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


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


In May, PRIM&R hosted the webinar Introduction to Research Misconduct for IACUC, IRB, and IBC Professionals. This webinar provided foundational knowledge in research misconduct for regulatory professionals who work in the human subjects protections and animal care and use fields. After the webinar, one of the presenters, Jim Kroll, PhD, responded to some of the attendee questions that time didn’t permit us to answer live. We’re pleased to share those answers with the readers of Ampersand. Read more


In April, PRIM&R hosted the webinar Compensation or Inducement? What IRBs Need to Know about Paying Subjects for Participation. Presented by Alex John London, PhD, and Betsy Ripley, MD, MS, RAC, this webinar provided foundational knowledge about the underlying ethical principles that govern compensating tresearch subjects. Through case studies, examples, and review of existing guidance and regulations, attendees learned strategies for evaluating payment to subjects for their participation in studies. Here, the presenters answer some of the questions time didn’t permit us to answer live. Read more

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