2024-27421. Request for Information on Proposed Conflict of Interest Disclosure Policy

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Department of the Interior

Office of the Secretary

1. [Docket No. DOI-2024-0009; 245D0102DM, DS600000, DLSN00000.000000.DX6CS25]

AGENCY:

Office of the Secretary, Interior.

ACTION:

Notice of request for public comments.

SUMMARY:

The Department of the Interior (DOI) is developing a conflict of interest (COI) disclosure policy and corresponding term and condition for financial assistance awards ( i.e., grants and cooperative agreements) to address undue foreign influence in DOI-supported research and development (R&D). DOI is soliciting public comment on its proposed policy and accompanying award term and condition to ensure government resources are managed with integrity to the greatest public benefit.

DATES:

Submit comments on or before January 21, 2025.

ADDRESSES:

Comments may be submitted through the Federal eRulemaking Portal at http://www.regulations.gov. Type in DOI-2024-0009 in the search bar. Follow the instructions on the website for submitting comments.

FOR FURTHER INFORMATION CONTACT:

Cara Whitehead, Director, Office of Grants Management, [phone], [e-mail]. Mailing address: Department of the Interior, 1849 C Street NW, Mail Stop 3023 MIB, Washington, DC 20240.

SUPPLEMENTARY INFORMATION:

On December 17, 2020, the U.S. Government Accountability Office (GAO) published GAO-21-130, Federal Research: Agencies Need to Enhance Policies to Address Foreign Influence in Research. The report alerted agencies of the need to develop conflict of interest policies to assess risks and protect U.S. investments in scientific research from undue foreign influences.

DOI plans to develop a conflict-of-interest policy to define core terms, require financial assistance award recipients to maintain written and enforceable policies, and mandate covered individuals to identify, disclose, manage, reduce, or eliminate COI. The policy will address required actions by DOI in instances where the covered individual intentionally fails to disclose COI information and will include a term and condition which will be incorporated into the DOI financial assistance award terms and conditions. The DOI Office of Grants Management intends to implement the policy for all R&D competitive and non-competitive grant and cooperative agreements after obtaining and considering public comment.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. If you submit a comment at https://www.regulations.gov, your entire comment, including any personal identifying information, will be posted on the website. If you submit a hardcopy comment that includes personal identifying information, such as your address, phone number, or email address, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

Definitions

Conflict of interest is a situation in which an individual, or the individual's spouse or dependent children, has a significant financial interest or financial relationship that could directly and significantly affect the design, conduct, reporting, or funding of research or other award-related activities.

Conflict of commitment is a situation in which an individual accepts or incurs conflicting obligations between or among multiple employers or other entities. Conflict of commitment includes conflicting commitments of time and effort, including obligations to dedicate time in excess of one organization's funding, policies, or commitments in favor of another organization's priorities. Conflict of commitment also includes obligations to improperly share information with, or to withhold information from, an employer or DOI, as well as other conflicting obligations that threaten research security and integrity. Such conflicts are also described as an organizational conflict of interest.

Covered individual or senior/key person is an individual who (a) contributes in a substantive, meaningful way to the scientific development or execution of a research and development project proposed to be carried out with a research and development award from a Federal research agency or (b) is designated as a covered individual by the Federal research agency concerned. As defined by the National Security Presidential Memorandum—33 (NSPM-33) Implementation Guidance, this means principal investigators (Pis) and other senior/key persons seeking or receiving Federal research and development funding ( i.e., extramural funding) and researchers at Federal agency laboratories and facilities ( i.e., intramural researchers, whether or not federally employed), including Government-owned, contractor-operated laboratories and facilities. A covered individual may also include a current or former DOI employee.

Financial Interest can be anything of monetary value, whether or not the value is easily measurable.

Intramural Researcher is an agency employee who conducts research supported by the agency in which they are employed.

Investigator is a principal investigator (PI) and any other person, regardless of title or position, who is responsible for the purpose, design, funding, conduct or reporting of a project funded or proposed to be funded by DOI.

Principal Investigator (PI) means a principal investigator of a project funded under a DOI financial assistance award; PI is included in the definitions of senior/key personnel and Investigator.

Research and development (R&D) includes basic research, applied research, and experimental development. Basic research is experimental or theoretical work undertaken primarily to acquire new knowledge of the underlying foundations of phenomena and observable facts. Applied research is original investigation undertaken in order to acquire new knowledge and directed primarily towards a specific practical aim or objective. Experimental development is creative and systematic work, drawing on knowledge gained from research and practical experience, which is directed at producing new products or processes or improving existing products or processes. Like research, experimental development will result in gaining additional knowledge. Experimental development includes the production of materials, devices, and systems or methods, including the design, construction, and testing of experimental prototypes. Experimental development also includes technology demonstrations in cases where a system or component is being demonstrated at scale for the first time, and it is realistic to expect additional refinements to the design (feedback R&D) following the demonstration.^[1]

( print page 92715)

Significant financial interest is anything of monetary value, including, but not limited to, salary or other payments for services ( e.g., consulting fees or honoraria); an existing loan; equity interest ( e.g., stocks, stock options or other ownership interests); and intellectual property rights ( e.g., patents, copyrights, and royalties from such rights), but does not include the following:

1. Salaries, royalties or other remuneration from the applicant organization;

2. Any ownership interests in the applicant organization if the organization is a commercial or for-profit entity;

3. Income from investment portfolio such as mutual funds and retirement account if the investigator does have direct control of the investment decisions in the portfolio;

4. Income from seminars, lectures, or teaching engagements sponsored by a public or non-profit entity;

5. Income from service on advisory committees or review panels for a public or nonprofit entity;

6. An equity interest that, when aggregated for the covered individual and the covered individual'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 percent ownership interest in any single entity;

7. An existing or offered loan or other financing to the covered individual or covered individual or covered individual's spouse and dependent children not exceeding $10,000 in the aggregate; or

8. Salaries, royalties or other payments that, when aggregated for the covered individual and the covered individual's spouse and dependent children, are not expected to exceed $10,000 during the prior 12-month period.

Responsibilities of Non-Federal Entities Regarding Conflict of Interest

Each non-Federal Entity shall:

1. Maintain a current, written, enforced policy addressing COI which aligns with the DOI COI policy.

2. Ensure that each subrecipient develops and implements a policy which corresponds with the DOI COI policy if the non-Federal entity implements the DOI award through one or more subrecipients.

3. Designate a non-Federal entity official to solicit and review disclosures of significant financial interests from each covered individual who is planning to participate in, or is participating in, the project funded under a DOI award, including disclosures of subrecipient investigators.

4. Disclose to DOI any potential or actual conflict of interest and submit common disclosure forms for the Biographical Sketch Common Form and the Current and Pending (Other) Support Common Form for PIs and other senior/key personnel, program officers, and intramural researchers with the application for competitive and non-competitive DOI grant and cooperative agreement awards, per NSPM-disclosure requirements indicated in the NSPM-33 Implementation Guidance.

5. Require each investigator who is planning to participate in the DOI award to disclose to the non-Federal entity's designated official the investigator's significant financial interests (and those of the investigator's spouse and dependent children) no later than the time of application for the DOI award. Disclosures must be updated during the period of the award, either annually or upon learning of new reportable significant financial interests.

6. Require investigators engaged in subaward activities to comply with the COI policies of the pass-through entity.

Management of Conflict of Interest

Prior to the non-Federal entity's expenditure of any funds under a DOI award, the designated official of a non-Federal entity shall review all investigator disclosures of significant financial interests, identify whether any of the disclosures relate to the project funded under the DOI award, and determine whether an actual or potential COI exists. In instances where a COI may exist, the non-Federal entity must develop and implement a management plan which manages, reduces, or eliminates the COI. Conditions or restrictions of which one or more may be imposed to eliminate an actual or potential COI include but are not limited to:

1. Public disclosure of any COI ( e.g., when presenting or publishing the project);

2. For projects involving human subjects, disclosure of any COI directly to participants;

3. Appointment of an independent monitor or oversight committee capable of taking measures to protect the purpose, design, conduct, and reporting of the project against bias resulting from any COI;

4. Modification of the project plan;

5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the project;

6. Reduction or elimination of the financial interest ( e.g., sale of an equity interest) creating the COI; or

7. Severance of relationship(s) that create the COI.

DOI will review the Biographical Sketch Common Form and the Current and Pending (Other) Support Common submitted by the non-Federal entity to assess qualifications and any conflict of interest or commitment which may impact the proposed project activities.

Reporting of Financial Conflict of Interest

Prior to the non-Federal entity's expenditure of any funds under a DOI-funded project, the non-Federal entity must inform the DOI financial assistance officer identified in the award(s), in writing, of any COI which cannot be satisfactorily managed, mitigated, or eliminated in accordance with the non-Federal entity's policy.

Any conflict of interest identified by the non-Federal entity during the course of an ongoing project funded under a DOI award must be reported to DOI by the non-Federal entity within 60 days of the identified COI that cannot be managed, mitigated, or eliminated.

Notifications must include sufficient information to enable DOI to understand the nature and extent of the COI and assess the appropriateness of the non-Federal entity's management plan. The notification shall include, but is not limited to, the following information: (a) DOI award number; (b) Name of PI or contact PI; (c) Name of the investigator with the COI; (d) Name of the entity in which the investigator's interest has created a COI; (e) Nature of any applicable financial interest ( e.g., equity, loan, consulting fee, travel reimbursement, honorarium) and/or applicable external relationships or activities; (f) Value of any applicable financial interest or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value; and (g) A description of how the financial interest relates to the project funded under a DOI award and the basis for the non-Federal entity's determination that there is a conflict with such project.

Remedies

Upon notification to DOI of a COI which cannot be managed, mitigated, or eliminated by the non-Federal entity or upon DOI independently learning of this, the DOI financial assistance officer must report the COI to the DOI Office of the Solicitor, Branch of Acquisitions ( print page 92716) and Intellectual Property, to review and take appropriate action, as necessary.

DOI will consider and take appropriate actions, as necessary, such as requiring and enforcing a corrective action plan and imposing specific award conditions under 2 CFR 200.208 as necessary. As appropriate, DOI will also utilize available remedies for non-compliance and terminations provisions pursuant to 2 CFR 200.339 through 200.343, as appropriate under the circumstances. Available remedies include but are not limited to: (a) temporarily withholding payment; (b) disallowing all or part of the cost of an award activity; (c) wholly or partly suspending or terminating the award; (d) initiating referrals for consideration of suspension or debarment proceedings, and (e) withholding further Federal awards for the project or program.

Conflict of Interest Award Term and Conditions

DOI's COI financial assistance award term and condition will be revised as follows:

The DOI COI policy for financial assistance can be found at the Office of Grants Management website. This policy is applicable to all non-Federal entities applying for, or that receive, DOI funding by means of a financial assistance award ( e.g., a grant or cooperative agreement) and, through the implementation of this policy by the entity, to each investigator who is planning to participate in, or is participating in, the project funded wholly or in part under the DOI financial assistance award.

The DOI COI policy establishes standards that provide a reasonable expectation that the design, conduct, and reporting of projects funded wholly or in part under DOI financial assistance awards will be free from bias resulting from financial conflict of interest or conflict of commitment. The recipient is subject to the requirements of the DOI COI policy and within each award for financial assistance, the recipient must certify that it is, compliant with all requirements in the DOI COI policy. The recipient must pass-through the requirements of the DOI COI policy to any subrecipient non-Federal entity.

Authority

The authority for this action is the Department's Financial Assistance Regulations at 2 CFR part 1402.

Cara Whitehead,

Director, Office of Grants Management, Department of the Interior.

Footnotes

1.   https://www.whitehouse.gov/​wp-content/​uploads/​2018/​06/​a11.pdf.