Final Scientific Integrity Policy

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>42 CFR Part 93</CFR> <CFR>45 CFR Parts 46 and 73</CFR> <SUBJECT>Final Scientific Integrity Policy</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Office of the Assistant Secretary for Planning and Evaluation, Office of the Secretary, HHS. <HD SOURCE="HED">ACTION:</HD> Policy statement. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Department of Health and Human Services (HHS) is publishing its Scientific Integrity Policy to increase access to and raise awareness of the Policy. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> The effective date of the Policy is October 16, 2024. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Karen Wehner, Ph.D., Scientific Integrity Officer, Office of Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation, Office of the Secretary, HHS at 240-453-8435 or <E T="03">scientificintegrity@hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION: </HD> Scientific integrity plays a vital role in the mission of HHS. Ensuring integrity in science throughout the Department allows HHS to foster and produce high-quality science, communicate effectively with the public, and base critical policy decisions on trustworthy and rigorous scientific findings. HHS has adopted a Department-wide scientific integrity policy to further strengthen scientific integrity and evidence-based policymaking throughout the Department. The Scientific Integrity Policy of the U.S. Department of Health and Human Services (Policy) was approved on September 16, 2024. The finalized Policy was announced to the HHS community and posted on the HHS scientific integrity website, at <E T="03">https://www.hhs.gov/programs/research/scientificintegrity/index.html,</E> on September 30, 2024. The effective date of the Policy is October 16, 2024. The content of the finalized Policy, reformatted to conform to the requirements of the <E T="04">Federal Register</E> , is provided below. This content is also available in its original format on the HHS website, at <E T="03">https://www.hhs.gov/sites/default/files/hhs-scientific-integrity-policy.pdf.</E> <HD SOURCE="HD1">The Scientific Integrity Policy of the U.S. Department of Health and Human Services</HD> <HD SOURCE="HD1">Purpose</HD> The purpose of this policy is to promote a continuing culture of scientific integrity at the U.S. Department of Health and Human Services (HHS). This policy aims to ensure the integrity of all aspects of HHS 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. <HD SOURCE="HD1">Core Values That Support Scientific Integrity at HHS</HD> The success of HHS's mission to enhance the health and well-being of all Americans depends on the development and use of accurate, complete, and timely scientific and technical information. Scientific integrity requires that such information be developed under and subjected to well-established scientific processes, free from inappropriate interference that undermines impartiality, nonpartisanship, or professional judgment. HHS agencies work to maximize the quality, accuracy, objectivity, utility, and timeliness of the scientific and technological information they produce, use, and disseminate. In turn, this information enables HHS to employ innovative approaches to effectively address the many public health and human services challenges that our work targets. These efforts allow accurate, complete, and timely scientific and technical information to improve the design, delivery, and impact of HHS policies and programs, and support equity, justice, and trust. Responsibility for upholding scientific integrity lies with the entire scientific ecosystem, including all HHS employees, its contractors and grantees, and those engaged in science and scientific activities outside HHS. <HD SOURCE="HD1">Definition of Scientific Integrity and Scientific Integrity Official</HD> HHS adopts the following Official Federal Definition of Scientific Integrity: <EXTRACT> 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. <SU>1</SU> </EXTRACT> HHS designates a senior career employee as the HHS Scientific Integrity Official (HHS SIO)  <SU>2</SU> to oversee implementation and iterative improvement of the HHS Scientific Integrity Policy and related processes. The roles and responsibilities of the HHS SIO are described in more detail on pages 17-18. This policy empowers the HHS SIO with the independence necessary to gather and protect information to support the review and assessment of scientific integrity concerns and ensure implementation of corrective scientific actions such as policy changes or correction or retraction of published materials. The HHS SIO also advocates for appropriate engagement of scientific leadership in decision making. <HD SOURCE="HD1">Effective Date and Policy Amendments</HD> This policy is effective 30 days after the date of finalization. This policy will be reviewed by HHS one year after its effective date and every two years thereafter. Proposals to amend this policy will be overseen by the HHS SIO, in collaboration with the HHS Scientific Integrity Council described below and communicated to the Director of the White House Office of Science and Technology Policy (OSTP) no later than 30 days after adoption. <HD SOURCE="HD1">Applicability & Scope</HD> Scientific integrity is the responsibility of the entire HHS workforce. Covered individuals who are required to adhere to this policy include all HHS employees, including all Operating and Staff Division (OpDiv/StaffDiv) employees; Public Health Service Commissioned Corps officers; political appointees; HHS fellows, trainees, and interns; and advisory committee members in their capacity as special government employees, when in the course of their official duties they propose, conduct, review, or communicate about science and scientific activities, and all levels of employees who manage or supervise scientific activities and use scientific information in decision making. HHS is composed of OpDivs/StaffDivs (hereinafter “Division”), some of which have division-specific scientific integrity policies and procedures. The HHS Scientific Integrity Policy applies to all covered individuals, as listed above; Division-specific Scientific Integrity policies apply to covered individuals within that division. Division-specific policies align with and support the HHS-wide policy at a minimum but may institute additional requirements and responsibilities as appropriate for the mission of the division. In addition to Division-specific policies, Divisions may develop their own scientific integrity procedures ( <E T="03">e.g.,</E> procedures for resolving differences of scientific opinion) at their discretion. HHS contractors; partners; permittees; lessees; grantees; extramural trainees and fellows ( <E T="03">i.e.,</E> those supported by HHS grants to non-HHS organizations); and volunteers who engage or assist in HHS scientific activities are not considered covered individuals but are strongly encouraged to uphold the principles of scientific integrity described in this policy, particularly those described in the Protecting Scientific Processes, Ensuring the Free Flow of Scientific Information, Protections, and Professional Development sections. Specific requirements may be incorporated into the terms of their engagement with HHS. In addition, each institution that applies for or receives Public Health Service (PHS) support for biomedical or behavioral research, research training, or activities related to that research or research training must comply with 42 CFR part 93, PHS Policies on Research Misconduct, overseen by the HHS Office of Research Integrity (ORI), and may need to comply with other applicable laws, regulations, and policies. Research misconduct, which includes fabrication, falsification, and plagiarism, is one way in which scientific integrity can be compromised. <HD SOURCE="HD1">Authorities</HD> Pursuant to the 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking, <SU>3</SU> and consistent with the 2009 Presidential Memorandum on Scientific Integrity  <SU>4</SU> and the 2010 Memorandum from the White House Office of Science and Technology Policy on Scientific Integrity, <SU>5</SU> 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 (SI-FTAC), Protecting the Integrity of Government Science  <SU>6</SU> (SI-FTAC Report), and align with the 2021 NSTC Framework for Federal Scientific Integrity Policy and Practice. <SU>7</SU> This policy is established in accordance with: <FP SOURCE="FP-2">1. Public Law 111-358—The America COMPETES Reauthorization Act of 2010, Section 103, as amended</FP> <FP SOURCE="FP-2">2. Public Law 115-435—The Foundations for Evidence-based Policymaking Act of 2018</FP> <FP SOURCE="FP-2">3. Public Law 106-554—The Information Quality Act of 2000</FP> <FP SOURCE="FP-2">4. 67 FR 8451—OMB Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies</FP> <FP SOURCE="FP-2">5. 70 FR 2664—OMB Final Information Quality Bulletin for Peer Review</FP> ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 77k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━