TAG ARCHIVES FOR ethical considerations


You are a member of an IRB reviewing a Phase 2 study for cardozamine, a new drug for treating stress. One of the exclusion criteria in the protocol is: “Educated or employed as an attorney.” The cover letter on the application explains that the study sponsor has been sued on three occasions by attorneys who were study subjects, and does not want it to happen again. You have no other information to make your decision and no clever way to dodge it. Read more


Suicide is an urgent and growing public health crisis. It was the tenth leading cause of death in the United States in 2015, with over 44,000 deaths, according to the CDC. Studying suicide, and including suicidal or potentially suicidal individuals in clinical research, is an important way to gain valuable data that can advance prevention efforts. Researchers and IRBs may tend to exclude suicidal individuals from research in order to avoid potential risks; however, in order for the research to be scientifically and clinically valuable, it is important that suicidal individuals are not excluded from research unnecessarily. Read more


About four years ago, my 2012 Advancing Ethical Research Conference (AER12) poster titled Incentive Parameters for International Human Subjects Research was published on Ampersand. I was a brand new public health faculty member with big ideas on how having incentive parameters could change the way we do research—but with little insight into the methods of doing so and little understanding of why the topic would be important to NIH reviewers. Read more


On July 22, the National Institutes of Health (NIH) announced it was seeking comment on a framework for a five-year, NIH-wide Strategic Plan. The plan, which will ultimately be submitted to Congress and is being generated with input from senior leadership and staff across NIH, is intended to “outline a set of unifying principles to guide NIH in pursuit of its mission” and “highlight major trans-NIH themes” in order to help advance the biomedical research enterprise.

In the framework, NIH identifies three areas of opportunity that apply across biomedicine: (1) the promotion of [...] Read more

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