National Institutes of Health

National Institutes of Health Ethics Program

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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 Documents

NIH 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. (NIH web site)

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 the forms page for links to the forms, and the procedures page for links to the detailed processing procedures.

2400-01 Introduction to Government Ethics at the NIH (6/18/08)
2400-02 Public Financial Disclosure Reporting System (OGE-278) (pending)
2400-03 Executive Branch Confidential Financial Disclosure Reporting System, OGE Form 450) (6/2/09)
2400-04 Managing Conflicts of Interests and the Introduction of Bias (6/18/08)
2400-05 Ethics Training (4/22/09)
2400-06 NIH Ethics Advisory Committee (NEAC) (1/8/10)
2400-07 Outside Activities (Outside Work) (pending)
2400-08 Managing Employee Non-Compliance with Government Ethics Requirements (8/15/08)
2400-09 Supplemental Financial Disclosure Reporting System (HHS 717-1) (pending)
2400-10 Gifts to Individual Employees From Outside Sources (6/18/08)

NIH Official Duty Activity Policy (1/23/08) includes link to the NIH Official Duty Activity Summary Table

Protocol Review Guide (COI Guide)

Senior Status at the NIH

Supervisor Responsibilities (2/16/04, pdf)

NIH/FAES Memorandum of Understanding Regarding Interactions (2/28/10, pdf, 6 pages)
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 Page

Department of Health and Human Services (HHS) Documents

Delegation of Authority to the NIH Deputy Ethics Counselor from the HHS Designated Agency Ethics Official (8/26/10, pdf, 4 pages, scanned and not compliant). The delegation memo referenced or attached the following guidance documents:

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.
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, pdf format, 318 pages)

Government-wide Documents

United States Constitution
See especially Article I, Section 9, Clause 8 regarding the "Emoluments Clause."
Conflict of Interest Statutes (United States Code) (Note:  § means Section)
The above link leads to the OGE website. The OGE page contains a short description for each statute plus links to an expanded description and full text on the GPO website. The links below will provide direct access to the full text on the GPO website.
Regulations promulgated by the Office of Government Ethics (Government-wide) 
These regulations implement the laws pertaining to ethics.

The following links go to the GPO web site, to the table of contents and full text of each regulation:

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's Deputy Ethics Counselor or Ethics Coordinator.

Updated: 1/30/13