by Anne Meade, MS, PMP, Senior Manager for Website and Social Media
IRBs are well versed in the regulations and ethical principles that govern research with human subjects, but what happens when they are presented with a protocol about a disease or disorder about which they are unfamiliar?
In this excerpt from People and Perspectives, Greg Koski, MD, PhD, co-founder of the Alliance for Clinical Research Excellence and Safety and a former director of the Office for Human Research protections, talks about reviewing a protocol about autism, a disorder with which members of the IRB were largely unfamiliar, during his time serving on the IRB at Massachusetts General Hospital. Members of the IRB did not feel they understood enough about autism to make a determination about whether the protocol, as outlined, was appropriate and reasonable. The IRB put together a working group with the goal of learning more about the disorder. After receiving more information from a local advocacy organization, the IRB gained a deeper understanding of the disorder and found a way for the research to move forward, which otherwise may not have happened.
[This experience] educated a whole group of us around the IRB and others about the value of looking beyond just what you know in order to get more information, a different perspective on the issues, as a means of resolving these ethical dilemmas.
Watch the full interview with Dr. Koski on People and Perspectives and share in the comments below what methods you use to educate yourself when reviewing protocols on unfamiliar topics.