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NIH has, for many years, been concerned about the increasing burden of applying for, reporting on, and the costs faced by researchers when complying with requirements on federally-funded research grants— so much so that it is even called out in our strategic plan as an area to address. Today, as we continue to implement the 21st Century Cures Act, NIH is requesting public feedback on some proposed approaches to reduce administrative burden on investigators use of laboratory animals in biomedical research (NOT-OD-18-152 and Federal Register Notice 2018-05173). Together with our colleagues at the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA), we are looking for constructive and thoughtful feedback on this topic from individuals, research institutions, professional societies, animal advocacy organizations, and other interested parties. Input will be accepted electronically during a 90-day comment period, that is until June 12, 2018.
Through your participation, we hope to gain insights into how we can best improve the coordination and harmonization of regulations and policies with respect to research with laboratory animals. This call will help shed further light on where the community feels that regulations and policies are inconsistent, overlapping, or unnecessarily duplicative.
Using animals in research is critical to scientific understanding of biomedical systems leading to useful drugs, therapies, and cures. It is important to note that, even as we strive to identify ways to reduce administrative burden on our supported investigators, we simultaneously aim to maintain the highest standards of integrity and credibility within the biomedical research enterprise. This further extends to NIH continuing to ensure the greatest commitment to the welfare of laboratory animals involved in our supported research endeavors.
As part of examining existing regulations, staff within the NIH, USDA, and FDA have conducted listening sessions on the topic and diligently reviewed published materials aimed at reducing burden faced by investigators within the research community. Such resources span findings from a workshop held last April, National Academies of Science recommendations from 2016, the National Science Board’s considerations from 2014, and a survey about faculty workload published in 2012.
Ideas have been collected and analyzed for their relationship to existing statutes, regulations, and policies, as potential approaches to implement in support of the 21st Century Cures Act requirements to reduce regulatory burden on investigators in their use of animals. Some examples include:
- Allow investigators to submit protocols for Institutional Animal Care and Use Committee continuing review using a risk-based methodology.
- Allow institutional annual reporting to the NIH Office of Laboratory Animal Welfare (OLAW) and USDA on the same reporting schedule and as a single report through a shared portal.
- Harmonize the guidance from NIH and USDA to reduce duplicative considerations of alternatives to painful and distressful procedures.
- Provide a minimum 60-day comment period for new OLAW policy guidance.
We hope to hear from you during this process. Insights from the community are critical to helping us refine and ensure the final recommendations and implementation plans are appropriate to reducing administrative burden while maintaining our long-standing commitment to the humane care and use of animals in research.
Every time the NIH ‘improves’ a process, it results in more burden on us.
LEAVE US ALONE so we can actually do the science we propose in our applications that get rejected >90% of the time.
If there’s something useful you can do, try figuring out how more people can get- AND stay-funded. If people are doing good work, as evidenced by strong and novel publications/patents, they shouldn’t have to worry about their next competitive renewal – yet we do, now more than ever.
I admit to being flummoxed by this statement about reducing administrative burden for animal research when NIH appears to have INCREASED this burden quite a bit over the past few years. I have been an NIH funded scientist for 20 years, and for every other grant I have had over this period the animal JIT information just involved giving the IACUC approval number and date. While the online JIT still only asks for that, it seems that the rules have changed. For example, regarding a recent experience, I received many non-nonsensical requests for more JIT information related to my animal work – such as turning in my approved IACUC protocol and extensive justifications for foreign components with whom I share mice. NO these mice transfers are NOT going to interfere with the conduct of a foreign government. I would not have minded so much if they asked for this from the beginning. Instead, every time I think NIH has all of the paperwork they need, they ask for something else. Each of these individual requests are not that time consuming in themselves, but take a couple of days at least since I can not submit any of this, it has to come from my university research office. WHAT GIVES!!! This is not paperwork reduction, this is the worst of bureaucratic red tape.
As amply documented in the 2012 (! – better late than never) report of the FDP, regulatory streamlining and simplification – most of all with the single greatest burden in that report, IACUC – has been urgently needed and, with the current Congress and White House, the time is ripe for Federal agencies actually to DO SOMETHING. So, I was hopeful upon seeing the initial “teaser” – and reminded why that hopefulness likely was delusional after taking some time to drill down, go through things, and for that matter look at the RFI [Federal Register Notice 2018-05173 (PDF) and NIH Guide Notice NOT-OD-18-152]. The latter is a classic – no space for actual free-entry input from anyone, and the only input requested must only address a set, fixed series of issues or questions that are almost all (a) dreary, impenetrable, soul-draining bureaucratese about technical tweaks that will not get to the heart of the matter or lead to any real change (or none within our working lifetimes, or (b) incomprehensible or nearly so. The likelihood of anyone actively doing research being able to make time to determine just what is meant or proposed in “Allow investigators to submit protocols for continuing review using a risk-based methodology” is essentially zero. I suppose nowadays that does not preclude making comments – uninformed commentary are much in vogue inside the Beltway. If this meant “Allow investigators an automatic renewal of previously approved research even after three years, as long as the previously approved experiments on rodents were not going to change much and were relatively low-risk”, well, that would be a step in the right direction. Ditto for changing the rules to “if a purely rodent-based program involves relatively low-risk activities, it can be approved for five years instead of three, without need for annual IACUC review of the entire protocol”, good! But who knows what the heck the gobbledygook actually means or would be as a rule?
I (amost) totally understand about the nature and method of Federal rule-making: would that all Executive Orders these days actually followed the process! And I totally understand that as soon as one says “OLAW”, “IACUC,” or “USDA”, we’re reminded by Kafka’s The Castle is an enduring classic. But, as far as actually accelerating research or cures, the RFI misses the real points:
a. Many or most IACUC’s make matters way worse than even what the regulations imply as a need, and even with regard to non-USDA species, and tend to over-regulate and to be over-cautious.
b. In part, (a) is due to intense fear and perceived institutional risk [what if NIH OLAW or USDA come down on us like a ton of bricks? [solution: provide reassurance and more nuanced enforcement, especially with regards to non-USDA species. Is that in this RFI? Doesn’t look like it.]
c. Simple matters that are huge obstacles don’t really show up here. One of the biggest obstacles to a pace of progress, if not THE biggest, is the insane burden created by the levels of justification and the cumbersome implementation of not only initial approval, but then also any modification, even if the proposed modification involves minimal risk or for that matter is a standard practice out in the research community of USA (i.e., passes IACUC muster reproducibly). [Solution: Create a database of standard acceptable practices with broad ranges of variances (for instance, range of doses) and a broad definition of de minimus that will not concern OLAW (and should not concern IACUC).
As a revealing example of the pathologies: the only potentially good thing I’ve seen come from these quarters in years was when OLAW provided guidance to the effect that for modest changes (for instance, different immunogen, modest change of dose, modest tweak to a chemical entity), the Vet staff could approve without major IACUC scrutiny. At least at the local level (and probably at many institutions), that got dragged beck into the tar pit and made excessively time consuming and bureaucratic by translating it into a requirement that the same cumbersome, inefficient online application for a modification would be required [but that behind the scenes MAYBE it would be approved quickly by Vet Staff . . .. ]. One cannot over-state how many PIs (self included) just don’t bother to try out some potentially exciting new angles because of the workload involved. And even if one tries, modifications can delay the onset of work by 6-9 MONTHS! For things that should require only brief scrutiny and be approvable in 6-9 days. So, in that, I’m with ProfessorQ
Start with the grant application: Revise/Refine/Reduce the vertebrate section requirements to focus on the scientific quality of the research as it pertains to animal use, not on those details that ACUCs review thoroughly anyway. All the rest should be JIT information. ACUCs and Reviewers are also wasting their time on proposals that get rejected 90% of the time!