2.1

VERSITI Research Staff Members

This Financial Conflicts of Interest in Research Policy shall apply to all VERSITI personnel, including VERSITI Research Staff Members. The Research Conflict of Interest Committee (RCOI Committee) shall identify and maintain a list of VERSITI Research Staff Members.

2.2

Subrecipients

If VERSITI carries out PHS-funded research through a Subrecipient (e.g., subcontractors or consortium members), VERSITI will take reasonable steps to ensure that Subrecipient Research Staff Members comply with federal conflict of interest regulations by incorporating as part of a written agreement with the Subrecipient terms that establish whether VERSITI or Subrecipient’s financial conflicts of interest policy will apply to Subrecipient’s Research Staff Members.⁹

3.1

Ongoing Duty to Disclose

Each VERSITI Research Staff Member has an ongoing obligation to disclose Significant Financial Interests (including actual or potential Financial Conflicts of Interest) to the Director of Research Administration or the EVP of Research on a VERSITI-approved Disclosure Statement.

3.2

Disclosure Statements

A Research Staff Member may submit an updated Disclosure Statement at any time, but must submit an updated Disclosure Statement to Director of Research Administration or the EVP of Research as specified below:

1. Upon initiation of employment;
2. Annually, as instructed by VERSITI;¹¹
3. Prior to the date of submission a proposal/application for PHS-funded research;¹²
4. Within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest;¹³ and
5. If added as a new Research Staff Member to an ongoing PHS-funded research project;
6. Upon request of the EVP of Research, the Director of Research Administration, or the RCOI Committee.

4.1

Review of Significant Financial Interests

The Director of Research Administration will review all disclosed Significant Financial Interests under $5,000 (except for consulting, employment compensation and intellectual property) within sixty (60) days of disclosure. The RCOI Committee will review all other disclosed Significant Financial Interests within sixty (60) days of disclosure. Disclosure Statements related to PHS-funded research will be reviewed as soon as practicable and prior to expenditure of any PHS funds for such research. The Director of Research Administration or the RCOI Committee will determine whether Significant Financial Interests constitute FCOIs.14 A Significant Financial Interest is an FCOI if the Director or Committee finds that:

1. the Research Staff Member has the ability to directly affect the design, conduct, or reporting of the research; and
2. an independent observer might reasonably question whether the Research Staff Member’s actions or decisions may be unduly influenced by his/her Financial Interests.

If an FCOI exists, the Committee will:

1. determine whether the FCOI is related to PHS-funded research;
2. develop, implement and document, on at least an interim basis, a management plan that specifies the actions that have been, and will be, taken to manage such FCOI (see Section 5);¹⁵
3. submit required FCOI reports, as necessary (See Section 6).

4.2

Review of Unaddressed Significant Financial Interests

An unaddressed Significant Financial Interest is a Significant Financial Interest that was not disclosed to or addressed by the RCOI Committee in a timely manner. For example, a Research Staff Member failed to disclose a Significant Financial Interest, or the RCOI Committee neglected to address a disclosed Significant Financial Interest. If an unaddressed Significant Financial Interest arises, the RCOI Committee will review the Significant Financial Interest in accordance with Section 4.1 to determine whether the Significant Financial Interest is an FCOI. If the unaddressed Significant Financial Interest is determined to be an FCOI, the RCOI Committee will also perform a retrospective review (see Section 4.3). ¹⁶

4.3

Retrospective Review of Unaddressed FCOIs.

An unaddressed FCOI is an FCOI that was not identified or managed in a timely manner, including failure by a Research Staff Member to disclose an FCOI, failure by the RCOI Committee to review or manage the FCOI; or failure by the Research Staff Member to comply with a FCOI management plan. If an unaddressed FCOI arises, the RCOI Committee shall, within one-hundred-twenty (120) days of the Research Committee’s determination of noncompliance, complete a retrospective review of the Research Staff Member’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.¹⁷

1. The RCOI Committee will document the retrospective review. Such documentation shall include all of the following key elements:
   1. Project number and title;
   2. PD/PI or contact PD/PI if a multiple PD/PI model is used;
   3. Name of the Research Staff Member with the FCOI;
   4. Name of the entity with which the Research Staff Member has an FCOI;
   5. Reason(s) for the retrospective review;
   6. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
   7. Findings of the review; and
   8. Conclusions of the review.¹⁸
2. If no bias is found, the EVP of Research shall submit an updated FCOI report to the PHS Awarding Component (see Section 6.2) and ensure that the RCOI Committee has implemented a management plan (see Section 5).19 Thereafter, the Institution will submit FCOI reports annually (see Section 6.3).
3. If bias is found, the RCOI Committee will: (1) ensure that the RCOI Committee has implemented a management plan (see Section 5); (2) notify the PHS Awarding Component promptly; (3) submit an updated FCOI report to the PHS Awarding Component (see Section 6.2); and (4) submit a mitigation report to the PHS Awarding Component (see Section 6.4). ²⁰

5.1

Development and Documentation

If the Director of Research Administration or the RCOI Committee determines that an FCOI exists, the RCOI Committee will develop, implement, and document a management plan that specifies the actions that have been, and shall be, taken to manage such FCOI.21 Such management plan shall include the following key elements:

1. Role and principal duties of the conflicted Research Staff Member in the research project;
2. Conditions of the management plan;
3. How the management plan is designed to safeguard objectivity in the research project;
4. Confirmation of the Research Staff Member’s agreement to the management plan;
5. How the management plan will be monitored to ensure Research Staff Member compliance; and
6. Other information as needed.

5.2

Conditions and Restrictions

Examples of conditions or restrictions that might be imposed to manage a Research Staff Member’s FCOI include, but are not limited to: ²²

1. Public disclosure of the FCOI (e.g., when presenting or publishing the research);
2. For research projects involving human subjects research, disclosure of the FCOI directly to participants;
3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;
4. Modification of the research plan;
5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
6. Reduction or elimination of the FCOI (e.g., sale of an equity interest);
7. Severance of relationships that create the FCOI; and/or
8. Any other restrictions that the RCOI Committee determines to be appropriate.

5.3

Monitoring and Compliance

All Research Staff Members are expected to comply with management plans established by the RCOI Committee. The RCOI Committee shall monitor Research Staff Member compliance with management plans on an ongoing basis, until the completion of the research project.²³

6.1

Initial FCOI Reports

Prior to the expenditure of PHS funds related to a PHS-funded research project, the EVP of Research will provide FCOI reports to the PHS Awarding Component²⁴ The FCOI report need not include FCOIs eliminated prior to the expenditure of PHS-awarded funds.²⁵ The FCOI shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of FCOIs and to assess the appropriateness of the RCOI Committee’s management plan.²⁶ The Initial FCOI Report shall include all of the following for each FCOI:²⁷

1. Project number;
2. Project Director/Principal Research Staff Member, or Contact PD/PI if a multiple PD/PI model is used;
3. Name of the Research Staff Member with the FCOI;
4. Name of the entity with which the Research Staff Member has a FCOI;
5. Nature of the Significant Financial Interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
6. Value of the Significant 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;
7. Description of how the Significant Financial Interest relates to the PHS-funded research;
8. Basis for the RCOI Committee’s determination that the Significant Financial Interest conflicts with such research;
9. Description of the key elements of the management plan, including (a) role and principal duties of the conflicted Research Staff Member in the research project; (b) conditions of the management plan; (c) how the management plan is designed to safeguard objectivity in the research project; (d) confirmation of the Research Staff Member’s agreement to the management plan; and (e) how the management plan will be monitored to ensure Research Staff Member compliance; and (f) other information as needed.²⁸

6.2

Updated FCOI Reports

For any new FCOI identified during an ongoing PHS-funded research project, but subsequent to submission of the initial FCOI report (e.g., a Research Staff Member is new to the research project or a Research Staff Member develops a new FCOI), the EVP of Research shall provide to the PHS Awarding Component, within sixty (60) days, an updated FCOI report regarding the new FCOI (see Section 4.2.2, and ensure that the RCOI Committee has implemented a management plan (see Section 5).²⁹

6.3

Annual FCOI Reports

For any FCOI previously reported by the EVP of Research, with regard to an ongoing PHS-funded research project, the EVP of Research shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of each FCOI and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether each FCOI is still being managed, or explain why the FCOI no longer exists. The EVP of Research shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.³⁰

6.4

Mitigation Reports

For any unaddressed FCOI identified during an ongoing PHS-funded research project, the EVP of Research shall also submit a mitigation report that includes, at a minimum:

1. the key elements set forth in Section 4.3 above;
2. a description of the impact of the bias on the research project; and
3. the RCOI Committee’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).³¹

7.1

Records

For at least three years from the date the final expenditures report is submitted to the PHS (or as otherwise required), the RCOI Committee will maintain records relating to all Research Staff Member disclosures of Financial Interests and the RCOI Committee’s review of, and response to, such disclosures (whether or not a disclosure resulted in the RCOI Committee’s determination of an FCOI) and all actions under this Policy.³² The RCOI Committee will make information available, promptly upon request, to the U.S. Department of Health and Human Services relating to any Research Staff Member disclosure of financial interests and the RCOI Committee’s review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution’s determination of an FCOI.33

7.2

Public Accessibility

This Conflict of Interest Policy will be made available on VERSITI intranet and internet websites.³⁴ Within five (5) business days of VERSITI’s receipt of written request from any requestor, the Compliance Officer/Corporate Counsel will provide a written response describing FCOIs related to PHS-funded research held by VERSITI Research Staff Members.³⁵ The written response shall include shall include, at a minimum, the following:

1. the Research Staff Member’s name, title and role with respect to the research project;
2. the name of the entity in which the Significant Financial Interest is held;
3. the nature of the FCOI; and
4. the approximate dollar value of the FCOI, 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.³⁶

8.1

Policy Review & Amendment

Corporate Counsel and the RCOI Committee will review this Policy as needed and at least every two years. Questions regarding the implementation of this Policy should be directed to VERSITI’s EVP of Research or Corporate Counsel/Compliance Officer.

8.2

Education

New VERSITI Research Staff Members will complete a training session that addresses the content of this Policy, the Research Staff Member’s obligations regarding the disclosure of Financial Interests, and the substance of applicable federal regulations regarding conflicts of interest during the orientation process and prior to engaging in research related to any PHS-funded grant. Thereafter, all VERSITI Research Staff Members will repeat the required training: (1) at least every four (4) years; (2) if and when VERSITI revises this Policy (if such changes materially affect the requirements for Research Staff Members); and (3) if and when VERSITI determines that the Research Staff Member is not in compliance with this Policy.³⁷

8.3

Violations

Failure to comply with the provisions of this Conflict of Interest Policy may result in discipline, up to an including termination of employment.³⁸

Replaces:

Policy is dated February 14, 2011

Review Period:

Every two years

Approvals:

July 31, 2012, Recommended by the VERSITI Compliance Committee

September 19, 2012, Approved by the VERSITI Board of Directors

February 12, 2015, Amendments approved by the RCOI Committee

March 18, 2015, Amendments approved by the VERSITI Board of Directors

February 20, 2019, Approved by VERSITI Board of Directors

November 25, 2020, Amendments recommended by the RCOI Committee

December 2, 2020, Approved by Versiti Board of Directors

November 16, 2022, Approved by Versiti Board of Directors