Guidelines for the
CONDUCT
OF
RESEARCH
in the
Intramural Research
Program at NIH
National Institutes of Health
Office of the Director
The Guidelines for the Conduct of
Research set forth the general princi-
ples governing the conduct of good
science as practiced in the Intramural
Research Programs at the National
Institutes of Health (NIH). They
address needs arising from the rapid
growth of scientific knowledge, the
increasing complexity and pace of
research, and the influx of scientific
trainees with diverse backgrounds. Guidelines for the
Accordingly, the Guidelines should
assist both new and experienced
investigators as they strive to safe-
guard the integrity of the research
process.
CONDUCT
The Guidelines, originally developed
OF
by the Scientific Directors of the
Intramural Research Programs at the RESEARCH
NIH, have been revised for this edi-
tion by the intramural scientists on in the
the NIH Committee on Scientific
Conduct and Ethics, and approved
Intramural Research
by the Scientific Directors. General
principles are set forth concerning
the responsibilities of research staff Program at NIH
in the collection and recording of
data, publication practices, author-
ship determination, mentoring, peer
review, confidentiality of informa-
tion, collaborations, human subjects
research, financial conflicts of inter-
est, and animal care and use.
It is important that every investigator
involved in research at NIH read,
understand, and incorporate the
Guidelines into everyday practice.
The progress and excellence of NIH
research is dependent on our vigilance
in maintaining the highest quality of
conduct in every aspect of science.
Michael M. Gottesman, M.D.
Deputy Director for Intramural 4th Edition
Research, NIH May 2007
1
S cientists in the Intramural Research
Programs at the National Institutes of
Health generally are responsible for con-
The formulation of these Guidelines is
not meant to codify a set of rules, but
rather to elucidate, increase awareness
ducting original research consonant with and stimulate discussion of patterns of
the goals of their individual Institutes and scientific practice that have developed
Centers. These Guidelines were developed over many years and are followed by
to promote high ethical standards in the the vast majority of scientists, and to pro-
conduct of research by intramural scien- vide benchmarks when problems arise.
tists at the NIH. It is the responsibility of Although no set of guidelines, or even
each Principal Investigator who oversees explicit rules, is likely to prevent willful
Introduction a research group, and successive levels of scientific misconduct, it is hoped that
supervisory individuals (especially Institute formulation of these Guidelines will
and Center Scientific Directors), to ensure contribute to the adoption of exemplary
that every NIH scientist is cognizant of standards of intellectual honesty in the
these Guidelines and to resolve issues that conduct of research by all scientists.
may arise in their implementation.
The public and our scientific colleagues
Intramural scientists at NIH, as is true will ultimately judge the NIH by its
for all scientists, should be committed adherence to high intellectual and ethical
to the responsible use of scientific tools standards, as well as by its development
and methods to seek new knowledge. and application of important new knowl-
While the general principles of scientific edge through scientific creativity. L
methodologies -formulation and testing
of hypotheses, controlled observations
or experiments, analysis and interpreta-
tion of data, and oral and written presen-
tation of all of these components to
scientific colleagues for discussion and
further conclusions - are universal,
their detailed application may differ in
different scientific disciplines and in
varying circumstances. All research staff
in the Intramural Research Programs
should maintain exemplary standards
of intellectual honesty in formulating,
conducting, presenting, and reviewing
research, as befits the leadership role
of the NIH.
These Guidelines complement existing
NIH regulations for the conduct of
research such as those governing human
subjects research, animal use, radiation,
chemical and other safety issues, and
the Standards of Conduct that apply to
all federal employees.
2 3
R esearch training is a complex process,
the central aspect of which is an
extended period of research carried out
experience. Mentoring should be adapted
to the needs and career stage of each indi-
vidual trainee.
under the supervision of an experienced
scientist. This supervised research experi- Specific aspects of the mentor-trainee
ence is not merely performance of tasks relationship deserve emphasis. Training
assigned by the supervisor, but rather is a should impart to the young investigator
process wherein the trainee takes on an appropriate standards of scientific con-
Responsibilities of increasingly independent role in the selec- duct both by instruction and by example.
Research Supervisors tion, conceptualization and execution of Mentors should be particularly diligent to
and Trainees research projects. The trainee should be involve trainees in research and related
provided with training in the necessary activities that contribute to their careers,
skills and knowledge necessary for a suc- including participation in intramural or
cessful career as a research investigator. It extramural collaborations, encourage-
should be recognized that the trainee has ment of presentations at scientific meet-
unique, time-sensitive needs relevant to ings, and networking. Mentors should
career advancement. Guidance and advo- provide trainees with timely and realistic
cacy from the supervisor in this regard are appraisals of their performance and
essential components of training. with advice regarding career opportuni-
ties and advancement.
In general, a trainee will have a single
primary supervisor, but may also have Trainees have responsibilities to their
other individuals who function as men- supervisors and to their institutions
tors for specific aspects of training and as well. These responsibilities include
career development. It is the responsibility adherence to these Guidelines and other
of the primary supervisor to serve as a applicable rules, and programmatic
role model and provide a rich research constraints related to the needs of the
environment in which the trainee has the research team and Institute/Center.
opportunity to acquire both the conceptu- The same standards of professionalism
al and technical skills of the field. In this and collegiality apply to trainees as to
setting, the trainee should be provided their supervisors and mentors. L
with clear expectations and undertake a
significant piece of research, usually cho-
sen as the result of discussions between
the mentor and the trainee, which has
the potential to yield new knowledge of
importance in that field. In order to pro-
vide a meaningful, high quality training
experience, the mentor should monitor
and guide the trainee’s progress closely,
and interact personally on a regular basis
to give timely feedback regarding research
findings and progress. Supervisors and
mentors should limit the number of
trainees in their laboratory or branch to
the number for whom they can provide
an appropriate and productive training
4 5
R esearch data, including detailed
experimental protocols, all primary
data, and procedures of analysis and pre-
Notebooks, other research data, and
supporting materials, such as unique
reagents, belong to the National Institutes
sentation are the essential components of of Health, and should be maintained
scientific processes and progress. Scientific and made available, in general, by the
integrity is inseparable from meticulous Laboratory in which they were developed.
attention to the acquisition and mainte- Departing scientists may take copies of
nance of these research data. notebooks or other data for further
work. Under special circumstances, such
Data Management The results of research should be carefully as when required for continuation of
and Archiving recorded in a form that will allow contin- research, departing investigators may
uous access for analysis and review. take primary data or unique reagents with
When possible, it is best to store data in them if adequate arrangements for their
both electronic and hard-copy form. safekeeping and availability to others are
Attention should be given to annotating documented by the appropriate Institute
and indexing notebooks and documenting or Center official. Transfer of reagents
computerized information to facilitate should be documented through a Material
detailed analysis and review of data. All Transfer Agreement.
data, even those from observations and
experiments not directly leading to publi- Data management, including the decision
cation, should be treated comparably. to publish, is the responsibility of the
All research data should be available to principal investigator. After publication,
supervisors and scientific collaborators the research data and any unique materi-
for timely review, consistent with require- als that form the basis of that communi-
ments of confidentiality. Investigators cation should be made available promptly
should be aware that research data are and completely to all qualified scientists
legal documents for purposes such as seeking further information. Exceptions
establishing patent rights or defending may be necessary to maintain confiden-
the veracity of published results, and are tiality of clinical data or if unique materi-
subject to subpoena by congressional als were obtained under agreements that
committees and the courts. preclude their dissemination. Consult the
PHS policy relating to the distribution
Research data, including the primary of unique research resources for further
experimental results and computer and guidance (http://grants2.nih.gov/grants/
statistical analyses, should be retained for guide/notice-files/not96-184.html). L
a sufficient period to allow analysis and
repetition by others of published material
resulting from those data. Seven years
is specified by the Federal Government
(http://www.ori.dhhs.gov/documents/FR_
Doc_05-9643.shtml) as the minimum
period of retention but this may be
longer under some circumstances, such
as clinical research.
6 7
P ublication of results is an integral
and essential component of research.
Other than presentation at scientific meet-
is controlled by human subjects protec-
tion requirements, as described in a later
section). However, it is an obligation of
ings, publication in a scientific journal NIH intramural scientists to make reason-
should normally be the mechanism for able amounts of expandable materials
the first public disclosure of new findings. (e.g. monoclonal antibodies, bacterial
Exceptions may be appropriate when strains, mutant cell lines) and analytical
serious public health or safety issues are amounts of reagents (e.g. polyclonal
involved. Although generally considered antibodies, purified proteins, uniquely-
the end point of a particular research pro- synthesized compounds) that are essential
Publication ject, publication is also the beginning of a for repetition of the published experi-
process in which the scientific community ments available to qualified scientists,
at large can assess, correct and further using appropriate Material Transfer
develop any particular set of results. Agreements or collaborative agreements
consistent with NIH policy. This can be
Timely publication of new and significant achieved by making arrangements to send
results is important for the progress of such materials to a central repository.
science. Fragmentary publication of the Consult the PHS policy relating to the
results of a scientific investigation or mul- distribution of unique research resources
tiple publications of the same or similar for further guidance (http://grants2.nih.
data are inappropriate. Each publication gov/grants/guide/notice-files/not96-
should make a distinct and substantial 184.html).
contribution to its field. As a corollary
to this principle, tenure appointments The current NIH Public Access Policy
and promotions should be based on the (http://publicaccess.nih.gov/publicac-
importance of the scientific accomplish- cess_manual.htm) requests and strongly
ments and not on the number of publica- encourages all NIH-funded investigators
tions in which those accomplishments to make their peer-reviewed final manu-
were reported. scripts available to other researchers and
the public at the NIH National Library
Each paper should contain sufficient of Medicine’s (NLM) PubMed Central
information for the informed reader to (PMC) (http://www.pubmedcentral.nih.
assess its validity, including all the infor- gov) immediately after publication of
mation that would be necessary for scien- the final version. Authors are given the
tific peers to repeat the experiments. option to release their manuscripts at a
Essential data that are not included in the later time, up to 12 months after the offi-
published paper due to space limitations cial date of final publication. NIH expects
(e.g. nucleic acid and protein sequences, that only in limited cases will authors
microarray data and crystallographic deem it necessary to select the longest
information) should be deposited in the delay period. L
appropriate public databases or made
available online. It is not necessary to
provide materials (such as proteins) that
others can prepare by published proce-
dures, materials (such as polyclonal
antisera) that may be in limited supply,
or clinical specimens (whose distribution
8 9
A uthorship refers to the listing of
names of participants in all commu-
nications, both oral and written, of exper-
should review and support the manuscript
that is to be submitted (originally or in
revision) for publication. Each author
imental results and their interpretation should be willing to support the general
to scientific colleagues. Authorship is the conclusions of the study. The NIH recom-
fulfillment of the responsibility to com- mends that the transmittal letter accom-
municate research results to the scientific panying a manuscript submission identify
community for external evaluation. the exact contribution of each author.
Authorship is also the primary mecha-
nism for determining the allocation of The corresponding author should be
Authorship credit for scientific advances and thus the considered the primary author (but is
primary basis for assessing a scientist’s not necessarily the first author), with the
contributions to developing new knowl- additional responsibilities of coordinating
edge. As such, it potentially conveys great the completion and submission of the
benefit, as well as responsibility. work, satisfying pertinent rules of submis-
sion, and coordinating responses of the
For each individual the privilege of group to inquiries or challenges. The
authorship should be based on a signifi- corresponding author should assure that
cant contribution to the conceptualiza- the contributions of all collaborators are
tion, design, execution, and/or interpreta- appropriately recognized and that each
tion of the research study, as well as on author has reviewed and authorized the
drafting or substantively reviewing or submission of the manuscript in its origi-
revising the research article, and a willing- nal and revised forms. Corresponding
ness to assume responsibility for the authors must be especially vigilant that
study. Individuals who do not meet these the above criteria are met before sending
criteria but who have assisted the research articles to journals that publish submis-
by their encouragement and advice or sions on line upon acceptance of the
by providing space, financial support, manuscript.
reagents, occasional analyses or patient
material should be acknowledged in the All manuscripts and abstracts coming
text but not be authors. These authorship from the Intramural Research Program
guidelines are comparable to those now must be cleared in accordance with the
described in the Uniform Requirements instructions included at http://www1.
for Manuscripts Submitted to Biomedical od.nih.gov/oir/sourcebook/oversight/
Journals, which were developed by the pub-clear.htm. L
International Committee of Medical
Journal Editors (http://www.icmje.org/).
Because of the variation in detailed prac-
tices among disciplines, no universal set
of standards for authorship can easily be
formulated. It is expected, however, that
each research group and Laboratory or
Branch will freely discuss and resolve
questions of authorship, including the
order of authors, before and during the
course of a study. Further, each author
10 11
P eer review is expert critique of either
a scientific treatise, such as an article
prepared or submitted for publication,
All material under review is privileged
information. It should not be used to the
benefit of the reviewer unless it previously
a grant proposal, or a clinical research has been made public. It should not be
protocol, or of an investigator’s research shared with anyone unless necessary to
program, as in a site visit. Peer review is the review process, in which case the
an essential component of the conduct names of those with whom the informa-
of science. Decisions on the funding of tion was shared should be made known
research proposals and on the publication to those managing the review process.
Peer Review and of experimental results must be based on Material under review should not be
Privileged Information thorough, fair and objective evaluations copied and retained or used in any man-
by recognized experts. Therefore, ner by the reviewer unless specifically
although it is often difficult and time- permitted by the journal or reviewing
consuming, scientists have an obligation organization and the author. L
to participate in the peer review process.
In doing so, they make an important
contribution to science.
Peer review requires that the reviewer be
expert in the subject under review. The
reviewer should avoid any real or per-
ceived conflict of interest that might arise
because of a direct competitive, collabora-
tive or other close relationship with one
or more of the authors of the material
under review. Normally, such a conflict
of interest would require a decision not
to participate in the review process and
to return any material unread. Some
review activities may require review and
approval by a supervisor and/or deputy
ethics counsellor in an IC (see http://
www1.od.nih.gov/oir/sourcebook/
ethic-conduct/officialdutypolicy.htm).
The review must be objective. It should
be based solely on scientific evaluation
of the material under review within the
context of published information and
should not be influenced by scientific
information not publicly available.
12 13
C ollaborative research brings together
investigators with distinct strengths
to work together on a defined problem or
CRADAs provide a protected environ-
ment for long-term collaborations; they
confer intellectual property rights to
address a specific research goal. Research NIH inventions. CRADAs are handled
collaborations, within NIH as well as by the Technology Transfer Office of
with extramural institutions, are strongly your Institute (http://ott.od.nih.gov/).
encouraged and supported; the complex
scientific questions that face us today Consulting can be viewed as a one-way
often require interdisciplinary or multidis- collaboration, in which an NIH scientist
ciplinary approaches. is asked to contribute to an outside
Collaborations project by providing expert advice.
Successful collaborations are character- Information about the NIH guidelines
ized by a strong sense of direction, a governing consulting activities and forms
willingness to commit time and effort, for obtaining permission can be found at
an efficient communication strategy for http://ethics.od.nih.gov/ L
discussion among the group members, a
system in place for reevaluation as the
project progresses, and a clear definition
of roles and responsibilities. It is advisable
that the ground rules for collaborations,
including eventual authorship issues, be
discussed openly among all participants
from the beginning. The NIH Ombuds-
man Office has developed a useful set
of criteria to consider in establishing
collaborations (http://www4.od.nih.gov/
ccr/collab.html).
Whenever collaborations involve the
exchange of biological materials they are
routinely formalized by written agree-
ments. Material Transfer Agreements
(MTAs) are used for the simple transfer
of proprietary research material without
collaboration, for example if you request
a reagent from, or give one to, a colleague
outside the NIH. Cooperative Research
and Development Agreements (CRADAs)
are agreements between one or more
NIH laboratories and at least one non-
federal group (private sector, university,
not-for-profit, non-federal government).
14 15
R eal or perceived conflicts of interest
due to financial relationships with
outside organizations may not be recog-
A specific Guide to Preventing Conflicts
of Interest in Human Subjects Research
at NIH covers participation in human
nized by others unless specific informa- subjects research in the Intramural
tion is provided. Therefore, the scientist Research Program (http://intranet.cc.nih.
should disclose all relevant financial gov/od/conflict_interest/conflict_memo.
interests, including those of the scientist’s shtml). L
immediate family, to the Institute or
Center during the planning, conducting
Financial Conflicts of and reporting of research studies; to fund-
Interest ing agencies before participating in peer
review of applications for research sup-
port; to meeting organizers before presen-
tation of results; to journal editors when
submitting or refereeing any material for
publication; and in all written communi-
cations and oral presentations. Financial
interests include, but are not limited to,
ownership of stock or equity, patents,
consulting arrangements, collaboration
agreements, honoraria, service on adviso-
ry boards, or management appointments.
Failure to disclose conflicts of interest
can threaten the integrity of research and
undermine the public’s trust in the NIH’s
intramural research activities. When
there is a potential conflict of interest,
full disclosure and complete transparency
are always the best policy. The NIH’s
Ethics Program (http://ethics.od.nih.gov/)
has specific rules concerning conflicts of
interest, outside activities (such as con-
sulting and speaking), gifts, honorary
awards, and investments. Intramural
researchers should become familiar with
these rules and refer any questions to the
Deputy Ethics Counselor of their Institute
or Center.
16 17
F or the purposes of these Guidelines,
clinical research is defined as interac-
tions with human subjects, or with mater-
benefits of the proposed research, and
qualifications of the investigators. The
protocol must undergo IC-specific scien-
ial or information obtained from human tific review and then be reviewed and
subjects, in order to produce generalizable approved by the IC Institutional Review
knowledge. This is distinguished from Board (IRB) (unless the research is specifi-
interactions designed solely to benefit a cally exempt by the OHSR because it
particular patient. The NIH Intramural does not qualify as human subjects
Research Program has a formal human research, e.g., when samples are fully
Human Subjects research protection program supervised anonymized). All clinical studies require
Research by the Office of Human Subjects that informed consent be obtained from
Research (OHSR). All intramural prospective subjects prior to commencing
research must be consistent with the the research. Studies using investigational
requirements of the human research pro- drugs or devices must also be reviewed
tection program and all intramural inves- and approved by the Food and Drug
tigators are responsible for knowledge of, Administration (FDA).
and compliance with, them. OHSR can
help investigators understand and comply Collection and Storage of Data:
with the ethical guidelines and regulatory Investigators must ensure the integrity
requirements for clinical research. and confidentiality of data collected in
the course of clinical research, and protect
All scientists working with human the privacy, as well as safety, of human
samples/subjects must take the course subjects. Attention should be paid to
“Protecting Human Subjects” (http://ohsr. appropriate storage and retention of
od.nih.gov/researcherCBT/intro.html?my research records, data, and samples, in
IPNum=128231088007). In addition, accordance with NIH and FDA guide-
OHSR has published a booklet “Guide- lines. Investigators are responsible for
lines for the Conduct of Research the oversight of all research personnel
Involving Human Subjects at the NIH” involved in the clinical study, ensuring
(http://ohsr.od.nih.gov/guidelines/Gray that they adhere to the research protocol
Booklet82404.pdf) to assist those doing and Good Clinical Practice1.
clinical research.
Intramural investigators who receive
Investigators involved in clinical research human samples or data from extramural
have special responsibilities regarding the investigators are responsible for ensuring
preparation of research protocols, registra- that they were collected in accordance
tion of clinical trials, protection of human with ethical guidelines and regulatory
subjects, supervision of trainees, collection requirements. This is usually satisfied by
and storage of research data, and conduct a clinical research protocol and consent
of epidemiologic research. These responsi- document approved by an IRB at the
bilities are briefly discussed below. extramural institution, but sometimes
may require a parallel clinical research
Protocols: Investigators must prepare a protocol at the NIH. Similar protections
written clinical research protocol describ- are required prior to sending personally
ing the scientific background, objectives, identifiable human samples or data to
subject eligibility criteria, design, methods extramural collaborators. The IC IRB
of data collection and analysis, risks and and OHSR should be consulted prior to
18 19
any transfer to determine the appropriate Development and review of detailed pro-
review and approval mechanisms. Specific tocols are as important in epidemiologic
regulations govern the use of archival research as in clinical research and any
materials (http://ohsr.od.nih.gov/info/ other health science. However, the time
DDIR_memo.html). for protocol development and review
may be appropriately shortened in cir-
Registration of Clinical Trials: Clinical cumstances such as the investigation of
trials (i.e., studies evaluating the safety or an acute epidemic or toxicological danger
efficacy of a diagnostic test or treatment where the epidemiologic investigation
intervention) should be registered with a may provide data of crucial importance
public trials registry (e.g., www.clinical to the identification and mitigation of a
trials.gov). threat to public health. Nevertheless, even
in these situations, systematic planning
Epidemiologic Research: Epidemiologic is necessary and the investigator should
research, the study of the distribution formalize the study design in a written
and determinants of disease in groups of document and have it peer-reviewed in
individuals, presents special challenges for an expedited manner before the research
investigators. Although epidemiologists is begun. L
are not usually responsible for clinical
care, they must nevertheless ensure that
epidemiologic investigations do not inter-
fere with the clinical care or privacy of
patients. The epidemiologist must ensure
that abnormal findings that could affect
a subject’s health and require medical
attention are dealt with appropriately.
Data on diseases, habits, and behavior
must be presented and published in a way
that protects the identity of particular
individuals, families, and groups.
Although it is the practice of some jour-
nals not to publish research findings
that have been partially released to the
public, it may be necessary for reasons of
immediate public health considerations
to report the findings of epidemiologic
research to the study participants, institu-
tional leadership, other researchers, and,
in some cases, health officials, before the
study has been completed. The health
and safety of the public has precedence.
1 Guidelines for Good Clinical Practice, developed by the
International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for
Human Use (ICH) can be accessed at www.ICH.org.
20 21
T he use of laboratory animals is often
essential in biomedical research and
humane and effective use of animals is
Prior to commencing animal studies,
an animal study protocol must be pre-
pared according to existing guidelines.
a necessary and important element of Investigators should contact the IC
such research activities. Animal research, ACUC for guidance on the requirements
for the purposes of these Guidelines, is for approval and implementation of ani-
defined as in vivo research performed on mal study protocols. When developing
laboratory animals in order to develop research proposals involving animals,
knowledge that contributes to improve- investigators should consider alternatives
ment of health and well-being of humans to the use of animals based upon the
Animal Care and Use as well as other animals. The NIH following guidance:
Office of Animal Care and Use (OACU)
(http://oacu.od.nih.gov/) has developed • Reduction: Reduction in the numbers
NIH Policy Manuals for Animal Care and of animals used to obtain information
Use in the Intramural Program to assist of a certain amount and precision;
NIH intramural investigators to under- • Refinement: Decrease in the incidence
stand and comply with the ethical guide- or severity of pain and distress in those
lines and regulatory requirements for animals that are used;
testing, research or training involving • Replacement: Use of other materials,
laboratory animal subjects. The use of such as cell lines or eggs, or substitution
animals in research is covered by proto- of a lower species, which might be less
cols that must be reviewed and approved sensitive to pain and distress, for a
by an NIH Animal Care and Use higher species.
Committee (ACUC). Investigators con-
ducting animal research must take the The animal research protocol should be
NIH course “Using Animals in Intramural circulated for comment and review by the
Research”. investigators and collaborators involved
in the project, and requires approval by
The animal care and use program of each the IC ACUC prior to study initiation.
IC is directed by a senior veterinarian, It should be scrupulously adhered to in
the Animal Program Director, and falls the conduct of the research, which should
under the oversight of an ACUC. All be carried out by appropriately qualified
components of the intramural NIH investigators and staff who are experi-
Animal Care and Use program are accred- enced in conducting procedures on living
ited by the Association for Assessment animals. L
and Accreditation of Laboratory Animal
Care International.
22 23
T he scientific community and general Scientific misconduct or misconduct in
public rightly expect adherence to research - Research misconduct is defined
exemplary standards of intellectual hon- as fabrication, falsification, or plagiarism
esty in the formulation, conduct, report- in proposing, performing, or reviewing
ing and reviewing of scientific research. research, or in reporting research results.
Investigators must act with honesty and
integrity when editing, analyzing, and Fabrication is making up data or results
presenting data. Deceptive manipulation and recording or reporting them.
of data, be it misrecording of data,
inappropriate exclusion of outlying Falsification is manipulating research
Research Misconduct data points, or enhancement of images materials, equipment, or processes, or
is research misconduct. changing or omitting data or results
such that the research is not accurately
Allegations of scientific misconduct are represented in the research record.
taken seriously by the National Institutes
of Health. The process of investigating Plagiarism is the appropriation of another
allegations must be balanced by equal person’s ideas, processes, results, or
concern for protecting the integrity of words without giving appropriate credit.
research as well as the careers and reputa-
tions of researchers. The procedures fol- Research misconduct does not include
lowed at the NIH are intended to permit honest error or honest difference of
allegations of scientific misconduct to be opinion.
processed promptly, confidentially, and
fairly. Prompt action on an allegation (from Federal Policy on Research
helps minimize any harm to the public Misconduct ) L
and allows those who are incorrectly
implicated to have their names cleared
without going through a lengthy process.
Allegations of misconduct that are
shown to be untrue, even if they were
made in good faith, can damage careers
and have a chilling effect on research.
Confidentiality helps protect both the
innocent scientists who are incorrectly or
unjustly accused and those who raise the
allegations. Fairness allows all who
become involved in scientific misconduct
cases to have the opportunity to partici-
pate appropriately in this important
oversight process and address the specific
issues at hand, while at the same time
protecting innocent participants from
adverse consequences.
24 25
These Guidelines are not intended to
establish rules or regulations. Rather,
their purpose is to provide a framework
for the fair, open, and responsible con-
duct of research without inhibiting
scientific freedom or creativity.
Advice on any of the topics can be
obtained from the offices cited in the
previous sections. You can consult
Concluding Statement with members of the NIH Committee
on Scientific Conduct and Ethics
(http://www1.od.nih.gov/oir/source
book/comm-adv/sci-conduct.htm),
with your Scientific Director or with
your IC Training Director. Advice is
also available from the NIH Office of
the Ombudsman (http://www4.od.
nih.gov/ccr/). L
26