TAG ARCHIVES FOR From the Director

10
May2019

The last few years have seen a growing call across the research enterprise to increase transparency around animal research—why we do it, why it’s important, and what it has accomplished. I also wonder whether there is another layer of transparency we ought to be promoting—namely, transparency about the ethical dimensions of animal research and its oversight. Specifically, how might being more open about the ethical issues and questions that are part of the day-to-day work of those involved in animal research serve our collective goals of educating and engaging the public; increasing their understanding, trust, and support for the animal research enterprise; and reframing the public conversation?  Read more

15
Jan2019

Despite the partial government shutdown, it’s business as usual at the Office for Human Research Protections (OHRP), and the revised Common Rule will go into effect, as planned, less than a week from today, on January 21, 2019. Last week, OHRP released a new draft guidance titled, “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))." Though it’s coming about six months later than would have been ideal, this is the most useful guidance related to the revised Rule released to date.   Read more

4
Dec2018

On October 10, the National Institutes of Health (NIH) published a Request for Information (RFI) from the public on Proposed Provisions for a Draft Data Management and Sharing Policy for NIH Funded or Supported Research. According to the NIH, it will take into account the feedback received as it develops a draft of a new NIH policy for data management and sharing. That draft will also be open for public comment, at a future date. Comments on this first stage of policymaking, the proposed provisions, are due December 10, 2018. Read more

11
Sep2018

In July of this year, the National Academies of Science, Medicine, and Engineering (NASEM) released a report titled, “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.” It’s a comprehensive report that raises many important considerations and proposes a number of thoughtful recommendations on this very timely topic. I won’t be able to do justice to all of its details and nuance here. Instead, I’ll share what I take to be some key themes and takeaways, including for IRBs. Read more

29
Mar2018

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