PRIM&R recently submitted comments in response to National Institutes of Health (NIH)’s March 14 request for information (RFI) on how best to improve the coordination of regulations and policies with respect to research with laboratory animals as prompted by a mandate in the 21st Century Cures Act. Comments on the RFI are due June 12, and I wanted to share what PRIM&R submitted in case the comments are helpful as you consider developing and submitting your own comments to NIH, which is coordinating the RFI with the Food and Drug Administration and the Department of Agriculture (USDA). Read more
TAG ARCHIVES FOR animal research
The Guide for the Care and Use of Laboratory Animals and the Animal Welfare Act Regulations describe rules and best practices for animal care and use professionals to follow in order to ensure high welfare standards are upheld for animals used in research. When an IACUC finds something that diverges from these regulations and standards, it can be a challenge to know whether and where to report the issue. To complicate matters, OLAW and USDA APHIS use differing terminology to describe these occurrences, and have different requirements for reporting. A solid, systematic framework for understanding, sorting, and managing “exceptions” and “departures” can help IACUC administrators more effectively sort through complex issues of compliance. Read more
On March 14, 2018, the National Institutes of Health (NIH), in coordination with USDA and FDA, published a 90-day request for comments “seeking information to improve the coordination of regulations and policies with respect to research with laboratory animals as required by the 21st Century Cures Act, Section 2034(d).” The animal research community now has an important opportunity to address long-standing concerns about regulatory burden—requirements that add administrative work without enhancing animal welfare or good science—and to help shape the future of animal research regulations. I urge you to take this opportunity to share with the federal regulators your ideas about how we can best streamline regulatory and administrative inefficiencies that don’t promote animal welfare or good science. Read more
This week’s Research Ethics Roundup looks at why researchers are not enrolling pregnant women in the early phases of Zika vaccine research, a new LGBTQ study that seeks to address participants’ health concerns, a new study that shows the sex of a mouse affects certain traits, and Dr. Susan Reverby’s case for making changes to a monument that fails to note how a prominent gynecologist used slaves in his experiments. Read more
In this month’s installment of PRIM&R’s featured member interviews, we hear from Maureen Greene, a longtime PRIM&R member working in human subjects and animal research. This series is intended to let our community get to know our membership and hear about the impact they make through their daily work. Read on to hear from Maureen!
PRIM&R: When and why did you join the field?
Maureen Greene (MG): I joined the field of research in 1985 when I had the inquiring mind to ask: Why? Early in [...] Read more