PRIM&R’s 2018 Advancing Ethical Research Conference (AER18) was very inspiring. It provided me an opportunity to be immersed in an interesting learning opportunity, wherein I noted a common theme of this conference was to highlight the changes in the revised Common Rule and its practical implementation. Changes to this Federal Policy for the Protection of Human Subjects were addressed in several sessions from a variety of different angles; presenters highlighted aspects of the Rule ranging from updating SOPs to navigating the single IRB review process. The event addressed both broad perspectives practical implications affecting in the real world of medical research.
I attended an IRB Chair Forum, where we also received FDA guidance on the revised Common Rule—specifically, it outlined the differences in practice depending on the jurisdiction of regulatory authority. For example, if FDA still requires continuing review mandating a one-year approval what are the oversight options for an institution? Should the IRB still require a continuing review? This may require the institution to thoroughly document the reason for this practice and/or an institution may decide to develop some other mechanism. For example, a “status update” rather than a "continuing review." However, certain important information must still be communicated to the IRB, including adverse events and protocol changes etc.
At another presentation, I learned about the elements of the new consent requirements, allowing broad consent option for the future use of data and biospecimens, and whether institutions will utilize this option. I learned more about exemption determinations and who makes these determinations. In my view, the most significant change was requiring consent for the use of all biospecimens in research, regardless of whether or not they are to be deidentified.
I also learned that the revised Common Rule will address problems with the informed consent documents; for example, when informed consent documents are too long, too complicated, or contain legal text designed more to protect institutions and researchers than to truly inform research subjects. Under the revised rule, there will be opportunities to improve informed consent—to highlight key information and specific elements outlined in the rule, and move non-essential information to a separate appendix.
It was helpful to listen to a comparison of both versions of the rules and to explore potential decisions a sponsoring institution could make. As IRBs integrate the revised rule into their practices, it is hoped that these adjustments improve protection for human subjects.
Attending AER18 helped me become more aware of the many new changes and considerations for IRB professionals (in the regulations and beyond). What I learned during the sessions I attended has enabled me to rethink some of the current practices at my own institution and continue to improve in my work.
Muhammad Waseem, MD, MS, CIP, CPI, CCRP, is currently Professor of Emergency Medicine in Clinical Pediatrics at Weill Cornell Medical College, New York. He completed a residency in Pediatrics and a fellowship in Pediatric Emergency Medicine. He also holds Master's degrees in Clinical Investigation and Epidemiology & Health Services Research from Cornell University, New York. He serves as the Research Director for the Department of Emergency Medicine and Vice chair for the IRB at Lincoln Medical Center Bronx, New York.
His special interests are ethical issues involving children and protection of vulnerable populations. He addresses these interests via his work in the pediatric emergency department as an investigator and educator. He has been serving an under-represented population in an urban community for over 20 years.
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 upcoming 2019 AER Conference (AER19) will continue to explore the Common Rule and other key issues in research ethics, research oversight, and human subjects protections. This year’s conference takes place November 18-20, 2019 in Boston, MA alongside our biennial Social, Behavioral and Educational Research Conference (SBER19) on November 17. Visit primr.org/boston19 to explore this year’s conference agendas and register!