Earlier this month, the National Academies of Science, Engineering, and Medicine (NASEM) publicly released a report on Simplifying Research Regulations and Policies: Optimizing American Science. The initiative aims to rightsize research regulations and policies that have evolved to be uncoordinated, duplicative, or inconsistent, leading U.S. researchers to spend more than 40 percent of their federally funded research time on regulatory and administrative matters.
While encouraging the scientific community to operate to the highest level of integrity, the document outlines three cost-cutting principles and offers options for improvements in seven areas of research regulation. The Committee, led by Dr. Alan Leshner, includes a depth and range of science policy experts from universities and industry with past service to the federal government, including Dr. Kelvin Droegemeier and Dr. Lisa Nichols. The report speaks to an Executive Order (EO), Unleashing Prosperity through Deregulation, signed on January 31 of this year.
The three cost-cutting principles are:
- Harmonizing regulations and requirements at both the federal and state levels.
- Tier new regulations and requirements to the risk involved in the research.
- Use technology to simplify compliance to the greatest extent possible.
The Committee recognized that any major overhaul of regulations and requirements will require leadership and coordination across 20 federal agencies funding science. The Committee offered several options for offices best suited to provide that leadership. The Office of Science Technology and Policy (OSTP) would be an obvious candidate for this role, however, it is currently short staffed on scientists, with leadership being more deeply steeped in the ‘T’ function of OSTP. Another leading candidate, the President’s Council of Advisors in Science and Technology (PCAST), is currently without an executive director after the departure of Lynne Parker back in August. The Office of Information and Regulatory Affairs, within the Office of Management and Budget (OMB), is another option. However, FABBS notes that recent OMB efforts to not only dramatically cut funding for science agencies but also claw back previous award commitments and hurl considerable changes independent of standard processes have led the science community to lose trust in OMB.
The report proposes 53 options for improvement across seven areas of research regulation:
- Grant Proposals and Management
- Research Misconduct
- Financial Conflict of Interest
- Protecting Research Assets
- Research Involving Biological Agents
- Human Subjects Research
- Research Using Nonhuman Animals
During the drafting process, FABBS communicated with Committee members to flag concerns about burdensome requirements for our scientists that came out of the National Institutes of Health (NIH) expanding its definition of clinical trials. If NIH embraces the advice to use uniform definitions of clinical trials and returns to the Food and Drug Administration’s (FDA) definition, it would be a welcomed development for many FABBS researchers whose work would no longer be classified as clinical trials, triggering unworkable registration and reporting requirements (see previous FABBS article).
The National Academies, while independent and not a federal agency, is greatly dependent on federal funds to conduct workshops, reports, and studies. Early in the second Trump Administration, NASEM leadership worked to reposition itself—and some might say preemptively—and respond to the stated goals of this administration. At the time of writing, NASEM had recently come under investigation by two House of Representatives Committees for being biased and championing liberal topics and perspectives.
