TAG ARCHIVES FOR PRIMR22

4
Nov2022

But how can IRBs engage communities while operating within the boundaries of their current regulatory role? Do IRBs have an ethical obligation to be proactive in ensuring diversity in clinical trials? Indeed, IRBs are uniquely positioned to influence research practices toward an equitable and more inclusive research world. Perhaps, the FDA and HHS should consider revisiting the scope of responsibilities of IRBs to provide broader latitude for making a greater impact on public health. The questions in this blog are the types of engaging thoughts I plan to discuss during the 2022 PRIM&R Annual Conference. I am most grateful that PRIM&R is providing a forum to discuss these important thoughts and expect more ideas will be generated as we continue the journey of straightening the path towards health equity for all. Read more

25
Aug2022

Research noncompliance occurs when researchers (intentionally or unintentionally) fail to comply with established regulations, policies, and/or committee-approved research protocols. Noncompliance comes in many forms. It is study-specific and not always identified by IRBs and IACUCs in the same manner.  Some instances of noncompliance may be discovered through post-approval monitoring activities, while others come to the committees via whistleblowers, or reports submitted by the researchers themselves.  Whatever the case, committees must decide what happens after noncompliance has been identified. Read more

9
Aug2022

In 2022, we surveyed IACUCs and Animal Resource Programs (ARPs) to learn more about changes, both temporary and permanent, to the regulated work environment for animal research oversight and laboratory animal care. At PRIMR22, we will take a deep dive into regulatory implications for remote work and oversight activities and examine the impact of recent changes to the labor market on ARPs. Read more

8
Aug2022

We are finally witnessing increasing adoption of digital pathology in clinical practice. Pathologists are beginning to embrace and utilize artificial intelligence (AI) tools and ideas to augment routine pathology practice. All stakeholders in pathology need to fully understand the ethical frameworks required to develop, deploy, and maintain transparent, trustworthy, explainable, scalable, interoperable, and sustainable digital AI tools. Read more