AVERA INSTITUTIONAL REVIEW BOARD
Standard Operating Procedures (SOP)
SOP: GA107
Effective Date:
Revised September 2013
Conflict of Interest Policy
Supersedes document: N/A
I. PURPOSE
The purpose of the Conflict of Interest Policy is to protect Avera Institutional Review Board’s
(the “IRB”) interest when it is contemplating entering into a transaction or arrangement that
might benefit the private interest of an IRB member, an investigator, or family member of a
board member or a principal investigator (PI). The mere existence of a conflict of interest with
the IRB is not necessarily illegal. The failure of the IRB to address possible conflicts of interest
is what may result in illegal activity. This Policy is intended to be in compliance with 42 CFR
50.604 et seq., relating to institutional responsibility regarding conflicts of interests of
investigators.
II. IRB ACTIVITIES SUBJECT TO A CONFLICT OF INTEREST
A conflict of interest of an IRB member , PI (or consultant) generally includes the following.
The aggregate interest of the IRB member, PI (or consultant) and his/her immediate family is
considered.
1. Participation in a project (IRB member is listed as an investigator on the project or is a
member of the research team);
2. Supervision of a project or a situation in which any investigator must report to or is under
the professional supervision of the IRB member;
3. Financial interest if it involves: (a) receiving more than $5,000 annually as salary,
consulting income, or other compensation related to the research; (b) having an equity
interest (including stock or stock options) that exceeds $5,000 or that represents more
than 5% of the company sponsoring the research; (c) having an ownership interest
(including patent, trademark, or copyright interest) in the drug/product/technology that
is the subject of the research project; or (d) receiving or expecting to receive
compensation with a value that may be affected by the outcome of the study;
4. Personal relationship with investigator (IRB member has an immediate family relationship
or other close personal relationship with the investigator);
5. Fiduciary relationship to sponsor (IRB member serves as an executive to a company
sponsoring the research or serves on the company’s board of directors);
6. Other nonfinancial interests that may be conflicting interests, such as if (a) the IRB
member has an interest that he/she believes conflicts with the member’s ability to
review a project objectively; or (b) the IRB member is in direct competition with the
investigator for limited resources, funding, sponsorship, or research subjects, or the
IRB member is considered a personal or professional adversary of the investigators , the
IRB member must disclose the circumstances to the IRB Chairperson for a determination
of whether a conflicting interest exists).
7. Any other reason for which the IRB member believes he or she has a conflicting interest
with the research.
III. PROCEDURES
1.
Duty to Disclose
In connection with any actual or possible conflict of interest, an interested party must
disclose the existence of a financial interest and all material facts to the IRB and have the
conflict noted in the IRB’s meeting minutes or complete the IRB Conflict of Interest
Statement.
2.
Procedures for Addressing the Conflict of Interest
A. An interested party may make a presentation to the IRB disclosing the possible
conflict of interest.
B. The chairperson of the IRB shall, if appropriate, appoint a sub-committee to
investigate alternatives to the proposed transaction.
IV. RECORDS OF PROCEEDINGS
1.
The minutes of the IRB shall contain:
A. Statements of Potential Conflicts of Interest (attached) or language that described the
conflict in the meeting minutes and how the conflict was addressed by the IRB.
B. The names of the persons who disclosed or otherwise were found to have a conflict of
interest in connection with a research project, the nature of the conflict of interest, and
the IRB’s decision as to how the conflict should be addressed.
C. The names of the persons who were present for discussions and votes relating to the
disclosed conflict of interest, the content of the discussion, and a record of any votes
taken in connection therewith (including a member’s recusal, no vote).
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