|
Items in cart [0] |
Questions? Call 888-624-8373 |
PAPERBACK PDF BOOK Free Resources |
||||||||||||||||
|
||||||||||||||||
|
||||||||||||||||
| ||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Copyright © 2009. National Academy of Sciences. All rights reserved. Terms of Use and Privacy Statement |
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.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 23
C=PrER 5
IONS
~ preparing rations, the cc~ni~ considered score Ian 60
pectorals developed ~ me six panels and plenary discussions of the
Meteor 6-8 workshop, regulatory portals published by Me National
Aspires of Health and the Department of Health and Amman Services
(l~i) in the Sumter 19 Federal Resister (~;~, 1988a, 1988b), a
draft report on scientific my onduct released by Me HHS Office of the
Or General ~ late ~ (USI~HS, 1988c), and legislative
proposals developed by I; of Congress (Lipton, 1988a). The -
cc~mi~e also reviewed ~ background papers carnmissioned for the
worl~hc'? (my, 1988; Jasanoff, 1988) and selected literature frog the
project bibliography, including reports on Maturity of Search am
scientific ~scor~uct published by the American Association for the
~ of Scions, the Association of American Universities, the
Ass aviation of American Medical Colleges, arm Sigma Xi discussed in
Copter 2.
Af ~ r r~riewirx~ this ma ~ rial, the cc~mitt== formulated the
following rrYx'T~enlations. They describe the actions that the committee
belle vex are most appropriate to be taken at this time by government
agencies, universities, professional organizations, and journals in
seeking to promote Integrity and quality in health sciences rls~irch.
RE~ONS FOR TO NATIONAL INgrnm~ OF HFAIQff
1. The National Institutes of Health shard establish an office to
Promote responsible reteach Practices. This office should be
coordinated with an expanded NIH effort to evacuee institutional
investigations of misconduct in scientific reteach. The primary
function of the office Should be to foster and monitor he development
of high professional stanx arcs of research practice by all grantee and
applicant institutions.
The National Institutes of Health needs to respond vigorously to the
perception that science has not maintained high standards of integrity.
Although the committee believes that the primary responsibility for
developing and implementing professional research standards rests with
principal research investigators, medical schools, universities, and
other research institutions and professional organizations, the members
conclude that NIH must provide leadership and motivation to induce the
research community to define professional standards for research
practice, monitor levels of supervision, arm provide education in
professional stanzas and the ethics of research. Taking sew; to
promote the development of these standards at the local level is one of
the nest important actions that NIB can take to improve the integrity of
research.
23
OCR for page 24
Pony academic institutions and ~dic-~1 schools have recently
developed policies art procures for report to allegations of
scientific m~s~nduct. Sane institutions did so ~ response to cases of
misconduct. Others are doing so now In r ~ onse to regulatory
requirements. m ese policies and procedures are important, but they are
insufficient to promote integrity and quality in the research
environment. The committed believes that additional standards are
necessary to define the means by which the institution will promote the
responsible conduct of research.
As with the requirements for safeguarding human and animal research
subjects, the proposed office will provide institutions an opportunity
to involve the ~ faculties and administrations in developing ~ licies
and procedures that are consistent with traditional practices and that
also meet federal standards. It is the perception of the committ^= that
institutional self-regulation will be strengthened as a result of this
approach.
The committee recommends that the propose] office be established as
an administrative unit within the Office of the Director of NIH and have
oversight responsibility for all NIH grant and contract awards. The
office should assist local research institutions in developing
professional standards of research practice and define those areas that
must be addressed by local policies and procedures, including the way
the institution monitors the research environment, and how it p y s
to respond to charges of misconduct In research. The areas to be
addressed by local institutions should include:
o policies for recording and retention of research data;
o professional standards for training and supervision;
O education In p~vfession~1 standards and the responsible conduct
of research;
policies and procedures for responding to allegations of
misconduct; -
designation of an institutional official to address concerns
related to the conduct of research; and
description of the process by which the university faculty,
staff, and students--are kept informed of institutional and
professional research standards and policies.
o
o
o
There are some potential disadvantages with the establishment of an
office to promote responsible research practices as proposed. For
example, the additional amount of paperwork required would involve time
of scientists and university officials, as well as the efforts of some
administrators at the NIH and comparable agencies, and for these reasons
could add some additional expense to research. In addition, the mission
of this office might be inappropriately broadened.
The proposed NIH office should disseminate information about
institutional policies and procedures governing professional standards
and assist in their development; receive regular reports, possibly on a
biannual basis from institutional officials charged with addressing
24
OCR for page 25
research concerns, describing developments that affect the integrity of
health sciences research; convene occasional forums for these officers
and the general research community to prcmcke broad awareness of
important trends or new issues that influence the conduct of research;
interact with other NIH officer that monitor compliance with regulations
on research involving human s Ejects and animals, the use of hazardous
substances, or recomb mant-DNA materials; and work closely with, but be
distinct from, the NIH office charged with evaluating the adequacy of
institutional misconduct investigations.
The proposal to locate the office for the promotion of responsible
~. . _ .
research In NIH is based on the relationship ot the sc~ent313c~lly
trained administrators at NIH with the researx h community, whose
activities they understand and whose expertise they often solicit in
evaluating specific problems.
NIH and other research funders can exercise an influential rode by
organizing conferences and workshops in which their grantees and
professional organizations exchange information about and experience
with the development of standards to promote responsible research
practices. m ese meetings could highlight useful models, identify
problems and barriers to the development of effective research
guidelines, and suggest collaborative solutions to problems that may
appear intractable to individual institutions.
2. By 1992, NIH should require all grantee and applicant
institutions to provide assurances that they have adopted policies and
pro secures to encourage responsible research practices. Research
applicants should affirm their familiarity with these policies and
prooe~ures and should also propose how they plan to store research data
in the course of their study.
The proposed NIH office should require assurances that applicant
institutions have adopted guidelines a ~ oversight mechanisms for the
responsible conduct of research analogous to those required for research
involving human subjects or animals. To enable the proposed office to
carry out its functions, NIH should require applicant institutions to
forward a copy of their research standards when developed. NDH should
plan ~nnnunce ~ specific date after which grant applications that do not
include the required assurances will not qualify for funding. The areas
to be addressed by local institutions are listed under Reccmmeniation 1.
The subjects of the propose] standards for the responsible conduct
-
of research involve difficult and controversial matters. Development of
policies and procedures for satisfying these requirements will take
time, because they require debate and education within the local
institutions. At the same time, it is important that these institutions
initiate a process to develop formal guidelines in onier to comply with
25
OCR for page 26
funding requirements. Thus, the committee suggests a three-y~r time
period, at the most, for the implementation of the institutional
assurances requirement.
When the assurances are received, the NIH office for the promotion
of responsible research should monitor the adequacy of local
institutional guidelines and statements of compliance by investigators
with these standards. The office should notify applicants and grantees
from institutions that have not. developed appropriate guidelines that
they will no longer qualify for NIH-funded research support. The office
should provide educational support and guidance for institutions that
have difficulties in developing appropriate standards.
The committee also encourages NIH to require their research grantee=
art applicants to describe within each prodded study the m ~ anises for
data retention and consider the issue of data are<=== in the course of
their research. While institutions are being charged to develop overall
policies to dead with these issues, the individual grant will serve as
the best location for detailed specifications of the data arctic an]
storage procedures to be followed. m e appropriateness of these
prooe~ures can then be evaluated as part of the study section review of
the research proposal.
m is approach provides for the increasingly common and difficult
circumstances of multi-institutional or other collaborative studies, in
which concerns about intellectual ownership may not become serious
problems if they are resolved before the research is performed. In such
circumstances, no single institution can provide oversight based on its
. .
con policies.
3. NIH should not implement random data audits as a mechanism for
_
ensuring the responsible conduct of investigator-initiated research.
Data audits are occasionally used by government research agencies
when there is reason to question an investigator's reported research
results. These "for-cause" audits are often useful in identifying
incidents of fabrication, falsification, or serious distortion of
research data. For-cause audits may result In punitive actions, such as
critical prosecution, disqualification of an investigator or, in the
cane of the Food and Drug Administration (FDA), restriction of his or
her access to new drugs (Shapiro and Charrow, 1985~.
In recent regulatory proposals the HHS Inspector General and the
Department of Health and Human Services have suggested various means to
enhance the detection of research fraud, such as the use of random or
systematic data audits by government investigatory bodies. These random
audits differ from the for-cause audits because they are conducted
without reason to suspect or question the reported research results.
It has been argued that data audits are useful and accepted by
investigators conducting studies subject to FDA oversight and by
26
OCR for page 27
investigators conducting mwlticentPr collaborative studies funded by the
National Cancer Institute (NCI) (Shapiro and Charrow, 1985; 1isook,
1986).
In the case of FEA-regulated studies, systematic review of data is
performed in the final stage of new drug applications to ensure
compliance with formal, muhIa1ly agr~P~-upon' predefined protocols and
to determine that all data have been correctly collected and recorded.
This form of data aunt can be carried out by individuals with minimal
~ ~ e _ ~ ~ ~
SCl~tl: -1C tralRllilg.
Similarly, contract work and multi-institutional studies for NCI or
NIH require precise adherence to protocols accepted by all investigators
at the initiation of the study. Spook agents of the Eta report
in these studies allow for a technical review similar to that used in
the FDA agents. In these studies, the investigators know about and
agree to the use of data aunts as a form of quality control in the
development of the study contract and the research protocol. Uniform
practices and prearranged agreements characterize these stories. Thus,
this research activity lends itself to a~;tina and is enhancer TV the
systematic audit requirement.
, i_
Some investigator-initiated, grant-supporbed research involves
therapeutic trials, other interventions, or measurements on human
subjects following clearly specified protocols that have been filed with
Institutional Review Cards. Data audits of these studies cod be
corx~uc~ by auditors without extensive scientific expertise.
On the other harm, Tech of Be investigator-initiat~ research that
NIH supports is basic or discovery research. The nature of the research
arm its susceptibility to scrutiny by nonscientists are dramatically
different fern clinical trials. Protocols sunlit In the research
application are often changed ~ preliminary results reveal unexpected
findings. The research is more exploratory and less repetitive. me
technical difficulty of comparing raw data with reported results is far
greater, because the data are not the end result of the investigation.
The task of auditing and interpreting data in basic research would
require scientists with considerable expertise in the subject matter to
interpret most laboratory records.
There are other potential problems and limitations to the extension
of random or systematic data audits to investigator-' nitiated research.
It is possible that the introduction of auditors into the scientific
laboratory would diminish spontaneity and creativity In research. The
anticipation of visits from auditors charged with the task of -
identifying inconsistencies between recorded data and reported results
might preoccupy researchers and administrators with defensive
recor~keeping, perhaps at the expense of the substance of the research.
27
OCR for page 28
Furthermore, the introduction of data allots will not identify all
dishonest researchers. As the program became known, unscrupulous
investigators in some fields might become adept at fabricating their
raw data as well as their reported results. Thus, there might still
be fraud, but it would be occurring earlier In the process of
reporting.
Finally, the costs of an aunt program for basic and disco very
research are unknown and might be prohibitive if the program is other
than very limited in scope, considering the extensive data that would
have to be reviewed by skilled scientists. Government policies
currently encourage regulatory approaches that provide the least net
cost to society (U.S. Office of the President, 1981).
To date, the number of cases of scientific fraud that have keen
publicly reported is small relative to the amount of research that is
conducted. Given that an audit program could have deleterious effects
on the research environment, would not detect all cases of fraud, and
would be associated with unknown and possibly large costs, the
committee does not favor its current intrcOuction into basic or
discovery Ask.
4. NIH should adopt professional stand ares to ensure responsible
research practices by its intramural scientists.
NIH is in a key position to develop and implement responsible
research practices in its intramural research program. NIH should
adopt professional standards that clarify the basic guidelines to be
observed by intramural investigators in the conduct of research.
m e intramural research standards should address, but not be
limited to, the recording and retention of research data, the training
and supervision of young scientists, and authorship and other
publication practices. NIH should take the lead in studying the issue
of rights and responsibilities of all relevant parties to research
data within the intramural program and prepare model guidelines for
data sharing and access. NIH should promote the quality and Integrity
of research conducted within the intramural program by adopting
incentives and guidelines that reduce the pressure to publish.
NIH should designate administrative officers or scientific staff
members to promote responsible research practices within the
intramural program.
These individr~As should be available to provide
mediation and counseling services for staff who wish to express
concerns about questionable training and research practices. They
should also work with the office for the promotion of responsible
~· . · · .
research co Disseminate gulaellnes developed By the Intramural
research program to other public and private research institutions.
5. NIH should adopt policies to limit the newer of publications
that can be considered as part of any grant application, in order to
emphasize quality over quantity.
28
OCR for page 29
NIT is in a key position to demonstrate Cat ~ali~ ral:her Can
q~anti~ of publications is the proper measure of scientific
adhiev~nt in the Oral romaji pr~rmn. qhr~ Be Division
of Research Grants, shad sections. and councils. for example. NIH
, . ,
dhadc3 add pot icies ~t 1 emit the namer of pubs ications considers
}fly initial review g~6 as part of a grant application. This action,
along with the deve~c~nent of a ~eJ sylvan for promotion of
responsible relearn Induct, -will demonstrate that NIH is firmly
China efforts to promote research q~i~r in Be hearth Icier;.
Among ff,e factors that predisEx~e to sloppy or dishonest sole we
is the emphasis on quantity of publications that pervades the research
community. Although it is clearly not the only such factor in the
research environment, it is one that is exacerbated by the competition
for research support. NIH, which has been in a pivotal position in
the creation of the competitive research environment, can alleviate
this problem by developing procedures ~ at reduce the incentive for
large bibliographies.
FOLIOS FUR UNIVERSE AND aTHER RESE~I CENTERS
6. Universities bedim] schools. and other research
organizations should adopt guidelines to clarify the expectations of
each institution about the professional StaDaard5 to be ok served by
Investigators In the conduct of research.
Recognizing that many medico schools and universities have begun
to develop policies and procedures to handle allegations of scientific
m~soonduct, the committee recommends that all academic institutions,
median schools, and research institutes develop guidelines for the
responsible conduct of research. These should be developed in
consultation with the faculty, research staff, and students and should
reflect the standards of accepted practice of the research community.
m e guidelines should specify desirable behavior and also provide a
basis for identifying unacceptable research practices. At a minimum,
these guidelines should be in accord with the requirements discussed
In Recondensation 1.
In addition to these requirements, the committee encourages
institutions to address= other areas in developing their research
conduct guidelines. m e committee recognizes the difficulties in
reaching a consensus or standard that can be applied by NIH within the
next few years to such matters as the appropriate conditions for
sharing research data, authorship and publication criteria,
regulations governing financial conflict of interest concerns, and
efforts to reduce excessive publication pressures, particularly in
appointment and promotion decisions.
However, Harvard Medical School has recently adopted a set of
research guidelines that address many of these issues. A faculty
committee at the University of Michigan has also reach ended
29
OCR for page 30
development of a code for ethical conduct in scholarship. Other
institutions, such as the University of Texas at Housbon, have adopted
policies on authorship and plagiarism that address selected aspects of
these issues.
The requirement that all research institutions develop
professional research stand ares as a rendition of NIH funding will
stimulate much debate and reflection among scientists. The committee
believes this discussion itself will improve the conditions under
which science is conducted and the environment that shapes the
training of young scientists.
7. Universities should provide formal instruction in good
research practices. Thls instruction should not be limited to formal
courses but should be incorporated into various places in the
undergraduate and graduate curricula for all science students.
The lack of formal discussion about responsible research practice
and the ethics of research is a serious flaw in the professional
training of young scientists and clinicians. Many medical schools and
universities-= have traditionally avoided this topic and have relied
instead upon the faculty to communicate the standards and traditions
of research practice through personal example and Restoring. Others
have suggested that this information can best be communicated through
guest presentations or occasional lectures in traditional science
courses. Although these approaches are often useful, they are no
longer adequate because of the size and complexity of the modern
research environment.
The committee believes that instruction ~ the standards and
ethics of research is essential to the proper education of
scientists. Some organizations, including Sigma Xi and the American
Association for the Advancement of Science, have published materials
appropriate for this instruction (Sigma Xi, 1986; ChaLk, 1988~.
The committee urges~professional organizations to expand their
training activities to help and encourage faculty to offer seminars or
courses on the standards and ethics of research. Private and public
research funding agencies are encouraged to support projects that will
create and disseminate model curricula and supporting materials
related to the responsible conduct of research.
The committee emphasizes that the value of mentoring should not be
overlooked in institutional efforts to communicate responsible
research practices. The challenge to the universities is to identify
ways to support and reward professional mentoring, to ensure that
investigators communicate responsible research standards in their
interaction with trainees and students, and to supplement this
informal communication with instruction designed to expand the student
awareness of the ethical and professional dimensions of research work
Rut the training experience.
30
OCR for page 31
8. Universities should designate one or more administrative
officers or faculty members to promote responsible research practicer
within the institution. The institution should also provide mediation
and counseling servi ~ for faculty, staff' and students who wish to
express concerns about professionally questionable training or
research practices.
Universities should not rely upon formal complaints of scientific
misconduct as the sole means of monitoring the integrity and causality
of the research conducted under their auspices. They need continuing
mechanisms to review and evaluate ~ e research and training
environment of their institution. They also need personnel who think
critically about the Integrity ad quality of the research environment
and ways ~ which it calls be iTr~roved. Ibese or other sell
irxlividuals shard be available to discuss, on a confidential basis,,
incidents that raise questions of j~c or professional behavior or
the a~prwriate stains that shard guide ~ conduct. Because
even serious ~scorx3uct mav be recognized oTlly by E~r~ mini
esridenoe or suspicion, it is important to be Men ~ questions of all
levels of aunt seriousness. he ir~ih~ions may wish to
designate such an indivi~1 for each collie or major research unit.
_ .. . . · . · .
· · · . . ~
· .
The current use of ombu~spersans by some universities and medics
schools deserves consideration as one means of providing mediation and
counseling services to those who raise concerns about questionable
practices. The organizational factors that pro mote or inhibit the
effectiveness of onbudspersons '-- ~ -~---~----~---~---~
deserve further analysis.
In cna~lr~ suostar~ru practices
Some universities may wish to form faculty committees to monitor
the conduct of research within their institution. These committees
Thy develop other T~anisms both to identify and correct subs~car~rd
practices within the university art to promote stanzas of excellence
the performers of research.
9. Universities art offer research institutions should at heathen
the integrity and quality of research by modifying incentives and
academic guidelines in order to reduce the pressure for excessive
publication.
Publication is the end result of nearly all scientific research,
and researchers are too often evaluated for academic appointments,
promotion, and funding primarily by their number of publications. A
prolific researcher may have several hundred publications, and
evaluating committees cannot possibly read them all. Although some
members of evaluating committees may read some of the papers and know
the reputations of the researcher and of the journals in which the
papers are published, the increasing tendency over the past 30 years
or more is to allow the number of publications to serve as an index of
quality.
31
OCR for page 32
Quantity of publications as an into of quakier may be r~sonabJe,
insofar as the number of pet ications suggests Dirty and
pr~ctivity, arid may be a valid indicator of fire r~a~
-
perfo~e. However, as large bibliographies became the norm, it has
became necessary to undertake smaller and -her projects to attain
the highest possible rate of publication. R#s archers bend to divide
a large or complicated study into many parts so that each can be
published separately, resulting in multiple, overlapping, and trivial
papers. This is also a feature of collaborative studies, which are
increasingly common in today's science.
The committee believes that the pressure to attain a long
bibliography leads to poorer rather than higher quality work. It also
leads to the widespread practice of including as authors those who did
not contribute substantially to the work. This is sometimes done out
of generosity towards a younger colleague, sometimes at the insistence
of the laboratory chief, and sometimes because it is thought that
including the name of a well-known senior researcher will enhance the
chances of publication in a particular journal.
Not only does the pressure to publish lead to Me practices of
repetitive Publication. trivial work. arm loose authorship. but it mav
_ , ~ _ _ , _ _ _ _ , ~ , , _ ,
~ . ~
also Apt researchers to engage on more serlcus m~scorK1uct to achieve
a publishable result. His miscor~uct may range freon sloppiness, to
trimnir~ arm selecting data for more compelling results, to major
fraud. How far a researcher is willing to I ~ e along this s ~ tr ~ of
misconduct is, of course, a function of personal character as sell as
of the external pressures. Cbvicusly, many are willing to engage in
forms of repetitive publication although it is likely that only a few
are willing to commit fraud.
~· ~· · · ~
~ ~ ~ _" _
It is of interests however, that several
recent highly publicized instances of fraud in biomedical research
occurred in very productive laboratories where the head of the
laboratory had a long bibliography and there was great emphasis on
frequent publication (Woolf, 1986~.
One way of dealing with the deleterious effects of excessive
publication pressure is to allow only a limited number of publications
to be considered for academic appointment, promotion, or funding.
Harvard Medical School, which at one time required a researcher to
have a minimum number of publications to be considered for appointment
as assistant professor on the basic science faculty, now has
guidelines suggesting maximum numbers of publications to be considered
for promotion or appointment to each faculty level: 5 for assistant
professor, 7 for associate professor, and ten for full professor
(Tbsteson, 1988~.
For such a scheme to have the desired effect of reversing the
trend toward greater numbers of publications, it will be essential
that the candidate submit a list of only the maximum number of
publications allowed (presumably those considered the best) without
mentioning others. Only in this way can the emphasis on numbers be
changed.
32
OCR for page 33
It is sometimes objects that this will deprive those evaluating a
rewarder freon learnir~ of the indivi - ~1 's worst work. But pi
Me T=St important factor thatch be Me best the r~er can c30 and
not the worst. the hope is that each stay acid beagle
ately more s ~ cantial and that evaluators w ~ d find it rot
only possible, but also near to read the limited number of
publications.
It is difficult to say what the effect of such a system would be
on the incidence of misconduct in scientific research. Almost
certainly, the p~-actioes of repetitive publication and honorary
authorship would be sharply curtailed. as would stockiness and more
benign forms of cutting corners.
neC~Y;c~rily be much affected, it is likely that in a less cluttered
system, misconduct would be easier to detect.
,
Although major fraud might not
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.
Several sociological analyses of seleabed professions, such as
medicine are] law, have concluded ~t the nest significant determinant
of cc~mpliar~ce with professional norm is the social settle of
professional practice (Bayles, l9Bl; Marlin, 1966; Freidson, 1970~.
In keeping with this firmly, there is a rum new for scientific
institutions to across the social ~vin~mner~t of their faculty,
staff, and sets are to identify organizational e1 ~ Its,
incentives, and barriers that shape their understanding of, and
adherence to, responsible research standards.
As a first step in implementing this approach, the committee
recommends that universities and research centers develop new policies
to guide the training and supervisory practices of their research
. _ _ ~ ~ ~ _ _ a
Ermine. ~
these pollcles sncula require that a primary supervisor He
designated for each trainee and that the supervisor provide adequate
review of the trainee's research performance.
me committee considered, but did not endorse, a proposal that
institutions limit the number of trainees assigned to a senior
investigator. Although this approach may be desirable, there is
insufficient information at this time to suggest that numbers ad one
significantly affect the quality of research supervision. m ere is a
critical need for more analysis of the organizational and social
components of research settings that influence the quality of research
performance.
There are many different steps that should be considered by
department chairs and laboratory chiefs in strengthening the research
environment. The most intense surveillance of research practice
should occur on an ongoing basis within the confines of the research
unit. Research personnel should be explicitly instructed in the
33
OCR for page 34
prier Cans of designing experiments arm volleying experimental
Am. Oratory chiefs chard insist that raw data be preserved
within Books and over repositories ~ a way that is readily
interpretable by qualified Others beyond those directly
responsible for correcting the I.
In addition, there should be frequent interaction between the
principal investigator of the research unit and the individuals
conducting the research. Effective interactions require frequent
review and interpretation of raw data. There should also be regular
meetings in which the individuals within a research unit are able to
scrutinize and critique each other's work.
Conversely, laboratory or clinical research practices that
encourage cxxlxur~nentalization, secrecy, or isolation within the
research unit should be viewed as incompatible with the conduct of
good research. Departmental officers and laboratory chiefs should
discourage practices in which experimentalists routinely describe
their work only to their supervisor and not to their peers.
The committee also recommends that universities, especially the
medical schools, expand the ~ use of interdepartmental reviews and
visiting committees as mechanisms to promote the integrity and quality
of research training prc grams. These evaluation procedures are
traditionally used in gL-dbuate research prcqrams throughout the
universities, but they have not been commonly applied to other
research settings, such as medical schools and hospitals that conduct
clinical research.
11. Academic departments and research units should adopt
authorship policies to improve the publication practices of their
faculty, staff, and students.
Authorship of a scientific report is a responsibility as well as a
privilege. It implies that a person has contributed essentially and
substantially to the study and is able and willing to defend the work
publicly. This does not mean that such author participated in all
parts of the study, but it does mean that all authors have
familiarized themselve_ with the general nrin~;nl-= of ~11 antic of
the study.
~ _ ~= ~,= ~,=~
Authors who have not substantially contributed to the study are
often added to papers, a situation that reflects the importance to
each researcher of lengthening a personal bibliography (Hush, 1988~.
Sometimes the head of the laboratory, who may have obtained the
funding for the study, requires recognition as an author. Sometimes
authorship is added willingly, because it is thought that the name of
a well-kncwn, senior researcher as author will increase the report's
chances of being published. In general there is a tendency to add
names as a form of collegiality.
34
OCR for page 35
leers are different Opinions as to the mind level of
participation By to qualify for authorship. For example, ore
primal has been suggests by the Intonational Cc~nitt~ of Medics
Journal Factors (ICMlE, 1988~: "Authorship Bit ~ d be bass only
on substantial contributions to (a) car ~ ption and design, or analysis
and interpretation of data; (b) drafting the article or revising it
critically for important intellectual content; an] (c) final approval
of the version published. Conditions (a), (b), and (c) must all be
met."
Although these criteria have been accepted by many medics journal
cantors, they have not been accepted by the research community as a
hole and have been qylestioned by those who think they are too
restrictive. A~rdi~ ~ he ISLE criteria, the contribution rest
be substantial, hit it need not be to all parts of the study. Incus,
sc ~ >ne who conceives of arx] designs a term hy sexy wok d be included
as an author even if the indiviarmn did not participate in the
analysis and Interpretation. However, merely generating the data, no
matter how laborious a task, without involvement in design or analysis
does not qualify a person for authorship. Nor does simply acquiring
the funding or supervising the laboratory where the work is done, if
the investigator is not involved in the substance of the research.
the committee did not endorse these particular criteria, but
believes that they represent a useful starting point for the
development of institutional guidelines. It is important to limit
authorship to those who mate substantial contributions. First, it is
confusing and deceptive to include supernumerary authors. More
important, gift co-authorship diminish== the concept of responsibility
and makes it easier for the writer to publish fraudulent data. When
criteria for authorship are loose, co-authors may evade all questions
about the integrity of the work. If stringent criteria for authorship
were widely accepted, this is less likely to happen.
Senior researchers can provide important encouragement to junior
researchers by designating them as co-authors. However, unjustifiable
authorship should not be used as encouragement, no matter how generous
the impulse, because it erodes the concept of responsibility.
Preferably, a junior researcher should be involved in a study early
enough and broadly enough to satisfy the criteria for authorship.
The committee considered, but opposes, a proposal that
universities review research manuscripts prior to their submission to
journals or professional meetings. This review is unnecessary and
intrudes upon traditions of academic freedom by suggesting that some
form of administrative or departments clearance is required prior to
the communication of research findings.
The committee believes that scientific journals and research
institutions can address the problem of supernumerary authors by
35
OCR for page 36
establishing criteria for authorship and requiring each author of a
report to specify a contribution that satisfies the criteria.
In addition, the committee recommends that each academic
department and research center maintain an up-to-date record of the
publications of its faculty, staff, and students. The deparLmenta~
record will help facilitate colloquial review of published research and
will also highlight Native publication p~-ac~ti~. If questions are
raised ascot inappropriate assignment of authorship credit, the
de~rtrarnt art its institution Uphold take appropriate steps to
investigate the allegation.
RE~ONS FOR ~E=SIC~L AND SCIENTIFIC
O~NIZ=rCNS AND Jay
12. Professional and scientific organizations representing the
research community should develop educational and training activities
and materials to improve the integrity of research. These
organizations should assist universities in identifying substandard
research and training practices that compromise the integrity or
quality of research.
Professional organizations. including the various discinlinarv
_ - - - , ~
a e ~ ~ ~
societies, play an important role in developing consensus about the
goals and values that should shape research practice. Scientific
meetings and journals often provide young scientists with a first
glimpse of the issues of importance to the research ccmmNnity as a
whole and allow greater insight into the social context of individual
or institutional research projects.
The committee hats taken note (Chapter 2) of several current
projects conducted by scientific and educational organizations that
address issues of research misconduct. These include a series of
workshops conducted by the National Conference of lawyers and
& dentists and the "framework" project currently sponsored by the
Association of American Universities and the Association of American
Medical Colleges.
The committee believes that much more can be done by these and
other organizations to promote the responsible conduct of research.
Some topics that are suitable for development include the issue of
rights and responsibilities with respect to sharing research data and
unique biological materials; the professional duties and expectations
that shape the career development of young scientists; and the
appropriate means of acknowledging scientific achievement and
contributions in collaborative efforts.
There are many practices that most researchers would recognize as
distasteful although they may not be viewed as serious scientific
36
OCR for page 37
m~scorx3uct. Several parts convent at the workshop suggest
emit of Seth practice, inch: misuse of statistics,
selective ~n~:~tation of r~h fistic, unjustified seer are
r~1ization of research projects, incomplete an
of m~ntriblltions f m n colleagues or train s, and inappropriate
publication practices, such as divided publication, repetitive
publication, or incomplete or inaccurate publication.
Most of thee= practices' although deplorable, do not fit the
prc posed federal definitions of scientific misconduct and they are not
suitable for investigation and punitive action by research
institutions. In the long run, however, substandard practices may
damage or seriously compromise the Integrity of scientific research
a ~ the quality of the research environment. Furthermore, these
practices, if left uncorrected, may evolve into research fraud or
ocher serious deviations four professional sban~ards (Bosk, 1981).
The committee recommends that prof-~-~cional organizations develop
forums and publications to identify substandard practices that
compromise the integrity or accuracy of scientific research. Once
consensus about these practices has been achieved, they should be
addressed by NIH and the university research guidelines a ~ oversight
mechanisms.
13. Scientific journals should develop policies to promote
responsible authorship practices including procures for responding
to allegations or indications of misconduct in published research or
reports submitted for publication.
The committee commissioned one background paper on issues of
scientific m~soonduct in connection with authors hip and publication
practices (Hush, 1988). mese issues were also addressed by a
workshop panel whose members included both research scientists and
editors of various research journals.
There are a host of topics related to The responsible conduct of
research that need to be addressed by scientific journal editors and
publishers. Several organizations, including the Council on Biology
Factors, the International Committee of M~dim~1 Journal Editors, and
the Amari ~ Medical Association, are developing programs and policies
that address many of these concerns (Culliton, 1988b; AMA, 1988~.
m e topics that require immediate attention by scientific journals
include repetitive publication, supernumerary authorship,
institutional responsibilities for discI06ure and notification of
research misconduct in publication, the use and misuse of peer-review,
and the appropriate response to suspicions or confirmations of
misconduct in published work or work submitted for publication.
The committee endorses proposals made at the workshop that
encourage journals to require all authors submitting a manuscript to
37
OCR for page 38
the journal to sign a statement that defines their individual
contributions to He manuscript. Doors of I reports might
be as} - explicitly to asinine r~nsibility for the ~ntegrit~r of He
data.
Alff,a~h the Soiree believes it is praise to require
insti ~ tional review and approval of manuscript submissions as a means
of assuring integrity in published work, the members conclude that
journals can do much more to ensure that authorship criteria are taken
seriously. In developing their policies, journals need to work
closely with research institutions to encourage good publication
practices that will protect the variation that is important for
discipline-specific journals.
The committ== also believes that journals should disclose to
appropriate persons at the research institutions substantial
allegations or indications of research misconduct that are detected in
the course of peer review. Many journals are presently in the
position in which research institutions found themselves before
federal regulations required the development of misconduct policies
and procedures. The editors are often ill-prepared to deal with cases
that are brought to their attention, and they are reluctant to c~11
attention to complaints of unprofessional behavior that have not been
formally substantiated.
Journals have an obligation to publish retractions of published
reports that have been found erroneous by the original authors or that
have been declared frand~nent by appropriate authorities at the
research institutions. The committee recommends that science journal
editors develop a uniform system for reporting serious violations of
professional standards to research institutions so that institutional
officers can be informed in a timely manner of the nature of these
complaints.
The committee does not encourage editors of journals to conduct
random data audits to ensure the responsible conduct of research (see
Recommendation 3~. Editors seldom have the resources or the expertise
to carry out such audits.
14. The National Academy of Sciences should pursue the issues and
findings developed by the Institute of Medicine In this report and
examine their relevance an___eplication to other fields of scientific
research.
The committee= has examined the issue of the responsible conduct of
research with particular emphasis on the health sciences, as requested
by the National Institutes of Health. Thrcoghout this study, however,
questions have been raise] about the significance and applicability of
this issue to other fields of scientific inquiry.
38
OCR for page 39
Scientific ~sco~ct is not limit ~ bit arid behavioral
~ Cohn, 1986~. Attach serious cast of scientific fray
have altars ~st camn~nly in heath sciences r~, there are
also examples of Cuba falsification, fabrication, and plagiarism in
chemistry, geology, physics, and other fields of scientific and
scholarly inquiry (John, 1986; Broad and Wade, 1982~.
The committee urges the Academy to develop additional activities
to pursue the issues and findings discussed in this report. Topics
that seem to warrant immediate attention by the Academy include the
following:
o Con~rr~s about scientific misconduct ark responsible research
practices are currently very visible In the health sciences. Alff~a~h
he committee believes that the issues address in this study are
relevant to over fields of ~r~, it has rot attempted to judge
the value of its ~ ations for all of science. The Academy
could play an important role by ebz~u~nung the need for policies and
procedure to assure responsible research practices throughout the
scientific community and by highlighting factors that differentiate
the quality ass~n~n~e programs of different disciplinary fields.
O The traditional procedures used by various research institutes
and fiel ~ of study to detect and correct errors an] to encourage
quality In research and scientific training are not well defined or
well understood. IN particular, training evaluation systems (such as
'visiting committees'') deserve further characterization and analysis
to determine their strengths and limitations. There is a need to
highlight effective methods of professionalization that should be more
broadly disseminated t ~ out the research community.
0 The rights and responsibilities swrll~ulling access to research
data, methods, and materials, deserve analysis to assist in the
development of policies and procedures that affirm the traditional
openness of the scientific p-m-cess while Plan nmt£~;na ;mnort~nt
intellectual property interests.
_ _ ,= ~.= ~
Although the issues of data access and data sharing have been
discussed in many settings, there does not yet appear to be real
acnsensus over the basic standard Fat dhaald govern individual
practice (a Ration 15). Sound policies require thoughtful
analysis by exams in Irony disciplines. This area provides an
opporiuni~r for the Academy to build upon its earlier work in
analyzing data sharing practices In the social sciences and to
rY~xn'~end practices that are consistent with the norms of good science
(Fienberg et al., 1985~.
o With the requirement that there be exposure to professional
stdrlilnis and ethical issues in the training of scientists will come
the practical need to develop ways to achieve this instruction. The
committee seeks to maintain creativity and flexibility In
39
OCR for page 40
-
institutional approaches fulfillir~ ~ his requ~x~. There is a need
for an = ~ of existing instructional materials. There is also
a new for national ford; to cti~te effective educational
materials, incl~irx~ talcs, case st~ies, Video tapes, or booklets:,
since few institutions can cla ~ to have the practical expertise that
will be require! for sound beaching materials.
o Although it is clear that poorly supervised scientists are more
likely to develop unacceptable research practices, it is not known
with any precision what constitutes adequate supervision. m e
perception needs to be a~]rPc~PO that there are large laboratories
with absentee chiefs, who are training a correspondingly large number
of young scientists and failing to indoctrinate them adequately into
the professional as well as the technic stanzas of science.
15. Art interdisciplinary cc~nnitt~ should] be cor~vened to shady
the issue of rights ark responsibilities of all relevant parties to
rearm data and to prepare model guidelines for data sharing and
data access.
The ~ntegri~r of science is directly influenced by the
verifiability arx] repr ~ ucibili~r of ~ h data. The c ~ nitty=
believes that the issues surrounding access to and sharing of research
data are especially complex, and the members wish to highlight this
topic as one that clearly deserves further consideration. This topic
is appropriate for individual or collaborative studies by
organizations such as the National Academy of Sciences, the American
Association for the AcvanKement of Science, and the Association of
American Universities.
As mentioned previously, the National Research Council has
conducted-a study on data-sharing practices in the social sciences.
Sharing Research Data provides a useful reference and good beginning
for a broader examination by professional and scientific organizations
of the principles that should guide research practice In all fields of
science. BAAS has also published an important report on this topic
(Science as Intellectual Property) and has hosted several symposia to
identify and evaluate current data sharing practices (Nelkin, l983~.
ALAS nas also Published an important resort on this tonic
The committee believes a sbudy-of the rights and responsibilities
of all parties to research data is especially important, given the
perceptions expressed by many works hip participants that commercial
and entrepreneurial interests as well as competitive academic
pressures are affecting traditional data sharing practices.
The committee suggests that this study not be limited to the
sharing of research data, but include related issues such as the
appropriate conditions for sharing research methods and materials.
40
OCR for page 41
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 reccmmen~s that professional and scientific organizations
initiate studies to understand and encourage responsible research
practices.
IN its review of the topic of fraud and quality assurance ~
hearth sciences research, the committee identified a number of areas
in which information is insufficient to warrant specific policy
recommendations. The committee urges professional and scientific
organizations, as well as individruH investigators, to undertake
studies in these areas to racist in the development of informed
policies and procedures to promote the responsible conduct of
research.
The following topic_ seem most appropriate for further analysis at
this time:
o The effectiveness of mechanisms currently used to monitor
quality ~ Xanadu ate research programs. The proposed study should
explore (1) how mechanisms such as visiting committees and research
r ~ systems actually work, (2) the experience of selected
institutions In using these systems to determine research quality, and
(3) the means by which they cculd be introduced into other research
settings.
o The existence of ethical concerns among research scientists and
trainees and The ways in which these concerns are ad~r==sed. A few
surveys have been oon~uc~P~ to determine professional awareness of
incidents of m~soonduct (Sigma Xi, 1988; Tangney, 1987, 1988~. Much
greater understanding is needed of the types and prevalence of ethical
concerns including, ~ t not Ignited to, concerns about m~soonduct-
among scientists and train ~ . It would be useful, for example, to
study the opinions of individual scientists about the manner ~ which
institutions develop and monitor risible ~ practices.
O the roles ark responsibilities: of r~a~ staff In the
laboratory or cl~ni~1 Leant center. He rapid growth ark
~lexit~r of heath scier~es rearm In recent decades has spat
t~rxious diversification ark variation within the Rae
~ at. There is same confusion over the role~--ar~
responsibilities~of junior and senior personnel. Studies designed to
analyze the expectations of the performance of different personnel in
the laboratory and clinical research centers will identify other
factors that affect the integrity of research.
O The detection and correction of error in science and
scholarship. Various disciplines rely on systematic mechanisms, such
as the replication studies required by some chemistry journals, to
41
OCR for page 42
identify research errors. The quality of research would be improved
by characterization and analysis of the procedures COPE by research
institutions, journals, professional groups, and individual
investigators in various disciplines to detect and correct error.
.,
42
Representative terms from entire chapter:
responsible research
