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 3rd 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.