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OCR for page 1
SPIN . 1
SUMMED
Several strong themes have emerged in policy dicr~==ions about the
appropriate nature of public and private institutional responses to
incidents of scientific fraud and research musoonduct. First,
government age ~ ies, professional organizations, and research
institutions have consistently affirmed that the primary responsibility
for handling these In should rest with awards institutions, the ones
doing the research. Second, recent federal regulations have generated
new D~qUirementS for research institutions to adept explicit, written
guidelines for handling allegations of scientific misconduct. m ird,
these mum conduct guidelines and policy directives revere a need for
additional mechanisms to encourage high ethical standards for DeS~arCh
m ere is wide variation among universities in their efforts to
define appropriate standards for De Perch, and professional standards
that govern various research practices have remained ambiguous in some
instances. The absence of formal standards or written guidelines for
the ethical performance of research has gene rater uncertainty about the
criteria for distinguishing practices that violate professional norms
from activities that are simply part of the variation around these
norms.
. · · .
..
Investigations of cases of scientific fraud suggest that various
factors in the research environment may contribute to the occurrence of
scientific misconduct even though they are not the direst causes of
these occurrences. Examples include pressures to "publish or perish,"
an emphasis on competition and secrecy in research performance, and
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 prampbed research institutions, professional
organizations, government agencies, and congressional oversight
committees to search for policies that will strengthen the integrity and
quality of the research environment. As in the case of public concern
over the research use of human and animal subjects, these policy
discussions raise fundamental questions about the adequacy and
effectiveness of the current self-regulatory system in assuring
responsible research practices and preventing scientific misconduct.
_ . _
· · . . · . .
PURPOSE OF THE STUDY AND APPROACH
The purpose of this study was to examine these questions and to
propose ways to encourage high ethical standards in the conduct of
research without damaging the freedom and creativity that have
traditionally characterized American research institutions. A workshop
1
OCR for page 2
was a prc*uctive means for the IOM study committee to gather information
and perspectives abcut standards and practices that affect the conduct
of research in the health sciences. More than 100 clinical and basic
research scientists, government and university officials, professional
society officers, journal editors, and members of the press attended the
workshop, held in September 1988 in Washington, D.C. An agenda and list
of participants are include d as appendices to this report.
AMOS AND EINDIN;S
In meetings before and after the workshop, the committee arrived at
assumptions and findings that.formed the basis for their policy
proposals and final recommendations contained in this report. In the
absence of definitive data documenting the integrity of existing
research practices and the level of misconduct in health sciences
research, the committee relied upon expert Opinion. These assumptions
and findings may not be shared by all members of the research
community indeed, they were not shared by all workshop participants-
but they quickly emerged as a consensus of the committee. These
assumptions and findings deserve explanation and clarification because
they form the foundation for this report.
O Scientists develop and maintain quality and accuracy in research
practice by self-regulation, extensive reliance on each investigator's
professional Standards' and the traditions and collegiality that
characterize research institutions.
o A variety of informal and formal practices and prom cures exist
in the academic research environment to assure and maintain the high
integrity of research conduct.
O Few academic institutions have established explicit standards for
responsible research practices, such as guidelines for the recording and
retention of research data or for inclusion as an author. The committee
believes that the absence of explicit institutional standards allows the
research system to tolerate substandard activities by a small number of
individual investigators who fail to observe generally accepted
practices. Furthermore, the absence of a mechanism to enforce standards
leads to a perception that the institution or the profession is
unwilling or unable to correct abusive practices.
O There are very few courses of instruction dedicated to
communicating professional standards and the ethics of research practice
to young scientists.
o m e culture of the American university is distinguished by
traditions and styles of governance that assume professional integrity
and that place great value on the independenoe and collegia~ity of
individual faculty.
2
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o Investigations of a ~11 number of publicly report cast of
scientific fraud and ocher r~a~ m~saor~c suggest that a mix of
factors ~i~ed to this deviant behavior. He of these was an
ur~healt~y ~ environ Cat failed to disparage (or even
tolerated) sloppy or careless r ~ arch Eta ~ ar do. Although the
committee believes that serious misconduct in science is rare and is
ultimately a manifestation of individual deviance, it concludes that
institutions fail to detect and correct early deviant behavior primarily
because of an excessively permissive research environment that tolerates
careless= practices. m e committee also believes that substandard
practices are encouraged by funding pressures and an overemphasis on
publication as the main means of achieving status and recognition for
scientific advancement and research support.
o Increasing budgetary and competitive press Yes in science demand
that local research institutions and government research fenders develop
standards to ensure responsible research practices to ensure the
integrity of the academic research enterprise.
O Effective institutional reforms to improve integrity and
responsible research practices require better understanding of the key
factors that influence professional development and performance in
ienoe.
INS
In developing recommendations, the committ== sought to define
appropriate rifles for government, universities, rPc=~rch institutions,
prof-=cion~1 organizations, and scientific journals that would stimulate
local institutional and professional efforts without creating an
unjustifiable regulatory burden on the research a G ity. These
recommendations represent the steps that the committee believes are most
appropriate for action at this time in seeking to promote integrity in
health sciences research.
Recommendations for the National Instituter of Health
1. The National Institutes of H~a1th should establish an office to
promote responsible research practices. This office should be
coordinated with an expanded NIH effort to evaluate instibutiona~
investigations of misconduct in scientific research. The primary
function of the office should be to foster ~ ~
of high professional standards of research
applicant institutions.
and monitor the development
practice by all grantee and
2. By 1992, NIH should require all grantee and applicant
institutions to provide assurances that they have adopted policies and
procedures to encourage responsible research practices. Research
applicants should affirm their familiarity with these policies and
3
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proc dares and should also:prcpose how They plan to store research data
in the course of their study.
3. NIH should not implement random data audits as a mechanism for
ensuring He responsible conduct of investigator-initiat^~ research.
4. NIH should adopt professional standards to ensure responsible
research practicer by its intramural scientists.
5. NIH should adopt policies to limit the number of publications
that can be considered as part of any grant application, in order to -
emphasize quality over quantity.
Recr~=E~.oations for Universities and Other Research Centers
6. Universities, medic schools, and other research organizations
should adopt guidelines to clarify the expectations of each institution
about the prof==cion~1 standards to be observed by investigators in the
conduct of research.
7. Universities should provide formal instruction In good research
practicum. This instruction should not be Amity to formal courses,
but it should be incorporated into various places in the undergraduate
and graduate curricula for all science students.
8. Universities should designate one or more administrative
officers or faculty members to promote responsible research practices
within the institution. The institution should also provide mediation
and counseling services for faculty, staff, and students who wish to
express concerns about professionally questionable Lrain~ng or research
practices.
9. Universities and other research institutions should strengthen
the integrity and quality of research by modifying incentives and
academic guidelines in order to reduce the pressure for excessive
publication.
10. Academic departments and research units Should monitor the
supervisory and training practices of their faculty and research staff
to ensure that adequate oversight is provided for young scientists.
11. Academic departments and research units should adopt authorship
policies to improve the publication practices of their faculty, staff,
and students.
Recommendations for Professional
and Scientific Organizations and Journals
12. Professional and scientific organizations representing the
research community should develop educational and training activities
4
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and materials to improve the integrity of research. These organizations
Should schist universities in identifying substandard research and
training practices that Promise the integrity or quality of research.
13. Scientific journals Should develop policies to promote
responsible authorship practices, including procedures for responding to
allegations or indications of misconduct in published research or
reports submitted for publication.
14. The National Academy of Sciences should pursue the issues and
findings develc~ed by the Institute of Medicine in this report and
examine their relevance and application to cipher fields of scientific
research.
15. An interdisciplinary committee should be convened to study the
issue of rights and responsibilities of all relevant parties to research
data and to prepare model guidelines for data sharing and data arctic.
16. There are many issues that deserve further analysis to enhance
institutional and policy efforts to discourage scientific misconduct and
to improve the integrity and quality of research. The committee
recon mend s that professional and scientific organizations initiate
studies to understand and encourage responsible research practices.
Representative terms from entire chapter:
responsible research
