Institutional Review Board Assessment—Balancing Efficiency and Quality

Institutional Review Board Mission

In this article, I scrutinize the process by which scientific research on human subjects is regulated by Institutional Review Boards (IRBs). At the outset, let us agree that at least some biomedical scientific research on human subjects must be externally monitored and that whether government should sometimes be involved in that process is at least an open question. We simply cannot forget the ...

Role of accreditation in quality improvement of institutional Review Board

AIM The aim of this study was to evaluate the process of accreditation resulting in improvement of the Institutional Review Board (IRB) functioning. METHODOLOGY Randomly selected projects from years 2007 (before accreditation), 2010 (after accreditation), and 2013 (after reaccreditation) were evaluated to assess parameters, namely, submission of good clinical practices (GCPs), completeness of...

Victor Frankenstein's Institutional Review Board Proposal, 1790

To show how the case of Mary Shelley's Victor Frankenstein brings light to the ethical and moral issues raised in Institutional Review Board (IRB) protocols, we nest an imaginary IRB proposal dated August 1790 by Victor Frankenstein within a discussion of the importance and function of the IRB. Considering the world of science as would have appeared in 1790 when Victor was a student at Ingolsta...

Stages of institutional review board activities.

Quality improvement and evidence-based practice change projects and the institutional review board: is approval necessary?

T here is often confusion in determining whether quality improvement (QI) projects and evidence-based practice (EBP) change projects require Institutional Review Board (IRB) approval. The distinction between research and QI-EBP change projects begins with an understanding of their distinct definitions. Research is defined in the U.S. Department of Health and Human Services Federal Regulations (...