SUBJECT: Conflict of
Interest
PURPOSE: To establish the guideline for
managing conflict of interest involving the IRB members.
POLICY: To ensure that no IRB member participates in the initial or continuing review of any protocol in which the member has a conflicting interest, except to provide information requested by the IRB. The IRB members, including the Chairperson, who have conflicting interests are required to disclose such interests and to recuse themselves from deliberations, quorum counts, and votes on the relevant protocol.
SCOPE:
This policy covers all IRB members, including the Chairperson and
alternate members, the Institutional Official, and the Director of the Office of
Research Integrity.
DEFINITION: Conflict of Interest is defined as any situation in which financial or personal obligations may compromise or present the appearance of compromising an individual’s or group’s professional judgment in conducting, reviewing, or reporting research. Conflict of interest is defined as any situation in which financial or personal obligations may compromise or present the appearance of compromising an individual’s or group’s professional judgment in conducting, reviewing, or reporting research. Conflict of interest may arise because the intellectual property involved in many research discoveries, industry academic partnerships and pharmaceutical or biotech companies may offer researchers or staff incentives for conducting trials or enrolling subjects.
RESPONSIBILITY:
The IRB Chairman and
members have the responsibility to report any situation in which
financial or personal obligations may compromise or present the appearance of
compromising his/her professional judgment in conducting, reviewing, or
reporting research.
PROCEDURE:
To avoid possible conflict of interest among institutional
officials, the Vice President for Research and the Director of the Office of
Research Integrity, do not serve on the IRB as voting members because those who
administer the research programs have access to wider knowledge, have the
ability to influence programmatic and budgetary decisions, and are in a position
to possibly exert undue influence on the IRB.
The IRB members,
including the Chairperson, who have conflicting interests are required to disclose such interests and to
recuse themselves from deliberations, quorum counts, and votes on the relevant
protocol. Such absences are
recorded in the meeting’s minutes as recused and not as
abstentions. The IRB is careful to
keep a quorum if votes are taken during absences.
"Immediate family" means spouse, children, parents, in-laws, and siblings.
"Interest related to the research" means an interest in the sponsor of the research or a product or service being tested.
An IRB member is considered to have a conflicting interest if the IRB member, or the member's immediate family have:
(1) Any Involvement in the design, conduct, or reporting of the research
(2) Any ownership interest, stock options, or other financial interest related to the research unless it meets four tests:
-
<$10,000 when aggregated for immediate family
-
Publicly traded on a stock exchange
-
Value will not be affected by the outcome of the research
-
<5% interest in any one single entity
(3) Any Compensation related to the research unless it meets two tests:
-
<$10,000 in the past year when aggregated for immediate family
-
Amount not be affected by the outcome of the research
(4) Any Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright, or licensing agreement.
(5) Any board or executive relationship related to the research, regardless of compensation.
(6) Any other reason for which an IRB member believes that the member cannot objectively review the research.
Procedures for Removal of Members. Any IRB member may be removed for not acknowledging conflict of
interest. In the event a member is
charged with not disclosing a conflict of interest, the IRB will review the
charges and a majority vote, not including the accused, may result in the
recommendation to remove the member from the Board. The Director, Office of Research
Integrity will make the final decision as to the removal and notify the member
and the IRB, in writing.
IRB Member Conflict
of Interest Checklist
FOLLOW-UP
RESPONSIBILITY: Director,
Office of Research Integrity
REFERENCES: 38 CFR 16
21
CFR 50
21 CFR 812
21 CFR 312