TAG ARCHIVES FOR ethical considerations

21
Feb2018

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

15
Feb2018

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

28
Jun2016

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

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