IRB Advisor – June 1, 2021
June 1, 2021
View Issues
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Diversity in Clinical Trials Should Start with the Fundamentals
Diversity in clinical trials involves more than just including more minority participants, panelists said at a recent webinar. It is a commitment from leadership that addresses the diversity topic within every aspect of the clinical trial process. -
The Role of Structural Racism in Lack of Clinical Trial Diversity
Structural racism is a powerful construct that may influence participation in clinical research studies, panelists of a recent webinar noted. -
The Issue of Using Race in Clinical Trials
One hot topic during a recent webinar on diversity in clinical trials centered around whether researchers should use race in a clinical trial. Using race as a variable is never neutral and never scientific, one expert noted. -
Clinical Trials with One Subject Raise Ethical Questions
It is unlikely IRBs will see many studies with one enrolled participant (the N=1 study design), but they should be prepared for this type of protocol. The single-subject study design can be applied to chronic conditions like cystic fibrosis or to ultra-rare diseases. -
IRBs Experience Some Obstacles in Tweaking Reliance Programs
Whether institutions are the IRB of record or the relying IRB, setting up a seamless process involves many time-consuming processes — and it can take years. One of the obstacles to an efficient IRB reliance effort is handling the technological details. -
Consistency Is a Chief Goal for Relying IRBs
Juggling the work of an IRB of record and becoming a relying IRB can be challenging. But one underlying goal can keep an IRB on track with both roles: consistency.