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Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
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OCR for page R1
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
OCR for page R2
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
OCR for page R3
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
OCR for page R4
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
OCR for page R5
- . ~ -
~ ~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
OCR for page R6
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
OCR for page R7
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
OCR for page R8
