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.
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.
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 trial processes should begin with diversity in mind
May 20, 2021
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.
Savings and benefits may revolutionize staff training
April 21, 2021
Virtual training for clinical trial teams may have existed for years, but it has gained significant attention during the COVID-19 pandemic. Experts expect the popularity of this kind of training to increase, even after COVID-19 restrictions are relaxed.
As IRBs review participant incentives for studies, they assess whether the incentives are coercive or exploitive. New research provides a snapshot of the diversity of these incentive offerings, revealing monetary payments for biomedical studies tend to be 10 times higher than payments for sociobehavioral studies.
IRBs and research institutions continue to hammer out processes and best practices related to the revised Common Rule. As one IRB found, this process requires a team effort. When collaborative IRB requests began to increase, the Augusta (GA) University IRB office formed a reliance team. The IRB also designated one team member, a reliance coordinator, to handle issues related to reliance agreements. A recent study revealed the reliance team helps IRB offices with collaboration and reviewing reliance agreements to ensure the research is in accordance with local policies. The team also can help investigators navigate through reliance process.
When an IRB office aimed to improve its staff training and work efficiency, the solution was to create a new program, called the IRB Staff Training and Onboarding Program. The process began with the IRB’s internal staff training and member work group and leaders identifying ways to improve training and onboarding of new IRB staff.