A Review of
NASA Human Research Program’s
Scientific Merit
Assessment Processes

Letter Report

Committee on the Review of NASA Human Research
Program’s Scientific Merit Assessment Processes

Board on Health Sciences Policy

James A. Pawelczyk, Larisa M. Strawbridge,
Andrea M. Schultz, and Catharyn T. Liverman, Editors

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
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A Review of NASA Human Research Program’s Scientific Merit Assessment Processes Letter Report Committee on the Review of NASA Human Research Program’s Scientific Merit Assessment Processes Board on Health Sciences Policy James A. Pawelczyk, Larisa M. Strawbridge, Andrea M. Schultz, and Catharyn T. Liverman, Editors

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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was requested by the National Aeronautics and Space Administration and supported by Award No. NNH08CC26B, Task Order 3, between the National Academy of Sciences and the National Aeronautics and Space Administration. Any opinions, finding, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-26050-3 International Standard Book Number-10: 0-309-26050-7 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2012 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2012. A review of NASA Human Research Program’s scientific merit assessment processes: Letter report. Washington, DC: The National Academies Press.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON THE REVIEW OF NASA HUMAN RESEARCH PROGRAM’S SCIENTIFIC MERIT ASSESSMENT PROCESSES JAMES A. PAWELCZYK (Chair), Pennsylvania State University MICHELLE H. BIROS, University of Minnesota Medical School DIVYA CHANDRA, Volpe National Transportation Systems Center, Department of Transportation IAN D. GRAHAM, University of Ottawa CHAVONDA JACOBS-YOUNG, Agricultural Research Service, U.S. Department of Agriculture KATHIE L. OLSEN, ScienceWorks, LLC TERRY M. RAUCH, Office of the Assistant Secretary of Defense for Health Affairs, Department of Defense SALLY J. ROCKEY, Office of the Director, National Institutes of Health CAROL E. H. SCOTT-CONNER, University of Iowa Hospitals and Clinics PETER SUEDFELD, University of British Columbia IOM Staff CATHARYN T. LIVERMAN, Project Director ANDREA M. SCHULTZ, Project Director LARISA M. STRAWBRIDGE, Research Associate JUDITH L. ESTEP, Program Associate ANDREW M. POPE, Director, Board on Health Sciences Policy v

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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its pub- lished report as sound as possible and to ensure that the report meets in- stitutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confi- dential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: David F. Dinges, University of Pennsylvania Karl Friedl, U.S. Army Medical Research and Materiel Command James Lightbourne, National Science Foundation Adrian Mota, Canadian Institutes of Health Research Sharlene C. Weatherwax, Department of Energy Laurence R. Young, Massachusetts Institute of Technology Although the reviewers listed above have provided many construc- tive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by David Longnecker, Association of American Medical Colleges. Ap- pointed by the Institute of Medicine, he was responsible for making cer- tain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments vii

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viii REVIEWERS were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Contents ACRONYMS xi LETTER TO NASA 1 DIRECTED RESEARCH AT THE NASA HUMAN RESEARCH PROGRAM 4 OVERALL ASSESSMENT 6 IDENTIFYING DIRECTED RESEARCH 7 Findings, 11 Recommendations, 12 SCIENTIFIC MERIT ASSESSMENT PROCESS 13 Merit Assessment Criteria, 13 Processes Used to Conduct Scientific Merit Assessment, 14 Length of Peer Review, 16 Findings, 16 Recommendation, 18 EVALUATION AND QUALITY IMPROVEMENT 19 Findings, 22 Recommendation, 22 SUMMARY 23 REFERENCES 25 ix

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x CONTENTS APPENDIXES A Workshop Agenda and List of Participants 27 B Committee Biosketches 35

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Acronyms ARS Agricultural Research Service (USDA) BAA broad agency announcement CIHR Canadian Institutes of Health Research DARPA Defense Advanced Research Projects Agency DOD Department of Defense DOE Department of Energy EAGER EArly-concept Grants for Exploratory Research (NSF) FAA Federal Aviation Administration HRP Human Research Program (NASA) IOM Institute of Medicine IRB institutional review board MIT Massachusetts Institute of Technology NASA National Aeronautics and Space Administration NIH National Institutes of Health NOAA National Oceanic and Atmospheric Administration NSF National Science Foundation xi

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xii ACRONYMS OER Office of Extramural Research (NIH) QI quality improvement RAPID Rapid Response Research (NSF) RFA request for applications RFP request for proposals SAIC Science Applications International Corporation UPCG Unique Processes, Criteria, and Guidelines (NASA) USDA U.S. Department of Agriculture VA Department of Veterans Affairs