N AT I ONAL I NSTIT U T ES OF HEALT H 

O F FIC E OF THE DIR EC TO R 

NIH POLICIES AND PROCEDURES FOR 

PROMOTING SCIENTIFIC INTEGRITY 

N OVE MB ER 2012 
NIH Policies and Procedures for Promoting Scientific Integrity

i

CONTENTS

LIST OF COMMONLY USED ABBREVIATIONS AND ACRONYMS________________ii

I. INTRODUUCTION___________________________________________________________1

II. NIH AS A FUNDER OF RESEARCH__________________________________________3

Peer Review_________________________________________________________________3

Funding ___________________________________________________________________4

General Standards of Extramural Research Conduct _______________________________5

Public Accessibility___________________________________________________________9

III. NIH AS A RESEARCH INNSTITUTION ______________________________________11

Staffing and Human Resource Adminstration ____________________________________11

Standards of Integrity and Objectivty in Research _________________________________12

Professional Development ____________________________________________________14

Professional Collaborations __________________________________________________15

Publication of Research Findings ______________________________________________16

Media and Interview Requests _________________________________________________18

Public Accessibility__________________________________________________________19

IV. NIH AS A POLICY DEVELOPMENT AGENCY ______________________________21

NIH Office of Science Policy____________________________________________________21

Federal Advisory Committees ___________________________________________________22

Use of Federal Advisory Committee Members ______________________________________23

Ethics Requirments for Special Government Employees ______________________________23

Federal Advisory Committee Meetings and Public Transparency_______________________24

Reports on Federal Advisory Committee Functions__________________________________25

Transparency in the Policymaking Process ________________________________________25

V. CONCLUDING STATEMENT ______________________________________________26

VI. CONTACT US ___________________________________________________________27
NIH Policies and Procedures for Promoting Scientific Integrity

ii

LIST OF COMMONLY USED ABBREVIATIONS AND ACRONYMS

APA Administrative Procedure Act

CFR Code of Federal Regulations

CMO Committee Management Officer

COR Contracting Officer Representative

DDIR Deputy Director for Intramural Research

FAC Federal Advisory Committee

FACA Federal Advisory Committee Act

FCOI Financial Conflict of Interest

HHS U.S. Department of Health and Human Services

IC NIH Institute or Center

LoC Library of Congress

NIH National Institutes of Health

OAMP NIH Office of Acquisition and Management Policy

OCPL NIH Office of Communications & Public Liaison

OER NIH Office of Extramural Research

OFACP NIH Office of Federal Advisory Committee Policy

OGE U.S. Office of Government Ethics

OHRP HHS Office for Human Research Protections

OIG HHS Office of Inspector General

OIR NIH Office of Intramural Research

OLAW NIH Office of Laboratory Animal Welfare

ORI HHS Office of Research Integrity

OSP NIH Office of Science Policy

OSTP The White House Office of Science and Technology Policy

PHS Public Health Service
NIH Policies and Procedures for Promoting Scientific Integrity

iii

PHSA Public Health Service Act

SGE Special Government Employee
NIH Policies and Procedures for Promoting Scientific Integrity

1

I. INTRODUCTION

What Is Scientific Integrity?

Scientific integrity, in this context, refers to maintaining the quality and objectivity of the 

research activities that the National Institutes of Health (NIH) funds and conducts, such that they 

are sound and worthy of the public’s confidence. NIH’s commitment to sound, objective science 

also strengthens the public’s trust in policy decisions informed by scientific data. In fostering 

scientific integrity, NIH aims to ensure that (1) scientific findings are objective, credible, and 

readily available to the public and (2) the development of policies based on science is conducted 

with appropriate transparency.

Purpose of This Document

On March 9, 2009, President Obama issued a memorandum to the heads of executive 

departments and agencies regarding scientific integrity. President Obama’s memorandum

ordered the Director of The White House Office of Science and Technology Policy (OSTP) to 

develop recommendations designed to uphold scientific integrity throughout the executive 

branch. On December 17, 2010, the Director of OSTP issued that guidance to the heads of the 

executive departments and agencies. Most, if not all, of the requirements set forth by OSTP were 

already in place at NIH but were located in multiple locations throughout the NIH Web site. 

Thus, this document consolidates summaries of and references to existing NIH policies and 

procedures so that interested members of the public can easily access vital information regarding 

NIH’s commitment to scientific integrity.

Scientific Integrity at NIH

The mission of NIH is to seek fundamental knowledge about the nature and behavior of living 

systems and apply that knowledge to enhance health, lengthen life, and reduce the burdens of 

illness and disability. NIH accomplishes this mission by funding research through its Extramural 

Research Program and through research conducted by NIH scientists in its Intramural Research 

Program.

NIH is the Nation’s largest single funder of 

biomedical research. Nearly 80 percent of the 

NIH budget goes to extramural research, and 

NIH funds more than 300,000 research 

personnel at over 3,000 universities and other 

research institutions throughout the United 

States and abroad.

NIH is also a research center with over 

5,000 scientists working at many of its 

27 Institutes and Centers (ICs). These 

scientists conduct applied and basic biomedical research within the laboratories and clinics of 

NIH’s intramural facilities.
NIH Policies and Procedures for Promoting Scientific Integrity

2

Ensuring the integrity of science and science-based policymaking is at the heart of everything 

NIH does in fulfilling its mission. NIH strongly supports appropriate degrees of transparency in 

the preparation and identification of the scientific and technological information that it uses for 

policymaking. NIH’s goal is to maintain integrity in the conduct of the science that the public 

funds and to assure the public of the credibility of our scientific findings.

In addition to the requirements of the U.S. Department of Health and Human Services (HHS) 

and Federal-wide requirements, NIH has numerous policies and procedures in place to help 

ensure and optimize scientific integrity in both the Intramural and Extramural Research 

Programs. NIH also serves as a policymaking institution for its own research. Aside from 

internal policymaking, NIH participates in a wide range of trans-Federal policy development in 

areas such as clinical research, biotechnology, and biosecurity.

The primary purpose of this document is to make more readily available to the public the policies 

that NIH follows to help ensure the highest degree of scientific integrity in the research we 

conduct and fund and in the policies we make.
NIH Policies and Procedures for Promoting Scientific Integrity

3

II. NIH AS A FUNDER OF RESEARCH

NIH is the Nation’s largest single funder of biomedical research. NIH seeks to ensure the quality 

and integrity of the research it funds by developing, implementing, coordinating, and overseeing 

policies and procedures that provide priorities and standards for the critical processes involved in 

issuing and monitoring research conducted under NIH awards. By developing and implementing 

program policies and procedures centrally, NIH enhances consistency across all NIH ICs and 

extramural business areas.

The NIH extramural research continuum is depicted in Figure 1 below. NIH follows many 

policies, procedures, and laws to help ensure that scientific integrity is maintained throughout the 

funding and conduct of peer-reviewed extramural research.

Peer Review Funding Conduct of 

Research

Publication of 

Research 

Findings

Training and 

Professional 

Development

Figure 1: NIH Extramural Research Continuum

Peer Review 

Peer-review groups at NIH generally are 

subject to the requirements of the 

Federal Advisory Committee Act

(FACA), except for charter renewal 

(Public Health Service Act [PHSA] 492, 

42 USC 289a). This means that the 

process by which grant applications are 

reviewed is transparent; all meetings are 

advertised and monitored by a Federal 

official; the criteria used to evaluate 

applications and membership are public 

information; and meeting records are 

filed with the Library of Congress 

(LoC).

Even though the privileged and confidential nature of information within applications 

necessitates meeting closures in accordance with NIH peer-review regulations (42 Code of 

Federal Regulations [CFR], Section 52h.6(b)), the public may request or access summary 

meeting minutes from LoC and access funded research using the NIH RePORT database.
NIH Policies and Procedures for Promoting Scientific Integrity

4

The NIH Office of Extramural Research (OER) develops and oversees the implementation of 

policy for the NIH peer-review process. This two-tiered system involves initial peer review for 

scientific and technical merit and subsequent review by advisory councils or boards in the ICs 

that are considering applications for funding. Both levels of the NIH peer-review process involve

the consistent application of standards and procedures that produce fair, equitable, 

informed, and unbiased examinations of grant and cooperative agreement applications to 

NIH. This two-tiered system described in 42 CFR, Part 52h and mandated by the NIH Reform 

Act of 2006 is extended by policy to other types of applications submitted to NIH.

Scientific integrity is the cornerstone of the NIH peer-review process and is exemplified in its 

core values: (1) expert assessment; (2) transparency; (3) impartiality; (4) fairness;

(5) confidentiality; (6) integrity; and (7) efficiency. These core values drive NIH to seek the 

highest level of ethical standards and form the foundation for the laws, regulations, and policies 

that govern the NIH peer-review process. To help ensure scientific integrity in the initial peerreview process, OER has developed a policy for managing conflict of interest, the appearance of 

conflict of interest, prejudice, bias, or predisposition. That policy can viewed at:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-120.html

To increase transparency, HHS policy also requires that grant applications be evaluated 

according to the review criteria specified in the Funding Opportunity Announcement be used in 

the evaluation of applications submitted for that announcement. In addition, the rosters of all 

NIH study sections and descriptions of all funded grants are made available to the public on the 

OER Web site.

NIH clearly delineates the roles of extramural staff members to avoid conflicts. Thus, no member 

of the NIH extramural staff may serve as a reviewer on an NIH review panel, and no member of 

the NIH review staff may participate in review functions and portfolio management in the same 

scientific area. Furthermore, input from individual extramural research staff into the process is 

restricted: an individual may not participate in both an application’s initial peer review and 

advisory council review.

Funding

The NIH Office of Acquisition and Management Policy (OAMP) helps ensure scientific 

integrity in the award process for contracts and acquisitions in accordance with the HHS 

Acquisition Regulation, Subpart 307.71. OAMP requires that the operating division involved in 

the award fully describe the acquisition strategy, funding approach, plans for full and open 

competition (or justification if limiting competition), and proposal evaluation criteria. In 

addition, in an effort to enhance competition, market research must be performed to identify 

prospective sources in addition to known sources. If it is best to limit competition, the 

requirement must satisfy stringent statutory authorities, and a justification must be approved to 

permit other than full and open competition.
NIH Policies and Procedures for Promoting Scientific Integrity

5

Similarly, OER ensures scientific integrity throughout the NIH grants process, including 

different types of awards (e.g., cooperative agreements, research training awards). The mission 

of OER is to provide the corporate framework for NIH research administration, including 

leadership, policy, oversight, and the tools and guidance needed to administer and manage NIH 

grants policies and operations. OER policies for grants administration are specified in the NIH 

Grants Policy Statement and the NIH Guide for Grants and Contracts.

General Standards of Extramural Research Conduct

NIH requires grantees to establish safeguards to prevent employees, consultants, members of 

governing bodies, and others who may be involved in grant-supported activities from using their 

positions for purposes that are, or give the appearance of being, motivated by a desire for private 

or financial gain for themselves or others, such as those with whom they have family, business, 

or other ties. These safeguards must be reflected in written standards of conduct. The grantee is 

responsible for enforcing its standards of conduct, taking appropriate action on individual 

infractions, and in the case of financial conflict of interest, informing the IC chief grants 

management officer if the infraction is related to an NIH award. The grantee must promptly 

report issues involving potential criminal violations, such as misappropriation of Federal funds, 

to the HHS Office of Inspector General (OIG). The grantee is not required to submit its general 

standards of conduct to NIH for review or approval. However, a copy must be made available to 

each of its officers, each employee and consultant working on the grant-supported project or 

activity, each member of the governing board, if applicable, and, upon request, to NIH.

If a suspension or separation action is taken by a grantee against a project director, principal 

investigator, or other senior key personnel under an NIH grant, the grantee must request prior 

approval of the proposed replacement as specified in Administrative Requirements, Changes in 

Project and Budget, Prior Approval Requirements of the NIH Grants Policy Statement.

An integral element of ensuring the integrity of NIH-sponsored research is adherence to specific 

requirements that foster the safe and ethical conduct of research. These are articulated in terms 

and conditions that must be agreed to by institutions receiving NIH funding. When an NIH 

grantee fails to materially comply with the terms and conditions of award, including confirmed 

instances of research misconduct, NIH may take one or more actions, depending on the severity 

and duration of the noncompliance. NIH will undertake such action in accordance with 

applicable statutes, regulations, and policies. Generally, NIH will afford the grantee an 

opportunity to correct the deficiencies before taking action unless public health or welfare 

concerns require immediate action. However, even if a grantee takes corrective action, NIH may 

take proactive actions to protect the Federal Government’s interests, including placing special 

conditions on awards or precluding the grantee from obtaining future awards for a specified 

period, or may take action designed to prevent future noncompliance, such as closer monitoring.

If a grantee fails to materially comply with the terms and conditions of award, NIH may take 

action to wholly or partially suspend the grant, pending corrective action, or may terminate the 

grant for cause. The regulatory procedures that pertain to suspension and termination are 

specified in 45 CFR, Sections 74.61, 74.62, and 92.43. A grant also may be terminated, partially 
NIH Policies and Procedures for Promoting Scientific Integrity

6

or totally, by the grantee or by NIH with the consent of the grantee. If the grantee decides to 

terminate a portion of a grant, NIH may determine that the remaining portion of the grant will 

not accomplish the purposes for which the grant was originally awarded. In any such case, NIH 

will advise the grantee of the possibility of termination of the entire grant and allow the grantee 

to withdraw its termination request. If the grantee does not withdraw its request for partial 

termination, NIH may initiate procedures to terminate the entire grant for cause. NIH also may 

decide to withhold support of a noncompeting continuation award in a current competitive 

segment. This postaward decision may be appealed by the grantee.

The policies and procedures found at the following Web links apply to research conducted, or 

proposed to be conducted, in facilities by any person funded by the NIH Extramural Research 

Program:

http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch8.htm#_Suspension,_Termination

Title 42, Part 52: Grants for Research Projects

Title 45, Part 74: Uniform Administrative Requirements for Awards and Subawards to 

Institutions of Higher Education, Hospitals, Other Nonprofit Organizations and Commercial 

Organizations

Title 45, Part 92: Uniform Administrative Requirements for Grants and Cooperative Agreements 

to State, Local, and Tribal Governments

Animal Welfare

OER’s Office of Laboratory Animal Welfare (OLAW) coordinates Public Health Service (PHS) 

regulations, policies, and procedures regarding the use of animals in research throughout the 

Federal Government. The NIH peer-review system evaluates justifications for the use of 

vertebrate animals in grant applications and descriptions for their use in research; any concerns 

raised during peer review must be resolved to the satisfaction of OLAW and the NIH program 

staff before an award can be issued. In addition, OLAW evaluates reports of noncompliance with 

PHS policy and conducts compliance oversight of PHS-supported animal care and use programs. 

OLAW provides oversight of all NIH-supported research activities that involve animals through 

its guidance and interpretation of the Public Health Service Policy on Humane Care and Use of 

Laboratory Animals.

More information about OLAW can be found at:

http://grants.nih.gov/grants/oer_offices/olaw.htm.

Human Subjects Protections

The HHS Office for Human Research Protections (OHRP) provides leadership in the protection 

of the rights, welfare, and well-being of human subjects involved in research conducted or 

supported by HHS. OHRP helps ensure this by providing clarification and guidance, 
NIH Policies and Procedures for Promoting Scientific Integrity

7

developing educational programs and materials, maintaining regulatory oversight, and providing 

advice on ethical and regulatory issues in biomedical and sociobehavioral research.

In implementing the regulations of 45 CFR, Part 46, “Protections of Human Subjects,” the NIH 

grants process includes numerous checkpoints to ensure compliance with PHS regulations and 

policy for human subjects protections. An NIH grant application that contains inadequate or 

unacceptable plans for protecting human subjects will not receive NIH funding. The NIH peerreview system evaluates the adequacy of protections for human subjects in each grant application 

and research and development contract proposal, and any concerns raised by reviewers must be 

resolved to the satisfaction of OER and program staff members before an award can be issued.

In addition, NIH requires education on the protection of human research participants for all 

investigators submitting NIH applications for grants or proposals for contracts or receiving new 

or noncompeting awards for research involving human subjects. Recently, OER launched the 

online tutorial “Protecting Human Research Participants” 

(http://phrp.nihtraining.com/users/login.php), which is designed for those involved in the 

design and/or conduct of research involving human participants. The training module is also 

available in Spanish.

Training in the Responsible Conduct of Research

Since1989 NIH has required that institutional training grant applications include a description of 

activities related to instruction about responsible conduct of research. The scientific 

community has responded by developing innovative courses, workshops, research projects on 

instruction in the responsible conduct of research, and instructional materials.

The NIH OER Research Training Web site (http://grants.nih.gov/training/extramural.htm) 

includes additional information on instruction in the 

responsible conduct of research and links to the HHS 

Office of Research Integrity (ORI) 

(http://ori.hhs.gov/), instructional materials, and 

examples of programs regarded as good models for 

instruction in the responsible conduct of research 

(http://bioethics.od.nih.gov/researchethics.html). 

Additional resources regarding the responsible 

conduct of research can be found at:

http://grants.nih.gov/training/responsibleconduct.htm.

Conflicts of Interest

NIH requires institutions that apply for or receive funding under grants or cooperative 

agreements (except Phase I SBIR/STTR applicants) to address financial conflicts of interest

(FCOI) by complying with the requirements of 42 CFR, Part 50, Subpart F, Promoting 

Objectivity in Research. These regulations were revised in 2011, and institutions are required to 

comply with the updated regulations as of August 24, 2012. The requirements under the FCOI 
NIH Policies and Procedures for Promoting Scientific Integrity

8

regulations promote objectivity in research by establishing standards that provide a reasonable 

expectation that the design, conduct, or reporting of research funded under NIH or other PHS 

grants or cooperative agreements will be free from bias resulting from investigator FCOI. 

“Investigator” is defined in the regulations to mean the project director, principal investigator, or 

any other person, regardless of title or position, who is responsible for the design, conduct, or 

reporting of research funded by PHS or who is proposed for such funding, which may include, 

for example, collaborators or consultants.

Information regarding the FCOI requirements, including links to the regulations and frequently 

asked questions, is available on the NIH Office of Extramural Research’s FCOI Web site at:

http://grants.nih.gov/grants/policy/coi/.

Research Misconduct

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, 

performing, or reviewing research or in reporting research results, according to “Public Health 

Service Policies on Research Misconduct,” 42 CFR, Part 93.

• Fabrication is defined as making up data or results and recording or reporting them.

• Falsification is defined as manipulating research materials, equipment, or processes or 

changing or omitting data or results such that the research is not accurately represented in 

the research record.

• Plagiarism is defined as appropriating another person’s ideas, processes, results, or 

words without giving appropriate credit.

A finding of research misconduct requires the following:

• There must be a significant departure from accepted practices of the relevant research

community.

• The misconduct must be committed intentionally, knowingly, or recklessly.

• The allegation must be proven by a preponderance of the evidence.

Research misconduct does not include honest error or differences of opinion. All institutions 

receiving PHS funding must have written policies and procedures for addressing allegations of 

research misconduct. NIH and ORI have specific procedures in place to address allegations of 

research misconduct. In addition, all NIH extramural staff members receive training biannually 

in the proper handling of allegations of research misconduct.

NIH identification of findings of research misconduct may result in special award conditions 

and/or enforcement actions, depending on the specific circumstances involved. Therefore, a
NIH Policies and Procedures for Promoting Scientific Integrity

9

grantee’s failure to comply with the terms and conditions of award, including confirmed 

instances of research misconduct, may cause NIH to take one or more actions, depending on the 

severity and duration of the noncompliance. NIH will undertake any such action in accordance 

with applicable statutes, regulations, and policies. Additional information related to NIH’s 

process for the handling of research misconduct allegations involving the extramural research 

community can be found at:

http://grants.nih.gov/grants/research_integrity/index.htm.

Fraud, Waste, and Abuse

Any individual who becomes aware of the existence (or apparent existence) of fraud, waste, or 

abuse related to NIH grants or grant funds should consider contacting: 

• The grantee institution’s Office of Sponsored Research, Compliance Office, or other 

responsible office

• The NIH chief grants management officer listed in the Notice of Award for the IC that 

funded the grant

• The Division of Grants Compliance and Oversight, Office of Policy for Extramural 

Research Administration, OER (DGCO/OPERA/OER)

In addition, allegations of criminal offenses should be reported to the HHS OIG Hotline.

OIG has authority within HHS to conduct criminal investigations. Further allegations of 

noncriminal misuse of grant funds and grantee conflict of interest should be reported to the NIH 

Office of Management Assessment (http://oma.od.nih.gov/). The policies and procedures 

available at the following Web link apply to research conducted, or proposed to be conducted, in 

facilities by any person funded by the NIH Extramural Research Program:

http://grants.nih.gov/grants/policy/nihgps_2011/index.htm

NIH requires that none of the funds made available in the governing appropriations act may be 

used to disseminate deliberately false or misleading scientific information.

This information can be found in Section 4.2.3, Dissemination of False or Deliberately 

Misleading Scientific Information of the NIH Grants Policy Statement.

Public Accessibility

Research Results

The NIH Public Access Policy (http://publicaccess.nih.gov/policy.htm) helps ensure that the 

public has access to published results of NIH-funded research. It requires scientists to submit 

final peer-reviewed journal manuscripts that arise from NIH-funded research to the digital 

archive PubMed Central® upon acceptance for publication. To help advance science and 
NIH Policies and Procedures for Promoting Scientific Integrity

10

improve human health, the policy requires that these papers be made available to the public on 

PubMed Central® no later than 12 months after publication.

The NIH Office of Communications & Public Liaison (OCPL) makes the public aware of 

individual IC clearinghouses, toll-free telephone numbers, and other contact information through 

the “Quickfinder” publication, a list of IC-based information resources. Another cornerstone of 

the NIH information program is ClinicalTrials.gov, a Federal repository of information about 

research sponsored by NIH and other entities. Although many ICs offer specialized trial searches 

through individual databases, ClinicalTrials.gov is a central repository for international research 

involving humans.

General NIH Information

OCPL offers a variety of mechanisms for direct public 

contact and recognizes the need for immediate, reliable 

responses to public inquiries, but by way of policy, does 

not offer personalized medical advice or product 

endorsements. Public inquiries that arrive via an online 

form on the NIH home page or by email (NIHinfo@od.nih.gov) are fielded by OCPL’s Editorial 

Operations Branch. Staff members respond daily to requests for information; OCPL has set a 

goal of responding to each inquiry within 48 hours of receipt.

Patients seeking medical advice are directed to their primary health care practitioners. Records of 

inquiries submitted to NIHinfo@od.nih.gov are kept for approximately 1 year. General 

information on NIH activities can be found at the following Web links:

NIH “A-Z” Health Information and NIH Publications List:

http://health.nih.gov/see_all_topics.aspx and http://nihpublications.od.nih.gov/

“Contact NIH”:

http://www.nih.gov/about/contact.htm

“Quickfinder”:

http://www.nih.gov/about/quickfinder.pdf

ClinicalTrials.gov:

http://www.clinicaltrials.gov/

Selected NIH Education and Awareness Campaigns:

http://www.nih.gov/icd/od/ocpl/resources/campaigns/

Biennial Report of the Director, NIH, including the Health Communication and Information 

Campaigns and Clearinghouses section:

http://report.nih.gov/biennialreport/
NIH Policies and Procedures for Promoting Scientific Integrity

11

III. NIH AS A RESEARCH INSTITUTION

The NIH Intramural Research Program conducts research, training, and technology transfer 

within its own laboratories and clinics. To help ensure the high quality and integrity of its 

intramural programs, NIH develops and implements NIH-wide policies and review standards for 

intramural research, training, and technology transfer.

The NIH intramural research continuum is outlined in Figure 2 below. Scientific integrity begins 

with the staffing process, which seeks to ensure that the scientists hired to conduct research at 

NIH are of the highest caliber. In addition, NIH has a wide variety of policies and procedures 

that help ensure scientific integrity throughout the conduct of research and the eventual 

publication of research results. Most importantly, NIH maintains a culture of scientific integrity 

by employing an overarching program of training and professional development for all scientists 

conducting research at NIH.

Staffing and Research 

Administration Conduct of Research

Publication of 

Research 

Findings

Training and 

Professional 

Development

Figure 2: NIH Intramural Research Continuum

Staffing and Human Resource Administration

Hiring Practices

The NIH Office of Intramural Research (OIR) is actively involved in the hiring of new scientists 

at NIH. The selection of new senior investigators, tenure-track investigators, senior scientists, 

and senior clinicians is considered one of the most important functions of the Intramural 

Research Program. To help ensure that overall standards of high productivity, equal opportunity, 

integrity, matters of safety, and many other general aspects of the research establishment are met 

throughout NIH, the NIH Deputy Director for Intramural Research (DDIR) must approve all 

searches for these individuals. The DDIR also provides hiring guidelines in the Intramural 

Research Sourcebook (https://oir.nih.gov/sourcebook).

Prior to a new search, the IC sends to the DDIR for approval a brief memorandum (with 

appropriate attachments) describing the general procedures that will be used for searches to fill 

vacancies. It is recognized that these general procedures may differ, even in principle, depending 

on the seniority and the nature of the desired or necessary expertise of the individual being 

sought. Specific information is sent to the DDIR regarding such matters as the names and 
NIH Policies and Procedures for Promoting Scientific Integrity

12

credentials of the proposed chairperson and members of the search committee, specific 

instructions contemplated for the committee, a draft of the vacancy announcement and where it 

will be placed, and any other pertinent information.

It is anticipated that the DDIR will designate 

an additional member of the search 

committee and work with the IC to modify 

the search plan when that seems advisable. 

Once a candidate is selected, a report about 

the search, including the number of 

applicants, as well as the name of the 

selected individual, is sent to the DDIR for 

approval (https://oir.nih.gov/sourcebook).

Whistleblower Protections

The term “whistleblower” refers to the act of reporting wrongdoing to stop illegal or 

unethical behavior. When an organization’s employees and scientific staff report such behavior, 

they draw attention to activities that undermine both the institutional mission and the public trust. 

Scientists and scientific staff members can play an instrumental role by surfacing latent problems 

so that they can be addressed. Scientists and scientific staff members will be reluctant to come 

forward, however, if they believe they may be subject to retaliation for having done so. The 

Federal Government has enacted whistleblowing provisions designed to encourage the reporting 

of personnel and safety violations while protecting Federal employees from acts of reprisal.

The NIH Office of the Ombudsman, Center for Cooperative Resolution, plays a crucial role in 

assisting whistleblower scientists. The Office of the Ombudsman provides a safe haven for 

scientific whistleblowers who otherwise might not report their concerns. Scientists and scientific 

personnel can speak with the NIH Ombudsman without fear of having their identities disclosed. 

NIH ombudsmen are able to shuttle information between whistleblowers and those in authority, 

helping to surface issues of scientific misconduct, the improper use of human and animal 

subjects, and other system-wide problems. Furthermore, the flexible nature of the Ombudsman 

Office allows scientific whistleblowers more control over the process.

Standards of Integrity and Objectivity in Research

Research Ethics

The progress and excellence of NIH research depend on NIH’s vigilance in maintaining the 

highest quality of conduct in every aspect of science. OIR has developed a set of general 

principles for the ethical conduct of research, published as the “Guidelines for the Conduct of 

Research in the Intramural Research Program at NIH” 

(https://oir.nih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/guidelines-
NIH Policies and Procedures for Promoting Scientific Integrity

13

conduct_research.pdf). These Guidelines define specific core areas critical for high-quality, 

ethical research. Individuals who are directly involved in the research activities of the NIH 

Intramural Research Program must read, understand, and incorporate the principles in the 

Guidelines into everyday practice.

The Responsible Conduct of Research policy requires one-time training 

(http://researchethics.od.nih.gov/) in the core areas and yearly followup using research ethics 

case discussions on specific themes encountered in research. These sessions review real-world 

case studies that engender discussions of scientific integrity. Case studies are archived, can be 

reviewed at any time, and can be accessed at https://oir.nih.gov/sourcebook/ethicalconduct/responsible-conduct-research-training

Research Misconduct

OIR, the research community, and the public at large rightly expect adherence to exemplary 

standards of intellectual honesty in the formulation, conduct, and reporting of scientific research. 

Allegations of research misconduct are taken seriously by NIH. The process of investigating 

allegations must be balanced by equal concern for protecting the integrity of research as well as 

the careers and reputations of researchers.

The online resource NIH Intramural Research Program Policies & Procedures for Research 

Misconduct Proceedings (NIH Intramural Policy) is intended to enable allegations of research 

misconduct to be processed fairly, confidentially, and promptly. Fairness allows all who become 

involved in research misconduct cases to have the opportunity to participate appropriately in 

addressing the relevant issues and seeks to protect innocent participants from adverse 

consequences. Confidentiality helps protect innocent people who are incorrectly or unjustly 

accused and those who bring allegations. A prompt response to an allegation helps minimize any 

harm to the public that could result if research misconduct is found and allows those who are 

incorrectly accused to clear their names without going through a long process. Fair, confidential, 

and prompt treatment of research misconduct allegations is important and also fosters an 

institutional climate supportive of honest, good-faith reporting of possible research misconduct.

The NIH Intramural Policy applies to alleged or actual research misconduct involving research 

carried out by any person in an NIH facility or who is funded by the NIH Intramural Research 

Program in any location or undertaken by an NIH employee or trainee as part of his or her 

official NIH duties or NIH training activity regardless of location.

Policies and procedures relating to allegations of potential misconduct in the Intramural Research 

Program at NIH, available via the Web link above, also have been summarized in the online 

resource “A Guide to the Handling of Research Misconduct Allegations” 

(http://sourcebook.od.nih.gov/ResEthicsCases/NIH%20Misconduct2.pdf).
NIH Policies and Procedures for Promoting Scientific Integrity

14

Conflict of Interest

Avoiding financial and other conflicts of interest are important for NIH, where the trust and 

protection of research participants are vital to our mission to improve public health. As members 

of the executive branch of the U.S. Government, NIH intramural scientists are subject to the 

Standards of Ethical Conduct for Employees of the Executive Branch. In addition, NIH scientists 

are subject to the requirements found in 5 CFR Part 2636, 5 CFR Part 2640, 5 CFR Part 2641, 5 

CFR Part 5501, and 5 CFR Part 5502. Each IC has dedicated ethics officials available to help 

NIH scientists understand and comply with the applicable ethics rules. A list of these officials’ 

names and contact information is found at: https://ethics.od.nih.gov/contacts.html. Additional 

information on the ethical conduct laws, regulations and policies can be found at: 

http://ethics.od.nih.gov/default.htm. In addition, OIR, working with the NIH Ethics Office, has 

prepared a guide to assist clinical investigators in avoiding real or perceived financial and 

nonfinancial conflicts of interest, which is available at:

https://oir.nih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/guidelinesconduct_research.pdf

Professional Development

NIH trainees have a single primary supervisor, but other individuals also may function as 

mentors for specific aspects of training and career development. It is the responsibility of the 

primary supervisor to serve as a role model and provide a rich research environment in which the 

trainee has the opportunity to acquire both the conceptual and technical skills of the field. In this 

setting, the trainee is provided with clear expectations and undertakes a significant piece of 

research, usually chosen as the result of discussions between the mentor and the trainee. To 

provide a meaningful, high-quality training experience, the mentor monitors and guides the 

trainee’s progress closely and interacts personally with the trainee on a regular basis to give 

timely feedback regarding research findings and progress.

Mentoring is adapted to the needs and career stage of each individual trainee. Mentors are 

particularly diligent to involve trainees in research and related activities that contribute to their 

careers, including participation in intramural or extramural collaborations, encouragement of 

presentations at scientific meetings, and networking. Mentors provide trainees with timely and 

realistic appraisals of their performance and with advice regarding career opportunities and 

advancement.

Scholarly writing, lecturing, editing, and publishing are essential parts of research and 

professional development. These activities are in the public interest and bring credit and 

distinction to both NIH and its employees. In encouraging investigators to share information 

about their official and professional activities, NIH seeks to advance scientific knowledge and 

contribute to its employees’ professional education.
NIH Policies and Procedures for Promoting Scientific Integrity

15

Ordinarily, scientific research results or other 

professional findings by NIH intramural 

scientists are reported via either publication in a 

scientific or professional journal or as a 

presentation at a professional organization’s 

meeting. Sometimes NIH provides “breaking 

news” to the public on research findings prior to 

publication in scientific journals and prior to peer 

review by journals of an important public health 

finding, such as publication of the results of a 

clinical trial result that has immediate health 

implications.

Professional Collaborations

The NIH Office of the Ombudsman also has resources aimed at fostering successful professional 

development for scientists and researchers. The NIH Office of the Ombudsman is a confidential, 

neutral resource that provides informal assistance to scientists, clinicians, fellows, and scientific 

personnel in addressing laboratory and other work-related issues. The Office offers a range of 

professional development services designed to help researchers (1) identify and prevent 

problems arising from scientific collaborations and (2) address interpersonal conflicts involving 

scientists or others they manage. Because the Office is a confidential resource that is unaffiliated 

with any institute or department, scientists and fellows are able to identify and address their 

sensitive coaching needs without disclosing them to their supervising investigator or scientific 

director. In addition, as a consequence of working with many scientists over time to resolve

scientific and interpersonal disputes, the Office of the Ombudsman is able to identify likely 

problems that a researcher may encounter when working collaboratively with other scientists. 

These potential issues, and concrete strategies for addressing them, are contained in 

Collaboration and Team Science: A Field Guide, a book written by the Office of the 

Ombudsman together with an intramural scientist. The Office of the Ombudsman also helps 

scientific collaborators think critically about the nature of their collaborations through its online 

resource Questions for Scientific Collaborators: A Collaborative Agreement Template, which 

helps foster proactive decision making. The following resources and documents on conflict 

resolution are available for use by NIH scientists and research staff members:

http://ombudsman.nih.gov/

Collaboration & Team Science: A Field Guide

Sample Partnering Agreement Template

Workplace Conflict
NIH Policies and Procedures for Promoting Scientific Integrity

16

General Guidelines for Authorship Contributions (PDF)

OAMP also offers professional development opportunities for the NIH scientific Contracting 

Officer Representative (COR) community. NIH COR staff members are responsible for the 

award and administration of contracts. The COR staff must meet Federal Acquisition 

Certification.

In addition, one of the general business competencies established by HHS relates to integrity and 

honesty in the activities as a COR.

Publication of Research Findings

Publication Policies

OIR has established policies and procedures for the review, approval, and distribution of 

scientific, technical, and other professional information by individual employees (including 

intramural, extramural, and NIH Office of the Director staff members). Guidelines are available 

for written, electronic, or oral presentations, which reiterate the many quality control measures 

embedded in the scientific process, and at NIH, to help ensure that the information disseminated 

by NIH employees is of the highest quality. Scientific and professional information presented by 

NIH employees must be considered differently from information presented in other professional 

settings (such as when scientists from universities or industry laboratories present information in 

public forums). A clear distinction must be made between the presentation of scientific data and 

the presentation of opinion that may be construed as the position of NIH. Publication policies can 

be found at the following Web links:

http://publicaccess.nih.gov/nih_employee_procedures.htm

http://sourcebook.od.nih.gov/oversight/non-peer-reviewed-instruct.htm

http://sourcebook.od.nih.gov/oversight/pub-clear.htm

NIH is committed to maximizing both the quality and effectiveness of NIH publications and 

audiovisuals while providing an orderly basis for review without hampering the free flow of 

information. OCPL also supports existing quality control measures found in the scientific 

process and works with the scientific staff to help ensure that peer-reviewed, research-based 

information disseminated by NIH employees is of the highest quality, recognizing that 

(1) information presented by NIH employees is considered and treated differently from that 

presented in other professional settings and (2) there is a clear distinction between the 

presentation of scientific data and opinion.

OCPL has developed an NIH-wide editorial policy and a policy for using the NIH name and logo 

for science and health information materials produced by NIH ICs 

(http://health.nih.gov/editorialpolicy.aspx). OCPL policies also guide the production and 
NIH Policies and Procedures for Promoting Scientific Integrity

17

dissemination of staff scientific publications and health materials designed for the public at large. 

The Office also reviews and clears all proposed NIH publications and public health campaign 

materials through HHS to ensure accuracy and adherence to Federal Government publication 

standards. Of equal importance is guidance for use of the NIH name and logo to help ensure 

consistency and accountability in the use of logos both within and outside the agency.

OCPL’s Editorial Operations Branch maintains guidelines for submission and clearance of 

NIH publications. Publications designed for wide public dissemination must undergo a series of 

internal approvals prior to printing. As a general policy, NIH publications may not include 

advertising. The clearance process follows a number of clear, prescribed steps. Speeches or 

journal publications, as well as letters to the editor from NIH directors or associate directors, are 

reviewed for editorial suggestions or policy implications. In some cases, material may be subject 

to a number of levels of review, including HHS review, especially when current policy issues are 

involved. Additional guidance for specific NIH publications, such as the NIH Record, is posted 

on the publication Web site at http://nihrecord.od.nih.gov/.

The NIH policy and procedures to be followed in the preparation, review, approval, and 

distribution of documents issued by NIH and its components can be found at:

http://oma.od.nih.gov/manualchapters/management/1183/.

The NIH policy and procedures for the review, approval, and distribution of scientific, 

technical, and other professional information by individual employees can be found at:

http://oma.od.nih.gov/manualchapters/management/1184/1184.pdf.

The Plain Writing Act of 2010 was signed into law on October 13, 2010. The law requires 

Federal agencies to use “clear Government communication that the public can understand and 

use” and sets down several requirements for Federal agencies. NIH’s “clear communication” 

policies, including plain-language requirements, can be found at the following Web links:

http://www.nih.gov/clearcommunication/

http://www.nih.gov/clearcommunication/plainlanguage.htm

http://plainlanguage.nih.gov/CBTs/PlainLanguage/login.asp

http://www.hhs.gov/open/recordsandreports/plainwritingact/index.html

http://www.plainlanguage.gov

The 1998 Amendment to Section 508 of the Rehabilitation Act requires that all Web site 

content be equally accessible to people with disabilities. This applies to Web applications, Web 

pages, and all attached files. The OCPL staff collaborates with IC and HHS counterparts as well 

as with Federal partners and the Office of the Chief Information Officer in an effort to ensure 
NIH Policies and Procedures for Promoting Scientific Integrity

18

that NIH meets Section 508 requirements and achieves Government-wide Section 508 goals. 

Information regarding 508 compliance can be found at the following Web links:

http://www.hhs.gov/web

http://www.hhs.gov/web/508/index.html

Media and Interview Requests

OCPL maintains clearance procedures for interview requests, press releases, media 

availabilities, and teleconferences and also serves as the point of contact for NIH policies 

governing video and photos during media sessions. OCPL serves as a central, coordinating 

media relations office and works closely with NIH’s component communications offices and 

staffs and with HHS’s Federal partners.

Public audiences for NIH communications include 

patients and their family members, nonprofit 

organizations, Congress, industry, the media, the 

scientific community (primarily through 

professional membership organizations), and the 

wider public that receives NIH communications 

through the NIH Web site, broadcast or print news outlets, and social media outlets. NIH seeks 

to be responsive to the media, recognizing that press inquiries about NIH-supported research are 

a high priority.

In general, NIH does not (1) participate in marketing efforts or for-profit activities, (2) comment 

on unfunded investigators or pending grants, or (3) contribute to ideological discussions. NIH 

employees may speak to members of the press about their work but are not required to do so. A 

number of specific requirements may apply, for example, those related to official duty activities 

for NIH employees and disclaimers to be used when scientists are not speaking in an official 

capacity. NIH also is committed to protecting the rights of patients and subjects used in photos 

and other media coverage while fulfilling NIH’s communication mission and meeting continuous 

media deadlines.

HHS media relations guidelines and style guidelines for press releases can be found at the 

following Web links:

HHS Guidelines on the Provision of Information to the News Media:

http://www.hhs.gov/news/media_policy.html

HHS and HHS Agency Press Contacts:

http://www.hhs.gov/news/contacts/index.html

NIH guidance material regarding media relations information can be found at the Web links 

listed below.
NIH Policies and Procedures for Promoting Scientific Integrity

19

Media Policies

NIH Media Contacts:

http://www.nih.gov/news/media_contacts.htm

HHS Center for New Media (resources, checklists, guidelines, policies, including new media at 

NIH):

https://www.hhs.gov/web/index.html

Authorization for Interviewing, Recording, Filming, and/or Photographing of Patients in the 

Clinical Center for External Media/Communications Purposes (Form NIH-549):

https://security.nih.gov/Documents/Guidelines%20for%20Photography%2C%20Filming%2C%2

0or%20Video%20Recording%20at%20the%20NIH.pdf

Publication Policies

NIH Policy on Scientific, Technical, and Other Professional Information Presented by NIH 

Employees: Review, Approval, and Distribution (including use of disclaimers, Section D3):

https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx

Office of Management and Budget and HHS Guidelines for Ensuring and Maximizing the 

Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies and 

NIH Guidelines for Ensuring the Quality of Information Disseminated to the Public:

https://obamawhitehouse.archives.gov/omb/fedreg_final_information_quality_guidelines/

Intramural Research Sourcebook for Publications and Meeting Abstracts Clearance:

https://oir.nih.gov/sourcebook/submitting-research-publications/publication-abstract-clearance

Public Accessibility

Research Results 

The NIH Public Access Policy (http://publicaccess.nih.gov/policy.htm) helps ensure that the 

public has access to published results resulting from research conducted by NIH. The policy 

requires scientists to submit final peer-reviewed journal manuscripts resulting from NIH-funded 

research to the digital archive PubMed Central® upon acceptance for publication. To help 

advance science and improve human health, the policy requires that these papers be made 

available to the public on PubMed Central® no later than 12 months after publication.

OCPL informs the public about individual IC clearinghouses, toll-free telephone numbers, and 

other contact information through the “Quickfinder” publication, a list of IC-based information 

resources. Another cornerstone of the NIH information program is ClinicalTrials.gov, a Federal 

repository of information about research sponsored by NIH and other entities. Although many 
NIH Policies and Procedures for Promoting Scientific Integrity

20

ICs offer specialized trial searches through individual databases, ClinicalTrials.gov is a central 

repository for international research involving humans.

General NIH Information

OCPL offers a variety of mechanisms for direct public contact and recognizes the need for 

immediate, reliable response to public inquiries but, as a matter of policy, does not offer 

personalized medical advice or product endorsements. Public inquiries that arrive via an online 

form on the NIH home page or by email (NIHinfo@od.nih.gov) are fielded by OCPL’s Editorial 

Operations Branch. Staff members respond daily to requests for information; the Office has a 

goal of responding to each inquiry within 48 hours of receipt.

Patients seeking medical advice are directed to their primary health care practitioners. Records of 

inquiries submitted to NIHinfo@od.nih.gov are kept for approximately 1 year. General 

information on NIH activities can be found at the following Web links:

NIH “A-Z” Health Information and online publications:

http://health.nih.gov/see_all_topics.aspx

http://nihpublications.od.nih.gov/

“Contact NIH”:

http://www.nih.gov/about/contact.htm

“Quickfinder” information resource:

http://www.nih.gov/about/quickfinder.pdf

ClinicalTrials.gov:

http://www.clinicaltrials.gov/

Selected NIH Education and Awareness Campaigns:

http://www.nih.gov/icd/od/ocpl/resources/campaigns/

Biennial Report of the Director, NIH, including the Health Communication and Information 

Campaigns and Clearinghouses section:

http://report.nih.gov/biennialreport/

IV. NIH AS A POLICY DEVELOPMENT AGENCY
NIH Policies and Procedures for Promoting Scientific Integrity

21

NIH Office of Science Policy

In addition to being a research institution and the Nation’s major funder of biomedical research, 

NIH is also a policymaking agency that develops and participates in the development of 

policies regarding the management and safety of science, as well as future directions for 

scientific inquiry. Spearheading the development and analysis of these policies is the NIH 

Office of Science Policy (OSP), which advises the NIH Director on science policy issues 

affecting the biomedical research community, NIH, and the public. OSP’s mission is to promote 

progress in the biomedical research enterprise through the development of sound and 

comprehensive policies for the conduct and oversight of biomedical research. OSP accomplishes 

this mission by taking a leading role in the development of new research policies and programs 

in a variety of arenas, including the conduct and oversight of clinical research, biosafety, the 

societal impact of genomics research and data sharing, the ethical use of stem cells in research, 

and biosecurity in the life sciences.

OSP also serves as a focal point in the coordination of the activities of the 27 individual IC 

science policy offices. OSP staff members also take a leadership role in a variety of working 

groups that have been established to provide in depth analysis of science policy initiatives. The 

Director of OSP also serves as the NIH liaison to important Federal science policy partners such 

as the U.S. Food and Drug Administration and OHRP. The various interagency and intra-agency 

coordination activities provided by OSP help ensure that the NIH Director is provided with the 

most balanced and sound advice possible when considering science policy matters.

OSP’s Role in Ensuring the Integrity of Science Policy Analysis

One of OSP’s most critical roles in science policy development is identifying and analyzing the 

needs of a diverse set of stakeholders. These stakeholders often include the national and 

international scientific community, patients, other Federal agencies, and the public. To fulfill the 

needs of such a broad spectrum of stakeholders, OSP must be adept in analyzing complex 

scientific information and its potential impacts. OSP has developed several successful 

mechanisms for reaching out and consulting with stakeholders. Such mechanisms include 

holding public stakeholder meetings where interested parties can provide their perspectives on 

proposed policy matters. Other mechanisms include providing stakeholders with clear, accessible 

information on emerging policy issues through one of the Web sites that OSP maintains.

Additional information regarding OSP, and the programs that OSP administers to promote sound 

policymaking decisions, can be viewed at the following Web link:

http://osp.od.nih.gov/

In addition to the aforementioned policymaking activities, NIH frequently makes use of Federal 

Advisory Committees when seeking balanced and expert input on science policy matters.
NIH Policies and Procedures for Promoting Scientific Integrity

22

Federal Advisory Committees

To develop sound, credible scientific polices, NIH often seeks the assistance of Federal Advisory 

Committees (FACs) to help guide policy discussions and engage key stakeholders to learn 

different perspectives regarding the proposed policy’s impact. The development of science 

policy at NIH generally follows the Administrative Procedure Act (APA) to allow for the 

appropriate engagement of members of the general public.

The general process utilized by NIH in policy development is outlined below in Figure 3. 

Scientific integrity begins with ensuring that scientific input regarding a proposed policy is 

appropriate. This information, in conjunction with public input, is then used to craft sound, 

credible scientific policy. A hallmark of the policymaking process is NIH’s commitment to 

transparency. In the case of policymaking, FACs are often used to provide crucial guidance to 

NIH. The advice from these committees, as well as input from the public is an integral element 

of NIH’s ability to craft sound, credible, scientific policies.

Staffing and Human 

Resources Proposed Policy Conduct of Research Public Input Final Policy Scientific and Subject 

Matter Expert Input

Figure 3: NIH Policy Development Process

Roles and Responsibilities of the NIH Staff in Managing Federal Advisory Committees

The Office of Federal Advisory Committee Policy (OFACP) is responsible for the oversight of 

all NIH FACs established and operated under the FACA. OFACP develops policies and provides 

guidance, resources, and training for NIH and serves as the central liaison to HHS on FAC 

management matters.

At NIH, each IC has a Committee Management Officer (CMO) or an agreement with a CMO

service center to coordinate all operational committee management activities within its 

organization (A CMO service center is a committee management office in one IC that has a 

memorandum of agreement with other ICs to provide them with committee management 

services). The IC CMO or CMO service center prepares nomination slates and furnishes OFACP 

generated policy guidance and assistance to IC leadership and FAC members to ensure 

compliance with the FACA.

Every FAC has a designated Federal official or executive secretary that attends all committee 

meetings, ensures that the meeting proceeds according to the agenda, and maintains 

responsibility for meeting records, among other requirements.

Use of Federal Advisory Committee Members
NIH Policies and Procedures for Promoting Scientific Integrity

23

The Federal Government recognizes the important 

roles played by FACs in developing effective policies 

and providing guidance on many issues. The influence 

and number of FACs have grown quickly, as have 

concerns within the Federal Government regarding 

FAC management, cost, and accountability. Since 1962 

several Executive Orders and Federal acts have 

established guidelines for using such groups. Today, 

the principal Federal act that FACs must follow is the 

FACA.

NIH maintains over 150 chartered FACs, the largest number of any executive branch agency. 

The majority of these committees are either mandated or authorized by the PHSA. This act 

authorizes appropriate scientific and technical peer review of biomedical and behavioral research 

grant and cooperative agreement applications, research and development contracts, and research 

conducted at NIH through FACs.

Recruitment of Federal Advisory Committee Members

The nomination and selection of FAC members are major professional responsibilities of each 

FAC’s manager. The selection process involves long-range planning and obtaining suggestions 

and information from many different sources. NIH draws on numerous resources to select 

suitable nominees for membership.

NIH utilizes four different types of FACs:

• Integrated/Initial Peer Review Groups

• Program Advisory Councils

• Boards of Scientific Counselors

• National Advisory Councils

More information regarding how NIH manages the different types of FACs can be found on the 

OFACP Web site: http://ofacp.od.nih.gov/. Additional information on the NIH selection criteria 

for FAC membership can be viewed at: 

https://ofacp.od.nih.gov/committees/pdf/SelectionCriteria.pdf

Ethics Requirements for Special Government Employees

Members of FACs, with the primary exception of members of integrated/initial peer review 

groups, are almost always considered Special Government Employees (SGEs). An SGE is an 

officer or employee in the executive branch of the Federal Government who is appointed to 

perform temporary duties, with or without compensation, for a period not to exceed 130 days 

during any period of 365 consecutive days. The SGE nominee must complete the U.S. Office of 

Government Ethics (OGE) Form 450 (Confidential Financial Disclosure Report) before serving 

and attending meetings as a member. OGE Form 450 is reviewed by the IC CMO in consultation 
NIH Policies and Procedures for Promoting Scientific Integrity

24

with the FAC’s executive secretary and the IC deputy ethics counselor to determine whether an 

actual or apparent conflict of interest exists.

As SGEs, FAC members are also subject to various additional ethics requirements and must take 

the course “Ethics Training for Special Government Employees,” which covers financial 

disclosure, conflict of interest, and misuse of positions, among other topics. The ethics rules 

governing FAC members and SGEs can be found at:

http://ofacp.od.nih.gov/ethics/pdfs/SGETRAININGOCT2004.pdf.

Additional resources related to ethics requirements and avoiding conflicts of interest for SGEs 

can be found at the following links:

http://ofacp.od.nih.gov/ethics/ethics_training.asp

http://oma.od.nih.gov/manualchapters/management/1810-1/

Federal Advisory Committee Meetings and Public Transparency

Specific policies must be followed when conducting a FAC meeting, including the following:

• The meeting must be held at a reasonable time and in a manner or place reasonably 

accessible to the public, including facilities that are readily accessible to and usable by 

persons with disabilities.

• The meeting room or other venue must be large enough to accommodate FAC members, 

agency staff members, and a reasonable number of interested members of the public.

• Any member of the public may be permitted to file a written statement with the FAC.

• Any member of the public may speak to or otherwise address the FAC within limits 

established in advance by the committee.

• FAC meetings conducted in whole or part by teleconference, video conference, the 

Internet, or other electronic medium also must meet the above requirements.

FAC meetings must be announced at least 15 days prior through a notice published in the 

Federal Register. The Federal Register notice must include the name of the FAC; the time, date, 

and location of the meeting; a statement as to whether the meeting will be open to the public or 

closed (if closed, the reasons must be cited); and the contact information for the agency official

responsible for the meeting.

The FACA requires that detailed minutes of each open meeting be kept and that they must 

include the names of the persons present; an accurate description of matters discussed and 

conclusions reached; copies of all reports received, issued, or approved by the FAC; and 
NIH Policies and Procedures for Promoting Scientific Integrity

25

certification by the FAC chair as to the accuracy of the minutes. The FACA also requires that a 

summary of each closed or partially closed FAC meeting be kept, including a summary of its 

activities that would be informative to the public.

Reports on Federal Advisory Committee Functions

Throughout the year, NIH contributes to the Annual Comprehensive Review of Federal Advisory 

Committees (https://www.gsa.gov/policy-regulations/policy/federal-advisory-committeemanagement/advice-and-guidance/the-federal-advisory-committee-act-faca-annualcomprehensive-review), which provides the public with detailed information about every FAC in 

the executive branch of the U.S. Government.

Transparency in the Policymaking Process

As described above, NIH often uses FACs to provide guidance on issues that NIH is weighing 

when developing sound, credible, scientific policies. When a FAC provides recommendations to 

NIH, these are taken under advisement and often are developed into a proposed policy for public 

review. These public policies are generally advertised broadly in accordance with the APA, 

which provides the framework for how Federal Government agencies communicate proposed 

policy matters to members of the public.

V. CONCLUDING STATEMENT
NIH Policies and Procedures for Promoting Scientific Integrity

26

As the Nation’s largest single funder of biomedical research and as a research institution 

employing over 5,000 investigators, it is of vital importance that the public trusts the research 

being funded and conducted by NIH. As shown throughout this document, NIH has extensive 

policies and procedures in place to help ensure that the highest degree of scientific integrity is 

maintained in the research that NIH funds and conducts. NIH consistently seeks innovative ways 

to further foster scientific integrity in everything it does. NIH has an unwavering commitment to 

scientific integrity, transparency, and public accountability that serves at the core of its mission.

We welcome any comments, suggestions, or concerns the public may have regarding the ways 

NIH seeks to ensure scientific integrity in the research it funds and conducts. A list of NIH 

contacts is provided below.
NIH Policies and Procedures for Promoting Scientific Integrity

27

VI. CONTACT US

NIH staff members are always available to answer any questions the public may have regarding 

the research that NIH funds and conducts. Please find the appropriate contact information below 

for any questions or comments you may have.

For questions regarding this document or general questions regarding scientific integrity 

programs at NIH, please contact the NIH Office of Science Policy at 

SciencePolicy@mail.nih.gov or visit our Web site at www.osp.od.nih.gov.

For specific questions on programmatic issues, please contact the appropriate NIH entity:

General NIH Information nihinfo@od.nih.gov

NIH Office of Extramural Research http://grants.nih.gov/grants/oer.htm

grantsinfo@od.nih.gov

NIH Office of Intramural Research http://irp.nih.gov

IRPinfo@mail.nih.gov

NIH Office of Communications & http://www.nih.gov/icd/od/ocpl/index.html

Public Liaison 

olib@od.nih.gov

NIH Office of Federal Advisory http://ofacp.od.nih.gov/

Committee Policy

spaethj@od.nih.gov

NIH Office of Management http://oma.od.nih.gov/

Assessment

omainfo@mail.nih.gov

NIH Office of Acquisition and http://oalm.od.nih.gov/

Logistics Management

Center for Cooperative Resolution/

NIH Office of the Ombudsman ombudsman.nih.gov

NIH Ethics Office http://ethics.od.nih.gov/