UAB Policy on IRB Member and Consultant Conflicting Interest - IRB POL009

UAB Policy on IRB Member and Consultant Conflicting Interest - IRB POL009

Abstract:
This policy defines the circumstances that constitute an IRB member and consultant conflict of interest. Immediate family members, dependents, and anyone else who has a personal, professional, or financial tie with an IRB member or consultant may not be reviewed by that member or consultant.
Effective Date:
1/25/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     POL009
Effective Date:   3/30/07
Revision Date:  1/25/10
Subject:  UAB Policy on IRB Member and Consultant Conflicting Interest

DEFINITIONS

Immediate family member means the spouse, parent or parent of a spouse, child or child of a spouse, sibling or sibling of a spouse, or a dependent. This includes “step” relationships.

Dependent means any person who resides with an IRB member or who receives 50% or more support from an IRB member, regardless of age. This includes “step” relationships.

Note: These definitions, which apply to IRB members and consultants, differ from those that apply to investigators who submit Conflict of Interest Disclosure Forms (SUP410) to the Conflict of Interest Review Board (CIRB).

POLICY STATEMENT

Personnel responsible for business development, raising funds or garnering support for research at UAB shall not serve as an IRB member or be involved in the daily operations fo the IRB.

An IRB member will not review, participate in the deliberations on, or vote upon any
research in which the member has a conflicting interest whether personal, professional, or financial except to provide information about the research at the request of the IRB whether the research is reviewed by a convened board meeting or expedited procedures. A personal conflicting interest means the IRB member or an immediate family member serves as a contributor to the research project as an investigator, collaborator, consultant. or research staff A professional conflicting interest means the IRB member (or immediate family member) serves as a trustee, director, officer, manager, or scientific advisor of any entity sponsoring the research. A financial conflicting interest means the IRB member or the spouse or dependent of a member or the spouse has or receives anything of monetary value (no de minimus amounts apply), including but not limited to, salary or payments for other services (e.g., consulting fees or honoraria), equity interests (e.g., stock, stock options, or any other ownership interests), intellectual property rights (e.g., patents, copyrights, and royalties from such rights) with respect to the research (including the product or service being evaluated) or research sponsors. Financial conflicting interest excludes an interest arising from investment in a business by publicly traded mutual, pension, or institutional investment funds over which the IRB member, spouse, or dependent does not exercise control of investment decisions. The above policy applies to both convened board and expedited review procedures and to IRB consultants as if they were IRB members.

IRB members must disclose a conflicting interest to the IRB and shall excuse themselves from a convened board meeting during deliberation and voting. The IRB will develop procedures to identify and disclose conflicting interests of members and consultants for full and fair review of research. The IRB will not retain consultants with conflicting interests unless it is impracticable to get needed information otherwise.

Notwithstanding the above, IRB members may, exercising their own judgment, absent themselves from discussion, deliberation, or vote on any agenda item to avoid the appearance, in their own judgment, of a conflicting interest, bias, or effects of undue influence.

Approved on March 1, 2010, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director