8
Jan2018

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

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

2
Jan2018

This month’s Research Ethics Roundup looks at why French authorities launched an oversight unit specific to first-in-human research, a massive study on golden retrievers and the implications for clinical research, Bioethics International’s work on improving trial transparency for phase I human subjects, and a new incentive program from the US Department of Agriculture’s Animal and Plant Health Inspection Service (USDA, APHIS) designed to improve communication between government investigators and facilities. Read more

18
Dec2017

The zombie apocalypse has arrived and is threatening the survival of the human race. Researchers have developed a treatment that might restore zombies to normal health and non-infectivity. There is a reasonable probability that the treatment will work as a cure but not as a protective measure. Failure of the treatment would be fatal for the subject. Potential study participants will not have the capacity to give consent. To the contrary, they will vigorously resist participation. No other possible treatments are known. There are no functioning governmental authorities, so the fate of humanity rests on your IRB. Time is of the essence. Read more

12
Dec2017

This fall marks the whirlwind one-year mark of my entry into the research compliance field, and what a year it has been! I have been fortunate to be able to attend several conferences and workshops, including PRIM&R’s IRB 101SM & 201, focused on human subjects protections and research integrity. These in-person learning experiences were invaluable but I’ve also been extremely impressed by the collegial and collaborative nature within this profession as a whole—even in the informal discussions and debate that happen on the IRB Forum and on the newly-created SBER network. These resources, available through PRIM&R, ignited my interest in research ethics questions as a whole and helped me to engage with larger issues in human subjects protection outside of my day-to-day work responsibilities. Read more

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