SUBJECT: Conflict of
Interest
PURPOSE: To establish the guideline for
managing conflict of interest involving investigators and research staff.
POLICY: To manage, reduce, or eliminate
potential or real conflicts of interest
(e.g. financial, relational,
or institutional) in approved research.
This policy covers the
investigators and their staff to ensure that they report any conflict of
interest and ensure that
financial or other incentives do not negatively impact the collection,
analysis and interpretation of data, scientific objectivity and integrity, and
ultimately the public trust in the research.
SCOPE:
This policy covers all investigators and research staff.
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:
Even though the Principle Investigator (PI) is responsible for ensuring that financial or other incentives do not negatively impact the collection, analysis and interpretation of data, scientific objectivity and integrity, and ultimately the public trust in the research all such potential conflicts of interest must be reported to the IRB.
In addition, if the investigator is also
the treating physician, he/she must not unwittingly exert coercion or undue
influence on subjects to participate in research.
PROCEDURE:
"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.
Investigators and other research staff involved in the design, conduct, or reporting of research must disclose to the IRB at the time of initial and continuing review the following financial interests:
(1) 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
(2) Any compensation related to the research unless it meets two tests:
-
<$10,000 in the past year when aggregated for immediate family
-
Amount not to be affected by the outcome of the research
(3) Any proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement
(4) Any board or executive relationship related to the research, regardless of compensation.
Investigators and other research staff involved in the design, conduct, or reporting of research must disclose to the IRB any change in the above interests during the period for which research is approved.
If an investigator checks "yes" in any box on the Conflict of Interest section of the application, the Director, ORI is responsible for reviewing that application and reporting this information to the MU Conflict of Interest Committee.
This facility requires all faculty to submit conflict of interest disclosure forms to the Office of Research Integrity to be evaluated by the Conflict of Interest Committee.
As one method of preventing, monitoring, managing, and resolving conflicts of interest, the IRB requires full disclosure of conflicts of interest by investigators. Full disclosure of conflicts of interest demonstrates good faith and protects the integrity of the research and the reputation of the institution and the investigator. If necessary, the IRB may require the information be included in the Informed Consent Form to inform prospective subjects about any conflict of interest.
Role conflicts (investigator/caregiver) may require particular attention
for studies involving more than minimal risks. Investigators who are also a subject’s
caregiver should not perform the recruitment action, but rather should enlist
the services of other personnel to approach potential subjects for subject
recruitment to avoid undue influence on subjects to consent. The IRB will also review proposals to
ensure the absence of an institutional conflict of interest (e.g., funding
arrangements of institution with protocol sponsor).
The convened IRB will review all financial interests disclosed by investigators and research staff as indicated on the application form regardless of whether the Conflict of Interest Committee determined that a conflict of interest existed. The convened IRB has the final authority to decide whether the financial interest and its management, if any, allow the research to be approved.
Investigator 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