National Institutes of Health

 

NIH requires recipient institutions and investigators (except Phase I SBIR/STTR applicants and recipients) to comply with the requirements of 42 CFR 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought" (FCOI Regulation). The requirements promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from any conflicting financial interest of an investigator.

Each Institution shall maintain an up-to-date, written, enforced policy on financial conflicts of interest which requires each investigator who is planning to participate in PHS-funded research to disclose significant financial interests at least annually

An investigator is someone defined as the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded or proposed for funding by PHS.

A significant financial interest means anything of monetary value, including, but not limited to, salary or other payments for services, equity interest, and intellectual property rights. 

The term does not include:

1. salary, royalties or other remuneration from the applicant institution;

2. any ownership interest in the institution, if the institution is an applicant under the Small Business Innovation Research Program or Small Business Technology Transfer Program;

3. income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;

4. income from service on advisory committees or review panels for public or nonprofit entities;

5. an equity interest that, when aggregated for the investigator and investigator’s spouse and dependent children, does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and

6. salary, royalties or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $10,000 during the twelve month period.

When submitting a grant application, the signature of the Authorized Organization Representative (AOR) certifies the applicant institution's compliance with the requirements of 42 CFR 50, Subpart F, including that:

1. There is in effect at the Institution an up-to-date, written and enforced administrative process to identify and manage Financial Conflicts of Interest (FCOI) with respect to all research projects for which NIH funding is sought or received;

2. The Institution shall promote and enforce Investigator compliance with the regulation's requirements including those pertaining to disclosure of Significant Financial Interests;

3. The Institution shall identify and manage FCOIs and provide initial and ongoing FCOI reports to the NIH consistent with this subpart;

4. When requested, the Institution will promptly make information available to the NIH/HHS relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of an FCOI;

5. The Institution shall fully comply with the requirements of the regulation. 

When the Institution determines that an FCOI exists, the Institution must report to the NIH awarding Institute or Center through the submission of an initial and annual FCOI report.

Elements of an FCOI Report 

The FCOI regulation requires institutions to submit the following information when reporting an FCOI:  

• The name of the investigator with the FCOI

• The name of the entity with which the investigator has an FCOI

• The nature of the Significant Financial Interest (SFI)  

• The value of the financial interest 

• Description of how the financial interest relates to the NIH-funded research and why the institution determined that the financial interest conflicts with such research

• Description of the key elements of the institution’s management plan, including other required information

National Science Foundation

 

NSF requires each grantee institution employing more than fifty persons to maintain an appropriate written and enforced policy on conflict of interest. Guidance for such policies has been issued by university associations and scientific societies.

An institutional conflict of interest policy should require that each investigator disclose to a responsible representative of the institution all significant financial interests of the investigator (including those of the investigator’s spouse and dependent children) (i) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF; or (ii) in entities whose financial interests would reasonably appear to be affected by such activities.

 

The term investigator means the principal investigator, co-principal investigators, and any other person at the institution who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF.

 

The term significant financial interest means anything of monetary value, including, but not limited to, salary or other payments for services, equity interest (e.g., stocks, stock options or other ownership interests), and intellectual property rights.

 

The term does not include:

1. salary, royalties or other remuneration from the applicant institution;

2. any ownership interests in the institution, if the institution is an applicant under the Small Business Innovation Research Program or Small Business Technology Transfer Program;

3. income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;

4. income from service on advisory committees or review panels for public or nonprofit entities;

5. an equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or

6. salary, royalties or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $10,000 during the twelve month period.

An institutional policy must ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to NSF. It must also require that those financial disclosures are updated during the period of the award, either on an annual basis, or as new reportable significant financial interests are obtained.

 

An institutional policy must designate one or more persons to review financial disclosures, determine whether a conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce or eliminate such conflict of interest. A conflict of interest exists when the reviewer(s) reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of NSF-funded research or educational activities.

 

Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate conflicts of interest include, but are not limited to:

 

1. public disclosure of significant financial interests;

2. monitoring of research by independent reviewers;

3. modification of the research plan;

4. disqualification from participation in the portion of the NSF-funded research that would be affected by significant financial interests;

5. divestiture of significant financial interests; or

6. severance of relationships that create conflicts.

 

If the reviewer(s) determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the reviewer(s) may allow the research to go forward without imposing such conditions or restrictions.

 

The institutional policy must include adequate enforcement mechanisms, and provide for sanctions where appropriate.

 

The institutional policy must include arrangements for keeping NSF’s Office of the General Counsel appropriately informed if the institution finds that it is unable to satisfactorily manage a conflict of interest.

 

Institutions must maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any NSF action involving those records, whichever is longer.