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Participation of NIH Staff in Extramural Grants--Conflict of Interest and Ethical Considerations

In light of the unique mission of the NIH and required interactions with the outside research community, it is generally in the interest of the advancement of biomedical research that NIH scientists collaborate with non-government scientists including those that are funded by, or applying to the NIH for grants.  As a result of these collaborations, the work of NIH scientists may be cited in grant applications or the NIH scientists may be asked to otherwise participate in NIH grants in a limited manner.  Such participation, however, should take place with knowledge of the criminal conflict of interest statutes and Office of Government Ethics (OGE) regulations.

This document addresses the applicable statutes and regulations to give the employee an overview of how those statutes and regulations proscribe appropriate interactions with outside organizations.  It does not address the use of Government property, such as an NIH lab, to conduct grantee research, does not apply to procurements, and does not consider the applicable provisions of the PHS Grants Policy Statement.

18 U.S.C. Sections 203 & 205

Whether compensated or not, NIH staff are prohibited from representing organizations in matters before the federal government such as representing a university or other entity on a grant application before NIH.

18 U.S.C. Section 208

NIH staff cannot participate personally and substantially in a government decision involving their own or imputed financial interests. Imputed financial interests include those of a spouse, minor child, an organization an employee serves as an officer, director, trustee, general partner, employee, or consultant, or an organization with whom the employee seeks employment.  A NIH scientist cannot participate in a grant with a university in which he or she has an ongoing outside activity, whether compensated or not.

18 U.S.C. 209

NIH staff may not accept any supplementation of their government salary as compensation for services they perform officially.

Executive Order 12674 and OGE Regulations at 5 C.F.R. 2635.502 and 2635.702

NIH staff shall act impartially in the performance of their government duties.  Even the appearance of preferential treatment or the use of public office for the private gain of another must be avoided.  An NIH scientist who, as an outside activity, served as an officer, director, trustee, general partner, agent, attorney, consultant, contractor or employee to an organization within the last year; or who, as an outside activity, has a business relationship with an organization (for example, gives a seminar and receives an honorarium); or who, as an outside activity, is an active participant in an organization, could not participate in a grant (for example, collaborate, review, or otherwise affect) to that organization without prior authorization.  The NIH scientist is considered to have a “covered relationship” with that organization. In addition to the NIH scientist’s affiliations with outside organizations, if any of the following individuals have defined affiliations with an outside organization, the scientist should not, without prior authorization,  participate in a grant to that organization:  scientist’s spouse, parent, member of the scientist’s household,  scientist’s child, or scientist’s close personal relative.

 

Executive Order 12674 and OGE Regulations at 5 C.F.R. 2635.703

NIH staff shall not use nonpublic information to further the private interest of another.  An NIH scientist cannot provide information that has not been made public, except as permitted by NIH  in the course of scientific collaborations, to a grant applicant.

 

OGE Advisory Opinions

NIH staff participation in a grant could create the appearance of giving preferential treatment, loss of independence or impartiality, or using public office for private gain, if that employee is a member or otherwise affiliated with an organization seeking the grant. (OGE 86 x 19)  This is applicable even in situations where the staff is participating in the outside organization as part of that employee’s official duties. (OGE 88 x 16)  NIH staff participation with outside organizations as part of their official duties must be carefully scrutinized “to ensure that government officials carry out their duties with complete impartiality and without undue influence from the outside organization.”  In other words, such participation may be appropriate only if the staff has no connection with the development of a Request For Applications (RFA) nor with reviewing, recommending, or approving the grant award.

Guidance

The following guidance permits NIH staff to comply with the criminal conflict of interest statutes and Office of Government Ethics regulations: NIH staff includes employees, post-doctoral fellows, special volunteers and guest researchers.

Conditions for Permissible Participation in Grants

  • a copy of the formal letter of collaboration, which will be included in the grant application, must be submitted to the scientist’s Scientific Director for review and approval
  • when an RFA anticipates collaboration, such collaboration must be available to any applicant
  • participation as the supplier of materials, such as cell lines, which are available to any requester
  • if it is determined that the NIH scientist’s participation is substantial, a cooperative agreement, rather than a grant, is awarded
  • participation solely to provide information about the scientist’s work, for example, by conducting a two day seminar for the grantee
  • all such participation must be authorized as official duty activity without compensation (other than the scientist’s NIH salary). Sponsored travel expenses (348) from a grantee are not permissible.
  • if an application on which the scientist is listed is being reviewed, the scientist may provide scientific/technical information at the request of NIH at site visits or meetings of the review group
  • a scientist can write a description of the scientist’s work for use by the applicant but otherwise cannot write the application
  • a scientist may be named as the PI in accordance with NIH Manual 4202/6003-1, when planning on leaving NIH. 

A scientist who has any of the following duties or affiliations must consult their Deputy Ethics Counselor prior to the collaboration:

  • drafting or review of an RFA in which he/she may participate as a collaborator    
  • review of an application on which the scientist is listed
  • awarding the grant on which the scientist is listed
  • supervising anyone involved with the review or award of grant on which the scientist is listed
  • acting as a project officer on a grant on which the scientist is listed or supervising anyone who has such duties
  • any other official duties involving the applicant or the applicant’s institution
  • the scientist is an officer, director, trustee, general partner, employee, or consultant of the applicant’s organization
  • the scientist is seeking employment  with the applicant’s organization
  • the scientist has a current outside activity with the applicant’s organization
  • the scientist’s spouse is or will be involved on behalf of the applicant in the grant
  • the scientist served the applicant’s organization within the last year as an officer, director, trustee, general partner, agent, attorney, consultant, contractor, employee
  • the scientist has a business relationship, including an honorarium within the last year, with the applicant’s organization 
  • the scientist is an active participant (e.g., spokesperson, committee chair, fundraiser) in an applicant’s organization
  • a member of the scientist’s household or a relative with whom the scientist has a close personal relationship is or will be involved on behalf of the applicant in the grant
  • the scientist’s parent or dependent child serves or seeks to serve the applicant’s organization as an officer, director, trustee, general partner, agent, attorney, consultant, contractor or employee
  • any other circumstances that would raise a question about the scientist’s impartiality

For additional information, see the NIH Office of Intramural Research (OIR) Sourcebook, on the OIR web site:

https://oir.nih.gov/sourcebook/ethical-conduct

This URL also applies if the scientist is asked to collaborate after the grant has been written, approved, or funded.

Office of General Counsel, Ethics Division, March 2000

Updated: 2/19/13