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OCR for page 17
4
ANALYSIS
~ meetings before and after he Sir work~hcp~ the commit
arrived at assumptions and fires that well] form the basis for the
evaluation of polity prc~;a:ts arx] final rations acntair~ In
this report. In the ad ence of data d ~ nting the in Angrily of
existing research practice= and the level of m~soonduct in hearth
sciences research, the committee relied on expert opinion. m ese
assumptions and findings may not be share] by all members of the
research community ~ indent, they were not share] by all workshop
participants but they quickly emerged as a consensus of the committee.
These assumptions and findings deserve expla ~ tion and clarification
because they form the foundation for this report.
AXONS AD EIND~
o Scientists should develop and maintain quality and accuracy in
research practice by self-regulation, extensive reliance on each
investigator's professional st end arise and the traditions and
collegiality that characterize research institutions.
The balance between emphasizing individual and emphasizing
oollegial responsibility for the integrity of research may vary by
discipline, research field, or institution, but self-regulation is the
principal system used by the government and the research community to
provide integrity and quality in research. m e nature of the scientific
enterprise is such that only those persons familiar with the methods and
analytical basis of science are capable of understanding and evaluating
the research results of others. Scientists are not separate freon
society' however' and they are subject to the same laws and standards
that govern responsible social behavior.
m e norms of responsible research practice are usually ccmmunicate~d
through oral tradition and personal example. m ese norms have exercised
a significant but poorly understood role in regulating the conduct of
individual investigators and in encouraging honesty in academic
research.
Self-regulation includes peer review and replication of reported
research findings. Peer review evaluates the adequacy of scientific
methods, the significance of the research, and the consistency of the
reported findings. Replication involved repeating the work of others.
It may confirm or contradict earlier work, a situation that requires
explanation.
17
OCR for page 18
The argument that replication and peer review will guarantee the
integrity of all research is incorrect. Many studier are not replicated
in detail (it would be highly inefficient if then were). Trust in
.
researchers, descriptions at- their methods and findings has been
fundamental to scientific communication. In the past, scientific
skepticism has not extended to the honesty of an investigator's factual
statements, but has been directed toward interpretation of reported
results.
~ ghost the discussions, the committee agreed that the primary
responsibility for the oversight of quality and responsible research
practices in the health sciences Should continue to rest with the
research community itself. At the same time, the committee recognized
limitations of the existing self-regulatory system in encouraging
responsible research con ~ at and detecting scientific misconduct.
O A variety of informal and formal practice= and procedures
currently exist in the academic research environment to assure and
maintain the high quality of research conduct.
Until very recently, governmental and private institutions a
that the principle of self-regulation was sufficient to promote and
maintain the integrity and quality of federally funded research. Recent
cases of scientific fraud, however, have challenged the wisdom of
relying entirely upon investigator honesty and unwritten collegian
standards as the sole means of assuring integrity and quality in
research. These cases have fostered a perception that existing
institutional and professional controls have been inadequate to assure
Integrity in federally funded research.
The effectiveness of ~elf-regulation depends upon those practices
and procedures that have evolved over time as part of the scientific
method. Such practices are intrinsic to the conduct of science and they
are expected to be a fundamental part of the professional training of
each scientific investigator. Informal practices include collegian
interaction, skepticism, and criticism; sharing of research ~ ta,
methods, and materials; serving as mentors and role models; consensual
assignment of authorship crept; and post-publication review by
colleagues.
Formal mechanisms that promote responsible research conduct include
the peer review systems administered by scientific journals and funding
agencies; departmental research seminars; the criteria, policies, and
procedures that govern appointment and promotion decisions; the use of
"visiting comic" and interdepartmental reviews in evaluating the
quality of graduate research and training pro grams; and the coordinating
committees and data-collection audits used in mwiticenter clinical
research programs. However, the use of these mechanisms varies widely
among different academic institutions.
18
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Die committee believes that existing Ins trysts of peer
review and university oversight in academic research are f~ntal ly
saux1, but it recognizes that many of these pi are not uniformly
followed and investigator practic ~ vary. M ~ of the existing
institutional controls rely upon the effectiveness of social and
professional sanctions. It appears that these controls may have limited
impact on some investigators.
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.
As a first step in promoting scientific responsibility and
providing quality assurance, some research institutions and scientific
organizations are trying to enhance the visibility and effectiveness of
generally accepted research practices already in place.
In adaption to institutional guidelines, the conduct of research is
governed in some matters by various professional and regulatory
standards. For example' federal and state Jaws govern the use of
animals at human subjects in research; the use of hazardous research
equipment arxt materials; He use of r~inant-lX~ maniac; and
general laboratory safety. Professional codes of ethics developed by
individual scientific societies ~ so establish certain standards for the
rx3uct of Joseph. For the Apt part, however, p~vfemcion~ and
rotatory stanzas are root ~n~ ~ an explicit Or into the
social setting and training of scientific irIvestigators.
He committee has recei~rec] reports that same institutional
investigations of allegations of scientific Truscor~ct are h ~ by
the absence of written standards against which to measure charges of
improper practice. For example, same investigators fail to keep
research data and are unable to document or verify their results when
questioned. Others may seriously neglect their supervision and training
responsibilities or may request "honorary authorships' on publications
for which they made no significant contribution.
The comity believes Hat the absence of explicit institutional
scarabs allows the r~ar~h system to tolerate subs activities
by a small Or of individual i~r~:tigators Ho fail to Serve
generally accepted practices. EDrthermore, the absence of a Satanism
to enforce these stanzas= leads to a perception ~ at 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.
Although some university courses and publications offer instruction
in the standards and ethics of research practice, most science students
do not receive formal exposure to this topic. me absence of these
19
OCR for page 20
courses limits the cpportuni~ for discussion of the norms arm ideals
that shalld guide resort practice and for identifying amount or
deviant practices. The lack of instruction In this area also creates a
perception that the faculty places refire Isis on Me results than the
methods of scientific research.
The communication of the ideals of science, its values and methods,
traditionally occurred through indivi~r~H discussions between senior
investigators and students. Given the increased size, complexity, and
heterogeneity of the research training process, the committee believes
that reliance on these discussions alone is not sufficient to provide
effective instruments of professionalization and education.
traditions and styles of governance that assume professional integrity
and that place great value on the independence and collegiality of
individual faculty.
O m e culture of the American university is distinguished by
In contrast to some other academic systems, American universities
are not hierarchical structures. m err demonstrated effectiveness in
generating new knowledge and training young scientists depends greatly
upon investigator autonomy and the collegial good will, trust, and
academic freedom that are the foundations of academic governance In our
society.
Although the committee agrees that American biomedical research and
training can benefit fern improvements In policies and practices, it
believes that some administrative changes cculd create more serious
problems than those they are designed to alleviate. Strict or intrusive
regulations governing the details of research conduct may damage the
creativity and quality of the research environment, especially if those
regulations are unsupported by documented evidence of widespread
dishonesty or-ethical misconduct by investigators.
m e collegiality of the faculty also discourages individuals from
revealing negative information about a colleague or student. If faculty
are to be encouraged to take a more active role in exposing the
deficiencies and weaknesses of their peers, they must be assured that
their institutions are prepared to act on their information and that
whistle-blowers will not be punished for exposing substandard or deviant
practices.
The committee believes that better education of academic officials,
faculty, and students and,
", there appropriate, legislative protection
could help reduce the barriers that discourage the reporting of
scientific misconduct when it occurs.
O Investigations of a small number of publicly reported cases of
scientific fraud and other research misconduct suggest that a mix of
factors contributed to this deviant behavior. One of these was an
20
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unhealthy research environment that failed to discourage (or even
tolerated) sloppy or careless research standards.
Cases of serious m~soon~uct in science are rare events and there
are only a handful of studies of their origins and rouses. Some factors
that have keen identified ~ these preliminary analyses include denial,
self-decepkion, and unwillingness to believe that such actions could be
detected and punished. Some of those found guilty of fabricating or
distorting research results denied that their practices were wrong or
substandard, often using the expression that "everyone does it." to
justify their behavior.
The committee believes that, in the long run, the quality of the
research environment may be more damaged by sloppy or careless research
practices and apathy than by incidents of research fraud or other
serious scientific misconduct. The committee did not have the resources
to try to conduct a systematic study of the integrity an] quality of
current research practices or incidence of scientific fraud in the
health sciences. But preliminary studies and workshop discussions
suggest that the research community tolerate.= too many substandard
practices. These abuses must be corrected to restore a sense of moral
integrity and professionalism in research.
there are several kinds of contemporary research activities that
Lie on Me edges of acceptable professional practice; many researchers
would regard them as irresponsible practices. Examples Include abuses
of multiple authorship, such as The practice of "gift authorship";
repetitive publication of short-term research results; the neglect of
young researchers by their peers and mentors; inadequate training and
supervisory practicer; and sequestering or withholding of research data
from peers and colleagues.
Although the committee believes that serious misconduct in science
is rare and is ultimately a manifestation of individual deviance, it
con crud-= that institutions fail to detect and correct early deviant
behavior, primarily because of an excessively permissive research
environment that tolerates sloppy and careless practices. the committee
also believes that substandard pr-acti~= are enccuraged 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 pressures in science demand
that local research institutions and government research funders develop
standards to ensure responsible research practices to ensure the
integrity of the academic research enterprise.
m e committee identified a nope for higher professional stand ard5
at all levels in the research system. m ere was consensus that,
although the fundamental values and standards of the research community
are appropriate, the expression and implementation of these standards
21
OCR for page 22
are insufficient to promote responsible research practices in an
increasingly large, heterogenec us, and competitive research
environment. New and comprehensive guidelines should be developed by
the research community to clarify traditional practices, to strengthen
the mix of formal policies and informal practices currently In place,
and to correct actions that seriously deviate from these standards.
The committed believes that the most effective sites for the
develcpment of these guidelines are the immediate social setting of the
investigators, represented by the laboratory and clinical research
centers, universities, professional societies, and scientific journals.
The adoption of such standards will require leadership from government
and other funding sources.
In developing final recommendations, the committee sought to define
appropriate roles for government agencies and the Congress= that would
stimulate local institutional and professional efforts without creating
an unjustifiable regulatory burden on the research community.
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
science.
During the workshop, many participants identified a need for
additional research to clarify the basic factors that influence
professional conduct in the contemporary research environment. In
particular, they cited the need to evaluate the experiences of different
kinds of research institutions In training investigators and monitoring,
rew;o~ling, or correcting research practices. Other participants urged
that extensive studies of the incidence and prevalence of scientific
misconduct should be undertaken before the development of
changes In resear1 h oversight.
substantive
Institutional policy reforms ideally should be based on a deeper
understanding of professional behavior and the effects of training, role
models, peer pressure, and the structure of the research system on
professional development and behavior. However, the limitations of
current understanding of these processes should not delay the
development of explicit guidelines when there is clear consensus about
what represents responsible research and training practices.
22
Representative terms from entire chapter:
research practices
