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Committee on Science and Innovation Leadership for the 21st Century: Challenges and Strategic Implications for the United States
3rd Meeting
February 11-12, 2020
Washington, DC

Committee on Science, Technology, and Law

39th Meeting
March 9-10, 2020
Pasadena, CA

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Committee on Science, Technology, and Law
The National Academies of Sciences, Engineering, and Medicine
Keck Center, Room 570
500 Fifth Street, NW
Washington, DC 20001
Tel: 202 334-1713

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Final Research Regulations Report CoverOptimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century reviews the federal regulatory framework for research institutions as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. The report identifies specific actions Congress, the White House, federal agencies, and research institutions should take to reduce regulatory burden. It urges Congress to create a public-private Research Policy Board to support the federal-academic research partnership and cooperative efforts to streamline research policies going forward, calls upon universities to demand the highest standards in institutional and individual behavior, and recommends a number of specific actions that are intended to improve the efficiency and harmonization of federal regulation and to reduce duplication.

Project Scope

An ad hoc committee under the auspices of the Committee on Science, Technology, and Law (CSTL) and the Board of Higher Education and Workforce (BHEW) will conduct a study of Federal regulations and reporting requirements with specific attention to those directed at research universities.  In conducting its analyses the committee will be aware of (a) the context and intended benefits and circumstances under which a particular regulation was issued and may have evolved, and (b) whether those contexts or circumstances still remain of public concern. The committee will develop a new framework for Federal regulation of research universities in the 21st century that addresses the needs of Congress, Federal agencies, and the broader public while advancing to the maximum extent feasible the missions of research universities.

Specifically, the committee will: 1) Identify by research agency and statutory authority the Federal regulations with significant impact, and the reporting requirements with which research universities must comply; 2) Work with research universities and associations to gather and review information on personnel time and costs of compliance with Federal regulations and reporting requirements; 3) Work with research universities and associations to gather and review information on methodologies for most efficiently and effectively estimating time, costs and resulting benefits;4) Work with federal research agencies to identify key regulations and requirements with significant impact that the committee should review; 5) Work with professional staff of congressional committees with jurisdictional responsibility for regulatory oversight and research funding; 6) Work with the stakeholders such as the Federal Demonstration Partnership to demonstrate methodologies for estimating the personnel time and costs of compliance for a subset of regulations and reporting requirements specific to research universities; 7) Develop a framework and supporting principles for the Federal regulation of research universities in the 21st century, taking into account: (a) the purposes, costs, benefits, and reporting requirements of regulation, (b) the processes used to promulgate regulations and reporting requirements, (c) the roles of Congress, Offices of Inspectors General and Federal agencies, including the Office of Science and Technology Policy and the Office of Management and Budget, and (d) the missions of research universities; 8) Recommend steps needed to implement the framework; 9) Assess how a subset of regulations and reporting requirements fit within the framework, and offer suggestions for evaluating those regulations and reporting requirements that are outdated or redundant, or where compliance burdens have become disproportionate with expected benefits; and 10) Identify regulations and reporting requirements that will require additional analysis in order to assess their fit with the framework and to develop improved approaches.

  Project Information  

Project Scope
Meetings and Events

Anne-Marie Mazza, Ph.D.
Senior Director, Committee on Science, Technology, and Law
Phone: 202-334-2469

Thomas Rudin
Director, Board on Higher Education and Workforce
Phone: 202-334-1596

Steven Kendall, Ph.D.
Program Officer, Committee on Science, Technology, and Law
Phone: 202-334-1713

Karolina Konarzewska
Program Coordinator, Committee on Science, Technology, and Law

Meetings & Events

This website contains unedited verbatim presentations made by meeting participants and is not an official report of the National Academies of Sciences, Engineering, and Medicine. Opinions and statements included in this material are solely those of the individual authors. They have not been verified as accurate, nor do they necessarily represent the views of other participants, the committee, or the National Academies.

1st Meeting

February 12-13, 2015
Washington, DC



*Arthur I. Bienenstock, "Reducing Investigators’ Administrative Workload for Federally-Funded Research"
*Yvette R. Seger, "Regulations and Reporting Requirements for Biological and Medical Research: Findings from FASEB’s Survey on Administrative Burden"
*Heather H. Pierce, "Measuring and Addressing Regulatory Burden"
*Cynthia Hope, "The Federal Demonstration Partnership"

2nd Meeting
April 16-17, 2015
Washington, DC



*Ann Bartuska, "USDA Uses of Reporting"
*Linda G. Blevins and Michael S. Zarkin, "DOE Office of Science Financial Assistance Regulations and Reporting Requirements"
*Thomas A. Burke, "NAS Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century"

3rd Meeting
May 28-29, 2015
San Francisco, CA 



*Keith Yamamoto, "Building a 21st Century Research Enterprise: Roles of the Research University; Where We Are, Where We Could Be, What It Will Take to Get There, Why It Matters"
*Wendy Streitz, "Federal Research Regulations: From a Systemwide Perspective"
*Cindy Kiel, "University of California at Davis Office of Research Regulatory Burden Presentation"
*Richard Seligman, "Presentation to the National Academies Committee on Federal Research Regulations and Reporting Requirements"
*Mary Lidstrom, "Federal Research Regulations and Reporting: University Perspective"
*Steven Beckwith, "Federal Regulations on Research"
*Randy Livingston, "Perspectives on Federal Research Regulations and Reporting Requirements"

4th Meeting
July 6-8, 2015
Woods Hole, MA

Meeting closed in its entirety.

5th Meeting
July 21-22, 2015
Washington, DC



*Brett Sweet and Tejus Kothari, "Vanderbilt University Federal Regulatory Cost Burden Study Overview Discussion"
*Sally J. Rockey, "Research Regulation at the NIH"'
*Gilbert Tran, "The Future is NOW, the New Uniform Guidance 2 CFR 200"
*Christian E. Newcomer, "AAALAC International: Perspectives on Regulatory Burden"
*Sarah Kiskaddon, "Accreditation: Establishing an Infrastructure to Allow for Flexibility and Efficiency"
*Kimberly Orr, "Commerce Export Controls Impacting University Research"

6th Meeting
October 29-30, 2015



*Barbara Evans, “The Need for Intelligible Principles to Guide Federal Research Regulations
*John Cornwell, “Human Subjects Research & The Common Rule
*Ellen Wright Clayton, “Biospecimens and Data in the Proposed Changes to the Common Rule
*Gerald Epstein, “Overview of Policy for Dual Use Research of Concern”
*James W. Le Duc, “Select Agents
*David Ivey, “Perspectives on Challenges/Problems in Export Control Compliance
*Amy McGuire, “(Genomic) Data Sharing, Privacy, and Academic Research
*Laura Beskow, “Patient Perspectives on Research Use of Electronic Health Records”
*Jilda Garton, “Managing University Technology Transfer (Intellectual Property, Material Transfer Agreements, Licensing)”
*Valerie McDevitt, “AUTM U.S. Licensing Activity Survey: FY2014

7th Meeting
January 14-15, 2016
Washington, DC


*Jeffrey R. Botkin, "Reforming the Human Subjects Oversight System"


Optimizing the Nation's Investment in Academic Research, A New Regulatory Framework for the 21st Century was released at a public briefing on June 29, 2016. 

View Webcast

News Release 



Larry R. Faulkner
President Emeritus
The University of Texas at Austin


Harriet Rabb
Vice President and General Counsel
The Rockefeller University


Ilesanmi Adesida (NAE)
Vice Chancellor for Academic Affairs and Provost
University of Illinois at Urbana-Champaign

Ann Arvin
Lucile Salter Packard Professor of Pediatrics and Professor of Microbiology & Immunology
Stanford University School of Medicine
Vice Provost and Dean of Research
Stanford University

Barbara E. Bierer
Faculty Co-chair
Multi-Regional Clinical Trials Center
Harvard University (Harvard MRCT) and
Professor of Medicine

Harvard Medical School and Brigham and Women’s Hospital

Jonathan D. Breul
Adjunct Professor
McCourt School of Public Policy
Georgetown University

Claude Canizares (NAS)
Bruno Rossi Professor of Physics
Massachusetts Institute of Technology

Arturo Casadevall (NAM)
Professor and Chair, Department of Molecular Microbiology and Immunology
Johns Hopkins University Bloomberg School of Public Health

Jonathan R. Cole
John Mitchell Mason Professor, Provost, and Dean of Faculties
Columbia University

Lee Ellis
Professor of Surgical Oncology and Molecular and Cellular Oncology and the William C. Liedtke, Jr. Chair in Cancer Research
The University of Texas MD Anderson Cancer Center

Geoffrey E. Grant
Research Advocates

Joseph R. Haywood
Assistant Vice President for Regulatory Affairs and
Professor of Pharmacology and Toxicology
Michigan State University

Steven Joffe
Emanuel and Robert Hart Associate Professor of Medical Ethics and Health Policy
University of Pennsylvania Perelman School of Medicine

David Korn (NAM)
Professor of Pathology
Massachusetts General Hospital and Harvard Medical School

Charles F. Louis
Professor of Cell Biology and Neuroscience and former Vice Chancellor for Research
University of California, Riverside

David W. Robinson
Professor and Executive Vice Provost   
Oregon Health and Science University 

Thomas J. Rosol
Professor, Veterinary Biosciences; Senior Advisor, Life Sciences, University Office of Technology Commercialization and Knowledge Transfer; and Special Assistant to the Vice President for Research
The Ohio State University 

Stuart Shapiro
Associate Professor and Director, Public Policy Program
Edward J. Bloustein School of Planning and Public Policy
Rutgers University


This project was sponsored by the U.S. Department of Education and by the National Institutes of Health.