Ethics Procedures

All reports and actions involving senior employees require clearance by the NIH DEC or designee. Actions for employees designated as senior in NEES automatically route to the NIH Ethics Office (NEO). Any hard copy requests should be submitted with relevant supporting information and documentation to the NEO Action Coordinator, with a cc to the NEO Ethics Specialist servicing the IC.Outside ActivitiesNIH uses the NIH Enterprise Ethics System (NEES) for submission and review of outside activity requests (HHS-520) and for the outside activity annual report (HHS-521). Guidance in the following documents is relevant, but go tohttps://nees.nih.gov/ instead of submitted paper forms. Logon onto NEES using your regular NIH logon and password.Submission of the HHS-520 Request for Approval of Outside Activity Review of HHS-520 Request for Approval of Outside Activity Completion and Review of HHS-521 Annual Report of Outside Activity NIH Ethics Advisory Committee (NEAC) Jurisdiction Acts of Self-Dealing: Prohibited Compensation from Private Foundations: The Internal Revenue Service (IRS) code prohibits compensation by private foundations to certain Government employees for "acts of self-dealing," e.g., an outside activity. Read the details on this page.Official Duty ActivitiesGift ExceptionsAward from Outside Organization: Acceptance of gifts associated with an award from an outside organization requires advance approval.NIH policy requires use of theNIH Enterprise Ethics System (NEES), https://nees.nih.gov/to electronically submit and review formNIH-2854 Request for Approval to Accept Gifts Associated with an Award from an Outside Organization (Rev 8/09). When an employee completes and submits the form in NEES, it is routed to their supervisor, who will add his or her recommendation and forward the requests to the IC ethics office. The Deputy Ethics Counselor will determine the permissibility of acceptance of the award and the employee will be notified of the decision. To obtain formNIH-2854, go to the forms page. 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 theAwards topic page. Ethics officials will follow thedetailed procedure for submissionof the review request package, including use of thecurrent summary review form (dated 04/29/21)The Internal Revenue Service (IRS) code prohibits compensation by private foundations to certain Government employees and prohibits agreements to make payments of money or property to these employees. The cash prize associated with an award may also be considered compensation. See details about the prohibition on the page entitledActs of Self-Dealing: Prohibited Compensation from Private Foundations" for details.Honorary Degree. Acceptance of an honorary degree requires advance approval. Use formNIH-2855 Request for Approval of an Honorary Degree (Rev 08/09) to obtain advance approval to accept and to set the period of disqualification. The signed NIH-2855 form, and a copy of the notification letter shall be forwarded to your supervisor, who will add a recommendation and forward the package to the IC ethics office. The Deputy Ethics Counselor will determine the permissibility of acceptance of an honorary degree and you will notify the employee of the decision. To obtainform NIH-2855, go the forms page. When the form is available in NEES, submission and review will be accomplished electronically.Free Attendance using the Widely Attended Gathering (WAG) Exception. Employees may be offered a “gift of free attendance” from an outside organization to attend an event. Employees generally are prohibited from accepting a gift given because of their official position or from a prohibited source. An exception to the general prohibition may allow an employee to accept a gift of free attendance if it is considered a “widely attended gathering” (WAG) under the ethics regulations. Acceptance of free attendance requires advance approval.Individual WAG request. If an employee is invited to attend a dinner or reception where they are notpresenting or participating in another way other than as an attendee, approval is requested through submission of formNIH-2803 Request to Accept Free Attendance Under the Widely Attended Gathering Exception (Rev 12/11).NIH policy requires use of theNIH Enterprise Ethics System (NEES), https://nees.nih.gov/, to electronically submit and review the form. An electronic copy of the invitation shall be attached to the form. Once it has been submitted in NEES, the form is routed to the employee’s supervisor, who shall add his or her recommendation and forward the request to the IC Ethics Office. The employee’s Deputy Ethics Counselor will determine the permissibility of acceptance of the free attendance and the employee will be notified of the decision via an email from NEES. To obtain a copy of formNIH-2803, go to the forms page. Data regarding individual Wags shall be entered into the individual employee’s ethics record in EMIS.Blanket WAG request.If several NIH senior and non-senior employees from multiple institutes have been offered the gift of free attendance for an event, an NIH-wide blanket WAG covering all or any category of invitees may be prepared. Contact the NIH Ethics Office to inquire. If several employees from one IC are invited, an IC-specific blanket WAG may be prepared to cover all or any category of invitees. If an IC-specific blanket WAG does not include any senior employees the IC DEC may make the final determination. If several non-senior employees from multiple ICs are invited, each IC may prepare a blanket WAG and the IC DEC may make a determination regarding employees within their IC. If an IC-specific blanket WAG includes any senior employees, the NIH DEC will need to make the final determination.The Blanket WAG administrative module in EMIS is used to capture information relating to NIH-wide and IC-specific Blanket WAGs.Individual employee WAG data shall still be entered into the individual employee’s ethics record in EMIS. Before preparing a blanket WAG, each ethics office will check EMIS to see if an NIH-wide or IC-specific blanket WAG has already been entered into EMIS for the same event. If no entry exists, the ethics office shall enter the blanket WAG data into EMIS so that others will be able to search for and view it. This will enable ethics offices to share information and collaborate in obtaining ethics clearance for employees’ acceptance of gifts of free attendance under the WAG mechanism.Protocol Review102 Policy - Investigator Conflict of Interest and Government Royalties Conflict of Interest (COI) Certification(8/1/22)COI Guide - A Guide to Avoiding Financial and Non-Financial COI or Perceived COI in Clinical Research at the NIH PROTECT IC DEC Submission Checklist for Study TeamsReporting New IPA Appointees/DetaineesMemo from NIH Deputy Director Initiating Reporting Requirement (8/24/07)Spreadsheet to report new IPA, use directed by above memo (8/24/07, Excel)Financial DisclosureHHS 717-1 Confidential Report of Financial Interests in Substantially Affected Organizations for NIH Employees (The HHS-717-1 is available on theforms page.)Employees:Detailed Instructions for Submitting the HHS 717-1 (9/2015)Supervisors:Detailed Instructions for Supervisor Review of the HHS-717-1 (9/2015)Ethics Officials:Detailed Instructions for Reviewing the HHS 717-1(9/2015) SAO Determinations Employees frequently consult the SAO lists on the NIH Ethics Program website to evaluate whether an organization has been identified as a “substantially affected organization” (SAO). When an entity’s SAO status is unclear, NEO determines if the entity is or is not an SAO, and records this determination on the NIH Ethics Program website. Please review the NEO SAO Determination Job Aid for the requirements to request an SAO determination.The SAO module in EMIS is used for submission and to track and maintain records relating to SAO determinations. The inquiring ethics office is responsible for entering data pertaining to the SAO determination request into the SAO module in EMIS – see the NEO SAO Determination Job Aid for additional guidance. NEO will complete and close out the determination data in the module.SAO Determination Form (2021)SAO Determination Job Aid (2021)Delegations of AuthorityAll delegations of authority and any re-delegations are processed through the NIH Ethics Office (NEO) and copies are sent to the Office of General Counsel, Ethics Division (OGC/ED). Contact your NEO Ethics Specialist for assistance with Delegations of Authority and re-delegations.The EMIS Delegation administrative module tracks the delegation of authority from the NIH Deputy Ethics Counselor (DEC) to each IC DEC, and any applicable re-delegation from an IC DEC to an IC Ethics Coordinator or Specialist. The re-delegation information in the Delegation module in EMIS will include details about which authorities are re-delegated.Managing Non-Compliance with Ethics RequirementsProcedure for Managing Employee Noncompliance with Ethics Requirements (Using Form NIH-2850)Form NIH-2850 Referral for Non-Compliance with Ethics RequirementsProcedure for Form NIH-2802 Annual Report of Referrals for Non-Compliance with Ethics Requirements (Rev 1/12)Form NIH-2802 Annual Report of Referrals for Non-Compliance with Ethics Requirements (Summary of Form NIH-2850) (Rev 1/12)HHS Co-Sponsorship Policy Model AgreementMemorandum from the HHS General Counsel regarding Co-Sponsorship of Events 8/8/02Memorandum from the HHS DAEO regarding Co-Sponsorship of Events 8/8/02Model Co-Sponsorship Agreement (8/8/02, Word)Conferences: A Guide for Ethics Officials(OGE, May 2010)

Ethics Procedures | NIH Ethics Program

Ethics Procedures