Articles Tagged With: irbs
-
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. -
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. -
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. -
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. -
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. -
Virtual Site Training Expands During the Pandemic
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. -
Exploitation Issues Arise in Study of Human Subject Incentive Payments
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. -
Reliance Teams Strengthen Relationships with Central IRB
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. -
IRB Improves and Simplifies Board Meeting Minutes Process
An IRB revised its board meeting minutes process from a clunky system of writing everything into an electronic document to one in which the minutes are automatically populated through the IRB’s electronic system, saving staff time and work. The old way of creating board meeting minutes sometimes took as long as a month for IRB staff to generate. Since the IRB revised its process, the staff can generate board meeting minutes within a week.
-
Researchers and IRBs Reconsider Minimal Risk After Trial Results
A clinical trial that involved studying electronic health record alerts for acute kidney injury seemed to be minimal risk to both the researchers and the IRBs that approved it. However, when two hospitals involved in the study reported an increased mortality rate, the researchers and the IRBs reconsidered what is truly minimal risk in these types of studies.