September 30, 2024
Effective Date: December 30, 2024
Office of The Director, National Institutes of Health (OD)
Summary
The purpose of this guide notice is to issue the Final NIH Scientific Integrity Policy to promote a continuing culture of scientific integrity at NIH. This Policy codifies NIHs long-standing expectations to preserve scientific integrity throughout all NIH activities, establishes key roles and responsibilities for those who will lead the agencys scientific integrity program, and, as appropriate, establishes relevant reporting and evaluation mechanisms.
Scientific integrity aims to make sure that science is conducted, managed, communicated, and used in ways that preserve its accuracy and objectivity and protect it from suppression, manipulation, and inappropriate influence. In support of our mission, NIH has always sought to incorporate robust scientific integrity principles and practices throughout every level of its scientific enterprise. 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 and implementation of policies and programs is transparent, accountable, and evidence-based. NIH has numerous policies and procedures to ensure the Nations investment in biomedical research is scientifically robust and rigorous and that our workforce maintains the highest standards of integrity. In supporting the NIH mission, all NIH researchers and staff are expected to:
In 2012, NIH summarized its continuing efforts to foster scientific integrity in its NIH Policies and Procedures for Promoting Scientific Integrity Report. In this report, NIH outlines the various roles it plays in fostering scientific integrity as a funder of research, a research institution, and a policy development agency. In 2021, the White House released its Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking. The Memorandum tasks NIH and other agencies to update their scientific integrity policies as appropriate to ensure agency alignment with the principles set forth therein and in Protecting the Integrity of Government Science, a report of the Scientific Integrity Fast-Track Action Committee of the National Science and Technology Council (NSTC), and A Framework for Federal Scientific Integrity Policy and Practice, a guidance document released by the Scientific Integrity Framework Interagency Working Group of the NSTC. In response to the Memorandum, and in accordance with its continued commitment to promoting scientific integrity, NIH has developed the Final NIH Scientific Integrity Policy, which is in alignment with the guidance set forth in the Presidential Memorandum and the Final Scientific Integrity Policy of the U.S. Department of Health and Human Services. The Final NIH Scientific Integrity Policy articulates the procedures and processes in place at NIH that help maintain rigorous scientific integrity practices and outlines several new functions to further enhance scientific integrity at NIH and throughout the NIH biomedical research enterprise.
NIH accomplishes its mission by funding extramural researchers throughout the country, conducting research within its intramural research program, and developing policies and programs to responsibly advance biomedical research. In 2022, NIH updated its NIH Policies and Procedures for Promoting Scientific Integrity (2022) report, which describes the robust processes in place to support scientific integrity for NIH-supported extramural research, intramural research, and policies and programs. Building upon this existing infrastructure for scientific integrity, the Final NIH Scientific Integrity Policy outlines several new functions to further enhance existing practices and processes. For example, the Final NIH Scientific Integrity Policy includes a Federal definition of scientific integrity that is shared across the U.S. Government as outlined in the White House Framework. This alignment across the U.S. Government will help ensure consistency in guidance and language, lending clarity and uniformity to interagency efforts concerning scientific integrity. The Final NIH Scientific Integrity Policy also establishes the appointments of, and roles and responsibilities for, the positions of the NIH Chief Scientist (CS) and the NIH Scientific Integrity Official (SIO). The CS and SIO will have prominent and critical responsibilities in steering the NIH scientific integrity efforts, advising NIH leadership on scientific issues, and playing key roles in NIH adjudication efforts related to scientific integrity. The Final NIH Scientific Integrity Policy also includes NIH practices that will address important emerging topics in biomedical research, such as protecting against political interference.
Overview of Public Comments
NIH released its Request for Information on the Draft NIH Scientific Integrity Policy on September 25, 2023 (88 FR 65696, comment period closed on November 9, 2023). In response to the Draft Policy, NIH received 26 responses from interested parties, and the comments are publicly available. The largest group of respondents reported no affiliation, followed by affiliation with professional societies, with a small percentage of respondents indicating affiliation with research institutions, industry, and advocacy coalitions. Respondents typically identified themselves as members of the public, while another sizeable section self-identified as scientific researchers. Remaining respondents identified as institutional officials, and smaller percentages self-identified as medical providers, government officials, and scholarly publishers. NIH considered all feedback in the development of the Final NIH Scientific Integrity Policy, and a discussion of the public comments on specific topics follows below.
Discussion of Public Comments on the Draft NIH Scientific Integrity Policy
Policy Scope
Draft Policy: The Draft NIH Scientific Integrity Policy explicitly outlined the categories of NIH employees and staff with defined roles and responsibilities when in the course of their official duties they propose, conduct, review, or communicate about science and scientific activities on behalf of NIH. It also stated that NIH has implemented separate policies for contractors, collaborators, awardees, and volunteers to uphold the principles of scientific integrity.
Public Comments: While commenters were generally supportive of the overall scope of the Draft NIH Scientific Integrity Policy, a few suggested clarifying how it might impact the extramural community, applicability to HHS officials and political appointees, and NIH employees engaging in program administrative roles.
Final Policy: The Final NIH Scientific Integrity Policy clarifies that the Policy applies to all NIH employees; Public Health Service Commissioned Corps officers assigned to NIH; NIH political appointees; NIH intramural clinical, research, and postdoctoral fellows; NIH intramural doctoral trainees; advisory committee members in their capacity as special Government employees; and all levels of employees managing scientific activities, engaging in program administrative roles, and using scientific information in decision making when in the course of their official duty activities they propose, conduct, review, or communicate about science and scientific activities on behalf of NIH. Extramural investigators are not encompassed under this Policy unless they otherwise meet the qualifications of a covered individual (e.g., membership on a Federal Advisory Committee in their capacity as a special Government employee); nevertheless, many individuals across the entire scientific enterprise have a role in supporting scientific integrity more broadly.
Roles and Responsibilities of the Chief Scientist and the Scientific Integrity Official
Draft Policy: The Draft NIH Scientific Integrity Policy proposed the appointments as well as roles and responsibilities for the positions of NIH Chief Scientist (CS) and NIH Scientific Integrity Official (SIO). It indicated that the CS and SIO will have prominent and critical responsibilities in steering NIH scientific integrity efforts, advising NIH leadership on scientific issues, and playing key roles in agency adjudication efforts related to scientific integrity.
Public Comments: While commenters were generally supportive of the establishment and proposed roles and responsibilities of the CS and SIO, a few suggested clarifying both roles and adding additional roles and responsibilities for other NIH leadership. Suggestions also included clearly defining the adjudication processes for losses of scientific integrity and ensuring adequate resources are allotted to the SIO and staff to implement the Policy and proactively seek out potential allegations of losses of scientific integrity.
Final Policy: The Final NIH Scientific Integrity Policy affirms the roles and responsibilities of the CS and SIO required by the 2021 Presidential Memorandum and includes some additional roles and responsibilities suggested by public comments. Detailed processes for adjudicating findings of loss of scientific integrity will be outlined in a NIH Manual Chapter and/or additional guidance. Additionally, NIH will ensure the SIO and other relevant agency offices and staff receive adequate support and resources to fulfill the functions outlined in the Policy.
Roles and Responsibilities of the Scientific Integrity Council
Draft Policy: The Draft NIH Scientific Integrity Policy proposed the establishment of a NIH Scientific Integrity Council comprising career employees from across NIH to be led by the NIH SIO. It indicated that the Council would assist the SIO in iterative review, policy development, and priority setting to ensure that the existing policies and procedures are responsive to issues that arise in the scientific integrity space.
Public Comments: Commenters were generally supportive of the establishment and proposed roles and responsibilities of the Council and suggested ensuring that it include a well-informed and a high-level group of experts on scientific integrity. Among the comments were suggestions for including desired areas of expertise for Council members, articulating a more explicit role of the Council in the adjudication process, and requiring the group to work with offices such as the NIH Tribal Health Research Office to consider any potential cultural implications. Additionally, a few commenters suggested that the NIH Scientific Integrity Council, the CS, and the SIO should consult with and/or include external experts to avoid potential conflicts of interest.
Final Policy: The Final NIH Scientific Integrity Policy describes desired expertise areas for Council members and affirms the roles and responsibilities of the Council. Processes for the role the Council will play in adjudicating findings of loss of scientific integrity will be outlined in additional implementation guidance. The Council will work with all pertinent NIH offices and seek public input when needed to ensure appropriate expertise on pertinent topics. All members of the Council, the CS, and the SIO will be expected to comply with existing conflict of interest policies and procedures.
Promoting a Culture of Scientific Integrity
Draft Policy: The Draft NIH Scientific Integrity Policy stated that diversity, equity, inclusion, and accessibility (DEIA) are integral components of the entire scientific process, and that attention to DEIA can improve the success of the scientific workforce, foster innovation in the conduct and use of science, and provide for more equitable participation in science by diverse communities. The Draft Policy additionally noted that all NIH employees will receive scientific integrity information or training as new employees, and NIH, in concert with HHS, will make available training for covered individuals and others, as applicable.
Public Comments: Several commenters expressed support for the inclusion of DEIA within scientific integrity principles. Several commenters noted the importance of mandatory training for all NIH employees, not just the sharing of information on scientific integrity.
Final Policy: The Final NIH Scientific Integrity Policy affirms the NIH stance that a strong culture of scientific integrity begins with ensuring a professional environment that is safe, equitable, fair, just, impartial, honest, and inclusive; DEIA are integral components of the entire scientific process. The Policy also states that scientific integrity training will be made available to all covered individuals, and some covered individuals may be required to complete role-specific training or refresher training as appropriate.
Ensuring Free Flow of Scientific Information
Draft Policy: The Draft NIH Scientific Integrity Policy affirmed NIHs commitment to the broad and equitable dissemination and promotion of rigorous and objective scientific information. It highlighted the role of the NIH Office of Communications and Public Liaison in disseminating objective and evidence-based research findings to the public and responding to public inquiries. It also reiterated that NIH scientists may communicate their scientific activities objectively without political interference or other inappropriate influence.
Public Comments: While commenters were generally supportive of the Draft NIH Scientific Integrity Policy provisions on ensuring the free flow of scientific information, a few noted that further delineation of scientists ability to communicate with the media and public freely about their areas of expertise was needed and indicated that protection from potential bad faith attacks should be provided. Some commenters also suggested clarifying the differences between and processes for scientific technical review and media review.
Final Policy: The Final NIH Scientific Integrity Policy provides additional guidance on how NIH scientists may communicate scientific information while performing official duty activities and defines and protects against retaliation. The Final Policy reaffirms that NIH scientists and other covered individuals can communicate their personal or individual views to the media or the public in their personal capacities, including on social media, subject to the limitations of government ethics rules, HHS supplemental ethics regulations, social media regulations, and obligation to protect nonpublic information. The Final Policy also clarifies the requirements and protections for scientific technical review processes.
Protections
Draft Policy: The Draft NIH Scientific Integrity Policy described NIHs commitment to prioritizing safe and respectful work environments as well as existing protections for employees to disclose information that the individual reasonably believes is evidence of a violation of law, rule, or regulation; gross mismanagement; gross waste of funds; and abuse of authority; or a substantial and specific danger to public health or safety. The Draft Policy also affirmed NIHs commitment to hiring and retaining candidates for NIH scientific and technical positions based on the candidates scientific and technical knowledge, credentials, experience, and integrity.
Public Comments: Some commenters expressed the need for further protections for individuals who report allegations of loss of scientific integrity. Several commenters affirmed the importance of promoting DEIA with regard to the NIH workforce, grantmaking apparatus, and other activities and recommended further elaboration of specific groups who should be included and considered in efforts to promote diversity.
Final Policy: The Final NIH Scientific Integrity Policy describes protections from reprisal for individuals who report allegations of loss of scientific integrity, including whistleblower protections. The Final Policy also affirms NIHs commitment to promoting equity in the scientific workforce and includes a robust description of the types of demographic groups that will be considered regarding efforts to promote equity.
Policy Implementation
Draft Policy: The Draft NIH Scientific Integrity Policy proposed a delay between a final policy release and its effective date in order to communicate policy expectations to covered individuals and develop specific implementation details and plans. Expected implementation activities would include the establishment of an evaluation plan to regularly measure, monitor, and evaluate ongoing scientific integrity activities and outcomes. As part of the monitoring and evaluation plan, an annual report on the number and outcomes of investigations involving allegations of loss of scientific integrity would be published.
Public Comments: Several commenters requested that additional implementation details be added to the Policy, including information on the allegations reporting and appeals processes, applicable consequences, an evaluation plan, publication best practices, and plans for public input, including meaningful engagements to build trust with marginalized communities. Specifically, a comment noted that the annual report should include specific details regarding the allegation, the inquiry process, and the outcome of the investigation.
Final Policy: Consistent with other NIH policy development activities, additional implementation details will continue to be developed and publicly released. Given the bulk of implementation activities fall on NIH directly and not on our grantee institutions or contractors, NIH has chosen to enact a three-month implementation period. All implementation plans will comply with existing policies and regulations regarding conflicts of interest, whistleblower protections, etc. The Final NIH Scientific Integrity Policy notes that, for investigations that have been resolved, the annual report will include the types of corrective actions recommended by the investigation panel to restore scientific integrity, and the types of actions ultimately taken. Additionally, NIH will continue to seek input from the public, and the scientific integrity reporting process will also allow opportunities for public transparency. NIH is committed to promoting equity across the biomedical research enterprise and will consider additional methods to engage with communities historically underrepresented in biomedical research, including through existing robust outreach programs and initiatives.
Additional Changes to Final Policy
Some additional changes were made to the Final NIH Scientific Integrity Policy in response to public comments, for clarity, or to maintain consistency with the Final HHS Scientific Integrity Policy. Some of these additional changes include slight revisions to the definition of political interference, a new definition of retaliation, clarification of training requirements, and under Protecting Scientific Processes, a statement noting that early termination of extramural awards is prohibited except under certain specific circumstances.
Concluding Points
The Final NIH Scientific Integrity Policy builds upon and consolidates NIHs longstanding efforts to foster an organizational culture of scientific integrity, protect the integrity of the research process, communicate science with integrity, and safeguard scientific integrity. This Final NIH Scientific Integrity Policy is another step in ensuring that NIHs work as an institution maintains the highest standards of integrity and represents the best of the Nations investment in biomedical research.
NIH looks forward to continuing to work across the U.S. Government to support our shared commitment to responsible stewardship of the Nation's investment in biomedical research by maintaining and bolstering rigorous scientific integrity practices in taxpayer-funded biomedical research.
The Final NIH Scientific Integrity Policy is set forth below.
Scientific Integrity Policy of the National Institutes of Health
Purpose
The purpose of this policy is to promote a continuing culture of scientific integrity at the National Institutes of Health (NIH). This policy aims to ensure the integrity of all aspects of NIH scientific activities, including proposing, conducting, reviewing, managing, and communicating about science and scientific activities, and using the results of science to inform policy and program decision making.
Scientific Integrity at NIH
In support of our mission, NIH funds extramural researchers throughout the country, conducts research within its intramural research program, and develops policies and programs to responsibly advance biomedical research. Embedding principles of scientific integrity throughout the NIH enterprise relies on two key elements. The first element is an all-hands-on-deck approach in which scientific rigor and research quality are prioritized. The second element is having inclusive, robust processes that safeguard scientific integrity.
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 and implementation of policies and programs is transparent, accountable, and evidence-based. NIH has numerous policies and procedures to ensure the Nations investment in biomedical research is scientifically robust and rigorous and that our workforce maintains the highest standards of integrity.
Public input and accountability are woven throughout NIH processes to assure the public of the credibility of our science and our scientific findings. These activities range from presenting potential scientific solicitations at public meetings (e.g., concept clearance) to soliciting community feedback during decision making activities. In supporting the NIH mission, all NIH researchers and staff are expected to:
NIHs long-standing commitment to fostering scientific integrity was summarized in its 2012 report, NIH Policies and Procedures for Promoting Scientific Integrity. NIH released a 2022 Update on its NIH Policies and Procedures for Promoting Scientific Integrity, partly in response to the 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking to reflect more than a decade of updates to agency policies and procedures that support scientific integrity. The NIH Scientific Integrity Policy articulates expectations to preserve scientific integrity throughout all NIH activities, establishes key roles and responsibilities for those who will lead the agencys scientific integrity program, and, as appropriate, establishes relevant reporting and evaluation mechanisms with a goal of ensuring scientific integrity is foundational to all NIH activities. The NIH Scientific Integrity Policy is consistent with the U.S. Department of Health and Human Services (HHS) Scientific Integrity Policy. The majority of procedures regarding scientific integrity described herein are longstanding and foundational to NIH-supported research. The NIH Scientific Integrity Policy integrates existing and new practices under a single harmonized framework.
Effective Date and Policy Amendments
This policy goes into effect on December 30, 2024. This policy will be evaluated by NIH one year after its effective date and every two years thereafter. Proposals to amend this policy will be overseen by the NIH Scientific Integrity Official (SIO), in collaboration with the NIH Scientific Integrity Council (Council) described below, and any such amendments will be communicated to HHS and the Director of the White House Office of Science and Technology Policy (OSTP) no later than 30 days after adoption.
Applicability & Scope
All NIH employees; Public Health Service Commissioned Corps officers assigned to NIH; NIH political appointees; NIH intramural clinical, research, and postdoctoral fellows; NIH intramural doctoral trainees; advisory committee members in their capacity as special Government employees; and all levels of employees managing scientific activities, engaging in program administrative roles, and using scientific information in decision making, are expected to adhere to this policy when in the course of their official duties they propose, conduct, review, or communicate about science and scientific activities on behalf of NIH. When relevant, NIH has also implemented separate policies for entities who are not covered individuals, such as contractors, collaborators, extramural awardees, peer reviewers and volunteers, to uphold the principles of scientific integrity established by this policy while carrying out activities on behalf of NIH or within the scope of NIH support or engagement. The primary focus of this policy is on covered individuals performance of official duty activities on behalf of NIH. Federal employees must adhere to the Standards of Ethical Conduct for Employees of the Executive Branch [i] which delineates requirements (and certain restrictions) for Federal employees when acting on behalf of the Federal government.
Exceptions
This policy will be implemented consistent with applicable Federal law and Executive Orders.
Definitions
For the purposes of this policy, NIH adopts the following definitions:
Allegation refers to a disclosure of a suspected loss of scientific integrity.
Chief Scientist (CS) provides oversight of all NIH scientific integrity policies and procedures. NIH recognizes organizational culture starts with leadership at the highest levels. It has designated the NIH Principal Deputy Director as the NIH CS.
Corrective scientific action refers to actions taken to restore the accuracy of the scientific record after a loss of scientific integrity has been determined, consistent with this policy, such as correction or retraction of published materials.
Covered individuals include all NIH employees; Public Health Service Commissioned Corps officers assigned to NIH; NIH political appointees; NIH intramural clinical, research, and postdoctoral fellows; NIH intramural doctoral trainees; advisory committee members in their capacity as special Government employees; and all levels of employees who manage scientific activities, engage in program administrative roles, and use scientific information in decision making when in the course of their official duty activities they propose, conduct, review, or communicate about science and scientific activities on behalf of NIH. NIH contractors, partners, permittees, lessees, grantees, extramural trainees and fellows (i.e., those supported by NIH grants to non-NIH organizations), and volunteers who engage or assist in NIH scientific activities are not considered covered individuals but are strongly encouraged to uphold the principles of scientific integrity described in this policy while carrying out activities on behalf of NIH or within the scope of NIH support or engagement, particularly those described in the Protecting Scientific Processes, Ensuring the Free Flow of Scientific Information, Protections, and Professional Development sections of this policy; additionally, specific requirements may be incorporated into the terms of their engagement with NIH.
Decision making refers to (1) development of policies or making determinations about policy or management; (2) making determinations about expenditures of Federal agency funds; (3) implementing or managing activities that involve, or rely on, scientific activities.
Ethical behavior refers to activities that reflect norms for conduct that distinguish between acceptable and unacceptable behavior, such as honesty, lawfulness, equity, and professionalism, and adherence to statutes, regulations, policies, and guidelines governing employee conduct.
Federal agency refers to an Executive department, a U.S. Government corporation, or an independent establishment.
Inclusivity refers to the practice of providing equal access to opportunities for full participation of all people and all groups, including marginalized, underserved, and underrepresented contributors, without bias or prejudice. Full participation is enabled through implementation of strategies that promote equitable access and fair treatment in the organization.
Inappropriate influence refers to the attempt to shape or interfere in scientific activities or the communication about or use of scientific activities, against well-accepted scientific methods and theories and without scientific, legal, programmatic management, or security justification [ii][iii].
Interference refers to inappropriate, scientifically unjustified intervention in the conduct, management, communication, or use of science. It includes censorship, suppression, or distortion of scientific or technological findings, data, information, or conclusions; inhibiting scientific independence during clearance and review; scientifically unjustified intervention in research and data collection; and inappropriate engagement or participation in peer review processes or on Federal advisory committees (FACs).
Loss of scientific integrity refers to the failure to comply with this Scientific Integrity Policy or to adhere to objectivity, transparency, and ethical behavior when conducting, managing, using the results of, and communicating about science and scientific activities. This loss may include research misconduct or inappropriate influence in the conduct, communication, management, and use of science.
Official duty activity refers to activities performed by an employee as part of, or an extension of, regular official responsibilities [iv].
Policy refers to laws, regulations, procedures, administrative requirements or actions, incentives, or voluntary practices of Governments and other institutions.
Political interference is inappropriately shaping or interfering in the conduct, management, communication, or use of science for inappropriate partisan advantage such that it undermines impartiality, objectivity, nonpartisanship, or professional judgment.
Research integrity refers to the use of honest and verifiable methods in proposing, performing, and evaluating research; reporting research results with particular attention to adherence to rules, regulations, and guidelines; and following commonly accepted professional codes or norms.
Research misconduct refers to fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion [v].
Research security refers to safeguarding the research enterprise against the misappropriation of research and development to the detriment of national or economic security, related violations of research integrity, and foreign Government interference.
Retaliation refers to, per 5 USC 2302(b)(8), taking or failing to take or threatening to take or fail to take a personnel action with respect to any employee or applicant for employment because of any disclosure of information that the employee or applicant reasonably believes evidences any violation of any law, rule, or regulation or gross mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety if such disclosure is not specifically prohibited by law and if such information is not specifically required by Executive Order to be kept secret in the interest of national defense or the conduct of foreign affairs. An employee or applicant is protected from retaliation for the disclosure of information the employee or applicant reasonably believes is evidence of censorship related to research, analysis, or technical information [vi] [vii].
Science refers to the full spectrum of scientific endeavors, including basic science, applied science, evaluation, engineering, technology, economics, social sciences, and statistics, as well as the scientific and technical information derived from these endeavors and including multiple forms of evidence (e.g., Indigenous Knowledge).
Scientific activities refer to activities that involve the application of well-accepted scientific methods and theories in a systematic manner, and includes, but is not limited to, data collection, inventorying, monitoring, evaluation, statistical analysis, surveying, observations, experimentation, study, research, integration, economic analysis, forecasting, predictive analytics, modeling, technology development, and scientific assessment, as well as any findings derived from these activities.
Scientific data refers to recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data does not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens [viii].
Scientific integrity is the adherence to professional practices, ethical behavior, and the principles of honesty and objectivity when conducting, managing, using the results of, and communicating about science and scientific activities. Inclusivity, transparency, and protection from inappropriate influence are hallmarks of scientific integrity. (Note: this is the Official Federal Definition of Scientific Integrity, consistent with OSTP and HHS definitions [ix].
Scientific Integrity Council will assist the NIH SIO in iterative review, policy development, and priority setting to ensure that the existing policies and procedures are responsive to issues that arise in the scientific integrity space.
Scientific Integrity Official (SIO) is the primary official for responsibilities over scientific integrity matters and reports to the NIH CS. This policy empowers the NIH SIO with the independence necessary to gather and protect information to support the review and assessment of scientific integrity concerns. The NIH SIO will also advocate for appropriate engagement of scientific leadership in decision making. NIH recognizes organizational culture starts with leadership at the highest levels. NIH has designated the Associate Director of Science Policy as the NIH SIO.
Scientific record refers to published information resulting from scientific activities. NIH is responsible for ensuring the accuracy of elements of the scientific record that are published by NIH.
Scientist refers to an individual whose responsibilities include collection, generation, use, or evaluation of scientific and technical data, analyses, or products. NIH scientists are NIH employees and other covered individuals who conduct these activities. It does not refer to individuals with scientific and technical training whose primary job functions are in non-scientific roles (e.g., policymakers, communicators).
Roles and Responsibilities
Chief Scientist and Scientific Integrity Official
The Chief Scientist (CS) will:
The Scientific Integrity Official (SIO) will:
NIH Scientific Integrity Council
The NIH SIO will establish and convene an NIH Council comprising career employees with expertise in ethics, research integrity, research misconduct, communications, whistle blower protections, and other relevant administrative areas from across NIH and from relevant NIH offices. This committee will assist the SIO in iterative review, policy development, and priority setting to ensure that the existing policies and procedures are responsive to issues that arise in the scientific integrity space.
The primary responsibilities of the Council are to:
Background on NIH Functions
Intramural Research
The Intramural Research Program (IRP) is the internal research program of NIH, known for its synergistic approach to biomedical science. The IRP is the largest biomedical research program on earth, and its unique environment means the IRP can facilitate opportunities to conduct both long-term and high-impact science that would otherwise be difficult to undertake. The NIH IRP conducts research and training within its laboratories and clinics, and when appropriate, collaborates with the private sector to develop technologies of importance to public health. To help ensure the high quality and integrity of its intramural programs, NIH has developed and implemented NIH-wide policies and review standards for research, training, and technology transfer. The NIH Policy Manual is an official mechanism of issuing NIH-wide policy and all Manual Chapter issuances. More information about the NIH IRP can be found on the NIH OIR website.
Extramural Research
Approximately 80 percent of NIHs investment in biomedical and behavioral research supports extramural researchers at institutions in every state in the country. Given the size and breadth of this investment, NIH has a robust infrastructure to ensure scientific integrity is embedded throughout the extramural research continuum and its workforce. While the covered individuals for this policy consist primarily of NIH employees, the principles of scientific integrity are foundational to NIHs role in funding extramural biomedical research, and the importance of scientific integrity is integrated throughout all NIH does as a funder of biomedical research. As such, existing policies to maintain scientific integrity of extramural research will continue. More information about the NIH extramural research program can be found on the NIH OER website.
NIH as a Policy Development Agency
NIH promotes progress in the biomedical research enterprise through the development of sound and comprehensive policies. To achieve this, NIH engages partners within and outside of NIH to develop policies on a wide range of issues including biosafety, biosecurity, genetic testing, genomic data sharing, public access to the results of NIH-funded research, human subjects and research animal protections, the organization and management of NIH, and the outputs and value of NIH-funded research. This is accomplished through a wide range of analyses and reports, commentary on emerging policy proposals, and the development of policy proposals for consideration by NIH, the Federal Government, and the public. More information about NIH policy development can be found on the NIH Office of Science Policy (OSP) website.
Policy Requirements
Promoting a Culture of Scientific Integrity
NIH leadership at all levels recognizes, supports, and promotes this policy and its underlying principles, and models behavior consistent with a strong culture of scientific integrity. NIH works to promote a culture of scientific integrity by creating an empowering environment for innovation and protecting scientists and the process of science from inappropriate interference. Scientific findings and products must not be suppressed, delayed, or altered for political purposes and must not be subjected to political interference or inappropriate influence.
A strong culture of scientific integrity begins with ensuring a professional environment that is safe, equitable, fair, just, impartial, honest, and inclusive. Diversity, equity, inclusion, and accessibility (DEIA) are integral components of the entire scientific process. Attention to DEIA can improve the success of the scientific workforce, foster innovation in the conduct and use of science, and provide for more equitable participation in science by diverse communities. The responsible and ethical conduct of research and other scientific activities requires an environment that is equitable, inclusive, safe, and free from harassment and discrimination.
NIH also works to apply scientific integrity practices in ways that are inclusive of non-traditional modes of science, such as citizen science, community-engaged research, participatory science, and crowdsourcing. This may include expanded scientific integrity practices and expectations, such as seeking greater input from communities and participants into the research questions and design, recognition of data and knowledge sovereignty, and inclusion of multiple forms of evidence, such as Indigenous Knowledge.
NIH will prominently post and maintain the NIH Scientific Integrity Policy on its website and will ensure education is available for all covered individuals, as well as contractors who perform scientific activities for the agency, on their rights and responsibilities related to scientific integrity. Scientific integrity training will be made available to all covered individuals, and some covered individuals may be required to complete role-specific training or refresher training as appropriate.
To promote a culture of scientific integrity at NIH, this policy outlines seven specific areas:
I. Protecting Scientific Processes
NIH has implemented a suite of complementary efforts to protect the integrity of research processes from bias and interference, which is essential to upholding public trust and confidence. These efforts rely on transparent processes, diverse community engagement, management of real or apparent conflicts of interest, and robust and open dialogue. NIH utilizes a variety of mechanisms to achieve these aims, such as holding policy discussions in open settings, soliciting public input on future research directions, and the use of Federal advisory committees (FACs) to advise the agency. In addition, for covered individuals, NIH explicitly prohibits political interference or inappropriately shaping or interfering in the conduct, management, communication, or use of science for inappropriate partisan advantage such that it undermines impartiality, objectivity, nonpartisanship, or professional judgment. Further processes will be developed and documented to support this policy in an NIH Manual Chapter and/or additional guidance.
It is the policy of NIH to:
II. Ensuring the Free Flow of Scientific Information
NIH is committed to the broad and equitable dissemination and promotion of rigorous and objective scientific information. The NIH Office of Communications and Public Liaison (OCPL) and communication offices within the NIH Institutes, Centers, and Offices (NIH ICOs) disseminate objective and evidence-based research findings to the public through websites, listservs, brochures, videos, social media, and other modes of communication as appropriate. NIH OCPL and the ICO communication offices also respond to public inquiries and engage with technical and non-technical audiences through media and online forums to ensure responsible communication regarding the research it funds.
At the foundation of the NIH mission is the generation of reliable and rigorous research results, and their publication in reputable, peer-reviewed scientific journals. NIHs IRP researchers adhere to the Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR Part 2635) [xx] and the NIH-wide Policy for Manuscript and Abstract Clearance Procedures, and follow established guidance to ensure transparency in research findings through Processes for Authorship Dispute Resolution if the situation arises.
It is the policy of NIH to:
III. Supporting Decision Making Processes
NIH utilizes multiple mechanisms for ensuring transparency and accountability in developing policy and informing decision making. The development of science policy at NIH generally follows procedures set forth under the Administrative Procedure Act (5 USC Subchapter II), where applicable, and draft policy proposals are routinely issued through the NIH Guide and the Federal Register, as appropriate, to obtain early feedback into policy proposals. Once a proposal has been issued for public comment, it is often supplemented with informational webinars, interactive discussion sessions, and a robust public engagement plan to promote broad dissemination and engagement in the policymaking process. NIH considers all comments submitted on draft polices and policy proposals to ensure final policy proposals are informed by the community and capable of responding to emerging opportunities and challenges. Final policies are also issued through the NIH Guide and the Federal Register, as appropriate, and incorporated into the NIH Grants Policy Statement and NIH Policy Manual, as appropriate. Policies are also posted to NIH websites with additional resources such as Frequently Asked Questions and other supplemental resources as needed.
It is the policy of NIH to:
2. Where legally permissible and appropriate, directly consult with scientists whose work is being used in policy and management decisions to ensure that the science is accurately represented and interpreted.
3. Ensure, to the extent possible, the accuracy of NIH communication of the science upon which a policy decision is based.
4. Ensure that covered individuals are free to express differing scientific opinions free from political interference or inappropriate influence.
IV. Ensuring Accountability
NIH is firmly committed to establishing and formalizing procedures to identify and adjudicate allegations regarding compromised scientific processes or technological information. NIH has established several adjudication processes within distinct offices (i.e., OER, OIR, and OMA), to address different ways in which scientific integrity may be violated. Each office handles allegations pertaining to its respective jurisdiction, but individuals may submit an oral or written allegation via email or hotline. When an allegation or complaint is received, the appropriate office determines if it is specific, credible, and meets the definition of research misconduct or an integrity violation. The procedures each office takes for investigating allegations or complaints, adjudication, and appeals are further detailed in the 2022 Update to the NIH Policies and Procedures for Promoting Scientific Integrity. The designation of an NIH SIO will allow for more centralized interagency communication and coordination concerning allegations to help ensure effective oversight and promote scientific integrity within the Federal Government. Additionally, the NIH SIO will provide review and adjudication of allegations (particularly related to political interference) that do not fall under the purview of these existing offices.
It is the policy of NIH to:
V. Protections
NIH prioritizes safe and respectful work environments that are free from harassment, including sexual harassment, discrimination, or other forms of inappropriate conduct that can result in a hostile work environment. Additionally, it is unlawful for NIH to take or threaten to take a personnel action against an employee because they made a protected disclosure of wrongdoing. A protected disclosure is defined as a disclosure of information that the individual reasonably believes is evidence of a violation of law, rule, or regulation; gross mismanagement; gross waste of funds; and abuse of authority; or a substantial and specific danger to public health or safety. Personnel actions that are covered by this can include poor performance review, demotion, suspension, termination, or revocation or downgrade of a security clearance. If staff members believe that whistleblower retaliation has occurred, they may get more information from the HHS OIG.
It is the policy of NIH to:
a. The requirements of the Whistleblower Protection Act of 1989, and its expanded protections enacted by Pub. L. 103-424 and the Whistleblower Protection Enhancement Act of 2012, 5 USC Part 2302(b)(8)-(9).
b.The National Defense Authorization Acts expansion of certain whistleblower protections to employees of Federal Government contractors, subcontractors, and grant recipients in 41 USC Part 4712.
c. Presidential Policy Directive 19, which prohibits supervisors from taking, failing to take, or threatening to take or fail to take any action affecting an employees eligibility for access to classified information in retaliation for making a protected disclosure.
d. The Military Whistleblower Protection Act (codified at 10 USC 1034), which is made applicable to the Public Health Service Commissioned Corps officers through 42 USC 213a(a)(18) and implemented by Commissioned Corps Directive 121.06.
6. Ensure scientific integrity staff at NIH are protected by all applicable employee rights as required by law. An SIO or other scientific integrity staff may only be terminated or reassigned for reasons consistent with applicable law.
VI. Professional Development for Government Scientists
A key aspect of the NIH effort to advance scientific integrity is encouraging NIH scientists and covered individuals to engage with the broader research community in maintaining the highest ethical standards and scientific norms, while adhering to the Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR Part 2635) [xxxiii]. Creating an inclusive environment for scientists from all backgrounds, including those from traditionally underrepresented groups, is essential to supporting scientific integrity. The IRP promotes professional development of all researchers from trainees at every level, to tenure-track and tenured investigators, and all other research staff. 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 researchers to share information about their official and professional activities, NIH seeks to advance scientific knowledge and contribute to its employees professional education.
It is the policy of NIH to:
VII. Federal Advisory Committees
FACs, as defined by the Federal Advisory Committee Act (FACA), are an important tool within NIH for ensuring the credibility, quality, and transparency of NIH science. NIH will adhere to FACA and develop policies in coordination with the General Services Administration and consistent with the guidance on lobbyists serving on FACs when convening FACs tasked with giving scientific advice.
Consistent with all applicable laws and guidance regarding FACs, it is the policy of NIH to:
Addressing Scientific Integrity Concerns
The NIH SIO has primary responsibility for assessing scientific integrity concerns and will develop procedures for addressing allegations of loss of scientific integrity and concerns that span or fall outside existing NIH adjudication mechanisms under the purview of OER, OIR, OMA, or OIG (e.g., as related to waste, fraud, abuse, and illegal activities) [xlv]. In particular, the NIH SIO will manage scientific integrity concerns related to political interference, if they do not fall within existing processes. Procedures for handling scientific integrity concerns will be made available on the NIH website. For information about rights and remedies against retaliation, employees may contact the HHS OIG Whistleblower Protection Coordinator [xlvi]. As noted above, existing procedures under the purview of OER, OIR, OMA, and OIG (e.g., as related to waste, fraud, abuse, and illegal activities) should continue to be followed. When those existing mechanisms do not cover a scientific integrity concern:
Handling Differing Scientific Opinions
Science and decisions based on science are strengthened by vigorous discussion and debate and by considering all available evidence. The process of challenging and improving ideas helps to guard against inadequate science and flawed analysis. Scientists can hold differing opinions without violating scientific integrity, and NIH encourages its scientists to respectfully express and engage with differing views as an integral part of the scientific process [xlvii]. Differing scientific opinions are diverging views held by researchers who are substantively engaged in the science subject area. In some cases, such as when a scientific dispute has a significant impact on public health or policy, a formal scientific dispute resolution process may be necessary. The goal of scientific dispute resolution should be to ensure that all perspectives are heard and documented in an unbiased way. A satisfactory resolution may involve adopting one opinion over another, deciding to conduct additional studies, formulating an alternate theory reconciling the differing opinions, or documenting the disagreement for the benefit of policymakers and fellow scientists. These steps may be completed in any order and are not necessarily an exhaustive list of dispute resolution measures. In general:
Monitoring, Evaluating, and Reporting Scientific Integrity Activities and Outcomes
NIH, working through HHS, will develop and implement an evaluation plan to regularly measure, monitor, and evaluate ongoing scientific integrity activities and outcomes. The plan will include a roadmap of activities, evaluation metrics, and methods of measurement for the purpose of ongoing improvement of scientific integrity processes, procedures, and policies. As part of the monitoring and evaluation plan, an annual report on the number and outcomes of investigations involving allegations of loss of scientific integrity will be published. For investigations that have been resolved, the report will include an aggregate summary of the types of corrective actions recommended by the investigation panel to restore scientific integrity, and a summary of the types of actions ultimately taken. To the extent possible, all descriptions of investigations will be anonymized.
Related Policies and Statutes
Violations of related and supporting policies may result in a loss of scientific integrity and it is appropriate for the SIO to coordinate across the agency in these matters, as appropriate. The following policies and programs intersect with the development of the culture of scientific integrity within the agency.
Research Misconduct
Diversity, Equity, Inclusion, and Accessibility in Addressing and Strengthening Scientific Integrity and the Disproportional Impact of Scientific Integrity Policy Violations on Underrepresented Groups
Public Access
Human and Animal Subject Protections
Research Security
Whistleblower Protections
Other Related Policies
Authorities
Pursuant to the 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking, and consistent with the 2009 Presidential Memorandum on Scientific Integrity and the 2010 Memorandum from the White House Office of Science and Technology Policy on Scientific Integrity, all Federal agencies must establish a scientific integrity policy. The requirements of this policy are derived from the 2022 National Science and Technology Council (NSTC) Report of the Scientific Integrity Fast Track Action Committee, Protecting the Integrity of Government Science, and align with the principles set forth in the NSTC guidance document, A Framework for Federal Scientific Integrity Policy and Practice.
This policy is established in accordance with:
REFERENCES
[i] Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR Part 2635) provide the basic guidelines for official duty activities, and NIH sets the policy for implementing the guidelines at the agency.
[ii] Examples may include 1) suppressing a decisionmakers ability to offer the best judgment based on scientific information; 2) suppressing, altering or delaying the release of a scientific product for any reason other than technical merit, security or legal review, review for compliance with existing policies, or providing advance notification; 3) removing or reassigning scientific personnel for any reason other than performance, conduct, or budgetary constraints; 4) using scientific products that are not representative of the current state of scientific knowledge and research (e.g., because of a lack of appropriate peer review, poor methodology, or flawed analyses) to inform decision making and policy formulation; or 5) misrepresenting the underlying assumptions, uncertainties, or probabilities of scientific products. This is not intended to be an exhaustive list.
[iii] Differences of scientific opinion are not necessarily inappropriate influence. Additionally, NIH officials are regularly expected to provide agency perspectives when acting in their official capacity.
[iv] The Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR Part 2635) provide the basic guidelines for official duty activities, and NIH sets the policy for implementing the guidelines at the agency.
[v] Federal Research Misconduct Policy, 65 FR 76260, 76262 (Dec. 6, 2000) and 42 CFR 93.103.
[vi] Protection of Certain Disclosures of Information by Federal Employees.
[vii] Prohibited personnel practices.
[viii] NIH Data Management and Sharing Policy.
[ix] A Framework for Federal Scientific Integrity Policy and Practice.
[x] This provision is further outlined in the NIH Policy Manual Chapter 3005 on Review and Evaluation of Intramural Programs.
[xi] This provision is further outlined in the 2023 8th Edition of Guidelines and Policies for the Conduct of Research in the Intramural Research Program at NIH.
[xii] This provision is further outlined in the NIH Policy Manual Chapter 3005 on Review and Evaluation of Intramural Programs.
[xiii] This provision is further outlined in the NIH Policy Manual Chapter 3006 on NIH Intramural Research Program (IRP) Research Misconduct Proceedings.
[xiv] This provision is further outlined in the NIH Conflict of Interest and Confidentiality Certification for Individuals Evaluating all NIH Intramural Programs.
[xv] This provision is further outlined in the NIH Policy Manual Chapter 3014 on NIH Intramural Human Research Protection Program and the NIH Policy Manual Chapter 3040-2 on Animal Care and Use in the Intramural Research Program.
[xvi] This provision is further outlined in Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022, Pub. L. 117-328, Division FF, Title II, Section 2321; Chips and Science Act, Pub. L. 117-167, Title VI, Subtitle D, Section 10631 (Aug 9, 2022); OSTP Guidelines for Federal Research Agencies Regarding Foreign Talent Recruitment Programs; and NIH Guide for NIH Intramural Principal Investigators to Navigate International Interactions and Avoid Inappropriate Foreign Interference with Their Research.
[xvii] This provision is further outlined in Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022, Pub. L. 117-328, Division FF, Title II, Section 2321 (Jan 3, 2023); Chips and Science Act, Pub. L. 117-167, Title VI, Subtitle D, Section 10631 (Aug 9, 2022); OSTP Guidelines for Federal Research Agencies Regarding Foreign Talent Recruitment Programs; and NIH Requirements for Disclosure of Other Support, Foreign Components and Conflicts of Interest.
[xviii] NIH Grants Policy Statement
[xix] 45 CFR 75.372
[xx] Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR Part 2635) provide the basic guidelines for official duty activities, and NIH sets the policy for implementing the guidelines at the agency.
[xxi] Per the Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR Part 2635), Employees shall not knowingly make unauthorized commitments or promises of any kind purporting to bind the Government.
[xxii] White House Office of Science and Technology Policy Memorandum for the Heads of Executive Departments and Agencies on Increasing Access to the Results of Federally Funded Scientific Research. February 22, 2013.
[xxiii] White House Office of Science and Technology Policy Memorandum for the Heads of Executive Departments and Agencies on Ensuring Free, Immediate, and Equitable Access to Federally Funded Research. August 25, 2022.
[xxiv] This provision is further outlined in the NIH Policy Manual Chapter 1184 on Preparation and Clearance of Scientific, Technical, and Public Information Presented by NIH Employees or Produced for Distribution by NIH.
[xxv]This provision is further outlined in the NIH Data Management and Sharing Policy.
[xxvi] Per the Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR Part 2635), Employees shall not knowingly make unauthorized commitments or promises of any kind purporting to bind the Government.
[xxvii] These provisions are consistent with and do not supersede, conflict with, or otherwise alter the employee obligations, rights, or liabilities created by existing statute or Executive order relating to (1) classified information, (2) communications to Congress, (3) the reporting to an Inspector General of a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety, or (4) any other whistleblower protection.
[xxviii] This provision is further outlined in the HHS Guidelines on the Provision of Information to the News Media.
[xxix] This provision is further outlined in the NIH Policy Manual Chapter 1184 on Preparation and Clearance of Scientific, Technical, and Public Information Presented by NIH Employees or Produced for Distribution by NIH.
[xxx] Office of Management and Budget. Final Information Quality Bulletin for Peer Review. Federal Register. Doc. 05-769.
[xxxi] This provision is further outlined in the NIH Sourcebook on Personnel
[xxxii] This provision is further outlined in the NIH Policy Manual Chapter 1311 on Preventing and Addressing Harassment and Inappropriate Conduct and the NIH Sourcebook Addendum to BSC Policies and Procedures.
[xxxiii] Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR Part 2635) provide the basic guidelines for official duty activities, and NIH sets the policy for implementing the guidelines at the agency.
[xxxiv] This provision is further outlined in the NIH Public Access Policy.
[xxxv] This provision is further outlined in the NIH Data Management and Sharing Policy.
[xxxvi] This provision is further outlined in the NIH Sourcebook on Tenure in the NIH Intramural Research Program.
[xxxvii] This provision is further outlined in the NIH Sourcebook on Activities with Outside Organizations and the NIH Official Duty Activities Chart.
[xxxviii]This provision is further outlined in How Scientists Are Selected to Be Members of a Chartered Review Group.
[xxxix] This provision refers to not only FACA Councils that have SGE members but also peer review FACA committees that have NIH peer review consultants as members.
[xl] This provision is further outlined in the NIH Selection Criteria for NIH Advisory Committees.
[xli] 2010 Memorandum from the White House Office of Science and Technology Policy on Scientific Integrity.
[xliii] This provision is further outlined in the NIH Policy Manual Chapter 1810 on Procedures for Avoiding Conflict of Interest for Special and other Federal Employees Serving as Advisory Committee Members.
[xliv] The NIH Office of Federal Advisory Committee Policy maintains the Special Government Employee (SGE) Portal for those interested in serving on an NIH Federal advisory committee as an SGE. The Portal contains all the requirements expected of advisory committee members who serve on advisory committees as SGEs, including ethics training, Foreign Activities and Lobbyist Certification, and the Confidential Financial Disclosure Report (OGE 450).
[xlv] OER reviews and refers allegations of research misconduct involving extramural researchers and peer review of grant applications to the HHS Office of Research Integrity (ORI) and may take corrective action against a grantee or peer reviewer based on the conduct identified in ORI findings. OIR reviews allegations related to research integrity involving NIH IRP researchers. The NIH Division of Program Integrity within OMA manages the review of allegations involving misuse of NIH grant or contractor funds, grantee or contractor conflicts of interest, and other misconduct or misuses of NIH resources by NIH employees or others doing business with NIH. The HHS OIG investigates allegations of criminal fraud, waste, and abuse.
[xlvi] As appropriate, employees can also contact the NIH Office of Equity, Diversity, and Inclusion for information regarding retaliation based on protected equal employment opportunity or the HHS Office of Special Counsel for information regarding retaliation based on whistleblowing. Additionally, although encouraged to use the process detailed herein, employees may also disclose wrongdoing to their supervisor or another individual higher up in management, the HHS OIG, the Office of Special Counsel, or to Congress.
[xlvii] Further information on the NIH IRP Authorship Conflict Resolution Process can be found in the NIH Sourcebook.
Please direct all inquiries to:
NIH Office of Science Policy
[email protected]