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TO RESP<~SInT~ C0NlIJCr OF RESEWED IN To Hi SCIENCES Report of a Study by a Committee on We Responsible Conduct of Research Indulge OF MEDICINE Division of HI Sciences Policy National Academy Press Washington, D. C. 1989
TRACE: me project that is the subject of this report was approved by me Gavernir~ ~ of me National ~a~ Orbit, - are drawn fmn the councils of the National Academy of Sciences, the National Academy of Engineering, and the Stitch of Medicine. me Hers of the camomile responsible for the Fort Woo those for their special Urgencies and with regarr] for appropriate Chance. His report has been reviewed ~ a group over than the authors according to prepares approved }fly a Export Purview C=nnitt~ cons~semg of namers of He National Academy of Sciences, the National Academy of Er~gin~ring, and He Institute of Medicine. m e Instibube of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the hearth of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an advisor to the federal government and its own initiative in identifying issue= of m~if~a~ cam, i, arm education. Smart for this project was provided by the National Institute of Health, ~artrent of Health am Human services pursuant to Contract No. NO1~7-2111. 2101 Constitution Avenue, N.W. Warn, D. C. 20418 (202) 334-2352 Publication IC~-89-01
INSlllUPE OF MEDICINE ~ FOR IlIE SlUDY ON THE RESE=SIRTF C~J~ OF RESEE AT H. ~NST~,* (Chairman), C~ainnan of Medicine, Un~versi~ of Chicago, Chicago, Illinois. WIT G. ANLYAN,* Chancellor for Heals Affairs, ~ Un~versi~r Medical Center, Durham, North Saliva. ME E. ALL, ExeaItive Editor, Be New Englar~ Journal of Medicine, Baton, ~ssadhuse~s. EDWARD HER, Airman of Sociology, Buzzard College, C301lmbia University, New York, New York. E=LIO. Q. I~O,* Attorney, Warn, D.C. JOSEEII M. DIXIE,* Widest, Searle Pesear~ arm Devela~nt, Skokie, Illinois. D~ASSI,* Professor of Chemistry, S~canford University, S~canford ~1 if ornia. PAUL J. PRO, Associate Tan of Ac:ad~nic Affairs, School of Medicine, University of - 1ifornia at San Diego, T^Tolla, =1 if ornia. Jl~ HALIIM, Airman of Microbiology and Penology, The Oregon Health sciences University, Portlarxt, Oregon. FRED ATE, Director, Media ~ Service, &ier~tists' Institute for Public Information, New York, New York. LINING K. ICIER, E-sident, Randolph Bacon Wc~nan's College, Erg, Virginia. WILLIAM F. MAY, retry M. MkGuire Professor of Ethic, Southern Methodist University, Dallas, Texas. CURTIS L. MEINERr, Professor of Epidemiology, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, Maryland. CHARIES G. MORE, Director of Cc mprehensive Cancer Center, Mayo Clinic, Rochester, Minnesota. *Member, Institute of Medicine . . . 111
HOWARD E. MORGAN,* Senior Vice President for Research, Geisinger Clinic, Da~ville, Pennsylvania. MARTIN F. SHAPIRO, Associate Professor of Medicine, University of California, Los Angel es, California. ROBERT A. WEINBERG, Associate Professor of Biology, The White head Institute for Bicmedica~ Research, Cambridge, Massachusetts. INSTITUTE OF MEDICINE SAMUEL 0. TH[ER, President RUTH FT TON EULGER, Director STAFF Division of Health Sciences Policy ROSEMARY CHALR, Study Director JAY STERNBE~G, Research Assistant (~y-October 1988) NACMI H. HUDSON, Administrative Assistant iv
- . ~ - ~ ~ACE: In 1985, We Resident of the Institute of Medicine (ICY) red its ED on Health Sciences Policy to advise him on a program that would respond to the Currency of misoondllct in bi~;c~1 Pea - I. The board cti~ruCc-~ this topic and concluded that the ICE! Should examine the subject in a context larger than the conduct of investigations into allegations of scientific fraud. m ose matters already were receiving widespread attention as a result of the development of federal regulations conacrnIng~research misconduct. m e board saw a need to identify the positive steps that could be taken to improve the conduct of research and to address types of scientific misconduct other than fraud. Subsequently, discussions were held with the National Institutes of Hearth (NIH) about areas of mutual concern in reference to possible misconduct that might not constitute fraud but would still represent potentially serious violations of prof~cciona1 norms in arctic of publication practice, recordkeeping, release of data, and other activities of hearth sciences research. In September 1987, the Institute of M~dicin~e initiated the project . . · · . . . to for which this is the report. ION appointed a 17-member committ== conduct a workshop and to develop recommendations that would assist NIH, other government agencies, prof-=cional societies and journals, and universities in formulating policies and procedures to improve the integrity and quality of biomedical research. m e committee was not asked to develop specific guidelines for the technical issues related to the conduct of research (such as the length of time that research data should be stored or retained) or to carry out a comprehensive study. Our study sought neither to improve research methodology nor to evaluate the technical quality of current individual research practices. The primary tank of the committee was the development of principles and proposals to guide both national and local institutions in strengthening the professional standards of academic research. Our concern was the moral and professional climate of the research environment, which influences everyday practice and sets the tone for future generations of regears hers. By improving the integrity and quality of the institutional environment of research, we sought to foster professional Des arch standards of individual researchers and to discourage future incidents of scientific misconduct. Quality in this sense refers to the rigor with which experiments are designed and carried out, statistical analyses performed, and results accurately recorded and reported, with credit given where it is due. Integrity In research means that the reporter results are honest and accurate arm are in keeping with generally accepted research practices. v
Error is accepted as part of the price of doing experiments research, but responsible investigators assume that when errors are detected they will be corrected by the publication of new findings. r Throughout this report we refer to terms such as lagoon research practices rt' listandards of research, Guidelines for the conduct of research,'" and so forth. ~ mese terms were used interrhang-~hly in both the committee dictions and in the workshop. They are synonymous, and The committee did not attempt to define them in detail. At some later point, we believe it will be important to clarify the meaning of concepts that are just beginning to emerge in the consideration of policies and procedures to encourage responsible research practices. This report summarizes the findings and recommendations of the committee following a your of discussion and analysis. The recommendations are based in part on ideas and proposals presented at a workshop on September 6-8, 1988, in Washlno ton, D.C. ~ ~ , ,~, , me works hop was cosponsored by the Institute of Medicine and the Academy's Committee on Science, Engineering, and Public Policy. The committee also commissioned two background papers and conducted, as part of the project, a limited review of selected government reports and research literature on scientific m~soon~uct, research quality, prof-~=iona] ethics, and deviance in science. The background papers included a review of the federal regulations establishing good laboratory practices, prepared by Sheila Jasanoff at Cornell University, and an analysis of scientific authorship and publication practices, prepared by Edward Huth, motor of-the Annals of Internal Medicine. _ . mese papers are not Included in the final report but are available fnum the National Academy Prep= upon request. The ccmmittee's findings and recommendations addr~cc the initial steps that should be taken to improve The responsible conduct of health sciences research in the American university system. me committed believes, however, that these insights and pectorals also will have value for other fields of research and other institutional settings. Arthur H. Einstein _ ~ Bern Committee on the Responsible Correct of ~s~ V1
C~P1~ l e C~sPIE~c 2 e C=PIE:R 3. CAMPIER 4. CHAP 5 e SENT DIP. A~ND~ A WO~:)P AT B LIST OF PAEt:LICIPAN~ (X)N~S SUMMON Purpose of the Study and P - roach Assertions arm Fir~i~3s P~ations HISIORY Professional arm University Efforts Ga~rer~ment Efforts enervations I: WO~P Key Issues ANALYSIS Assumptions are Fire R~F[ONS For the National =;titut~ of Hoff For Universities arm Other Rearm enters For Professional and Scientific Organizations and Journals C OPEL REPORT body Practices ~ SO Clinical Arch Stands and Practice= Institutional Oversight Education and Trainer for Rewash Academic arm Arm r Ant A~or~hip, Referee, and Publication Practices V11 1 2 3 6 7 9 13 14 14 17 17 23 23 29 36 43 46 59 60 62 68 75 78 83 87 93