At the 2020 Advancing Ethical Research Conference (AER20), I attended the “Nuts and Bolts of Assessing IRB Compliance” session presented by Lisa Buchanan, MAOM, CIP; Keren Dunn, CIP; and Heather Savage, CIP. The session included topics like departmental self-audits, corrective and preventive actions, and working with researchers around IRB noncompliance. The presenters guided attendees on unanticipated problems involving risks to subjects or others, serious or continuing noncompliance, and any suspension or termination of IRB approval. Panelists described ways to reduce IRB noncompliance:
- Audits of IRB performance
- Quality checks on IRB meeting minutes
- Regular updates for IRB written procedures
- Training for the IRB Chair, IRB members, and staff
How can IRB administrators convey the importance of IRB compliance to researchers?
Before I joined the IRB administration team, I thought IRB reviewers were members of a secret society whose sole purpose was to strike down research. Like others before me, I believed my research would be put on the IRB butcher’s block and be chopped into little bits. However, IRB administrators are not the menacing force I had originally perceived. In fact, IRB administrators want to see quality research out in the field and will work tirelessly to help guide researchers towards compliance to reach that goal.
New researchers may hesitate before creating an IRB protocol because they are concerned about submitting their study with human subjects to a rigorous and comprehensive review process. But researchers should instead feel empowered to submit an IRB protocol for review because the IRB protocol submission is systematic, comprehensive, all (mostly) possible, and an intellectual exchange.
Just like stops on a train line, the IRB protocol submission process is systematic. Prior to submitting an IRB protocol for review, researchers should be properly trained in courses like the “IRB Social and Behavioral Researchers Basic Course,” which provides the foundation on how to conduct human subject research and ways to avoid noncompliance. To submit an IRB protocol, researchers should systematically organize the study content for IRB reviewers to ensure they can provide a thorough review of the proposed research activities.
Just like managing any important task, IRB protocols are comprehensive and take time to complete. As such, researchers should develop study protocols early to avoid delays, especially if the research plan includes vulnerable populations. To decrease the chances of noncompliance, researchers should consider the risk-level of the study and ask themselves:
- Are participants experiencing minimal risk?
- If they will be exposed to more than minimal risk, how will you reduce the chance of harm?
- Have you thought through the parameters of your research plan including implementation, data storage, and digital data security?
The IRB will review a research protocol submission and offer feedback to ensure the researcher is protecting research participants.
It's all (mostly) possible
Most research plans are possible to conduct (with some justifications, negotiations, explanations, and compromises). When preparing an IRB protocol, researchers should remember that the IRB is composed of experts who have a wealth of information and experience in research design, implementation, and research ethics and regulations.
It's an intellectual exchange
Just like putting puzzle pieces together, the IRB and researchers engage in an intellectual exchange. IRB members will offer feedback that supports compliance and ethical conduct to ensure the researchers work best fits federal and institutional parameters.
Collectively, IRB reviewers consider the parameters of the proposed work and how the researcher is presenting it to ensure participants are informed and protected. Based on their knowledge, the IRB board will make recommendations that can further ensure the researcher protects participants and follows compliance procedures.
Myra Luna-Lucero, EdD, is the research compliance director at Teachers College, Columbia University. As a researcher and teacher, people are her highest priority and she instinctively communicates personal concern with others. She is an adept communicator who thrives on face-to-face interactions with a diverse body of students, faculty, and staff. She brings these qualities to her work to empower others to make informed decisions and reach their goals.
Dr. Luna-Lucero encourages researchers to ponder the roles they might play in the alleviation of the troubling inequities that continue to shape our world. She guides researchers on how to treat everyone as autonomous decision-makers who possess unique opinions. She presents campus workshops on the importance of ethics, confidentiality, and protecting vulnerable populations. She meets individually with researchers to strategize ways to protect human subjects and do good work in the world.
Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.
PRIM&R's next AER Conference takes place virtually—in conjunction with our Social, Behavioral, and Educational Research Conference—November 16–19, 2021. Early bird discounts are available until July 22. Learn more and register online!