The Future of Work and the Impact on Research Institutions
International organizations such as the World Economic Forum have been researching and analyzing the “future of work” and its implications for economies. Likewise, consulting firms have been predicting the important training needed to prepare workforces for new labor markets. Surveys of company leaders indicate an increasing need for employee upskilling and retraining.
The COVID pandemic and dizzying changes to our work environments accelerated the already-occurring changes in how we work. For research professionals, the changes have impacted how we start-up and manage clinical trials. The breakneck speed with which pharmaceutical companies developed, tested, and deployed COVID vaccines may have been a preview. The clinical trial community should understand the lessons learned from these expedited processes and consider how to prepare for “the next time.”
It remains to be seen which changes will remain for the long term. But some experts say that some permanent changes are inevitable, whether it’s remote patient visits, online collaboration, or remote digital monitoring.
Studies about the future of work tend to focus on the use of artificial intelligence and increased dependency on automation. There are human factors to consider, as well. Managers must define how to run hybrid teams and encourage resilience among workers. The World Economic Forum identifies major changes in three categories:
- Technology in the form of machine learning, artificial intelligence, and automation
- Ongoing learning and skill acquisition
- Talent mobility
This was supported by a report by McKinsey & Company, published in October 2020, that said workers in the life sciences had to double their efforts to focus on patients, leverage technology, and cultivate workplace agility.
Flexible work force
The ability to accommodate the ebb and flow of clinical research activities, or rapid redeployment based on shifting priorities, means that leaders need flexible staffing.
Hybrid work situations will require the need for cross-training among staff and the increased use of external resources to supplement internal staff. Highly responsive teams, augmented by expert hands-on external staff, can ensure sustainability of existing research projects even when new or urgent needs emerge.
Improving patient communication
The requirement to obtain informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46 and 21 CFR 50.
The Revised Common Rule introduced new informed consent standards that focus on providing prospective research participants with information that a reasonable person would want to have in order to make an informed decision about participation in a research study. Additionally, the presentation of information to the participant must be organized and include sufficient detail to facilitate the participants understanding of why they may or may not want to join the research study.
These requirements, along with the shift to e-consent and other technologies, have changed not only the language of consent forms but also the process and workflow in obtaining consent.
This is just one example of many patient-centered shifts in the paradigm of clinical research.
Beyond the required certifications in Good Clinical Practice or foundations for clinical research coordinators, research institutions must offer ongoing upskilling opportunities for staff to keep them up-to-date on the shifting technology and regulatory landscapes of clinical research.
Even prior to the pandemic, online learning was dominating the professional development field. Hiring managers who wanted to cultivate a more diverse and agile workforce were using online solutions such as CITI Program to ensure their skills were up to date.
Leveraging technology for better collaboration and improved workflow
Writing a protocol for a clinical trial has become a complex team sport requiring multidisciplinary input from various sources. Researchers are collaborating with colleagues at their own or other institutions, across clinical disciplines.
The protocol-writing process — from version management to IRB review — can be cumbersome. The use of paper-based systems, or even email, can result in confusion or delays. The result can mean incomplete IRB submissions and frustration for investigators.
Cloud-based guided applications, such as Protocol Builder, can expedite the process by fostering communication and teamwork. These systems build teaching into the writing process, which is essential for residents or new investigators. A complete and compliant protocol submission can result in a smoother IRB review process.
While no one has a crystal ball into the future, many organizations and foresight consultants are in general agreement that the workplace is undergoing a paradigm shift. Research institutions are not immune to these major changes, particularly if they focus on the key areas of change — mobility and flexibility, increased use of technology, and ongoing learning and upskilling.
Is Your Institution Prepared to Identify Exempt Research?
The disruption of clinical research as a result of COVID-19 cannot be overstated. Virtually everything about developing protocols and starting clinical trials has been upturned. In some cases, trials have been closed indefinitely. Others have been delayed or streamlined. Much of the interaction, such as IRB review meetings, has been shifted online, decentralized or outsourced to free up resources in the fight against the pandemic.
Anecdotally, we have observed a change in the types of protocols submitted for IRB review, as many investigator-initiated trials have pivoted toward better understanding of COVID-19. At BRANY, we have seen an influx of exempt research — protocols that pose minimal risk and fit into pre-specified categories that are exempt from IRB review. This type of research still requires a determination that it meets criteria for exemption. The regulations do not specify who at an institution may determine that research is exempt under 45 CFR 46.101(b). However, the U.S. Office for Human Research Protection (OHRP) recommends that, because of the potential for conflict of interest, investigators not be given the authority to make an independent determination that human subjects research is exempt. The IRB is often tasked with making exempt determinations.
Institutions should develop standards and procedures for determining research is exempt. However, this can be complex and complicated as exempt categories must be interpreted for specific situations. In developing these policies, OHRP recommends the following:
• Develop standardized mechanisms for collecting sufficient information to make the determination. This can include checklists, standard operating procedures and requirements for training.
• Policies should clearly define who has authority to make these determinations and provide sufficient training for those people.
• Define categories for exemption and use them in making the determination. This is useful in case of audit, but also helps the institution to establish policies.
• Provide clear guidance to investigators about federal and institutional guidelines.
This last point is crucial, as there is no federal mandate that anyone other than investigator make the determination that a research study is exempt. Some institutions may be tempted to expedite research and avoid delays by allowing investigators to make these determinations. The provision of detailed checklists, or the use of a guided protocol writing tool such as ProtocolBuilder, may help the investigator in these cases. The OHRP, and we at BRANY, strongly advise that someone other than the investigator make this determination in order to avoid possible conflict of interest.
Research institutions and academic medical centers must continue to adjust to the rapidly shifting landscape brought on by COVID-19. Resources have focused on understanding the pandemic and have been funneled toward both interventional and observational research in this area. This has resulted in a possible increase in investigator-initiated studies that may be considered exempt. Institutions may need to review their policies and procedures for making these determinations to ensure they are both in compliance and, more importantly, continue to protect human subjects.
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 are examining how to enroll smokers in their studies. They are evaluating e-consents, online surveys and questionnaires, as well as smartphone-enabled devices.
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
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 about insurance coverage of telemedicine visits demonstrate some shifts in reimbursement.
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.
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.
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.
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.
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
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.
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.
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.
Through its consulting division, the HRP Consulting Group, BRANY provides institutions human subject protection and research compliance consulting services.
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.