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 the chairperson of an IRB overseeing a study comparing three diabetes drugs. Some of the study participants have been talking about the study on social media. The investigator believes their posts have affected study enrollment, adherence and retention. How should the investigator deal with study participants who are sharing their study experiences online? Read more
You are a member of the board at Florida Central IRB. You are reviewing a vaccine study for Zika2, a deadly infectious disease that has recently emerged in Florida and is spreading fast. The only clinical study discussed in the Investigator’s Brochure was conducted in Brazil, where Zika2 originated. It provides scientifically sound evidence that supports the proposed study. However, you have just learned that, because of the emergency situation in Brazil, the investigators made the decision to conduct their study without regulatory or ethics committee approval, in a vulnerable population, and without informed consent. The Brazilian manufacturer and investigators will not be involved in the proposed study. Time is of the essence. Will you vote to approve the study? Read more
This week’s Research Ethics Roundup looks at why researchers are not enrolling pregnant women in the early phases of Zika vaccine research, a new LGBTQ study that seeks to address participants’ health concerns, a new study that shows the sex of a mouse affects certain traits, and Dr. Susan Reverby’s case for making changes to a monument that fails to note how a prominent gynecologist used slaves in his experiments. Read more
For this month’s question you are a member of a local IRB reviewing an influenza vaccine study. The investigator wants to ask enrolled study participants to help recruit additional study participants. The investigator wants to express her gratitude for this assistance. She has asked the IRB whether tangible expressions of gratitude, e.g., cash, would be acceptable. Read more
