Simplifying Research Regulations and Policies: Optimizing American Science (2025)
Chapter: Front Matter
Consensus Study Report
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This study was supported by contracts between the National Academy of Sciences and the Ralph J. Cicerone and Carol M. Cicerone Endowment for NAS Missions, and the Simons Foundation International. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2025. Simplifying Research Regulations and Policies: Optimizing American Science. Washington, DC: National Academies Press. https://doi.org/10.17226/29231.
The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.
The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. Tsu-Jae Liu is president.
The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.
The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.
Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.
Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer review process and it represents the position of the National Academies on the statement of task.
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COMMITTEE MEMBERS
DAVID SKORTON (Chair until May 22, 2025), Association of American Medical Colleges
ALAN LESHNER (Chair from May 22, 2025), American Association for the Advancement of Science (retired)
DAVID APATOFF, Arnold & Porter LLP (retired)
LINDA COLEMAN, Stanford University
KELVIN DROEGEMEIER, University of Illinois Urbana-Champaign
MELANIE L. GRAHAM, University of Minnesota
LISA NICHOLS, University of Notre Dame
JULIA PHILLIPS, Sandia National Laboratories (retired)
STACY PRITT, The Texas A&M University System
STUART SHAPIRO, Rutgers University
CHRISTOPHER VIGGIANI, Oregon State University
EMANUEL WADDELL, North Carolina Agricultural and Technical State University
STEPHEN WILLARD, ICaPath, Inc.
Study Staff
ALEX HELMAN, Study Director
ANDRÉ PORTER, Senior Program Officer
KATIE WULLERT, Program Officer
JOHN VERAS, Associate Program Officer
EMILY MCDOWELL, Research Associate
ANDREA DALAGAN, Senior Program Assistant
JORDAN GRAVES, Program Coordinator
TOM WANG, Senior Board Director
RIAN LUND DAHLBERG, Board Director
EMMA COSTA, Mirzayan Fellow
Consultant
JOE ALPER, Science Writer
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Reviewers
This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.
We thank the following individuals for their review of this report:
B. TAYLOR BENNETT, National Association for Biomedical Research
KEVIN GAMACHE, The Texas A&M University System
C.K. GUNSALUS, University of Illinois Urbana-Champaign
BRUCE MORGAN, University of California, Irvine
ELIZABETH PELOSO, University of Pennsylvania
KAREN PLAUT, Purdue University
CRAIG REYNOLDS, Van Andel Institute
JOHN ROSENTHALL, Tougaloo College Research and Development Foundation
MEGAN SINGLETON, Johns Hopkins University
JOANNE TORNOW, National Science Foundation
RUTH WILLIAMS, University of California, San Diego
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by DAVID ALLISON, Baylor College of Medicine, and CHERRY MURRAY, Harvard University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.
Acknowledgments
The committee would like to express its gratitude to the many individuals and organizations that made this report possible. First, the committee would like to thank the Ralph J. Cicerone and Carol M. Cicerone Endowment for NAS Missions and the Simons Foundation International for their sponsorship of this study.
The committee is deeply grateful for the many individuals who took time to contribute to the study process and inform the committee’s work by providing public testimony, submitting written comments to the request for information, answering questions, and helping the group to understand the scope of the issue and the needs for reform. Although space does not permit identifying them all by name, the committee could not have done its work without their critical contributions.
Finally, this report is only possible thanks to the dedication of the staff at the National Academies of Sciences, Engineering, and Medicine. The study team of Alex Helman, André Porter, Katie Wullert, John Veras, Emily McDowell, Andrea Dalagan, Rian Lund Dahlberg, Tom Wang, and Jordan Graves worked tirelessly to help the committee produce a report on such a short timeline. The committee also extends its thanks to Joe Alper for his writing and editing contributions throughout its work.
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Contents
STATE AND INSTITUTION-LEVEL REQUIREMENTS
MANY RECOMMENDATIONS FOR CHANGE
THE CURRENT PUSH TO REDUCE REGULATIONS
COMMITTEE APPROACH TO THE REPORT
REDUCING BURDEN AND OPTIMIZING SCIENCE
2 Options to Optimize the Research Enterprise
A NEW APPROACH TO RESEARCH REGULATIONS AND REQUIREMENTS
2-5 Option to Address the Uncertain Impact of New HHS Guidelines (Regulatory Area 2)
2-6 Options to Address the Inconsistent FCOI in Research Procedures (Regulatory Area 3)
2-7 Options to Address Research Security Compliance Issues (Regulatory Area 4)
2-8 Options to Address Export Controls (Regulatory Area 4)
2-9 Options to Address Cybersecurity and Data Management (Regulatory Area 4)
2-12 Options to Address Challenges with Implementing a Single IRB (Regulatory Area 6)
2-17 Options to Address Burdensome NIH OLAW Requirements (Regulatory Area 7)
Preface
The world needs a strong science enterprise now more than at any time in history. Virtually every major issue confronting society has a scientific component to it, either as a cause or a cure, and America has long been among the best in the world at using science to tackle important issues. Maintaining that global eminence has required substantial public trust and financial investment that has been reliable and stable since World War II, and it has paid off handsomely for the United States. Appropriately, along with that trust and investment have come obligations on the part of the scientific enterprise to be transparent in accounting for the responsible use of the funds it receives and to ensure the work is conducted at the highest level of integrity.
However, as the number of federal agencies that support scientific research has grown, and as the science evolves to require new areas of oversight, federal requirements have proliferated, and the workload for researchers, their institutions, and the agencies that fund the research projects have increased to the point of being nearly unmanageable. If this proliferation were only the result of increasing need for oversight, it would be warranted. Instead, federal requirements have become more complex, duplicative, and even contradictory in ways that lead to a more limited gain in productivity and a heavy tax on the time researchers can devote to science. According to the Federal Demonstration Partnership, more than 40 percent of a scientist’s research time is now spent on administrative requirements. There is widespread agreement that this proportion is too high, is inhibiting the
progress of science, and is therefore limiting return on public investment and benefits to society.
This is not a new problem, and we know much about how to solve it. Conversations about administrative workload were happening when I was a faculty member more than 40 years ago. The issue followed me to my role as an institute director at the National Institutes of Health in the 1990s, when our grantees, who needed to submit proposals to multiple agencies to ensure support in the face of tight funds, had to waste research time rewriting their proposals to meet the idiosyncratic format preferences of each agency. It was still an important issue when I was CEO of the American Association for the Advancement of Science, and I even wrote an editorial calling for a reduction in administrative burden in 2008.1 Many organizations have weighed in on this issue since, yet it is telling that I am chairing a study on this same topic in retirement. Few recommendations from previous reports have been implemented, and only a small amount of progress has been made reducing the administrative overload for the nation’s scientific enterprise.
It is true that the societal context for science has become more complex over the years, and there are more issues that both need and deserve attention. But those changes cannot account for all the added rules, policies, and reporting requirements. There is clear agreement from all the existing analyses that some administrative requirements are overly detailed and that there is too much variation in the ways different agencies approach the same concerns. Much could be accomplished by streamlining reports to agencies, developing common formats for proposals and reports, reducing unnecessary redundancies, and adopting a philosophy of regulating only when there is clear risk to prevent. As I wrote in 2008, “an ideal goal would be for every science-related rule or regulation to be rationalized and streamlined. As a group, they should be integrated as much as possible to reduce unnecessary duplication.”1
This report takes a different approach from earlier National Academies of Sciences, Engineering, and Medicine studies and others on this issue. Like other analyses, it first identifies the major problem areas requiring policy or regulation reform, but then, rather than making a single recommendation about how to deal with each problem, we offer alternative ways to approach the issue. Any of the options chosen would result in significant progress in reducing the administrative workload on researchers and their
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1 Leshner, A. I. 2008. Reduce administrative burden. Science 322(5908):1609.
institutions, as well as on the agencies that fund them. We hope this menu will help agencies more easily find the right approaches for them and will stimulate action—something that is challenging but also of tantamount importance at a time of significant reductions to the federal workforce. Critically important, those efforts must be well coordinated across agencies, or the resulting redundancies will offset any progress.
Our nation has never needed the science enterprise to operate at full steam as much as it does now for our health, security, and prosperity. The time is right for streamlining the rules, policies, and requirements that keep that from happening.
During its work, the committee has consulted with numerous individuals and organizations who enthusiastically contributed their thoughts and ideas. We are grateful to them all. We also benefited greatly from the work of the superb and expert staff of the National Academies involved in this project. The project would not have been completed without their efforts, expertise, and wisdom.
Alan I. Leshner
Chair, Committee on Improving Regulatory
Efficiency and Reducing Administrative
Workload to Strengthen Competitiveness and
Productivity of U.S. Research
September 2025
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Acronyms and Abbreviations
| ACURO | Animal Care and Use Review Office |
| AI | artificial intelligence |
| API | application programming interface |
| BMBL | Biosafety in Microbiological and Biomedical Laboratories |
| CCL | Commerce Control List |
| CDC | Centers for Disease Control and Prevention |
| CHIPS | Creating Helpful Incentives to Produce Semiconductors for America |
| COC | conflict of commitment |
| COGR | Council on Governmental Relations |
| COI | conflict of interest |
| CUI | Controlled Unclassified Information |
| DOD | Department of Defense |
| DOE | Department of Energy |
| DURC | dual-use research of concern |
| EO | Executive Order |
| FCOI | financial conflict of interest |
| FDA | Food and Drug Administration |
| FDP | Federal Demonstration Partnership |
| GAO | Government Accountability Office |
| GOF | gain of function |
| HHS | Department of Health and Human Services |
| HIPAA | Health Insurance Portability and Accountability Act |
| HRPP | Human Research Protection Program |
| IBC | Institutional Biosafety Committee |
| IRB | Institutional Review Board |
| LOI | letter of intent |
| NIH | National Institutes of Health |
| NIST | National Institute of Standards and Technology |
| NOFO | Notice of Funding Opportunity |
| NSDD | National Security Decision Directive |
| NSF | National Science Foundation |
| NSPM-33 | National Security Presidential Memorandum-33 |
| NSTC | National Science and Technology Council |
| OFAC | Office of Foreign Assets Control |
| OIRA | Office of Information and Regulatory Affairs |
| OLAW | Office of Laboratory Animal Welfare |
| OMB | Office of Management and Budget |
| ORI | Office of Research Integrity |
| OSTP | Office of Science and Technology Policy |
| PHI | protected health information |
| PHS | Public Health Service |
| PID | persistent identifier |
| SciENcv | Science Experts Network Curriculum Vitae |
| SECURE | Safeguarding the Entire Community in the U.S. Research Ecosystem |
| SFI | significant financial interest |
| USDA | Department of Agriculture |
| USG | U.S. Government |
| USML | United States Munitions List |
| VA | Department of Veterans Affairs |
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