NIH Ethics Program

Overview

The mission of the NIH Ethics Program is to support the NIH mission of better health for the public. To achieve that, ethics staff assist NIH staff to meet the requirements of the statutes and regulations governing behavior of employees of the Federal Government. The Program consists of a central NIH Ethics Office located organizationally within the NIH Office of the Director (OD/NEO) and an ethics office in each IC, managed by a Deputy Ethics Counselor and staffed with one or several Ethics Coordinators/Specialists (view Ethics Contacts). 

Oversight of the NIH Ethics Program is the responsibility of the Director of the NIH Ethics Office in consultation with the NIH Deputy Ethics Counselor. In addition, ethics attorneys from the Department of Health and Human Services (DHHS) Office of the General Counsel, Ethics Division (OGC/ED) maintain an office at the NIH to provide legal advice and assist IC Deputy Ethics Counselors (DEC), and Ethics Coordinators as needed.   Staff in the central NIH Ethics Office are charged with providing leadership, guidance and advice to the NIH community, especially to the ethics staff in the ICs.  In addition, the NIH Ethics Office also serves as the servicing ethics office for the Office of the Director employees and the NIH Senior employees (per the definition of senior in the HHS regulation at 5 CFR 5501).

The IC Deputy Ethics Counselors (DECs) are responsible for oversight of their IC's ethics program. Specifically, they carry out the duties outlined by the Office of Government Ethics in their memorandum regarding responsibilities in an ethics office (DAEOgram DO-03-011pdf-icon.jpg) and the authority delegated to the NIH Deputy Ethics Counselor pdf-icon.jpg, which is redelegated to a DEC for each IC. The IC ethics staff are charged with specific responsibilities in support of the program, such as reviewing forms, assisting staff with procedures and questions, and submitting appropriate reports on ethics activities.

Employees have a responsibility to learn the how the statutes and regulations are implemented at the NIH.  For questions, employees will initially contact their IC's DEC or Ethics Coordinator with their questions, who will contact staff in the NIH Ethics Office or ethics counsel as needed.

Areas of Interest

Financial Disclosure

Information on financial disclosure reporting, report types, and filing deadlines. Read more

Official Duty Activities

Information and NIH policy to identify types of activities conducted as part of your official duty, and level of approval needed. Read more

Outside Activities

Information on personal activities with outside organizations, including criteria for approval, prohibitions, forms, detailed instructions for submission, and review. Read more

 

Principles of Ethical Conduct for Government Officers and Employees

The following Principles of Ethical Conduct are an excerpt from Executive Order 12674 of April 12, 1989, as modified by Executive Order 12731. These Principles apply to all employees of the Federal Government.

Part I-Principles of Ethical Conduct

Section 101. Principles of Ethical Conduct. To ensure that every citizen can have complete confidence in the integrity of the Federal Government, each Federal employee shall respect and adhere to the fundamental principles of ethical service as implemented in regulations promulgated under sections 201 and 301 of this order:

  1. Public service is a public trust, requiring employees to place loyalty to the Constitution, the laws, and ethical principles above private gain.
  2. Employees shall not hold financial interests that conflict with the conscientious performance of duty.
  3. Employees shall not engage in financial transactions using nonpublic Government information or allow the improper use of such information to further any private interest.
  4. An employee shall not, except pursuant to such reasonable exceptions as are provided by regulation, solicit or accept any gift or other item of monetary value from any person or entity seeking official action from, doing business with, or conducting activities regulated by the employee's agency, or whose interests may be substantially affected by the performance or nonperformance of the employee's duties.
  5. Employees shall put forth honest effort in the performance of their duties.
  6. Employees shall make no unauthorized commitments or promises of any kind purporting to bind the Government.
  7. Employees shall not use public office for private gain.
  8. Employees shall act impartially and not give preferential treatment to any private organization or individual.
  9. Employees shall protect and conserve Federal property and shall not use it for other than authorized activities.
  10. Employees shall not engage in outside employment or activities, including seeking or negotiating for employment, that conflict with official Government duties and responsibilities.
  11. Employees shall disclose waste, fraud, abuse, and corruption to appropriate authorities.
  12. Employees shall satisfy in good faith their obligations as citizens, including all just financial obligations, especially those such as Federal, State, or local taxes that are imposed by law.
  13. Employees shall adhere to all laws and regulations that provide equal opportunity for all Americans regardless of race, color, religion, sex, national origin, age, or handicap.
  14. Employees shall endeavor to avoid any actions creating the appearance that they are violating the law or the ethical standards promulgated pursuant to this order.

The Standards of Ethical Conduct for Employees of the Executive Branch pdf-icon.jpg are available on the Office of Government Ethics (OGE) web site.

Contacts for Ethics Assistance

ICO Deputy Ethics Counselors (DEC) 

The Deputy Ethics Counselor (DEC) is responsible for the ethics program within his/her jurisdiction, e.g., an Institute or Center (IC) DEC has jurisdiction over activities for employees within his or her IC.  DECs are also responsible for ensuring employee compliance with ethics rules, regulations, and policies by working with employees and supervisors. DECs may also provide in-person training on various ethics issues. 


ICO Ethics Officials (DECs, Coordinators, Specialists, and Other Staff) 

This list contains names and contact information for ethics officials in the NIH Ethics Office (NEO) and within the Institute and Center (IC) Ethics Offices. The list includes names and contact information for the DECs, the Ethics Coordinators and Specialists, and in some cases, the assistants. The Ethics Coordinators and Specialists are responsible for being the first line of contact for employees.  They handle the day-to-day functioning of the IC's Ethics Office, assist employees, review forms, distribute information, and follow up with employees when additional information is needed. Coordinators and Specialists may also provide in-person training on various ethics issues.  This list also includes the names and contact information for the NIH Ethics Counsels in the HHS Office of the General Counsel Ethics Division.


HHS Office of the General Counsel Ethics Division (OGC/ED) (HHS access only)

This list is staff from OGC Ethics Division only. Their client is the NIH, therefore the attorneys are available to provide legal advice to the NIH on ethics matters. However, they also work with IC DECs and Ethics Coordinators and Specialists to resolve issues relevant to a particular employee. Names and contact information for the NIH Ethics Counsels are included on both lists above.

Ethics Topics

Ethics Forms and Deadlines

The following ethics forms are provided to assist employees to obtain advance approval where required, and manage real and apparent conflicts of interest. Descriptions are provided to help identify when to use each form. For questions regarding the forms or when they are required, contact your IC's ethics official. 

Outside Activities
1.

The following forms are used as indicated to request approval to engage in an outside activity (personal, outside work).

The HHS-520 form, Request for Approval of Outside Activity, is used within the Department of Health and Human Services (DHHS) to request approval of proposed Outside Activities (activities which are totally outside regular official duties, and with outside organizations). Required for all Outside Activities. NIH policy requires electronic submission of the HHS-520 using the NIH Enterprise Ethics System (NEES) at https://nees.nih.gov/.

HHS-520 (1/06), Request for Approval of Outside Activity: The following link to the Acrobat* version of the form is provided only to permit viewing the form to see its arrangement and text while using NEES to submit a request. Detailed instructions documents below are helpful for employees and reviewers to determine appropriate responses to the questions. Form HHS-520 Outside Activity pdf-icon.jpg

Instructions for Submitting an HHS-520 pdf-icon.jpg 

Instructions for Reviewing an HHS-520 pdf-icon.jpg

2.NIH-2657 (5/14), Supplemental Information to the HHS-520  pdf-icon.jpg This NIH form is used to provide additional information for certain Outside Activities.  Required for consulting for industry (complete Part B), legal consulting/testimony (complete Part C), and Professional Practice for physicians, nurses, and allied health care professionals (Complete Part D).
3.NIH Policy Regarding Supervisory Review of Outside Activities:pdf-icon.jpg   
This memorandum, dated February 16, 2004, from the NIH Deputy Director/NIH Deputy Ethics Counselor to all supervisors details supervisory and management responsibilities for reviewing the HHS-520 Request for Approval of Outside Activity.
4.

Form HHS-521 (1/06), Annual Report of Outside Activities, is used to submit a report of all Outside Activities in which you engaged during the previous calendar year, including activities for which you should have obtained advance approval but did not do so. The report is due on February 28th each year. NIH policy requires electronic submission of the form HHS-521 using the NIH Enterprise Ethics System (NEES) at https://nees.nih.gov/. You will be notified when it is time to submit the Annual Report.

Form HHS-521 (1/06), Annual Report of Outside Activities: The following link is provided only to permit viewing the form to see its arrangement and text while using NEES to submit a report. Instructions below provide assistance in providing appropriate responses to the questions on the form. Form HHS-521 Annual Report of 520s pdf-icon.jpg   
Detailed Instructions for Completing and Reviewing the HHS-521 pdf-icon.jpg

5.Detailed Instructions for Completing and Reviewing the HHS-521 pdf-icon.jpg Clinical Fellows: HHS-520 Request for Approval of Outside Activity: For use ONLY for Outside Professional Practice for Clinical Fellows.

 

Activities Involving Foreign Entities
HHS-697, Foreign Activities Questionnaire (8/24)  pdf-icon.jpg   
Use this form for activities involving a foreign entity or organization. Also for use by SGEs (special Government employees).

 

Official Duty Activities
 Memo to Request Approval of Official Duty Activity   
An official duty memo is used to request approval of certain activities involving outside organizations which are outside your regular official duties but will be performed as part of your official duties. Four samples are provided, as described below.
1.Requests from employees to their IC Deputy Ethics Counselor or Supervisor (Rev 9/07).
2.Requests from NIH Senior Employees (Top 5), and DECs, to the NIH DEC (Rev 1/11).
3.Blanket Official Duty Activity Guidance with REVISED Blanket ODA Request Memo [Template] (7/15). 
4.Request for Approval of Participation in a Leadership Position of a 501(c) Nonprofit Professional Organization (4/19).
Publication Copyright and Public Access Issues: An employee working in an official capacity is working on behalf of the NIH, not in a personal capacity. Without appropriate authority, employees may not sign legal documents which bind the NIH. Employees may NOT sign any forms from publishers or other outside entities, but must use the approved NIH forms and follow the NIH Procedure for Complying with the NIH Public Access Policy. The procedure and public access policy documents are maintained on the NIH Office of Intramural Research Source Book web site. Use the above link for access to the various documents.
Presentation Disclosure Form: Some organizations require speakers to sign a form for the organization to confirm the speaker has permission to use copyrighted material in the presentation, or for the speaker to declare financial interests, if any, in a commercial organization with an interest in the topic of the presentation. When giving an official speech, employees must use the NIH Presentation Disclosure Formpdf-icon.jpg unless the organization requires the employee to use their own form. In that case, the organization's form must be reviewed by the appropriate official in each IC, often in the Technology Transfer Office, before the employee signs and returns it to the organization.

 

Gift Exceptions (Permission to Accept Certain Gifts)
1.

NIH-2854 Request for Approval to Accept Gifts Associated with an Award from an Outside Organization (08/09): This form is used to request permission to accept gifts associated with an award from an outside entity, such as a professional association. NIH policy requires electronic submission of the form NIH-2854 using the NIH Enterprise Ethics System (NEES) at https://nees.nih.gov/.   
The following link to the Acrobat* version of the form is provided only to permit viewing the form to see its arrangement and text to assist with submission of your request while using NEES to submit a request. Form NIH-2854 Award pdf-icon.jpg   
Awards with cash (or equivalent) gifts require prior review and confirmation that the award meets the regulatory criteria before NIH employees may accept a cash prize. See information on the Awards topic page. Ethics officials will follow the detailed procedure for submission of the review request package, including use of the current summary review form pdf-icon.jpg

2.NIH-2855 Request for Approval of An Honorary Degree pdf-icon.jpg(08/09): Use this form to obtain advance approval to accept an honorary degree. Your Deputy Ethics Counselor will determine the permissibility of an honorary degree.
3.

NIH-2803 Request to Accept Free Attendance Under the Widely Attended Gathering (WAG) Exception (12/11): This form is used to request permission to accept free attendance at a Widely Attended Gathering, e.g., receptions or dinners, where you are not presenting or otherwise participating, other than as an attendee. NIH policy requires electronic submission of the individual form NIH-2803 using the NIH Enterprise Ethics System (NEES) at https://nees.nih.gov/. Blanket WAG requests will use the paper form (see link below).

The following link to the Acrobat* version of the form is provided for use with Blanket WAG requests. For blanket WAGs, provide names, titles, or group identification for all who will be covered by the blanket request. Individuals may use this link to view the form to assist with electronic submission of individual requests using NEES. Form NIH-2803 WAG  pdf-icon.jpg

 

Conflicts of Interest
 

Conflict of Interest (COI) Certification: The protocol Conflict of Interest (COI) statement is used to request conflict of interest clearance of a protocol by the IC Deputy Ethics Counselor (DEC) for all investigators.

For additional information on protocol review view the procedures page.

 

Managing Real and Apparent Conflicts of Interests
1.Ethics Agreement: An ethics agreement is typed on plain paper. Insert the employee's name, title, IC and date. Add the facts which cause a real or apparent conflict and explain how the conflict will be managed. For example, an employee new to NIH may have to agree to resign from certain activities. Provide details and the final date of recusal, or authorize employee continue as fits the situation. Sample ethics agreements are available from the NIH Ethics Office.
2.Waiver of Actual Conflict of Interest [18 USC Section 208(b)(1)] (Word format): This is the standard waiver format used to manage an actual (real) conflict of interest under 18 USC 208(b)(1), the governing statute. A waiver permits the employee to participate in certain official matters involving outside entities even though the employee has a conflict of interest as defined in 208(b)(1). For additional information, see the HHS Policy (1/09) (HHS Access) regarding granting waivers.
3.Waiver of Actual Conflict for Officers or Directors [18 USC Section 208(b)(1)] (Word format): This is the waiver format used to manage conflict of interest issues for employees serving as an officer of director of an outside organization when such service is done as part of their official duties. The waiver permits the employee to serve in an official capacity despite the real conflict of interest. For additional information, see the HHS Policy (1/09) (HHS Access) regarding granting waivers.
4.Authorization to Participate [5 CFR 2635 Section 502] (Revised 3/06) (Word format):  This is the standard authorization format used to manage appearances of conflicts of interest (vs. real conflicts which use a waiver, above). The authorization permits the employee to participate in official matters involving certain outside entities despite the appearance of a conflict of interest as defined in 5 CFR 2635.502.
5.

Recusal/Disqualification:  This is the standard format used to identify and obtain approval to be disqualified from certain official duties with outside organizations with which you have another ongoing personal relationship, such as an outside activity entity or company in which you have a financial interest (i.e., stock), or with which you may be seeking employment.

Employees other than IC Directors (Word format)IC Directors (Word format)
6.STOCK Act Job Negotiation and Recusal Form:The STOCK Act requires public filers (employees required to file the OGE-278e Public Financial Disclosure Report), to file a statement notifying their agency ethics official of any negotiation for or agreement of future employment or compensation with a non-federal entity within three business days after commencement of the negotiation or agreement (does not apply to outside activities). Use the Notification of Future Employment Discussions or Agreement and Recusal Statementpdf-icon.jpg form.

 

Financial Disclosure
1.Public Financial Disclosure Report (OGE Form 278e) (12/2011) for senior level (SES, ST, SL, O-7 and above, and others in identified positions). NIH policy is to submit the OGE Form 278e electronically using the NIH Enterprise Ethics System (NEES) at https://nees.nih.gov/. Information is available on the Public Financial Disclosure Report information page.
2. Public Financial Disclosure Periodic Transaction Report (OGE Form 278-T) (01/2019) for public filers to report their reportable transactions, e.g., stock purchase, sale, or exchange. NIH policy is to submit the OGE 278T electronically using the NIH Enterprise Ethics System (NEES) at https://nees.nih.gov/.  Information is available on the Public Financial Disclosure Report information page.
3.Confidential Financial Disclosure Reports (OGE Form 450) (01/2019) for employees in designated positions with relevant responsibilities. NIH policy is to submit the OGE Form 450 electronically using the NIH Enterprise Ethics System (NEES) at https://nees.nih.gov/. Information is available on the Confidential Financial Disclosure Reports information page.
4.Confidential Report of  Financial Interests in Substantially Affected Organizations for Employees of the NIH (HHS-717-1) (8/11) pdf-icon.jpg Required of all public and confidential filers, and all clinical investigators. Use this form to submit the report of your financial interests in SAOs, i.e., when you become a filer or clinical investigator and when you acquire a financial interest in an SAO (e.g., purchase, gift). See information about SAOs, including lists of SAOs and non-SAOs. Submission and review procedures for the employee, supervisor, and ethics officials are available on the procedures page.
5.OGE Form 201: Request to Inspect or Receive Copies of OGE Form 278e, OGE Form 278-T, or Other Covered Records

 

Referral of Employees for Non-Compliance with Ethics Requirements
1.Form NIH-2850, Referral for Non-Compliance with Ethics Requirements  pdf-icon.jpg(Rev 5/14)
2.Procedure for Managing Employee Non-Compliance with Ethics Requirements (Using Form NIH-2850)pdf-icon.jpg
3.Form NIH-2802 Annual Report of Employee Referrals (Summary of Form NIH-2850) (Rev 1/12)
4.Procedure for Completing NIH-2802 pdf-icon.jpg(Rev 1/12)
HHS Co-Sponsorship Policy Memoranda and Model Agreement
Semiannual Report of Payments Accepted from a Non-Federal Source
SF 326 - Main Form pdf-icon.jpg   
SF 326A - Continuation Sheet pdf-icon.jpg