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
When research subjects’ capacity to consent is absent, diminished, or fluctuating, additional consent enhancements, safeguards, and support may be required by the IRB. AAHRPP Standard II-4 requires IRBs to provide additional protections for vulnerable subjects in research, including policies and procedures to protect subjects whose capacity to consent is potentially absent, diminished, or fluctuating. The regulations, however, are generally silent on the specifics of these additional protections. 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
The potential benefits of data sharing for secondary research purposes are well recognized, but certain ethical barriers must be addressed before these benefits can be fully realized. American Indian and Alaska Native (AI/AN) individuals and tribes that participate in research are often interested in sharing their data when doing so will help answer important questions or contribute to improved population health outcomes, and when appropriate protections are in place. While perspectives on data sharing agreements and processes can vary among AI/AN individuals and tribes, some views are consistent and much can be learned by examining how specific studies have navigated data sharing in ways that both respect tribal sovereignty and meet the overall study goals. What best practices, lessons, and examples exist for IRBs, researchers, and funders who wish to include a data sharing component in research with AI/AN individuals and tribes? Read more
