II.05

 

 

CPHS Member and Consultant Conflict of Interest

 

 

 

Objective

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. This Policy/Procedure describes the process for disclosing these conflicts of interest (COI). 

 

Policy/Procedure

I.    Conflicting Interest: CPHS Members and consultants are considered to have a conflicting interest if they have any:

 

A.   Significant financial interest (see definitions);

 

B.    Role in the conduct of the research; or

 

C.    Other individual conflict of interest.

 

II.  A CPHS Member and/or consultant must declare any financial or non-financial COI as follows.

 

A.   When a study is assigned to a CPHS Member or consultant  he/she must notify the person who assigned the study that there is a conflict and that the protocol must be reassigned.

 

B.    At the opening of the CPHS meeting, the chairman will call upon CPHS members or others in attendance at the meeting to declare any conflicting interests with items on the agenda.

 

C.  If the Chair of CPHS knows of a possible conflict for a particular Member, the Chair should discuss the issue with the Member prior to the CPHS meeting.

 

D. A Member or consultant must declare any COI with any of the research being reviewed prior to the Research being discussed.

 

E. A member or consultant must absent himself/herself from the meeting room prior to any discussion, except to provide information requested by the CPHS, and during the deliberative discussion and vote on the research.  This absence does affect the number of persons necessary for a quorum, which will be noted in the minutes.

 

F.    A CPHS Member or consultant may refrain from the discussion and vote for any reason, if they feel it is necessary to avoid any appearance of a conflicting interest.

 

G.   Any CPHS Member associated with an investigative effort must also declare if there is a conflict of interest.

 

 

 

Definitions

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:

á       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 UTHSC-H or, as applicable, other academic institutions.

á       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.

á       Intellectual property rights (e.g. patents, patents in which the investigator has a financial interest, copyrights, and royalties from such rights.)

á       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.

á       Service as an officer, director, or fiduciary for a financially interested company.

 

In addition to the exceptions noted above, the term significant financial interest in research does not include:

á       Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.

á       Income from service on advisory committees or review panels for public or nonprofit entities.

á       Investigators should also disclose other significant financial interests not specifically required by the Policy if they have concerns the 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.)

 

Non-financial interests – Non-financial conflicts of interest should also be considered, such as a significant personal or scientific interest or administrative involvement with one of the investigators.  For example, a non-financial conflicting interest exists when a CPHS member who reviews research is the spouse of the principal investigator.  

 

Applicable Regulations and Guidelines

21CFR 56, 45CFR 46, ICH E6, AAHRPP Accreditation Standards, UTHSC-H HOOP 23.10

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