As the ethicist for the Caribbean Public Health Agency (CARPHA) and founding president of the Bioethics Society of the English-Speaking Caribbean (BSEC), Dr. Derrick Aarons is on a mission to educate. His conscientious work has helped build a culture of bioethics in the Caribbean, and he is committed to sharing his region’s bioethical perspectives with the rest of the world. Read more
As leaders in the development of best practices for repositories, the International Society for Biological and Environmental Repositories (ISBER) recently announced the release of The ISBER Best Practices: Recommendations for Repositories, Fourth Edition. In addition to covering a wide range of scientific and technical issues, The ISBER Best Practices also covers various ethical, legal and social issues (ELSI) related to biorepository operation. 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
One of my favorite parts of attending PRIM&R's annual Advancing Ethical Research Conference is that it refocuses my efforts on what really matters. In the year since the last conference, I've processed countless exempt 2 determinations, requests for waivers of signed consent, and study team member modifications. I have been doing this while also contributing to new institutional policies and procedures, software requirements, and workflows in order to comply with the revised Common Rule. Some days, we all feel drowned in an ocean of regulations and rules—some days, we all get the Regulatory Robot Blues. However, the first keynote speaker at the 2017 Social, Behavioral, and Educational Research Conference reminded me of why human subjects research protection is my passion. 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
