New Report Identifies Policy Options to Improve Federal Research Regulations, Bolster U.S. Scientific Competitiveness

(National Academies of Sciences, Engineering and Medicine) The U.S. scientific enterprise has produced significant advances in the nation’s health, security, and prosperity, making the United States a global leader in science and technology. However, there is increasing concern that scientific and technological progress are being hampered by policies and regulations that are outdated, inconsistent, duplicative, or contradictory.

A new report from the National Academies of Sciences, Engineering, and Medicine presents 53 approaches for policymakers to consider that can improve current regulations and ease administrative burden on researchers.

While regulations are crucial to ensuring the highest ethical standards and safety in research, the current regulatory ecosystem has ballooned in recent years, hindering productivity and increasing costs for research institutions without sufficient gains. At a time when U.S. leadership in science, technology, engineering, medicine, and mathematics is being challenged globally, optimizing this system is critical to ensuring the research enterprise can provide the greatest benefit to the country.

“This is not a new problem, and we know much about how to solve it. The current policy climate is right to finally tackle this issue and unburden American scientists from excessive administrative requirements,” said committee chair Alan Leshner, chief executive officer emeritus of the American Association for the Advancement of Science and former executive publisher of Science.

Overarching Principles

The committee identified three overarching principles to underpin a new national strategy for a more efficient research regulatory framework.

To implement these principles, the report outlines options at a system-wide level and in seven research areas. Within each of these areas, the committee identified multiple problems in the current regulatory environment and proposed various options to address these, examples of which are provided here.

System-wide Change

Insufficiently centralized U.S. government oversight of the regulatory environment is a key issue driving the proliferation of burdensome regulations. Options to address this include creating a role within the White House Office of Management and Budget to coordinate cross-agency requirements; appointing a Federal Research Policy Board with input from both federal agencies and institutional representatives; and using the Federal Demonstration Partnership to explore innovative ideas and practices.

Human Subjects Research

Research involving human subjects is critical for developing lifesaving and other high-priority research, but a continued lack of harmonization across agencies can lead to unnecessary delays and hindrances. One potential policy option is to establish an interagency working group to align human subjects research policies, definitions, and review processes across agencies for ongoing coordination.

Protecting Research Assets

In this area, proposed policy options are categorized into three groups: research security, export controls, and cybersecurity and data management. One option is to amend the CHIPS and Science Act to make research security training mandatory only at the time of award and to provide flexibility in the frequency of the training. The committee noted that the NSF-funded Safeguarding the Entire Community of the U.S. Research Ecosystem (SECURE) Center could also be leveraged as a research security hub to ensure U.S. research assets are adequately protected.

Financial Conflict of Interest in Research

There is no standard policy for financial conflict of interest (FCOI) in research applied across funding agencies. Rather than having different FCOI thresholds across agencies, agencies could create a uniform FCOI policy or eliminate unnecessary reporting requirements that go beyond the federal standard of reporting noncompliance.

Grant Proposals and Management

In this area, the report identifies inconsistent and burdensome grant processes as a key issue. Options to address this include a single federal process for preparing and submitting proposals and leveraging AI-enabled tools to automate application and reporting systems.

Research Misconduct

Differing standards for research misconduct proceedings across agencies leads to confusion about investigation processes, definitions, and lack of clarity about the lead agency when multiple federal agencies are involved. Potential solutions include establishing a single, flexible federal misconduct policy that all agencies adhere to.

Research Involving Biological Agents

Multiple agencies oversee research involving biological agents, but complex and overlapping regulations cause unnecessary complexity and confusion. The federal government could adopt a more centralized approach that designates a single agency to coordinate this type of research and to tier guidance to the risk of the research, eliminating unnecessary oversight for low-risk research.

Research Using Nonhuman Animals

Research involving nonhuman animals is governed by multiple agencies with varied and sometimes contradictory policies. Options to remedy this include eliminating duplicative offices in different agencies and establishing a single agency or office to oversee the use of vertebrate animals in research.

The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, engineering, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln. READ MORE