RAND Corporation Report on IRB Demographics and Function October 2, 2019

In August, the RAND Corporation, a policy research organization, released the first comprehensive profile of IRB demographics and function in 20 years: a “Profile of Institutional Review Board Characteristics Prior to the 2019 Implementation of the Revised Common Rule.” The report investigates questions about IRB practices, efficiency, and effectiveness on the cusp of implementation of the revised federal regulations, including single IRB review. (In December of 2017, PRIM&R helped get the word out to potential survey respondents.) Read more

11
Jun2019

PRIM&R’s Response to FDA’s Draft Guidance on “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients”

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11 Jun

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In March, the Food and Drug Administration (FDA) issued a guidance, "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients." The guidance is one of the latest moves by the agency to expand eligibility criteria, and hence the knowledge base for how drugs work in various populations, for the clinical trials they regulate. It makes recommendations not only for sponsors but also for IRBs. On May 13, PRIM&R submitted comments in response to the draft guidance. PRIM&R also has an upcoming webinar, Pediatric Risk Determination: IRB Considerations and Cases, on Thursday, September 19 that will review considerations for IRBs in assessing the risks and benefits of pediatric studies. Read more

10
Jun2019

Worry and Hope: A Reflection on Public Perception of Animal Research

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10 Jun

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During the 2019 IACUC Conference, I attended a discussion on engaging the public in conversations about the use of animals in research. In reflecting on this session, I felt both worry and hope. My gut tells me that when regulatory agencies ask for input on items of importance to research, an overwhelming number of responses are from detractors of animal research in support of their personal agenda, while those of us in the research world remain silent, maybe finding comfort in the thought that “someone else will reply”. We have to start speaking openly and honestly about what we do.We have to be strong advocates and build bridges for communicating with the public so that a new generation continues to carry the torch in support of responsible animal research into the future. Read more

4
Jun2019

The Research Animals We Love

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4 Jun

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Those in the field of laboratory animal medicine come to this job with love for animals, but a special kind of love—one that understands that we will be separated, but agrees to love anyway. We give these research animals the best we can give; so they play and are healthy and can serve science and society. Because we understand that a rescued pet is a healthy old dog today thanks to the vaccines and heartworm medication developed using lab animals. We understand that my mother-in-law is healthy today thanks to the surgery, chemo, and radiation developed using lab animals. And we dream that someday, hopefully sooner than later, cancer and diabetes and heart disease will all be diseases of the past, thanks to lab animals. Read more

31
May2019

Rounding up the Belmont Report Retrospectives

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31 May

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Last month brought the 40th anniversary of the publishing of the Belmont Report, and along with that milestone came a reflection on how its values, conclusions, and imperatives have changed in the intervening years. A celebration of its durability has been accompanied by a necessary reckoning with the ways that a 40-year-old document may be ill-equipped to process the ethical issues brought about by technological, cultural, and political changes. Here, we’ve gathered a range of resources that look back on 40 years of the Belmont Report. Read more

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