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.

First, a little background. The Cures Act, a landmark piece of legislation designed to accelerate the pace of scientific research and discovery, was signed into law by President Obama in December of 2016. Buried within its 300 pages is a small section—section 2034(d)—on reducing administrative burden in animal research. The law requires that within two years of the date of the enactment of Cures, NIH, in collaboration with USDA and FDA, complete a review of current animal welfare regulations and policies and make revisions “to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.” Specifically, it directs the NIH to:

“(1) identify ways to ensure such regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative, including with respect to inspection and review requirements by Federal agencies and accrediting associations;

(2) take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and

(3) take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals.”

The NIH has until December 16, 2018 to complete its review and propose regulatory revisions.

The Cures Act also directs NIH to seek out the input of experts as it conducts its regulatory review. Anticipating that request, in April 2017, the Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), with assistance from the National Association for Biomedical Research (NABR), convened a workshop of stakeholders involved in animal research and its oversight. In August, that group put out a report titled, Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden, which seeks to provide “actionable recommendations for promoting regulatory efficiency, animal welfare, and sound science.”

At last week’s IACUC18 Conference in Columbus, OH, JR Haywood, Assistant Vice President for Regulatory Affairs at Michigan State University and one of the authors of the FASEB/AAMC/COGR report, nicely articulated the guiding assumptions behind the report (assumptions that, it’s worth noting, were also articulated in the 2015 National Academies report, Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century, which also had a significant influence on the Cures Act). According to Haywood, both science and animal care techniques have evolved faster than the regulatory environment. New technologies permit less invasive procedures, reducing animal distress. And as a result of advances in training for those who both care for animals and oversee animal research, noncompliance rates have dropped dramatically over the last 10 years. It is time, said Haywood, for the regulations to catch up with advances in both laboratory animal science and workforce training, and to reimagine a regulatory oversight system that better fits today’s research and animal care enterprises. These themes will be familiar to those who have been following the Common Rule revision process.

Many of the Report’s recommendations focus on NIH and USDA. Particularly noteworthy recommendations include consolidating regulatory oversight under one federal agency, with one primary set of regulations and guidance documents; instituting a risk-based process of review for animal protocols; ensuring that IACUC-approved alternatives to “should” statements in the Guide are not classified as departures or deviations; requiring only annual inspection by the IACUC; and, consistent with a risk-based framework, replacing annually conducted USDA inspections with inspection frequency determined by compliance history.

Now it’s your turn to weigh in. In the RFI, NIH specifically asks for feedback on the following four burden-reducing strategies being considered:

  1. Allowing investigators to submit protocols for continuing review using a risk-based methodology.
  2. Allowing annual reporting to OLAW and USDA on the same reporting schedule and as a single report through a shared portal.
  3. Harmonizing the guidance from NIH and USDA to reduce duplicative considerations of alternatives to painful and distressful procedures.
  4. Providing a minimum 60-day comment period for new OLAW policy guidance.

Importantly, there is also a fifth proposed action for “other approaches not previously considering,” meaning that NIH is also accepting other burden-reducing proposals not explicitly mentioned. 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. 

NIH is accepting comments until June 12, 2018.  Submitting comments is simple, and to help make it even easier, below are some tips:

The text of the RFI can be found in two places: NIH Guide Notice NOT-OD-18-152 and Federal Register Notice 2018-05173.

  • Comments must be submitted to the NIH electronically via a form at this link: https://grants.nih.gov/grants/rfi/rfi.cfm?ID=71 There are text boxes for each of the specific recommendations in the RFI. You can type into the boxes directly, or cut and paste text into them.
  • The only personal information required with submission is a name and email address. You do not have to identify your organization. NIH may make the comments public, and they will remove personally identifiable information, other than organizational affiliations and addresses, before doing so. (Note that if the comments are made public through the website regulations.gov—and they may be—then the name of the person who submits is typically made public.) Remember to get appropriate clearance from your institution if you are going to identify yourself as affiliated with the institution. But also remember that anyone can submit as an individual.
  • You do not have to come up with your own comments; you can quote and cite others that you agree with, including, for example, recommendations from the FASEB/AAMC/COGR report or from PRIM&R. PRIM&R is currently crafting its comments, and will make them available to the community ahead of the submission date, so you can reference them if that’s of interest.

Let’s take advantage of this opportunity to shape a future federal regulatory framework that better serves animal welfare and scientific progress, and the dedicated community of professionals that is committed to both.

Correction: This post originally listed JR Haywood's institution as Mississippi State University. JR Haywood, PhD, is actually the Assistant Vice President for Regulatory Affairs and Professor of Pharmacology and Toxicology at Michigan State University (MSU).

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