Policies, Laws, Regulations

Statutes, and the implementing regulations published by the Office of Government Ethics (OGE), detail the Standards of Ethical Conduct and other requirements for Federal Government employees. In addition, HHS has regulations and policies, and NIH has additional policies and guidance documents. The documents are listed below, organized by the entity which produces the document, i.e., NIH, HHS, Government-wide.NIH DocumentsNIH Manual Chapters web site (NIH/OMA web site)NIH Policies and Procedures for Ensuring Scientific Integrity: Information regarding the policies that the NIH follows to ensure the highest degree of scientific integrity in the research we conduct and fund, including avoiding conflicts of interest for NIH scientists. (Document located on theNIH Research and Training page under Safety, Regulation & Guidance). The NIH Ethics Manual is comprised of numerous chapters in the NIH Manual Chapter 2400 series. Additional chapters may be added as needed. The chapter links go to the NIH Manual Chapter web site maintained by the NIH Office of Management Assessment (OMA). See theforms page for links to the forms, and theprocedures page for links to the detailed processing procedures. 2400-01Introduction to Government Ethics at the NIH (6/18/08) 2400-02 Public Financial Disclosure Reporting System (OGE-278) (pending) 2400-03Executive Branch Confidential Financial Disclosure Reporting System, OGE Form 450) (6/2/09) 2400-04Managing Conflicts of Interests and the Introduction of Bias (6/18/08) 2400-05Ethics Training (4/22/09) 2400-06NIH Ethics Advisory Committee (NEAC) (1/8/10) 2400-07 Outside Activities (Outside Work) (pending) 2400-08Managing Employee Non-Compliance with Government Ethics Requirements(8/15/08) 2400-09 Supplemental Financial Disclosure Reporting System (HHS 717-1) (pending) 2400-10Gifts to Individual Employees From Outside Sources (6/18/08)NIH Official Duty Activity Policy (1/23/08) includes link to theNIH Official Duty Activity Summary Table*NEW* NIH Ethics Policy:Official Participation in a Leadership Position of a 501(c) Nonprofit Professional Organization (includes links to the Employee Guidance Notice andSide-by-Side comparison documents (10/14)Protocol Review Guide (COI Guide)Senior Status at the NIH Information for Supervisors on the National Institutes of Health Ethics Program (2/2020)Supervisory Review of Outside Activity Requests (2/16/04)NIH/FAES Memorandum of Understanding Regarding Interactions (2/28/10)The MOU describes the relationship between NIH and the Foundation for Advanced Education in the Sciences (FAES) for official interactions. It identifies the NIH DDIR as the non-voting NIH Liaison to the FAES Board of Directors and describes the appropriate procedure for initiating joint activities between NIH and FAES.NIH Conflict of Interest Web PageDepartment of Health and Human Services (HHS) DocumentsDelegation of Authority to the NIH Deputy Ethics Counselor from the HHS Designated Agency Ethics Official(10/2/2020)Delegation of Authority to the NIH Associate Deputy Ethics Counselor from the HHS Designated Agency Ethics Official(10/2/2020) The delegation memos above include references to the following guidance documents:Deputy Ethics Counselor HHS Ethics Program Statement of Functions, Responsibilities, and Authority (Revised 09/13/22) OGE DAEOgram DO-03-011 (June 30, 2003) entitled "Inherently Governmental and Commercial Ethics Official Activities." Available from the OGE web site inweb html format andPDF.HHS Designated Agency Ethics Official (DAEO) Supplemental Instructions (HHS Intranet) HHS Supplemental Standards On February 3, 2005, HHS published revised Supplemental Standards of Ethical Conduct (5 CFR 5501) and a new Supplemental Financial Disclosure Requirements section (5 CFR 5502), both effective on that date. On August 31, 2005, HHS published the Final Rule for both sections.5 CFR 5501 -- Official Published format (links to table of contents on GPO website)5 CFR 5502 -- Official Published format (links to table of contents on GPO website)5 CFR 5501 -- "Unofficial Compilation" (full text, incorporating the changes) (8/31/05)5 CFR 5502 -- "Unofficial Compilation" (full text, includes revision of 10/26/05) (10/26/05)5 CFR 5501-5502 -- "Unofficial Compilation" of both parts in one document (full text, includes revision of 10/26/05)Federal Register Notice (August 31, 2005, Volume 70, No. 168, pages 51559-51574). Includes the preamble (description and rationale for the changes) and text of the changed sections.Federal Register Notice of Corrections (October 26, 2005, Volume 70, No. 206, page 61713. Corrects wording in 5502 sections 106 and 107.HHS Residual Standards of Conduct (45 CFR § 73) (HHS intranet, HHS access only) The HHS Standards of Conduct were published in a booked entitled "Standards of Conduct" on March 30, 1989 (45 CFR Part 73). Subsequently, HHS published the Supplemental Standards of Ethical Conduct (5 CFR 5501, see above links), superceding much of the original HHS standards of conduct. The remaining sections are the "Residual Standards," applicable to activities not covered by ethics regulations.HHS Travel Manual (HHS web site)Government-wide DocumentsUnited States ConstitutionSee especially Article I, Section 9, Clause 8 regarding the "Emoluments Clause."Conflict of Interest Statutes: Summary for Executive Branch Employees. The links below will provide direct access to the full text on the GPO website.18 USC § 201, Bribery of public officials and witnesses18 USC § 202, Definitions18 USC § 203, Compensation in matters affecting the Government (representation issues)18 USC § 204, Practice in US Claims Course or US Court of Appeals by Members of Congress18 USC § 205, Activities in claims against and other matters affecting the Government (representation issues)18 USC § 206, Exemption for retired officers of the uniformed services18 USC § 207, Post-employment18 USC § 208, Acts affecting personal financial interests (Conflicts of Interest)18 USC § 209, Salary payable only by the United States (supplementation of Federal salary)18 USC § 216, Penalties for violating the above statutes Regulations promulgated by the Office of Government Ethics (Government-wide) These regulations implement the laws pertaining to ethics.Standards of Ethical Conduct for Employees of the Executive Branch (07/2011) (5 CFR Part 2635) Published by OGE.The following links go to the GPO web site, to the table of contents and full text of each regulation:5 CFR § 2634, Financial Disclosure guidance (public, confidential, certificates of divestiture)5 CFR § 2635, Standards of Ethical Conduct for Employees of the Executive Branch 5 CFR § 2636, Outside Employment Limitations 5 CFR § 2638, Ethics Responsibilities, especially for ethics staff5 CFR § 2640, Guidance for 18 USC § 208, Exemptions to conflicts (e.g.,de minimis)5 CFR § 2641, Post-Employment Conflict of Interest (agency designations, exemptions)DO-08-020: OGE issues the final post-government employment rule, to be codified in 5 C.F.R. part 2641.Executive Order 12674 (4/12/89) as modified by Executive Order 12731 (10/17/90)The original Executive Order outlining the Principles of Ethical Conduct for Federal Employees. The modifications of the 1990 amendment are included in this document. For additional information, contact your IC'sDeputy Ethics Counselor orEthics Coordinator

Policies, Laws, Regulations | NIH Ethics Program

Policies, Laws, Regulations