13
Feb2018

The Gravity of Becoming a Regulatory Robot

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13 Feb
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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

5
Feb2018

Webinar Follow-up: Data Sharing in Research with American Indians and Alaska Natives: Informed Practices, Considerations, and Case Studies

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5 Feb
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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

30
Jan2018

Clarifying Limited Review

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30 Jan
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Just before I left for San Antonio, I held an educational session with my IRB members, focusing on the revisions to the Common Rule that were likely to have the greatest impact on our processes. As an institution focused primarily on social, behavioral, and educational research (SBER), it seems likely that a large number of our currently expedited review projects will become exempt projects, especially under .104(d)(2) and .104(d)(3). Read more

8
Jan2018

Clinical Research Question of the Month: January 2018

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8 Jan
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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

5
Jan2018

Webinar Follow-up: Research with Aquatic Species

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5 Jan
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The use of aquatic species is increasing in a range of scientific fields, including biomedical research, evolutionary biology, and environmental research. In December, PRIM&R hosted the webinar Research with Aquatic Species: New Strategies for Health and Welfare to address common concerns and emerging issues for researchers and animal care and use personnel involved in research with fish. Presenter Victoria Braithwaite, DPhil, professor of fisheries and biology and the co-director of the Center for Brain, Behavior and Cognition at Penn State University, addressed considerations related to social housing and environmental enrichment as well as the minimization of pain and distress through innovative methods of administering analgesia, anesthesia, and euthanasia. Read more