Justification and authority in institutional review board decision letters

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 ...

The Responsibility of the Institutional Review Board in Good Clinical Practice: First, Do No Harm

Dear Editor,I read with interest the article on outpatient management of burn wounds published in a recent issue of the IJMS.1 There are many questions that arise which are worth mentioning. Under the methodology section, no description was provided on how patients were randomized into the two treatment arms and, therefore, it is not possible to assess how confounding variables were controlled....

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.

Institutional review board (IRB) and ethical issues in clinical research

Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. Intern...