Workgroups composed of representatives of the research community were formed to identify instances of regulatory burden of concern to them in a structured manner. Several research professional organizations assisted in identifying a broad spectrum of potential participants for these professionally facilitated workgroups. Participating in the effort to identify potential members were Applied Research Ethics National Association (ARENA), the Association of American Medical Colleges (AAMC), the Association of American Universities (AAU), the Association of Independent Research Institutions (AIRI), the Council on Governmental Relations (COGR), the Federal Demonstration Partnership (FDP), the Federation of American Societies for Experimental Biology (FASEB), the Government-University-Industry Research Roundtable (GUIRR), and Public Responsibility in Medicine and Research (PRIM&R). With the assistance of these organizations a workgroup was formed for each of the five subject areas, with the exception of Human Subjects Protections. In that case, two workgroups were formed. One was formed with representatives from institutions that perform a mid-to-high volume of human subjects research; another, with representatives from institutions performing a low-to-mid volume. Two were formed because there is some evidence that institutions’ Institutional Review Boards may be organized and operated differently, depending on the numbers of protocols that must be reviewed.

Each workgroup was composed of approximately 10 members of the research community. In forming each, care was taken to include both active researchers as well as officials having institutional responsibility for the enforcement of Federal regulations. This diversity is necessary to capture the perspective both of those performing the research and those charged with developing, implementing and overseeing the administration of these regulatory programs.

The day-long agenda for each workgroup was the same. This format had been established, in advance, by a Planning Workgroup composed of one or two members from each subject-specific workgroup to assure that a common approach was followed. Each workgroup was professionally facilitated and was asked, at the outset, to identify the objectives and the protections that the system of regulation should accomplish if it is to be successful. Then, within the overall context of these objectives and protections, they were asked to identify potential aspects of the regulatory process that could be streamlined. Once these items were identified, workgroup members were asked to identify potential solutions to the issues. About mid-way through the day, the members met with key officials who administer the specific regulations under review, to better understand the Federal perspective, and to explore opportunities for change with them.

The regulations under examination are administered by multiple Federal agencies. While the specific request came from the Appropriations Subcommittee that oversees the activities of NIH and most of the agencies of its parent organization, DHHS, it was not always possible to assess the regulatory burden of the NIH/DHHS regulations without assessing the regulations of the other agencies involved because of the considerable overlap. In those cases, the workgroup was asked to identify specific aspects of this larger set of regulatory programs that could be made more efficient and to propose solutions for the issues that were identified.

For the purpose of this effort, regulatory burden was defined as any aspect of the Federal legislation, regulation, or policy, or Federal/research institution practices that could be made more efficient without diminishing the intended level of protections. This definition recognizes that regulatory burden may arise from a variety of sources. It may be the result of restrictive Federal legislation, regulations, policies or practices that ultimately force requirements considered to be burdensome by the research community. An additional level of complexity is added when there are conflicting legislation, regulations, or policies administered by multiple Federal agencies, by Federal and State agencies, or by different components within the same agency. Burden also may result from ineffective or inefficient practices by the research institution in administering the system of regulation imposed by Federal organizations.

Finally, it should be noted that the purpose of the workgroups was not necessarily to come to consensus. While there was general agreement on the issues and the proposed solutions, there was not necessarily unanimity on each. The issues and solutions identified by each of the workgroups, is presented as sections III through VII of this Report. The membership of each group follows in this Appendix. The members of the Planning Workgroup merit special recognition and they are denoted on the listings.

Conflict of Interest - Workgroup Participants

Donald Baldwin
Assistant Provost for Research
Office of Research
University of Washington

Gary Isom
Associate Vice President and
Professor of Toxicology
Sponsored Program Development
Purdue Research Foundation
Purdue University

Joyce Jentoft *
Associate Provost and
Dean of Graduate School
School of Medicine
Case Western Reserve University

Russ Lea
Associate Vice Chancellor for
Research Administration
North Carolina State University

Anthony Merritt
Director of Sponsored Programs
University of Pennsylvania
Mary Ellen Sheridan
Assistant Vice President for Research
University Research Administration
University of Chicago

Barbara Siegel
Director, Office of Research and
Sponsored Programs
Northwestern University

Sharon Sumpter
Administrator
Seattle Biomedical Research Institute

Delia Talamentez
Director, Conflict of Interest Office
University of California, San Diego

Frederic Y. M. Wan
Vice Chancellor for Research and
Dean of Graduate Studies
University of California, Irvine

* Denotes member of Planning Workgroup.

Research Integrity - Workgroup Participants

Mark Brenner *
Vice Chancellor for Research and Graduate Education
Indiana University Purdue University

David Kauffman
Departments of Pathology/Lab Medicine
University of North Carolina

Ronald S. Newbower
Senior Vice President for Research and Technology
Massachusetts General Hospital

Julie Norris
Director, Office of Sponsored Programs
Massachusetts Institute of Technology

Robert Rich *
Executive Associate Dean
School of Medicine
Emory University

Garrett Sanders
Assistant Vice President for Research
SUNY at Albany

S. Andrew Schaffer
Senior Vice President and
General Counsel
New York University
Eleanor Shore
Dean of Faculty Affairs
Harvard University
John Slattery
Associate Dean for Academic Programs Director, Office of Scholarly Integrity
University of Washington
Kenneth P. Trevett
Chief Operating Officer and
General Counsel
Schepens Eye Research Institute

* Denotes member of Planning Workgroup.

Human Subjects Protection - Workgroup Participants (Mid to High-Volume Institutions)

Richard Atkinson
Academic Program Director and
Professor of Medicine
University of Wisconsin

Gary Chadwick *
Clinical Associate Professor of Medical Humanities and
Executive Director for the Research Subjects Review Board Office
University of Rochester School of Medicine and Dentistry

Barbara Echols
Assistant Vice Chancellor for Academic Affairs
Duke University Medical Center

R. Peter Iafrate
Director, Pharmacy at Shands at AGH
University of Florida

Philip Ludbrook
Professor of Medicine
Washington University

Helen McGough
Manager, Human Subjects Division
University of Washington

Judith Nowack *
Assistant Vice President, Research
University of Michigan

Gwenn S. F. Oki
Director, Research Subjects Protection
City of Hope National Medical Center and
Beckman Research Institute

Lucille Pearson
Director, Human Subjects Program
University of California, San Diego

Ada Sue Selwitz
Director, Sponsored Program Development
University of Kentucky

* Denotes member of Planning Workgroup.

Human Subjects Protections - Workgroup Participants (Low to Mid-Volume Institutions)

Warren K. Ashe *
Associate Dean for Research
Howard University

Jeffrey M. Cohen *
Research Compliance Officer
SUNY Albany

Ed Conradi
IRB Chair
Medical University of South Carolina

Louise Griffin
Director, Grants & Contracts
University of Massachusetts/Lowell

Karen Hansen
Institutional Review Administrator
Fred Hutchinson Cancer Research Center

Susan Kornetsky
Department of Clinical Investigations
Children’s Hospital
Boston, MA

Robert M. Nelson
Associate Professor of Pediatrics and Bioethics
Medical College of Wisconsin

Gabriel Radvansky
Assistant Professor, Psychology
University of Notre Dame

Ardis Savory
Associate Vice Provost, Sponsored Programs and Research
University of South Carolina

* Denotes member of Planning Workgroup.

Animal Care and Use - Workgroup Participants

Ted Cicero *
Vice Chancellor for Research
Washington University School of Medicine

Ralph Dell
Executive Director, ILAR
National Academy of Sciences

Melvin Dennis
Professor and Chairman, Department of Comparative Medicine
School of Medicine
University of Washington

Molly Greene *
Executive Assistant to the Vice President
University of Texas Health Science Center

J.R. Haywood
Department of Pharmacology
University of Texas Health Science Center

Tanise L. Jackson
Director, Animal Research Facility
Florida A&M University

Marky Pitts
Director, Animal Subjects Program and
Director, Animal Research Information
University of California, San Diego

Steven Schiffer
Director, Division of Comparative Medicine and
Associate Professor, Department of Cell Biology
Georgetown University

Walter M. St.-John
Department of Physiology
Dartmouth-Hitchcock Medical Center

John L VandeBerg
Scientific Director
Southwest Foundation for Biomedical Research

* Denotes member of Planning Workgroup.

Hazardous Waste Disposal - Workgroup Participants

Bruce Backus
Director, Environmental Health and Safety
Washington University

Stephen Benedict
Director, Environmental Health and Safety Department
Fred Hutchinson Cancer Research Center

Janet Greger *
Associate Dean for Research
University of Wisconsin - Madison Medical School

Brian Hales
Chair, Department of Chemistry
Louisiana State University

Suzanne Howard
Director, Environmental Health and Safety
Boston College

Gordon Kaye
Alden March Professor of Pathology and Laboratory Medicine and
Chairman, Waste Reduction by Waste Reduction, Inc.
Troy, NY

David Rainer *
Director, North Carolina State University Environmental Health and Safety Center
North Carolina State University

David Silberman
Director of Health and Safety Programs, School of Medicine
Stanford University

Karen VanDusen
Director, Environmental Health and Safety Department
University of Washington

* Denotes member of Planning Workgroup.