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OCR for page 68
APPENDIX C
PANEL 1
Emit OF IlIE PANEL CN IA1~R~ORY UNIT AND PRACrI~
Ihe parer was aomrened to discuss ways to inprc~re Arrant laboratory
ream practices ~ the academic ~viro~nt. me namers indicated
that two goals were the Hit desirable: ill!praving the overall quality of
research as currently practiced by university investigators and also
remedying conditions that mav fail to discourage Misconduct in the
rearm press.
Sixteen members participated in the panel digressions, most of whom
were practicing scientists (primarily Ph.Ds) covering a wide range of
fields, including molecular biology, biophysics, biochemistry, and science
and law. The group also included several senior research administrators,
including two academic research center directors, two vice-president/vice-
chancellors for research and graduate deans, a chief scientific officer of
a major private research funding agency, a laboratory chief frown the
National Institutes of Health, and staff members frog the Academy.
The panel addressed a broad set of topics during its discussion.
These topics included the handling, storage, and archiving of research
data; existing models for quality control in science, including
regulations governing the use of animals, the handling of hazardous
materials, and experiments with recombinant DNk technologies; the
applicability of the Good Laboratory Practices (GLPs) guidelines used by
the Food and Drug Administration and the Environmental Protection Agency;
the value of external admits in basic research; training and supervisory
practices; the relevance of lab size and structure to research ~ntPoritv
authorship practices; the significance of formal and informal rules in
achieving good laboratory practice; the communication of high standards of
research practice; and the relevance of good laboratory practices to
fields of research beyond the biomedical sciences.
_ _ =_ _ _, ,
In these discussions, the panel numbers identified problems in
evaluating the effectiveness of current mechanisms designed to promote
integrity and quality in academic research.
participants thought that instances of fraud in science are rare but that
sloppy research practices are more common than would be desired. The
.
A majority of the
pane' members expressed concern that the relatively rare instances of
scientific fraud might provoke regulatory reforms that would be
inappropriate for improving the conduct of responsible research practices
and that would also threaten the vitality of creative research.
Most of the panel members agreed that substantial improvement in
laboratory practices could be achieved mast readily through mechanisms
that improve oversight of the work of those directly involved in
experimentation. An appreciable member of the participants thought that
certain reforms Should be initiated by the universities and professional
68
OCR for page 69
organizations to improve He effectiveness of existing oversight
i~. A mirror expressed Sambas that these reform were
redry, indicatir~g that the monitoring In worked well, that peer
refries was highly su~:ful, are that evic3~e of serials prciblems in the
conduct of r~r~ was insufficient to justify Changes;. A smaller
minority support Ire emotive reforms, including the use of vernal
auditing as a Ned; of assuring Cavity in academic i.
(300D IA=R~O~ PRACTICE GUIDELINES AND 1~ USE OF AlJDlI~
~ of the part participants express serials reservations abet
the need for and in act of legislative or r ~ atory actions In improving
the quality of basic research practices. For example, the panel
considered the rules associated with the FDA and EPA GLP guidelines that
regulate c hemio=1 and drum testing. Thea- GLEs describe in detail the
_ _
procedures to be followed during the tests and include periodic agents by
a regulatory agency to ensure adherence to the guidelines and the study
protcool agreed upon at the inception of an experimental study. Federal
regulations governing the handing of radioactivity and other hazardous
materials, He manipulation of recombinant He, arm the use of animal and
human research subjects also rely extensively upon oversight of research
protocols.
me panel believed this rotatory approach was impractical and
injuries to He conduct of good science in fields ir~rolving basic or
discovery res ~ and noted that the agencies that use GLPs had rejec
their application to basic research. A regulatory approach based on
oversight of the research protocols requires that a detailed canon of
_~
a,
research practices He establlsned, that detailed research plans be drawn
up at the initiation of the study, that deviations from the seedy protocol
be justified in advance, and that adherence to these practices and
protocols be monitored through periodic agents by responsible parties
outside the research unit. m e agents might be conducted by granting
agencies, by governmental ablating agents, or by institutional officials
empowered to conduct such procedures.
These plans were viewed as unworkable by the panel. such of the
research in question concerns basic discovery research, and it necessarily
involves constantly changing protocols and research procedures. Adherence
to a preplanned search trajectory would hamper basic science a ~ foreclose
the pursuit of unexpected but promising findings. The auditing bodies
will be unlikely to acquire the n cessary expertise to monitor effectively
the activities of a large and diverse array of specialized research
enterprises. Perhaps most important, the concept of rout~nized
institutional auditing of the details of basic research procedures
undermines the principles of trust and personal integrity that currently
govern the conduct of academic research and the professional status of its
practitioners.
69
OCR for page 70
me panel explored a second regulatory strategy involving a
sbr~ of existing peer review presses. me pass of peer
review oars at several distinct levels, arm a majority, of me panel
agreed Cat each of these cold benefit Frau Potential i~r~rer~nt.
Peer Review within the Pram laid
me most intense surveillance of ~a~ prac~ti~: Occurs on a
fr~ent and ongoing Uris within me confines of the r~i ~it.
review of this work cams on a ~ of practices, many of math are
implicit or intrinsic in the correct of scientific iT~restigation arm
experimentation. mese include:
0 instruction of learn pE=sorme1 in how to primely design
experiments and collect experimE~n~cal eta;
o insis ~ :e that raw data be preserved within no ~ books; and offer
repositories so that they are clear and readily infer pret=d by qualified
researchers beyond those directly responsible for conducting the retrench
· ~
In ques ion;
o frequent interaction between the principal investigator of the
research unit and the individuals conducting the research. Effective
interactions require frequent review of raw data and interpretation of
their implications; and
o frequent interactions between the experiment~1ists within a
research unit involving those not directly concerned with the research in
question. The panel thought it desirable that research units conduct
frequent, periodic semurars in which investigators and trainees are able
to scrutinize and critique each others' work. Conversely, laboratory
practices that encourage corpartment~lization, secrecy, or isolation
within the research unit were viewed as incompatible -with the conduct of
good research. Moreover, the panel sought to discourage practices in
which experimenta~ists would describe their work only to a supervisor and
not routinely discuss findings with their peers within the laboratory.
Peer Review Within the Department
Most research units are affiliated with a larger administrative unit,
usually termed a "department." The panel thought it important to
recognize that departments have an essential role in monitoring the
integrity and quality of the science within their constituent research
units. Intradep}rtmenta1 review may not be invested with the same degree
of specialized expertise that resides within the research unit. itself, but
it should play a useful and essential part in assuring quality. The panel
members indicated that departmental affiliation implies interest and
70
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willingness to subject one's research to the scrutiny of other
departmental membered including those outside one's own research group.
A variety of mechanisms can be used to achieve this end, including:
0 ~rn:a1 Irk Emit,
0 joint research meetings involving: multiple research uniter
0 annual or semi-annual reports of investigators' work, a ~
o other means of engaging contact between members of different
research units, including participation in joint training programs.
This approach assumes that such review and scrutiny should be
undertaken as a matter of common practice and not only on rare occasions
and in response to suspicion of implications of poor quality or
misconduct. Md~Na1 review performed in a constructive and collegial
manner was viewed by the pane] as a normal, routine element of good
science and a characteristic of an active and productive research
department.
Review of the Department by Outside Peers
Because the departments exercise a central role in the existing peer
review produce' the panel considered mechanisms to ensure that departments
and their component research units function in an appropriate manner. One
useful mechanism is the use of periodic review, often performed every
several years, by peers outside a department. mese peers may cam_ from
related departments within a university or fort other universities in the
form of "visiting committees." mese departmental reviews often include:
0 surveys of representative research projects,
o surveys of the entire output of the department,
arid
0 interviews with trainees, supervisors, and principal investigators,
o preparation of candid reports for department heads and higher
administrative personnel, including deans, provosts, and the president of
the university.
Review of Published Work by Peers
The three levels of peer review discussed above monitor the everyday
process of science within The laboratory. These activities include data
acquisition and interpretation. The panel felt that the end point of this
works the formalization of results in a published report also requires an
increased level of peer monitoring.
71
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m is monitoring of published work begins at The stage of drafting
reports for event publication. me panel thought it essential that all
parties contributing to the report and appearing as authors be involved in
its creation. In certain Hasp=, this sight involve only a detailed
reading of the report prior to submission. In others, co-authors ~ ght
redraft portions of the text. In all cases, the panel staled that
participation as author implies a detailed understanding and agreement
with the report and a certification that the results contributed be an
author are properly represented by the finished text.
_ . , _
~ ,~ ~ .
A subsequent level of manuscript review occurs by qualified peers
following submission for publication. me panel did not micros= changes
in this prone== as presently constructed. mey did focus attention on the
post-publication prices the scrutiny of a published report by peers
throughout the world. me central effectiveness of this scrutiny relic=
on the ability of peers to reproduce or replicate published results. In
the end, the panel believed that independent reproduction represents the
ultimate and most credible measure of scientific veracity.
SHARlNiG I, ME~)D6, AND Rat
the panel indicated that authors of published work have a traditional
obligation to aid scientists interested In independent replication. m is
obligation includes the duty to assist in providing raw data, if
requested, and access to the methods and reagents necessary for
reproduction. the panel further noted that this obligation is usually an
unstated assumption in academic research and that there may be a need to
develop written policies to clarify and strengthen traditional practices.
the pane] observed that whether or not written guidelines were developed,
certain practices needed to be addressed to improve the fulfillment of
data retention and sharing duties.
Raw Data
In certain cases, questions frail peers may arise that can only be
adequately addressed by exam m mg the raw data that underlie a published
report. These data should be written in a form that is subject to
independent reexar mation, readily interpret~hle by qualified
practitioners in the field. Moreover, the data need to be preserved for
reexamu nation for a period of time after publication. Several panel
members suggested that five years seemed to be an appropriate period for
data retention.
Equally important is the implied readiness to supply these data to a
qualified peer. The panel indicated that customary practice attaches two
conditions to this access:
o The party requesting arc=== to raw data should have a
well-articulat=d justification for reexamination of the raw data and a
history of experience in the scientific speciality in question or in the
72
OCR for page 73
examination of closely related problems in the field. This experience
ensures qualification to interpret critically the data requested.
O The data requested should directly underlie a scientific conclusion
that has keen questioned. Requests for data not associated with published
reports are seen as improper and may intrude on the rights of an
investigator to man individual control of preliminary results.
Moreover, requests for raw data not directly related to the narrow issue
in question are seen as inappropriate. The panel recognized the need for
safeguards to prevent requests for wide-ranging, blanket surveys of data
records stored In a laboratory's archives. These surveys are seen as an
unreasonable imposition on an investigator's time and resources and
represent unjustifiable and arbitrary intrusions into the workings of a
scientist's activities. ~
pn-==c to Methods and Reagents
Publication of methods in a fashion enabling independent replication
is a well~ablished procure and requires little elaboration. A more
difficult problem is the customs that govern access to reagents mercury
for ~qprc~uction of the work. In most instances these are readily
available commercially or through wide distribution among laboratories;
In some instances they are not. The panel suggested that investigators
have a responsibility to share with qualified peers attempk~ng
reproduction of published work the reagents that are ~C=pntial to the
independent reprc~uction of the work when these reagents are not generally
available. It is believed that many big; research journals, such as
Cell, have formal guidelines requiring this practice as a condition of
publication.
Panel members identified several considerations that may govern the
sharing of reagents.
o m e reagents should be made available within a reasonably short
time after publication, such as several months.
O The reagents may be distributed to academic research for their
own `~=, but investigators should not be expecbel to share them with
industrial concerns.
O The amount requested should be minimally essential for reprc~uction
of published results.
O The request should not impose an unreasonable supply burden on The
original laboratory.
O Certain requests for distribution may be unreasonable. These would
include reagents available only in small amounts, such as unique antiserum
or animal strains bred in small number, or otherwise unique and not
susceptible to distribution. Certain animal populations, as well as human
clinical sty pupations, for example, cannot be ~ to be shad - .
73
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Rainier are S~;lsory Lactic
The panel participants did training ark supervisory practices
and rate that many principal investigators may be inad~at~ly trained to
manage a Heard group. This was thought to be Ire camnan in bile case
of ~ restigal;ors who receive research train) ~ In a ~ ical school rather
than a graduate school program.
There was also significant discussion about the effect of size of
research grc ups on the quality of academic research. Recognizing that
individual investigators are competent to direct the activities of a
limited number of people, the pane] hesitated to suggest an effective
limit because of the wide variance of managerial competence among
investigators. The panel notes with concern, however, that when an
investigator heads a group that exceeds his or her competence, these
circumstances heighten the possibility for inadequate control, sloppy
research, and fraud.
He panel suggested that each laboratory employing trainees and
students have a set of generally accepted good laboratory practices
defined for the members of the research staff. There was consensus that
it would be important and useful for a national research organization to
describe the essential elements of these practicer in a document that
could be provided to all investigators and trainees involved in discovery
research.
INSTTTUTION~L OVERSIGHT
me panel observed that various institutions place significant
pressures on invesigators which, if carried to the extreme, threaten the
responsible ~nduct~of research. mese pressures include the perception
that administrative officers value numbers of publications and the
accumulation of research dollars from external funding agencies as the
most important indicators of research quality.
me panel also noted that spots oring instigations and universities
have a right to expect mechanisms to be in place to ensure and improve the
reproducibility of published work. In particular, panel members suggested
that the instibution needs to recognize the crucial role an] influence of
The laboratory director. Academic officers need to provide guidance to
Their lab chiefs about the probe ems of overcommitment, distraction by
other activities, and how to resolve individual variations In the
quantitative arcs of laboratory direction.
Finally, the panel stated that universities, medical shoots,
hospitals, and other ~a~ aerate; have a Pica re~ponsibili~
for He r~ ~viro~nt of Heir faculty and staff. There was
general agreement that the officers of th ~ institutions need to assure
themselves and others, when questioned, that the environment for their
research faculty, staff, and students is intellectually, structN rally, and
administratively supportive of the conduct of good science.
Chair: Robert Weinberg
74
Rapporteur: R. William Butcher
OCR for page 75
PANEL 2
hi OF THE PANEL ON CLINICAL REFLEX ~Ac]'lCF~ AND ~
lee panel e~i~ issues file rearm practice and training,
with specific relevar~ce to clinical hi. hue main topics Aged
ding its digressions: the diverse nature of clinical r~z=, the
adequacy of training, and the efficacy of existing monitoring Anise;.
m e panel included research directors and scientists frum academic,
industrial, and government research centers; the chairman of medicine and
faculty members from major medics schools; the director and staff members
from professional associations representing academic health centers and
clinical investigators; and the editor of a journal on institutional
review boards. In addition to medical specialties, the participants
included two sociologists an] a bio6~atistician.
IHE DIVERSE NATURE OF CIINIC~L RESEARCH
m e panel examined the diverse nature of clinical research, which may
include both physicians conducting original research and those conducting
therapeutic drug trials. m e former group represents the focus of the
discussion; the latter often have technical rather than scientific
responsibilities. Ire panel indirect that scientists To conduct
reseal in a clinical setting should be guided bar the same principles in
research as their colleagues In the university. me rest of the
clinical scientist, hammer, may be subject to additional regulations
associated with human subjects research.
Given this distinction, clinical rearm on human subjects is still
c~xr~licat~l by diversity. For ex ~ le. clinical trials sc~reti ~ ; involve
multiple institutions and Large numbers of subjects. These studies are
quite different in scope and execution from more conventional studies
within a single institution on a limited number of individuals.
Behavioral research on humans is inherently different from trials of
Therapeutic agents in a specialized medical unit. The principles and
practice of chaining "informed consent" are more straightforward in some
experimental circumstances than in others.
In the conduct of research on humans, conflicting pressures can arise
if the established experimenter design entails a risk to the welfare of
the patient. This prospect is minimized by the careful design of
experiment=] proboools so that guidelines for behavior of the investigator
will prevent loss of scientific Objectivity. Nonetheless, despite the
best experimental design, DeSeBrCh on humans often has to strike a riddance
between patients' rights and welfare on the one hand and the scientific
endeavor on the other.
m e panel discussed a third feature of research on humans: it is often
conducted in a "fishbowl," in full view of many parties with diverse
75
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it. Ihis is er~tirely app' - riate. lever, it Is sciatic
difficult to transmit to all i~t~ parties, professional arx] lay, ff`e
nature of he r~ and he balance between rip art benefit.
ha: ADB~CY OF RESET A:
Not intently, those Crouching research on hens are physicians
trained In a postdoctoral pa ~ n within a m ~ Iran school. As a rule,
this training IS supervised by an experienced individual, often termed a
'mentor,' rather than a department. As a result, the nature of training
for research within a specialty can vary widely. Panel members suggested
that the sponsoring institution often plays only a minor role in the
training of a physician-scientist.
The background of the physician-scientist before undertaking research
training also bears upon the behavior of the clinical investigator.
Premedical education is a highly competitive undertaking. Inevitably, the
habits and attitudes acquired before entry into medio~1 school and
hospital staff overflow into the D~SearCh experience. Collaborative
efforts are uncommon. The combination of competitiveness and lack of
opportunity for collaborative underba kings is an obstacle to the team
research requirements that are often mandated by clinical investigation
studies. Scientists trained in a medic school setting oft en do not
receive the same exposure to courses in statistics and research techniques
as their colleagues trained in a graduate school curriculum.
The panel numbers suggested that the role of the mentor is central to
responsible research training for human research, as may also be the case
in other fields of basic research. In recent years, mentors have become
increasingly remote from junior personnel, depriving emerging
investigators of necessary moral and professional as well as scientific
guidance. Responsibilities for training have become diffused, while the
number of fellows has increased. As a result, ccmmunications between the
scientific head of the laboratory and those in the initial phases of
training have become increasingly casual and sporadic.
The physician-scientist also operates under different conditions than
the basic scientist. The physician-scientist is often required to commit
extensive time to activities that are peripheral to research. For
example, patient care is a demanding pursuit that can disrupt ra search
schedules. Committee assignments and administrative responsibilities in
the clinical- departments are time consuming. These distractions from
research generate stresses and may impede proper professional development
in research. Rarely is the developing independent investigator protected
frail the pressure to achieve independent funding and to participate in
teaching and administration during the formative period of a physician-
scientist.
Some panel members observed that the absence of a written set of
research guidelines exacerbates the dependence of the young physician-
scientist. Consequently, much of the prof visional training of the
76
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clinical SCimltist is influence by me merrier In With the Hearth
Filet ~ this} ~ trainee ~ I ~ iamb ~ ~
practices, include He tedhniq~s and its of r~r~ deign; the
har~lir~ am Waring of r~r~ data; the emulate of e~peri~ntal
results; am the general sense of has science is priorly cold.
~ e panel believed ~ at, as a rule, there ~ little explicit at ~ cion
to the ethics of good scientific research on humans or to the
responsibility of the indiviflu~] scientist to the scientific community at
1ar - .
NORM;
Clinical research is often mare intensely monitored than other types
of research. Institutional review boards are central to the review
process. Moreover, collaborative trials generally have built- m review
-
In research universities, institutional review beards are quite busy
Men working at full capacity. the panel ban ieved that, In considering
strategies for improving r~h monitoring, ~ oversight
re~ponsib;1 ities ~ Id not be it on these boards.
`3 panel;suggest" that effective in develc~ping proper reseal
axes and practices are the Manias each to brain yaw
scientists. Of particular concern is the Craig of the EShysician-
sci~ist as a responsible indulgent investigator. knee no;
exp~ Morn abarc the lack of attention by the tea<~ir~ institutions
to Negro ark their roam an. This clefici~y affects bag the
~ainir~ Of physician scientists and also influerxx; their subagent
behavior as indulgent irwestigators.
~air: Alfred P. Finn
77
Rappor~ur:
Leonard Barter
OCR for page 78
PANEL-3
REPORT OF THE PANEL ON INSTITUTIoN~L OVERSIGHT
The panel focused on the role of the university or academic research
center, as an institution, in ensuring and promoting scientific
responsible ity. Recognizing that goverurenlal institutions, including the
National Institutes of Health and the Congress, have emphasized the role
of the universities in detecting and preventing scientific misconduct, the
panel sought to discern institutional practices that would support and
promote good science.
The 17-member panel included government and university attorneys,
academic a,chinistrators,,government,officials, and professional society
officers. Many of the members had direct experience in handling or
investigating allegations of scientific misoonduct.
The pane] acaep~P~ the premise that peer review at the institutional
leaved is the cornerstone of good science. They explored whether a system
of incentives and structures can be devised to enhance,responsible science
and to discourage the impulses and practices that contribute to scientific
misconduct. In discussing actions to enhance good science, the panel
sought to identify areas where initiative by university officers, rather
than action at the level of The laboratory or professional association or
journal, would have a oo~parative~advantage. ,
The panel identified five areas where institutions could profit from
increased attention:
o, training and Hectoring;
o handling, storage and maintenance of research data;
o the meaning and responsibilities of authorship;
O definition and as _ nt of scientific acacmplishment; and
o processes to assure full and fair review of allegations of
. . .
- r~prle~.
A common theme for all five areas was the need for each institution to
clarify and communicate its expectations for individual investigators
about the environment In which scientific inquiry is to be conducted. A
striking example of one institution's efforts to articulate these
expectations is the set of guidelines recently adopted by the Harvard
M~di~1 School, which address many of theme five areas.
~N~ AND MEN
Effective training of young scientists is an essential duty for the
perpetuation of good science. Training is teaching, and the primary
responsibility for carrying out this duty ne~-c=~rily rests with
individual faculty members and research supervisors. The academic
institution's role is seoon~ary and largely supportive.
78
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To or ~t is this institution? ~iviclua~ are collective faulty
are administrative officers cerise the university. the Collective
face y, overseer He individual faculty ~rbe:r, is tile core of a modern
anemic instillation. Ire collective faculty holds the primary
r~nsibility for He ~n~ri~ are quakier of the institution, although
He degree of care with Rich they Anise this r~nsibility is often
influenced by the administration. He administration ~nicat~ with
the a~tsicle world arxl serx3s into nal nYY;~ges as well, supervises the
expenditure of grants and contracts, and prods the faculty to provide the
oversight and verification duties described above.
In exploring the often-discussed issues of academic advancement and
the reward structure of science, the panel identified some urexpectel
problems on first taking up the initial steep of an academic career:
appointment. The panel considered whether individuals were adequately
reviewed with regard to their ethical as well as their scientific
qualifications.
AM
- Personality defects of varying seriousness usually play a significant
and perhaps dominant role in cases of scientific misconduct. However, it
is difficult to screen for deviant personalities at the stage of faculty
or staff appointments because the interview process is unreliable and is
usually not aided toward this particular goal. The communication of
relevant information four previous employers and associates is restricted
by federal state and privacy laws. Frank and candid answers may often be
obtained only by asking specific questions directed tc ward the detection
of imprcger behavior, and it is rare that this behavior would be suspected
at the time of recruitment. The panel suggested that a formal waiver of
privacy by academic applicants could help overcome the legal barriers to
sharing information about prior force of misconduct. They proposed that
this waiver could be modeled on the statement used as a standard for
obtaining clinical privileges to avoid deleterious efforts.
The panel also Suggested that it would be useful have models for
responsible reference letters, highlighting the questions that should be
routinely asked in the course of recruitment and evaluation of
applicants. They proposed that state privacy laws could be surveyed to
determine the legal standards governing communication of misconduct or
deviant behavior. Pane] members suggested that there may be a need for
legal protection for institutions who wish to request or report
confidential information relevant to academic performance in cases
involving scientific m~saon~uct or when resignation has occurred during
the course of an investigation. Several panel members questioned the
legality as sell as the desirability of incorporating gag orders into
private agreements or settlements between academic institutions and
faculty or research staff members act of misconduct.
88
OCR for page 89
AD~NCE~ENT
Panel Is coved mat maw people perceive an onrer~asis on
publication as a source of aft bow by instib~ions and no
furlers. Is "publish or perish" pe~pti=1 has been s~est"1 as a
safe of Motive pressure on fawner ant the cause of major ark minor
abuses of row standards.
Better au Cow hip practice== might en ~ rage the fat to talk more
individual and collective responsibility for the integrity of published
material. These practices could be achieved by.sbep6 designed to resume
gift co-authorship and the fragmentation of data. However, the pane] was
not certain that reducing the number of publications by each author will
significantly relieve the "publish or perish" pressure. A more important
consideration, in seeking to reduce the reality of this pressure as well
as the perception of its importance by the faculty and young scientists,
may be the nope for institutions to structure their performance
evaluations to reflect the value of quality aver quantity.
The criteria for advancement outlined in recent guidelines issued by
the Harvard Medical & hoof were considered by The panel, particulary the
criteria in the guidelines that limit the number of Dublications used to
support a promotion derision.
needed to be further developed:
The panel thought ~ at these criteria
Should The candidate be allowed to select
the papers to be considered? Should the candidate justify the value of
the selected papers? Should the entire biblicg~aphy be available to the
Section committee, automatically or on request? What are effective
methods of distinguishing competent individuals of differing
productivity?
The panel suggested that the faculty of a selected institution should
develop the criteria that affect their 'appointment Fond advancement
decisions. If different institutions adopt significantly different
guidelines, a broader consensus will need to be achieved to change the
existing criteria used by funding agencies to predict productivity and
quality.
The issue of size of bibliography stimulated debate within the panel,
partly because of a paucity of information about the significance of
either unusually long or short bibliographies of research scientists. The
identification of correlative factors and other assessments of creativity
were thought to be desirable, and the panel suggested that this area be
designated for further study.
The panel also oonsidered problems in obtaining genuinely critical
peer reviews of performance or even quality of publications by colleagues
or referees. Some obvious reasons for these difficulties include the
time-consuming and analytical nature of careful reviews and the lack of
incentive to devote significant time to this area. Many faculty do not
wish to risk faulty judgment that may hurt someone else's chances, and
they are lens likely to write negative than positive comments when there
89
OCR for page 90
is un~a~n=. Collegial relationships are ~ntial to ff,e snow
furx~ioni~ of the academic unit and thee may be threat by coo frank
criticism. ~ E;mall specialities or grows, If nay be taco few
individuals willing to provide the newsy reviews. Faculty engaged
clinical work and teaching may have limit eviderxx of creative
scholarship and may active hatch criticism at Off ti~ of academic
adva~t reviews by peers to are often tenure faculty, primarily
engaged in starch.
lee pant suggests bat we area of group procures and psychosocial
Imitations on peer review needed f ~ her sandy. Research In this area
could lead to significant improvements in the quality of journal or
personal referee systems. There is also a need to define and popularize
alternatives to counting papers in evaluating faculty performance.
Many young fat develop unrealistic expectations based on lack of
knowledge of and experience with actual performance evaluations. The
panel members thought this was a problem of uncertain dimensions, but it
may refle ~ an underlying disorder and it can be agy=avat^~ by the
competitive, averprc~uctive atmosphere of same disciplines. Many young
faculty are uncomfortable about their perceptions of what is expected of
them, although even accurate perceptions may not diminish pressures to cut
corners in order to advance quickly. The panel suggested that closer
supervision and restoring of junior faculty would help them to understand
prafe~ciona] standards and would provide an early opportunity to detect
aberrant. ideas or behavior.
The panel also considered the special problems of M.D. rather than
Ph.D. investigators. These often include little or no formal research
training before faculty appointment and inadquate research time following
appointment. The panel believed these problems promote sloppy or
inaccurate reearch' bad authorship practi ~ ~ and even misconduct. One
approach that may alleviate these problems is extending the probationary
period, with subsidized research e ~ fence, for M.D. investigators.
Another may be stricter requirements for appointment of mea; Bad school
Graduates to research investigator positions. Neither approach may be
realistic in many specialities. A more feasible approach may be The
promotion of support for part-time clinical investigators by experienced
researchers through special grant mechanisms.
The periodic peer review of Ph.D. prc grams in many gra Mate schools
(often through the use of 'visiting commit') is a common mechanism for
assuring The quality of graduate school training and research programs. A
common feature of this review is the use of outside expert scholars to
evaluate The strengths and weaknesses of an individual graduate program.
It is not certain whether these reviews also ~ the experience of
postdoctoral fellows or the sectoring of junior faculty. The panel
observed that research and trainer program conducted in the ~di~1
~ ols usually do not receive treble Cereal peer reviews. They
surest that a sty of the mesons use to evaluate academic swears
art training practices, and their aE1plicahility tO the Id school
viro~nt, deserved consideration.
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ASS[~CF~
me part spent substantial time disa~ssir~ the need for Aims to
demonstrate He performance and Maturity of acadenic Cart. Ike panel
did not suborn He net for broader institutional involvement In
pr~iding assurer At Art performance and -alrthonihip
contributions. Whey did ire a need for more e~censive tinseling and
red iation services within academic institutions, with cony and
confidential adepts to debit ated institutional officers.
m e panel oomsidered one suggestion that an individual outside of a
research group be designated to sign off on manuscripts but concluded that
this approach was exo~=ively intrusive and overly ~ aucratic for the
academic environment. A similar institutional sign-off mechanism was
explored in the context of confirming attribution of authorship. The
consensus of the panel was that this confirmation should be made by the
research group itself, not a supervisor or administrator.
m e panel considered with favor a proposal that each co-author should
sign a statement confirming approval of a final manuscript and concurring
in the designation of authors as part of the submission of the manuscript
to scientific journals. The value of an additional confirmation statement
by a university official seemed superfluous.
These propceals a ~ directly aimed at remedying the problem of
co-authors failing to take collective responsibility for the Integrity and
quality of a research project or publication. Panel members observed that
some faculty seeking to build their bibliographies would not be inhibiter
by these procedures. Faculty willing to put their name on anything may
also be willing to sign anything. In the final analysis, the criteria
pro posed by many organizations and journals for entitlement to authorship
are no more useful than the scrupulousness of those who use the criteria.
Some persons who have not taken any responsible action may claim to have
performed several functions, including the planning and the writing or
rev ~ ion of a paper, without objections by co-authors.
Part Is expressed concern that coauthors to are not satisfied
with Me ~.=cig~t of credit have limited Irks ~ racist then in
selling disputes. it chairs Should racist in mediating these
conflicts in theory, but in; an era of ~a~epar~rents and multia~nter
collaboration, they Tnay not be able to play an effective role. Junior
co-authors may be unwilling to approach senior faculty to avoid being
characterized as troublemakers. The panel perceived a need for improved
consultation and mediation services within the academic institution and
expre~cPO particular interest in the omtodsperson positions used by
several universities and medical schools (including MIT and Stanford). In
many cases, the owbuisperson provides a confidential advisory service and
has the resources to assemble a panel of experts to mediate disputes on an
ad hoc basic.
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The panel suggested that authorship guidelines may be helpful in
resolving disputes by clarifying in advance of the submission of a
manuscript the criteria to be observed in recognizing indivi~rmn
contributions. Professional societies and journals play an important role
in defining these criteria, since authorship is often influenced more by
disciplinary customs than institutional traditions.
AREAS FOR FURTHER STUDY
the panel emphasized the increasingly important influence of
commercial or industrial ties by university research laboratories and
academic scientists. There has been concern about the effects of these
affiliations on graduate education and the open exchange of ideas and
research materials, but there has been less discussion of their Am pact on
row City.
Though research fraud cases have been extensively disr~=P~, there is
still much to learn about patterns of misconduct, their pr~-ipitatir~g
factors, and ultimate altcome5 of Me corrective pates. SCAR swim of
deviance have indicated that these incidents have a significant impact on
the "victims" or colleagues of the perpetrator. Me panel bought it
wand be useful to sway research chars where fraud Is ~ to
end ore how this incident has affect the S-lC~1~5, practioes, arm
relations trips; of the research ~virorment. For example, ~t happens to
Me ~istle-bic~wers and to those guilty of m~scor~uct? Ire panel
identified a row for a comprehensive review arx] follaw~up on randy
d~ cam.
The panel also reviewed the subject of data ~hip, cushy, and
access. Ones members recognized this as a complex area ark express ~ a
lack of knowledge about the status of intellectual property law and
government regulations and their Am pact on research data-handling
practices. The panel suggested that this important area deserved careful
analysis, separate from the study of other research practices, and that
this analysis should precede the development of institutional guidelines
and 5t3ndar~5.
Finally, the panel considered the importance of collaborative efforts
in modern research. Multiple authorship practices suggest that
collaborative efforts have been increasing for years. The problems
discussed above take on a new complexity when considered in the context of
interdepartmental or multicent~r research efforts. There may be unique
problems in assigning credit when first authorship must be limited'
although these problems may be aileviat=d when multiple papers are
produced. Data access and storage issues acquire greater significance
when the research data result from a unique, time-consuming, and valuable
collaborative effort. Institutional assuranc s of validity and integrity
require new forms of Interinstitutional cc operation. The panel suggested
that the particular influences of interdisciplinary and multicenter
collaboration deserve priority in further investigations of this topic.
Chair: William Anlyan Rapporteur: Paul Friedman
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PANEL 6
REPORT OF THE PANEL ON AUTHORSHIP, REFEREE,
AND SCION ~
The panel addressed current authorship practice=, publication
procedures in institutions and journals, and post-publication procedures
that may affect the integrity and reliability of published results, with
particular attention to Neal science and clinical research in the
Uniter States.
The 14 panel members included editors from basic science and clinical
journals (including one British journal), faculty face. basic research
departments, and government agency officials (including the National
T.;hrary of Medicine).
The panel discussed an array of topics concerning authorship and
publication standards. These topics iw luded repetitive publication,
supernumerary authorship, institutional responsibilities, peer review,
documentation of reported research results, errors and corrections,
frequency of fraud and other misconduct, the role of government, and
pressures to publish.
RE;~1'1W ~m
The panel members recognized that.publication of more than one report
of the same research material (repetitive publication) may be advantageous
to authors for their personal interests and to readers who use the journal
literature for llawareness needs.ll Members indicated that these interests
needed to be weighed against the economic costs and intellectual
confusions caused by this practice.
The panel attempted to define repetitive publication. This practice
includes identical republication; rere porting observations in one or more
additional papers with different emphasis and detail; and reporting a
small portion of data from a single study, often referred to as "salami
science" or the "least publishable unit." Authors may justify the
practice of repetitive publication to address different audiences or to
meet requirements for Participation in a sYmc06ium or con-tress. Editors
· e
view repetitive publication as causing excessive costs in manuscript
handling, peer reviewing, and journal space and distribution. Readers may
have difficulty deciding on the uniqueness of the content of a particular
paper.
The panel considered several possible solutions to this practice,
including the need for editors to define repetitive publication
explicitly, to state penalties for violations, to find means of informing
readers of occurrences, and to consider other possible means of prevention
such as maintenance of a "blacklist" for a jourr~l's own use.
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SUPERNUMERARY AUTHORSHIP
Are new criteria for authorship needed? Panel members indicated that
the criteria ado pte1 by some journals may not be wellknown to the
community of authors. Should a category "contributing author" be
established and added to present definitions of true authorship? Should
readers assume that all listed authors can take responsibility for a
paper?
The panel agreed that proper authorship practices protect the
scientific community against Mets conduct in research and its reporting.
m e trend of an increasing number of authors per paper may be explained by
the increasingly complex nature of research, but there is also evidence of
not infrequent gratuitous or '~gift" authorship.
Authorship assignments tend to be based on traditional practices.
Professional societies, editors' associations, and a few institutions have
published detailed criteria for authorship, but panel members believed
these criteria are often violated. It is difficult for the editors to
obtain proof of violation of authorship guidelines. They could ask for
more detailed and explicit justifications of authorship, but these
requests would not necessarily be more reliable than present authorship
statements or copyright agreements.
The panel indicated that editors would prefer to trust authorship
assignments. The members believed that the proper locus of authorship
control is institutions. They proposed alternate means for institutions
to screen papers prior to their submission so that authorship criteria
could be properly applied. The panel indicated that existing authorship
criteria should be disseminated more widely. There may also be a need for
new collective efforts to develop a national standard of authorship
criteria for academic institutions. New categories of authorship, such as
a secondary level like Contributing author." or wider use of collective
, - ~
or corporate authors hip may be needed, and a few individual editors have
established criteria for these categories.
INSTTTUTION~L RESPONSIBILITIES
Should universities screen papers prior to their submission for
publication? Should this screening seek to prevent repetitive
publication? What disadvantages Bight result form institutional
screening?
Panel members indicated that a few academic departments and research
units do screen manuscripts of their faculty and staff. m ey suggested
that institutional screening could reduce undesirable publication
practicer. The members recognized that screening could add a new
administrative burden in academic departments and Bight pose risks of
censorship. Although screening manuscripts may not be the best solution,
the editors on the pane] thought that academic institutions near to
est~h~ish some means of controlling irresponsible publication practices.
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Ed REVIEW
The panel also examined aspects of the pear review process including:
Can peer review detect fraud? How sight adequate peer review be
facilitated? How desirable is anonymity of reviewers an4/or authors in
peer review?
The panel concluded that research fraud is unlikely to be detected by
peer review. Data that are "too good," logically impassible, or from
unspecified locations can be clues to fraud ~ a particular paper, but
well-oonstrucbed fraud may readily escape detection. Large numbers of
papers attributed to a particular author could be a signal to an
institution of possible fraud, if it maintains manuscript records.
Peer review is expensive. It might be improved if journals conduct
more vigorous screening and reject submitted papers immediately. me
process It also be improved by providing reviewers with mow explicit
criteria for making critical judgments. At present, He pared concluded
that He advantages of using anonymity for reviewers outweighs the
disadvantages. It is more difficult to ensure the anonymity of authors,
and the editors believe they can easily detect the biases often attributed
to author non-anonymity. The panel indicated that there is a need for
more research on the peer review process to develop firmer answers to
these questions.
DCCLMEN~ATION OF REPORIEu RESEARCH RE SUITS
The panel examined the question of whether authors should be expected
to supply data to editors and peer reviewers beyond those presented in the
caner itself. A Darer should carry all the data needed to support its
. ~ at. I. -
· ~ ~ ~ ~ . ~ . ~ · .
analyses and conclusions. Authors should be expected' however, to submit
a~;tior~al data for an editor or pew reviewer if resect for critical
joints. The panel believed oft routine relents for submission of
s~l~ntary data with papers would put Inns administrative
}dens on Me journal editors.
RESPONSES TO FRAUD, REIRAC1'IONS, AND CORRECTIONS
How should editors respond to charges or suspicions of fraud?
should journals publish retractions or other
How should they handle errors and correctional
How
statements concerning fraud?
-
Some differences of opinion emerge] ~ the panel regarding the
appropriate procedures for editors ~ addressing the first issue. Mast
panel members believed that editors have a limited ability to resolve
questions of fraud and that allegations of wrongdoing are more properly
addressed at the institutional level. Others suggested that editors
should respond to these incidents by initially approaching the authors and
Sheen approaching their institutions to investigate the claims if the
initial approaches have failed. A differing view is that the problem
should be taken to the institution immediately.
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me parcel noted that me I:nternational C~i~ee of Medical Journal
Editors Is issued a policy sextant on editors' responsibilities for
r~porxti~ to Barges of scientific m~scorx~uct, With require the
appropriate publication of relevant notices. me National Library of
Medicine has Revels a Dyson for tagging refed; in MED=NE ~ alert
bibliographic seen Hers to notices of fraud or scientific e m or. With
this system in place, the panel believed that editors have a responsi-
bility to publish notice== of retraction, investigatory conclusions of
fraud, and errors and corrections. m is responsibility includes a duty to
publish these notice= in a standard format and location. m e panel agreed
that there is a need to publicize this res,oonsibility to editors and
Editors' associations.
EMINENCY OF FRAUD AND TIER ms~cr
How frequent are fraud and other kinds of substantial misconduct? How
does this question affect editorial and institutional responses to
scientific misconduct?
The panel had no evidence of an increase in the frequency of fraud and
other kinds of misconduct in publication, but members indicated an
impression that there is an increase in the number of incidents. This
perception may simply be the result~of wider awareness of the problem.
Two members of the panel favored the use of research audits as a means of
determining the extent of the misconduct in science. Other members felt
that the lack of evidence of incidence should not preclude the development
of measures to control or reduce the problem. While serious research
misconduct must be controlled, most pane] members felt ~ at other
publication abuses, such as irresponsible authorship and repetitive
publication, are probably far more frequent and present a greater threat
to the efficiency of research and the integrity of the publication
pass.
rHE ROLE OF Go~r
What should be the rGle of government ~ supporting the responsible
conduct of research? Should federal agencies require institutional
controls as part of grant-supporbed or contract research? Should
government exert more direct controls, such as audits?
m e panel members believed that government's interest in reliable
authorship stems free,` a need to verify reported research results,
especially when the products of research have economic and regulatory
importance (e.g., patents and copyrights). In addition, government
agencies are publicly account he for proper use of tax funds, and
maintaining the integrity of authorship is one avenue of demonstrating
accountability. Misconduct in research can suggest evidence of
governmental mismanagement of public funds.
The panel suggested that government can provide incentives and apply
pressure for the responsible conduct of research. At a minimum,
government research furriers new assurer that the research is conduct
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~ a responsible namer. me ~ ~a <~ fear institutional
and journal pros related to authorship ark publication practices.
SO TO ~5H
me panel discos" the variers ply to publish and ways to
Rae =~c pro. the econc~nic rewards fmn publication are seen as
driving }=th ~ ary authorship ark rep etitive publication. Ihe
rewards include nck only direct monetary gains but also the professional
prestige derived four appointment, promotion, and tenure decisions. One
aLtr-ac.tive dinero} on pressures to publish might be the creation of
institutional limits on the number an] frequency of publications to be
considered for decisions on faculty status.
One panel member questioned whether photo Patrols wound reduce
unjustified authorship, as there are substantial personal gains other than
academic status associated with the high visibility resulting from
frequent and widespread publication. Some control might come from cantors
limiting the numbers of authors and more frequently requiring collective
authorship, but these controls may require wide adoption to be effective.
As noted above, the panel come to general agreement on a number of
steps that academic institutions, individuals, and government might take
to reduce the severity, number, and frequency of at uses of scientific
publication. These actions could demonstrate the research communi~y's
cc~nitment to assuring the integrity of scientific restore. The panel's
portals were format with t:he following criteria In mid:
0 In order to remain highly productive, the research cc~nity must
take resEx>nsibili~ for the conduct of its work and its relations with the
public arm gaver~nt.
O Appropriate conduct in research Should be develops arm supports
as far as possible bar the Iran il:u:tions of science it~If.
o Recomb nations should identify measures that avoid excessive
control, address present concerns, and not expect a utopian state of
scow.
O Reccmmen~ations should not suggest measures likely to increase the
burdens of documentation.
O Clear distinctions should be drawn between misrepresentation, such
as fraud and data-trimming, and errors of fact and interpretation.
Chair: Marcia E. Angell
97
Rapporteur: Edward Ruth
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Representative terms from entire chapter:
laboratory practices
