Conflict of Interest Policy
IRB Members
5.23.06
Saint Louis University
Institutional Review Board
CONFLICTS OF INTEREST
Institutional Review Board (IRB) Members
I. POLICY:
Federal regulations [DHHS 45 CFR 46.107(e), FDA 21 CFR 56.107(e)] state: No
IRB may have a member participate in the IRB’s initial or continuing review of
any project in which a member has a conflicting interest, except to provide
information requested by the IRB.”
To assure compliance with federal regulations, the Saint Louis University IRB
requires members to disclose conflicts of interest (COI) related to a project. The
IRB member should notify the IRB Chair and/or IRB Director prior to the meeting
date at which the project will be reviewed.
II. DEFINING CONFLICTS OF INTEREST:
A conflict of interest (COI) generally includes, but is not limited to 1) participation
in the project; 2) a significant financial interest, as defined by the University’s
Conflict of Interest in Research Policy; 3) immediate family involvement in the
project; and/or 4) conflicting personal beliefs. Following is specific information
relating to each of these potential conflict of interest situations.
1) Participation in the project may include serving as a member of the
research team, mentoring, supervising, or being supervised by the
Principal Investigator.
2) A significant financial interest, as defined by the Saint Louis
University’s Conflict of Interest in Research Policy, means anything
of monetary value, including, but not limited to:
a. Any financial interest such as equity interests (e.g., stock
ownership, stock options, or other ownership interests) or
other securities of the organization; partnership interests;
loans to or from the organization; leases of property to or
from the organization; or intellectual property rights more
than $10,000 or representing an ownership of more than 5%
of the organization either from researcher’s own sources or
when aggregated with the interests of the researcher’s
spouse and dependent children. However, it does not
include ownership of any securities in which the researcher
has an interest solely through CREF or another mutual fund.
b. Salary, royalties, consulting fees, honoraria, or other
payments from any organization, if those payments exceed
$10,000 per year when aggregated with the interests of the
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Conflict of Interest Policy
IRB Members
5.23.06
researcher’s spouse and dependent children. This does not
include salary, royalties, or other remuneration from Saint
Louis University, or payments from governmental or nonprofit organizations for seminars, lectures, service on
advisory committees, or service on review panels.
3) Immediate family involvement occurs when the IRB member has a
spouse, minor/dependent child, or live-in family member
participating in the project.
4) A conflicting personal belief occurs when the IRB member has a
religious, moral, or political view that would interfere with the review
of the project.
5) Non-financial conflicts of interest may occur when the IRB member
is in direct competition with the Principal Investigator for resources,
funding, sponsorship, or research subjects.
III. IDENTIFYING CONFLICTS OF INTEREST:
IRB members are responsible for identifying their individual COI and disclosing
this information to the IRB Chair and/or the IRB Director as soon as possible, at a
minimum prior to the meeting date at which any related project is to be reviewed.
The IRB members receive an agenda and meeting packet (copies of the projects
being reviewed at the meeting) generally one week prior to the convened
meeting. An IRB member should not review any materials for which there is a
COI, and should return the materials to the IRB for reassignment.
Typically, if an IRB member is listed on the application as a member of the
research team, the administrative staff and/or IRB coordinators will flag this COI
prior to the IRB meeting, and, the IRB member with conflicting interest would not
be requested to review that particular project.
IV. ACTIONS TAKEN WHEN IRB MEMBER DECLARES CONFLICT OF
INTEREST:
 If the IRB member discloses a COI prior to the IRB meeting, the Chair will
request that the IRB member leave the meeting room prior to the discussion
and vote on the relevant project.
 If an IRB member recognizes a COI during the meeting, he/she must inform
the Chair immediately and will be asked to leave the meeting prior to the
discussion and vote on the project.
 The IRB member with a COI related to a project may provide information
about the project at the request of the IRB as stated in federal regulations.
[DHHS 45 CFR 46.107(e), FDA 21 CFR 56.107(e)]
 The IRB member may not be present for discussion of and vote on any
project for which the member has disclosed a COI.
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Conflict of Interest Policy
IRB Members
5.23.06
IRB Records:
 Voting: IRB members with COI will not be included in the quorum or
the vote for the project.
 Minutes: The IRB will record the COI in the meeting minutes.
V. REFERENCES
Saint Louis University Conflict of Interest in Research Policy
http://www.slu.edu/x27916.xml
Federal Regulations
DHHS 45 CFR 46. 107(e)
FDA 21 CFR 56. 107(e)
Other sites that contributed to the development of this policy:
Association of the Accreditation of Human Research Protection Programs, Inc.
http://www.aahrpp.org/Documents/D000081.PDF
Partners Human Research Committee
http://healthcare.partners.org/phsirb/handbook/IRB_Member_Conflicts_of_Intere
st.1.11.pdf
Stanford University Research Compliance Office
http://humansubjects.stanford.edu/research/documents/IRBMembersCOI.pdf
The University of Texas at Austin
http://www.utexas.edu/research/rsc/humansubjects/forms/irb_policies_and_proce
dures.pdf
Washington University Medical Center- Human Studies Committee
http://medcoi.wustl.edu/medadmin/coisite.nsf/0ee53e934810efcd86256a94005e5
f7d/1da8f38a49d1966786256c0d0055337e?OpenDocument
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