Providing payment for participation in research studies is an accepted practice, but until recently little guidance existed on the ethical aspects when deciding research payments. Gelinas et al recently presented a framework that researchers and IRBs can use when deciding ethical payments. Yet one major gap remains beyond the framework: data on the types and amounts of incentives provided historically in research studies. Read more
For all the years I’ve been in this industry, I’ve wondered why we haven’t learned from the horrific events scattered throughout its history. Why do we continue to make mistakes, go against the regulations, and sometimes do bad research? Read more
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
This webinar explored controversial new trends in political science research, including increased field experimentation and research conducted overseas, and aimed to clarify the IRB’s role in addressing the ethical challenges these protocols often present. Read more
