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OCR for page 6
.
CHAPTER 2
HIsIoRY
Many ag ~ cies and organizations have recently di ~ the policies
and procedures that government, universities, and other~research
organizations should develop to d~1 with complaints of scientific
misconduct. However, insufficient attention has been given to
identifying and encouraging practices that will promote responsible and
honest science. The purpose of this report is to foster these practices
and to identify next steps that can be taken by various components of
the research system to improve the quality and integrity of research in
the health sciences.
Quality in this sense refers to the rigor with which experiments are
designed and carried out, statistical anal. performed, and results
accurately recorded and reported, with credit given where it is due.
Integrity in research means that the reported results are honest and
accurate and are in keeping with generally accepted research practices.
Error is accepted ~ part of the price of doing experimental research,
but responsible investigators assume that when errors are detected they
will be corrected by the publication of new findings.
Discussions of integrity and quality in research have led the
research community and others to examine more closely the reliability
and effectiveness of the current mix of formal and informal practices
and procedures in promoting a healthy research environment. Many
organizations are now seeking to define appropriate guidelines that
should govern scientific research and the principles that should be
observed by individual m castigators and trainees in day-to-day
practice.
Over the past decade misconduct in research has attracted increasing
attention f ram the press, the public, the Congress, and the academic and
research communities. This attention was initially drawn by a few
highly publicized instances of data fabrication, plagiarism, and
misrepresentation, such as the incidents involving John Long at
Massachusetts General Hospital, Vijay So man at Yale University, and Mark
Spector at Cornell University (Broad and Wade, 1982~. Because many of
theme cases involved federal research funds and prestigious
institutions, congressional hula rings were convened in 1981 to review the
policy implications of scientific fraud (U.S. Congress, 1981). During
these hearings, representatives of the scientific community claimed that
incidents of scientific fraud were rare, that existing mechanisms were
adequate to Bead with these events, and that there was no near for
additional policies or procedures to ensure the integrity of federally
funded biomedical research.
Shortly after these hearings, new cases of serious scientific
misconduct came to light. m e handling of these cases, involving John
OCR for page 7
Darsee at Harvard Medical School, Marc Strauss at Boston University, and
others, raised new questions about the ability of academic institutions
to conduct Objective investigations of m~soonduct by their own faculty
members or research staff.
PROFESSIONAL AND UWIVERSIrY EITC~S
In October 1981, the Association of American Universities (AAU)
established a Committee on the Integrity of Research, chaired by William
H. Danforth, chancellor of Washington University. The charge to the
conic star:
Incidents of m~soon~uct which raise concern about ~ntaaritY in
scientific research have come to cur attention.
such instances to be rare for such a large enterprise as university
research, even rare occurrences are unacceptable.
_
Although we believe
m e AAU therefore recognizes a need for universities to collaborate
with ~rofecciona' societies and related organizations in the
_
~ ~ . ~ , a ~ _ , _
exam m arlon or roe sources or suan problems and remeoles available
to them (AAU, 1983).
m e report of the A~U Committed on the Integrity of Research was
published in 1982. It affirmed the principle of self-requlation in
maintaining the integrity of the academic researr h process. m e
committee concluded, however' that informal and quiet efforts to deal
with intellectual dishonesty were no longer acoept~hie: "Although these
methods may have generally worked well in the rant, experience suggests
that it is now appropriate to give serious thought to better methods for
preventing and detecting irregularities and to the manner in which
universities deal with them" (AAU, 1983).
m e A~U committee recommended that all academic research
institutions develop policies and procedures to ensure a high standard
of ethical behavior for researchers, to define mechanisms for dealing
with suspected deviations four intellectual honesty, and to warn of
available sanctions. m e report was approved by the AAU., the American
Council on Education, an] the National Association of State Universities
and land Grant Colleges. Ibe report was dissŁ~minat~ to a broad
audience of university administrators, p~vf~sional society ark
government officials, and others;, but the sc~cie~r did not correct a
systematic iffy to evaluate the response of the university unity
to its rations.
In January 1982, he Association of American Medical Colleges (AA =)
appointed an ad hoc Committ^= on the M~ntenanoe of High Ethical
Standards in the Conduct of Research. Chaired by Julius R. Krevans,
then dean of the Medical School of the University of California at San
Francisco, the AAMC committed reaffirmed the responsibility of research
faculties and their institutions to maintain research standards and to
7
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investigate allegations of scientific m~s~r~ucL. The guidelines and
rations set forth ~ e cc~mmi~ report were adopted by AAMC
In June 1982 as a guide for the faculties of ~;c~1 schools and
t~6hj~ hospitals to assist then in probing the integrity of the
bill 1~ enterprise (AAMC, 1982~.
The AAMC report reccmmended nine elements, including an explicit
mechanism for dealing with allegations of misconduct; policies on
openness of research; policies to assure that quality rather than
quantity of publications be emphasized in prcmotion-decisions; and
policies to ensure appropriate supervision of research teams.
Despite these initiatives by professional organizations, only a
small number of research institutions made a systematic effort in the
- =rly 1980s to develop written policies or procedures to handle cases of
scientific misconduct. A survey conducted from 1982-1984 by Penelope
Greene and her colleagues at Harvard University reviewed the policies
and prccedur-= adopted by universities following the ALEC report (Greene
et al., 1985). Almost 500 institutions responded to the Greene survey.
Of this number, about 25 percent (116) had adopt Ed rule= for dealing
with allegations of misconduct; another 25 percent (124) had no such
rules. More than half of the respondents indicated that they were
formulating prcce~ur~ at the time of the survey. About half of the
institutions that had adopted policies at the time of the Greene survey
indicated that they had used the AAMC recommendations in developing
their misconduct rules.
Mast academic institutions appeared to believe that the problem of
scientific misconduct did not deserve policy or procedural guidelines
and that existing faculty disciplinary mechanisms were adequate to
handle the problem if it Should arise on their campus.
Other national organizations have since prepared materials to
educate young scientists on the responsible conduct of research. The
best known among these efforts is the report Honor In Science, published
by the research honorary society Sigma Xi (Sigma Xi, 1986). m is
42-page booklet offers "practical advice to those entering careers In
scientific research" and sets forth clearly and informally the basic
principles of intellectual honesty In science.
At the local level, a few universities formed faculty committees in
the m~d-1980s to promote research integrity and to discourage scientific
misconduct. The University of Michigan, for example, published a report
of the Joint Task Force on the Integrity of Scholarship In June 1984.
Entitled Maintaining the Integrity of Scholarship, the report defined
the ethical obligations of scholarship, pressures that can discourage
integrity in schol s hip, and steps to be taken to encourage integrity
in scholarship and offered reccmmen~ations, guiding principles, and
procedures for the university community.
8
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In September 1985, Donald Kennedy (1985), president of Stanford
University, published a report titled.On Academic Authorship, which
died the need to clarify the allocation of responsibility and
credit for scholarly work and the factors That complicate determinations
of appropriate authorship.
Harvard Medical School released a set of guidelines in February 1988
for the performance of scientific research by all faculty, trainees and
research staff at that institution (Tosteson, 1988~.
_
· .
- , _
The Harvard
gulOel mes have attracted national attention because they codify
generally accepted research practices and set forth recommendations for
supervision of research trainees, data recording and retention,
responsible authorship, avoidance of endive publication Cacti.
and individu~d laboratory written procedures.
These recommendations are
not promulgated as rules, but are Intense] to guide the development of
written prooedurem for each research group affiliated with The Harvard
Medical School, according to its dean, Daniel C. Io6teson.
During the pant year, this IBM committee has learned of other
professions] efforts to encourage research integrity and to improve the
ability of academic institutions to handle incidents of scientific fraud
an] research misconduct. The National Conference of Lawyers and
Scientists, a joint project of the American Association for the
Advancement of Science and the American For Association, is spore oring a
series of workshops to evaluate the features of effective m~soon~uct
policies and procedures for universities. Background papers
commissioned for the NCIS workshops provide additional analysis of the
significance of the publicly reported conic of scientific Discos duet and
institutional efforts to handle these cases (ALAS, 1988~.
A consortium of educational organizations under the leadership of
AAU is also develc ping a framework, or Gel guidelines, for
instit~tiorm1 policies arm pr~r~c to d-al wit research fraud (AAU,
1988) .
~ EELS
One of the first efforts by a government agency to address The issue
of scientific Tn~sconcluct was a workshop Torment in 1981 by the
E= siclent's ~ emission for the Study of Ethical E = bl en; In M Medicine and
Biomedical and Behavioral Research (U.S. President's Commission, 1982~.
In response to reports of harassment of persons who raised concerns
about scientific misconduct (these individuals are often called
'~histle-blowers"), the commission cosponsored the workshop with ALAS
and the organization Medicine in the Public Interest to review
institutional experiences in handling reports of research fraud. The
workshop report, Whistle blowing in Biomedical Research, provide= a study
of He initial policies arid pros use by universities to
investigate charges of scientific misconduct.
9
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We oversight Ire of the muse Science and Tec~noic~y
niece hell] hirings on March 31-~r;1 1, 1981, to review
institutional ex~rienaes in haywire f~PC of scientific fraud in
bi~i~al Ah (U.S. C30r~ress, 1981~. Airy-Tentative
prow Senator) Albert Gore, ye ~ittee received testifier fawn
variants insti~cional representatives, inch Ehilip Hoer, then
president of the National Academy of Sciences. me witches surest
Bat the problem of scientific fraud had been greasy ~ggerat~ and
that the cash that had surface were adeaaate1v at be existing
self-r~ulatory Humanisms.
_ _ _ _
Following continued press reports of cases of serious scientific
misconduct, Congress enacted legislation In 1985 that required the U.S.
Public Health Service (USERS) to develop procedures for investigating
charges of scientific misconduct involving federally funded research
activities (P.L. 99-158~. USPHS subsequently adopted interim guidelines
(USOHHS, 1986) in July 1986 that required local research institutions to
adopt misconduct guidelines as a condition of funding for grants and
contracts awarded by the National Institutes of Hearth and other
USE HS-funded research programs.
_
In September 1988, USERS proposed draft regulations in the Federal
Register further defining the responsibilities of USERS awardee and
applies nt institutions for dealing with and reporting possible
misconduct (USDHHS, 1988a). The notice of proposed rulemaking (NORM)
states:
Before 1980, instances of reported misconduct in EHS-funded research
programs were infrequent. In recent years, however, there has been
a small number of highly publicized instances of scientific
sconduct....From what little we do know, it would appear that
reported instances of scientific misconduct represent only a small
fraction of the total number of research an] research training
awards funded by EHS. Nevertheless, even a small number of
instances of scientific m~soonduct is considered a threat to the
continued public confidence in the integrity of the scientific
process an] in the stewardship of Federal funds. The traditional
safeguards such as peer review and guidance form professional
organizations must be supplemented by explicit institutional
oommitment to high ethical standards in research.
The proposed rule sets forth The following definition for
'misconduct in science": "~1) fabrication, falsification, plagiarism,
deception or other practices that seriously deviate freon those That are
commonly accepted within the scientific community for proposing,
conducting or reporting research; or (2) material failure to comply with
federal requirements that Cared uniquely related to the conduct of
research." The latter portion of this definition covers areas such as
the federal regulations governing the handling of hazardous research
materials, the use of animals or human subjects in research, and the use
of recombinant-DNA materials.
10
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the proposed rule again affirms that the primary responsibility for
detecting, investigating, reporting, and resolving allegations of
scientific miscrnduot rests with awardee institutions. These
institutions will now be require] to provide assurances that they have
established appropriate procedures to review reports of misconduct in
biomedical or behavioral research at their institution. m e proposed
rule establishes minimum sban~ard5 for these procedures and requires the
institutions to notify the funding agency when Bus conduct investigations
are initiated.
In the some issue of the Federal Reaisber announcing the proposed
rule discussed above, the U.S. Public Hearth Service also published an
advanced notice of proposed rulemakina (AVERS) in the development of
fabure regulations protecting against scientific fraud or misconduct
(USDHHS, 1988b).
m e ANP~M invited public comment on several complex and
oontravearsial aspects of scientific misconduct that m:g'ht be considered
by the government in formulating new regulations. In particular,
comments were solicited on the following topics:
o definition of scientific misconduct;
o responsibilities of awardee institutions;
o responsibilities of the Department of Health and Human Services;
o joint responsibilities of the department and awardee
institutions; and
gancrDmentwide policy on scientific misconduct.
o
A 60-day comment period was provided for the NERD, and 90 days were
provided for comment on the ALARM.
The pace of governmental interest in scientific misconduct picked up
in 1988. In addition to the regulatory proposals discussed above, three
oongressional hearings and an investigative study by the Office of the
Inspector General in the Department of Health and Human Services focused
on this topic.
In April 1988, two separate House subcommitt~Pc held hearings to
review regent allegations of scientific misconduct and the experience of
NIH In investigating therm bases. Representative John Dingell, chairman
of the House Energy and Commerce Committee, strongly criticized
government agency performance, contending that the agencies inadequately
an dressed key issues regarding disclosure, notification, and protection
of whistle-blowers in these cases (U.S. Congress, 1988a).
Representative Ted Weiss, chairman of the Human Resources and
Intergovernmental Relations Subcommittee of the House Government
Operations Committee, also held hearings to review similar charges and
to explore the public health and safety questions that might arise as a
result of fraudulent research (U.S. Congress, 1988b).
11
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Congressman Swiss convene] a strand day of hearings in September
1988 to pursue the=- issues and to examine conflict of interest charges
in academic research (U.S. Congress, 1988c). The congressional hearings
attracted~national media attention and highlighted congressional
concerns about the appropriateness of the governments policy of relying
upon local institutions to investigate charges of scientific mum conduct.
In late September 1988, the Office of the Inspeabor General (OIG) of
the Department of Health and Human Servicer rely a draft report on
misconduct in scientific research pUSDHHS, 1988c). m e report included
the results of a recent study of the extent to which NIH and its ~
grants== have developed policies and procedures to prevent! detect' and
handle scientific muscorduct and a description of what selected grantee
institutions have learned as a result of experiences with research
fraud.
m e draft GIG report recur mended that the Secretary of HHS establish
inve ~ igatory and oversight functions independent of the research
funding agencies and develop a more formal process to deal with
scientific misconduct. The recommendations included additional
notification requirements for the awardee institutions an] the
development of alternative methods of detecting possible misconduct,
including spot alerts of scientific data and specific reviews by editors
of scientific journals.
The GIG staff surveyed a random sample of FY 1986 NIH grantee
institutions by telephone and also conducted site visits to nine such
institutions that had experience with scientific misconduct cases. m e
draft report concluded that although only 22 percent of NIH grantee
institutions overall have policies and procedures to d-~1 with
scientific misconduct, 93 percent of such grandson with 100 or more
awards have such policies and procedures In place. The scientific
misconduct procedures that are In place are generally not comprehensive,
often failing to require notification to NIH. The report noted that 36
percent (17 of 47) of the grantee institutions with est~hlished
pro endures reported cases of m~soon~uct that required their use. -
Sixteen of the 34 ca~-m (47 percent) investigated by these 17
institutions were substantiated. Extrapolating from these figures, the
GIG estimated that 95 scientific misconduct races (47 substantiated and
48 unsubstantiated) have been addressed by NIH grantee institutions.
This estimate, as noted in the GIG report, is consistent with
records maintained by NTH since 1982, which show that 102 cases have
been investigated by its grantees and reported to the agency in that
time period.
Ihe GIG report (USDHHS, 1988c) emphasizes that, "Ihe estimate of 95
cases does not represent an estimate of the actual prevalence of
scientific misconduct. In fact, our grants== were about evenly split on
whether or not more misconduct occurs than is reported."
12
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OBSER;i~
Several strong themes have emerged in policy discussions about the
appropriate nature of public and private institutional response to
incidents of scientific fraud and research misconduct. First,
government agencies, professional organizations, and research
institutions have consistently affirmed that the primary responsibility
for handling Chew- Marc should rest with awardee institutions, the ones
doing the rose arch. Second, recent federal regulations have generated
new requirements for research institutions to adopt explicit, written
guidelines for handling al legations of scientific misconduct. Third,
these misconduct guidelines and policy directives revere a need for
additional mechanisms to encourage high ethical standards for research.
m ere is wide variation among universities in their efforts to
define appropriate standards for research, and pruf=mcional standards
have remained ambiguous in some instances. The absence of formal
stats or written guidelines for the ethical performance of
him amneratŁ~ uncertainty beat the c~rit~r;~ for ~;=tinnn,;!::hinr'
· · · ~ · · . _ · _ . . . . . . .
prattle stat violate processions norTre al a~lvltl~ mat at
simply part of the variation armed These norm.
Ir~restigations of Marc of scientific fraud Mu ~ est that various
factory in the research environment may contribute to the occurrence of
scientific misconduct even though they are not the direct canes" of
these occurrences. Examples include pressures to "publish or perish,"
an emphasis on competition and secrecy in research performance. and
^, r
Inadequate Interaction of young researchers with their peers and
mentors. There is concern that not only ethics, but also the quality of
scientific research in general may suffer in this environment.
These concerns have pivoted resewn h institutions, professional
organizations, government agencies, and congressional oversight
cc~nmi~ees to search for policies that will strengthen the ~n~riLv and
quality of the research environnent.
Over the research use of human and aniLrla1 subjects, these policy
disa scions raise 9~cal questions abut the adequacy and
_ _ ~
As In the case of public corKxrn
ertectlveness or- the current se 't-regulatory system in assuring
responsible research practices and preventing scientific misconduct.
The purpose of this stay was to examine these questions and to
propose ways to encourage high ethical stand adds in the conduct of
research without damaging the freedom and creativity that have
traditionally characterized American research.
13
Representative terms from entire chapter:
scientific fraud
