local Medicare contractor, approval prior to enrolling patients or the institution risks not being reimbursed for the device or the services provided. This can have significant implications for clinical trial budgeting.

To read the full draft guidance, click here. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm504091.pdf

BRANY Announces Acquisition of University of Miami’s CITI (Collaborative Institutional Training Initiative) Program

(Lake Success, NY) — BRANY (Biomedical Research Alliance of NY), a national organization providing support services to research institutions and investigators in a wide variety of therapeutic areas, medical devices, biologic and diagnostic trials, announced today its acquisition of the Collaborative Institutional Training Initiative Program (CITI), a leading provider of online research ethics education to the research community.

“With roots steeped in academic research and advancement, both BRANY and CITI share the distinction of excellence in human subject protection,” says Brian Currie, MD, chairman of the board of BRANY, representing Montefiore Medical Center, one of BRANY’s owner institutions. “We look forward to maintaining the CITI mission and legacy.”

“The University of Miami, since its founding of CITI, has remained committed to fostering the development of this program, making it an international center of excellence in online research ethics education and training,” says Thomas LeBlanc, PhD, executive vice president and provost of University of Miami. “We are pleased to see the continuation of this commitment with BRANY, and we look forward to continued collaborations with the CITI program, BRANY and its owner institutions.”

Like BRANY, which was founded by four leading academic research institutions, CITI’s founding in 2000 started as a collaboration between academic and commercial research centers from around the US. Experts from the original 10 organizations comprised the first group of content developers for the CITI Program. The initial focus was on human subjects research (HSR) protections in biomedicine and social sciences. CITI has since expanded to include course content in good clinical practice (GCP), the responsible conduct of research (RCR), biosafety and biosecurity, clinical trial billing compliance, conflicts of interest, disaster planning for the research enterprise and information privacy and security, to name a few.

“As the leading provider of research support services to hospitals, academic medical centers and investigators, BRANY continues to demonstrate its commitment to improving research efficiency and quality through education,” says Joseph Lhota, senior vice president, vice dean and chief of staff at New York University School of Medicine, another founding member of BRANY.

“CITI’s mission to provide educational opportunities to the entire research team fosters research integrity and promotes the public’s trust in the global research enterprise.   The CITI Program’s commitment to quality research practice is in perfect alignment with BRANY’s mission of providing quality service to the research community,” says Paul Braunschweiger, PhD, director of the CITI program.

The CITI Program, at www.citiprogram.org is used by thousands of subscribing academic institutions, government agencies, and commercial organizations worldwide to train more than a million researchers annually.

About BRANY

BRANY is the leading provider of research support services to hospitals, academic medical centers and investigators. BRANY’s services, which are designed to improve research efficiency and quality, include an array of outsourced clinical trial start up services such as a IRB review, contracting and Medicare coverage analysis. BRANY was the first IRB in New York to be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

Through its consulting division, the HRP Consulting Group, BRANY provides institutions human subject protection and research compliance consulting services.

BRANY is also the developer of Protocol Builder®, a protocol writing tool for investigator-initiated research.

Founded in 1998, BRANY is owned by academic medical centers — NYU School of Medicine, Montefiore Medical Center, Mount Sinai School of Medicine, Northwell Health — is an expedited, end-to-end solution for clinical trials.

More information at www.brany.com.

About CITI

The Collaborative Institutional Training Initiative (CITI Program) at the University of Miami is the leading provider of online research ethics education courses and materials. CITI’s web-based training materials serve millions of learners at academic institutions, government agencies, and commercial organizations in the U.S. and around the world.

More information at www.citiprogram.org .

CONTACT:

Emily Avila

Emily@calypsocommunications.net

415.254.4745

HRP Consulting Group joining BRANY

HRPs Conulting Group joining BRANY

HRP Consulting Group, Inc. (“HRP”) will be joining BRANY (Biomedical Research Alliance of New York, LLC (“BRANY”) as a separate division of the company, both companies announced today. The partnership will provide a platform to support the growth of HRP as it continues to respond to the needs of its public and private clients in human subject protections and compliance needs. HRP will operate as its own division within BRANY enabling HRP to maintain its culture and identity as one of the leading advisory groups in the research industry.

“We are excited about this new relationship and the benefits it will bring to the HRP team and our clients,” said Cheryl Savini, senior vice president and managing director of HRP Consulting Group. “We will continue to operate HRP with the same client focused philosophy, putting our clients’ needs first.”

“BRANY shares HRP’s commitment to excellence in human subject protection and research compliance. We are proud to have HRP and its thought leaders as part of the BRANY family,” said Kimberly Irvine.

“Our relationship with BRANY will allow us to maintain our approach in helping our clients achieve excellence in their human subject protection and research ethics and compliance programs,” added Jeff Cohen, senior advisor, HRP Consulting Group.

BRANY

The Biomedical Research Alliance of New York (BRANY) is a national organization that provides support services to sponsors and investigators involved in research in a wide variety of therapeutic areas, medical devices, biologic, and diagnostic trials.  Staffed by multi-disciplinary experts, with a robust network of more than 200 academic based investigators, BRANY is able to offer its partners a turnkey solution for expedited site identification and 60-day study start-up. More information at www.brany.com.

HRP Consulting Group

HRP Consulting Group (HRP) was founded in 2005 as a consulting firm focused solely on human research protections and has since evolved; now additionally providing a broad array of consulting services to support organizations with their research ethics and compliance efforts.  HRP Consulting Group is committed to providing expert advice to institutions seeking to develop or improve their research programs.  More information at www.thehrpconsultinggroup.com.

For further information please contact:
Emily Avila | Calypso Communications

415.254.4745

Laura Donohue Joins BRANY’s IRB Team

We are pleased to announce that Laura Donohue has joined the team as IRB Supervisor, where she will work with BRANY’s central, AAHRPP-accredited IRB.

“Laura’s extensive experience as a research coordinator at one of our founding institutions provides her with insights that will be invaluable to our other clients,” says Raffaella Hart, vice president, IRB and IBC Services.

Ms. Donohue comes to BRANY from Northwell Health, formerly North Shore-Long Island Jewish, where she was a senior research coordinator for the last eight years. In her role there she provided training to new research coordinators, as well coordinating clinical trials in rheumatology.

Conflict of Interest: Implications for Clinical Research Sites

September 30 marked the first day of implementation of the Physician Payment Sunshine Act, with the launch of the Open Payments Program and the release of an online database of the financial relationships between drug and device companies’ and physicians.

The Web site will eventually report all payments or transfers of value—including payments for research, travel, honoraria and speaking fees, meals, educational items like textbooks and journal reprints—whether made directly to a physician or teaching hospital or indirectly through a third party.

A group of experts at Johns Hopkins published an opinion letter this week in the Annals of Internal Medicine that “took issue” with the monetary value of drugs donated to clinical trials being counted in the database as “research payments” to physicians who run those trials.

While some critics suggest the data paints an incomplete or even confusing picture, it is a major milestone in the federal government’s increasing scrutiny of the relationships that investigators have with industry clinical trial sponsors. There is still debate in the scientific community over whether increased transparency guarantees scientific independence. But the reality is that researchers and their sponsoring organizations are facing tighter regulations. The amounts of money have raised the attention not only of NIH and FDA; the IRS is also reviewing financial relationships between investigators and sponsors.

The U.S. pharmaceutical and biotechnology research companies invested a record $58.8 billion in 2007 toward research and development, an increase of nearly $3 billion since 2006.[1]

This increase in industry-funded research occurred at the same time of increased regulations over the last several years, starting with the U.S. Senate Financial Committee’s investigation of Emory University Professor Charles Nemeroff, who failed to report hundreds of thousands of dollars in payments from GlaxoSmithKline while researching that same company’s drugs with an NIH grant. Starting in 2013, the Patient Protection and Affordable Care Act (PPACA) sunshine provisions require pharmaceutical, medical device, biological and medical supply manufacturers to report certain types of payments to “covered recipients,” specifically physicians.

The Department of Health and Human Services (HHS) issued its “final rule” in 2011 regarding objectivity in research. If your organization receives any public funding for research, you need to be familiar with the changes. Some of the rules represent an increased burden of documentation and reporting, primarily:

• Lower financial disclosure thresholds
• New conflict of interest training
• New public accessibility requirements
• Increased transparency for travel reimbursement

These policies went into effect August 2012, and institutions were required to revise their policies, establish procedures for compliance and train investigators.

The following key provisions are in effect:

• Disclosure – Organizations must report all significant financial interests, regardless of its relationship to the Public Health Service (PHS) funded research.
• Public accessibility – The institution’s policy must be made available via a publicly accessible Web site, or within five days of a written request.
• Training – Training will be required for all investigators before engaging in PHS-funded research, and every four years thereafter.

The final rule is clear about institutions’ responsibilities and accountability for oversight. Even fully staffed research offices may find the regulations onerous.

Filling the gap

There is still a significant gap within research organizations regarding their conflict of interest policies. The HHS reported in January that among NIH grantees fewer than half had written institutional policies. This presents a significant vulnerability for organizations, and means they will be busy over the next nine months to prepare their policies and post them publicly. They also must consider the best approach for training investigators, and for tracking and documenting compliance.

Organizations that do not have explicit conflict of interest policies – and even those who do but must now revise them to comply with the new regulations – should consider outside professional help to ensure compliance.

Additionally, setting up and executing a new education requirement for investigators can be a challenge.

The cost of non-compliance can be the withholding of payments for research, as well as ill will and negative publicity.

[1] PHRMA 2008

BRANY to participate in community education event

BRANY is pleased to announce its participation in AWARE for All-New York City, a free educational event featuring a health fair and informative presentation about clinical research participation.

AWARE for All is a free program that aims to educate and empower patients and the public to make informed decisions about clinical research participation. Learn how we can all help advance public health and contribute to new medical advancements.

Since 2003, AWARE for All Clinical Research Education Days have been offered in cities across the country. Attend the NYC program for free health screenings and information, complimentary refreshments, and an engaging talk with local doctors and patients.

We encourage you to attend or share this information with your patients, so they can be recognized for their participation in clinical research.

Location
D’Angelo Center, St. John’s University
8000 Utopia Pkwy.
Jamaica, NY 11439

Date & Time
October 3rd from 11:00 AM-2:00 PM

Highlights of the Day:

• Free refreshments
• Giveaways
• Health screenings & informational resources
• First 75 to pre-register will be given at $20 gift card at the end of the event
• In honor of each AWARE attendee, a vaccine will be donated through the Greater Gift Initiative to a child in a developing country.

TO REGISTER for this free event, visit awareforall.org or call: 1-877-MED HERO (1-877-633-4376)

BRANY Earns Five-Year AAHRPP Accreditation

News release

March 2015

BRANY Earns Five-Year AAHRPP Accreditation

BRANY has successfully continued its Full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The five-year accreditation reflects BRANY’s continuing commitment to protecting the rights and welfare of research participants. AAHRPP’s accreditation process help organizations consistently meet ethical principles and standards for protecting research participants.

“We are pleased to have earned this ‘gold seal’ for the 3^rd consecutive time,” says Raffaella Hart, CIP, Vice President of BRANY IRB and IBC Services. “For over 15 years, BRANY has strived to meet and exceed regulatory compliance standards while focusing on strengthening protections for study participants.”

To prepare for the reaccreditation process, BRANY completed a detailed self-assessment that included a thorough review of the policies and procedures of its Human Research Protection program, which includes BRANY’s Institutional Review Board (BRANY IRB). The effort is designed to ensure regulatory compliance as well as compliance with AAHRPP’s standards, and is followed by an extensive site visit by AAHRPP representatives to evaluate the records and confirm processes are aligned with policies and procedures.

Once an organization achieves accreditation, subsequent programmatic changes must account for both regulatory standards and how the accreditation standards will be maintained. Accreditation requires an ongoing commitment to protection of human subjects and maintenance of best practices.

BRANY also assists organizations to successfully complete the accreditation process. BRANY’s expert consultants have played an instrumental role with clients in the successful realization of full AAHRPP accreditation. The team starts with an initial readiness assessment and gap analysis. Clients then go through a systematic process—from the initial application to preparation of written materials, through mock site visits and interviews. BRANY experts guide clients through each step. The team will also help clients respond to site visit reports that result from the evaluation.

AAHRPP is a non-profit accrediting body that promotes ethical research through processes that help organizations to evaluate and strengthen their human research protection programs. BRANY is one of approximately 200 national and international organizations that have earned full accreditation status from AAHRPP.

BRANY licenses SMART system

BRANY (Biomedical Research Alliance of New York) has licensed its proprietary SMART (Study Management and Revenue Tracking) system to Tech Software, an information technology company that currently offers IRBManager, a fully Web-based software product that supports the administration of institutional review boards at leading hospitals throughout the country.

The BRANY SMART system is a clinical study management and revenue tracking system that allows study sites to develop study budgets and conduct cost analyses utilizing pricing information stored within the database. Users can also manage and store regulatory documents. The Web-based software-as-a-service (SaaS) also allows clients to track patient encounters, revenue and accounts receivables. The SMART system, which is 21 CFR 11 ready, gives clinical research sites, research administration and clinical trial offices the ability to develop their own customized work flows to track and monitor new study opportunities as they progress through a site or hospital’s internal review process. This includes budget, contract, conflict of interest and IRB review. The SMART system also tracks enrollment against the study and includes integration with Tech’s award winning IRBManager solution.