Third-Party Involvement in NHGRI-Supported Extramural Projects

This guidance applies to NHGRI-funded extramural investigators that are subject to the NIH Data Sharing Policy or the NIH Genomic Data Sharing (GDS) Policy, excluding grantees or contractors funded through the Small Business Innovation Research or Small Business Technology Transfer program. 

The guidance also applies to any parties that are in a subcontracting or a fee-for-service relationship (e.g., cloud/data storage, computational or laboratory service) with the recipient of an NHGRI-funded cooperative agreement or contract.

A ‘third party’ is a private or public entity that is not a party to the grant or contract issued by NHGRI. This can include companies, charities (such as FNIH), nonprofits, and other governmental agencies.

‘Third-party involvement’ means any support provided by a third party to the direct recipient of an NHGRI grantee or contractor, including any other parties that are in a subcontracting or a fee-for-service relationship (e.g., cloud/data storage, computational or laboratory service) with the direct recipient. Support can include financial support, direct participation in a study, provision of resources, and the provision of services.

Third-party involvement may entail, but is not limited to:

• Providing cost-free study resources including, but not limited to, drugs, reagents, equipment, labor, computing capabilities, sequence and phenotype data, and data storage infrastructure;
• Providing financial support;
• Participating directly in a study.
   

Sometimes, third parties may offer this type of support in exchange for receiving special access to study results, data, findings, or intellectual property.

NHGRI may approve third-party involvement when the following key criteria are met:

1. The nature of the third party's support, relationships/agreements between the third party and grantee or contractor, and the conditions under which the support is to be provided, is clearly stated.
    
2. The third-party involvement neither raises the appearance of nor creates conflict of interest issues with the study investigators, NHGRI, or its employees.
    
3. The third party agrees to work collaboratively with the grantees and the rest of the consortium, if applicable, including agreeing to any NIH, NHGRI, and consortium policies on providing and sharing data and resources, accessing data, participant privacy and data protection, meeting quality metrics for data production, and participating in group data analyses. The third party should not attempt to modify existing consortium policies in exchange for its services.
    
4. The third party is not an NHGRI grantee or contractor and therefore the third party should not attempt to influence, govern, or act as the grantee or contractor.
    
5. The third party agrees to abide by any publication rules, including not inhibiting publication by grantees, contractor, or consortium and not separately publishing the project results if they are to be published jointly with the grantees, contractor, or consortium.
    
6. The third party does not condition its services on a requirement to review draft publications or presentations.
    
7. A grantee or contractors should not be dependent on a cost-free relationship with a third-party such that termination of the service could prevent the grantee or contractor from completing the project.
    
8. If support from the third party is in the form of a drug, device, or biologic, the third party will ensure the greatest protection of participants by providing NHGRI and the investigators with all information regarding adverse events reasonably attributable to the intervention, drug, device, or biologic.
    
9. The third party agrees to not publish press releases or similar statements about participation, or use logos from NIH, NHGRI, or NHGRI programs unless cleared by the grantee, contractor, consortium (if applicable), and NHGRI staff.
    
10. The third party will make no commitments with the study investigators on intellectual or tangible property or other issues that conflict with Public Health Service (PHS) policy on grants or contracts (particularly as to reporting, distribution of unique research resources, inventions, or commercialization).
     
11. Third parties may not require exclusive participation in such an agreement, by being the only third party with, for example, access to data or provision of a service.
     
12. All restrictions that the third party would impose on the grantee, such as on publication, presentation, or public disclosure of results, other than those related to proprietary information, must be limited in duration and scope.

Contact with third parties should be initiated exclusively through the grantee or contractor. NHGRI cannot directly contact or negotiate with third parties regarding a potential agreement for third party involvement. In the case of multi-center projects with a central project governance body (e.g., Project Steering or Executive Committee), contact with third parties seeking collaboration should be initiated exclusively through the project governance, or in unusual situations, with their advice and concurrence. The grantee, contractor, or project governance should preliminarily assess whether the third-party involvement is appropriate according to this guidance. For multi-center projects, any preliminary informal contact concerning a potential agreement with a third party should be brought to the study governance promptly.  

If the grantee, contractor, or project governance body is unsure whether the third-party involvement adheres to this guidance, they should contact their respective Program Director(s) to submit information about the proposed third-party involvement to NHGRI. Examples of information/documents that the grantee or contractor should provide to NHGRI should include: 

1. The proposed agreement 

2. The nature and any conditions of third-party support 

3. The benefit to the project from the third-party support 

4. Information about the third-party’s involvement or influence in study governance and conduct, and in the data and sample production, storage analysis, interpretation, and ownership; and reporting of results 

5. Third-party access to results, access to the data, and any commitments with the third party for intellectual or tangible property 

6. Any conflict of interest issues (e.g., any relationship between the grantee or contractor with the third party) and a proposed resolution to these conflicts

Upon receipt of the information/documentation, NHGRI will review and provide the grantee or contractor with a written assessment regarding the proposed third-party involvement in a timely manner (no more than 30 days). NHGRI will use the criteria outlined in this guidance to assess whether the involvement is “appropriate”, “appropriate with minor changes”, or “inappropriate.”

If the grantee or contractor receives an “appropriate” assessment, they may proceed with the agreement with the third party.

If the grantee or contractor receives an “appropriate with minor changes” assessment, this means that NHGRI has minor changes to suggest before the grantee or contractor may proceed with the agreement.

If the grantee or contractor receives an “inappropriate” assessment, this means that NHGRI feels that the proposed third-party involvement deviates significantly from NHGRI’s guidance and therefore, NHGRI expects that the grantee or contractor will not enter an agreement with the third party.

In the case of an “inappropriate” assessment, the grantee or contractor may make a single response. In case of a response, the grantee or contractor, must provide more information to support their argument for the acceptability of the third-party involvement. NHGRI will review and provide a grantee or contractor with an assessment in the case of a request for reconsideration within 30 days. The NHGRI Director or their designees makes the final assessment on the acceptability of proposed third-party involvement and what terms or conditions may be needed for them to be acceptable. 

• Conflict of Interest: A financial conflict of interest exists when the recipient's designated official(s) reasonably determines that an investigator's significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
   
• Third party: A private or public entity that is not a party to the grant or contract issued by NHGRI. This can include companies, charities, nonprofits, and other governmental agencies.
   
• Third-party involvement: Any support provided by a third party to a direct recipient of an NHGRI grantee or contractor, including any other parties that are in a subcontracting or other participatory relationship (e.g., a clinical unit or central laboratory) with the direct recipient. Support can include financial support, direct participation in a study, provision of resources, and the provision of services.