Conflict of Interest - CPHS Members and Consultants

II.04

 

 

Conflict of Interest - CPHS Members and Consultants

 

 


PURPOSE

1. The purpose of this policy and procedure is to describe the process for managing conflicts of interest (COI) of CPHS Members and Consultants.

SCOPE

2. This policy and procedure is applicable to CPHS Members and ORSC Staff.

POLICY

3. CPHS members and consultants may not participate in the review of any protocol in which they have a conflicting interest, except to provide information requested by the CPHS.

DEFINITIONS

4. Significant financial interest - Significant financial interest in research is defined as the aggregate interests of the investigator and his/her immediate family (spouse and dependent children.). It also refers to anything of monetary value that would reasonably appear to be affected by the outcome of the proposed research, regardless of whether that entity is sponsoring the research. Such interests include, but are not limited to:

  1. Salary or other payments for services (e.g. consulting fees or honoraria) expected to exceed $10,000 in the next 12 months from a single entity. This does not include salary or other remuneration from UTHealth or, as applicable, other academic institutions.
  2. Equity interests (e.g. stocks, stock options, or other ownership interests) that exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value or represent more than a 5% ownership interest in any single entity. This does not include interest in mutual funds where the individual has no control over the selection of holdings.
  3. Intellectual property rights (e.g. patents, patents in which the investigator has a financial interest, copyrights, and royalties from such rights.)
  4. Payments or entitlements paid by the sponsor in connection with the research, including bonus or milestone payments, that are not directly related to the reasonable costs of the research.
  5. Service as an officer, director, or fiduciary for a financially interested company.
  6. Any other financial interests if the CPHS Members have concerns that these interests would reasonably appear to be affected by the proposed research (e.g. significant financial interests of family members other than a spouse or dependent children)

4.2. The term significant financial interest in research does not include:

  1. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.
  2. Income from service on advisory committees or review panels for public or nonprofit entities.

4.3. Non-financial interests – Non-financial conflicts of interest include a significant personal or scientific interest, being member of the research team or administrative involvement with the research.

PROCEDURE

Identifying Conflict of Interest

5. A CPHS Member and/or consultant must declare any significant financial or non-financial COI. When a Member / Consultant has a COI for a research proposal that assigned to them for review, they must notify the ORSC Staff. The ORSC Staff will reassign the research proposal to another reviewer.

6. At the opening of all CPHS meetings, the Chairperson will remind CPHS Members or Consultants in attendance at the meeting, to declare any conflicting interests with items on the agenda.

Managing Conflict of Interest

7. A member or consultant with COI must absent himself/herself from the meeting room prior to any discussion, except to provide information requested by the CPHS. This absence does affect the number of persons necessary for a quorum, which will be noted in the minutes as not present for vote.

8. Even when a member does not have conflict of interest as defined in this policy, they may refrain from discussion and vote to avoid any appearance of a conflicting interest.

9. Members with conflicting interests will not be assigned as primary or secondary reviewers for review of the specific research protocol for which conflict exists for initial review, continuing review, expedited review, review of protocol amendments, review of SAE reports and review of non compliance reports.

RESPONSIBILITY

10. The CPHS Members and Consultants are responsible for disclosing COI and refraining from participating in the review of research in which they have a conflicting interest.

 

Applicable Regulations and Guidelines

1. 45 CFR §46.107(e)
2. 21 CFR §56.107(e)

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Updated 2/2009, Report broken links