Conflict of Interest Pertaining to Investigators
The Institutional Review Board must ensure that financial or other business interests do not compromise the protection of human subjects in research.
The regulations protecting human research subjects are based on the ethical principles described
in the Belmont Report. Transparency and full disclosure are indicators of the Principle of Respect for Persons. This principle maintains that individuals should be treated as autonomous agents and demands that subjects enter into the research voluntarily and with adequate information.
If an investigator on the study team has an actual, potential, or perceived conflict of interest, this information must be disclosed to the IRB.
Conflict of Interest: A financial or other business interest in the source(s) of funding, materials, or equipment related to a research study.
Investigator: For the purposes of this policy, “investigator” refers to any member of the study team or a member of their family.
Family: For the purposes of this policy, “family” refers to an investigator’s spouse, and the parents, children, and siblings of either the investigator or the investigator’s spouse.
Examples of potential conflicts of interest in research involving human subjects may include, but are not limited to:
• A researcher or family member participates in research on a technology, process or product owned by a business in which the faculty member holds a financial interest.
• A researcher participates in research on a technology, process or product developed by that researcher.
• A researcher or family member has a financial or other business interest in an entity which is supplying funding, materials, products, or equipment for the current research project.
• A researcher or family member serves on the Board of Directors of a business which is supplying funding, materials, products, or equipment for the current research project.
•A researcher receives consulting income from an entity that is funding the current research project.
The IRB may require additional safeguards, restrictions, disclosures, or access to non-conflicted individuals when, in the IRB’s judgment, such measures would add protection to the rights and welfare of subjects. The research consent form provided to subjects must include an appropriate description of any relationship that might be perceived as a potential conflict of interest. This requirement is consistent with §46.109(b) .
It is the responsibility of a Principal Investigator to inform the entire study team and all research subjects of any COI related to a research study.
Conflict of Interest Committee (COIC)
In the event that an investigator indicates on an IRB submission that a COI may exist, a copy of that submission will be forwarded to the COIC Administrator as part of the administrative pre-review process. The related IRB file will be open to examination by the COIC, so long as that file remains active.
If the investigator disclosing a conflict of interest has an approved management plan through the COIC, the IRB may not limit or reduce the conditions imposed by that management plan, but may impose additional requirements if necessary in order to find that the regulatory criteria for approval of the research have been met.
§46.109(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
Policy approved February 16th 2010.