To establish conflict-of-interest rules in order to regulate the disclosure and avoidance of these conditions.
This policy establishes points to consider in determining whether specific conflicts of interest in research might affect the rights and welfare of human subjects, and if so, what actions the IRB should consider to protect those subjects.
This policy supports the requirements established by the HHS guidance entitled, "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection" dated May 5, 2004.
Conflict of Interest is a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) is unduly influenced by a secondary interest (such as financial gain).
I. Underlying Principles
The regulations protecting human research subjects are based on the ethical principles described in the Belmont Report: respect for persons, beneficence, and justice. It is important to ensure that conflicts of interest do not compromise any of these principles.
The most frequent conflict of interest is financial. Concerns have grown that financial conflicts of interest in research, derived from financial relationships and the financial interests they create, may affect the rights and welfare of human research subjects. Financial interests are not prohibited, and not all financial interests cause conflicts of interest or harm to human subjects.
II. IRB Review
In order to ensure that an investigator does not have an undue conflict of interest in a research study, the investigator will be asked to submit a Financial Disclosure Statement as part of the Research Application. In addition, the IRB will request information to help answer questions such as these:
If a conflict of interest is found to exist, the IRB shall meet to determine if the rights and welfare of human subjects could be better protected by asking the investigator to initiate any one or more of the following actions, if necessary:
- Does the research involve financial relationships that could create conflicts of interest?
• How is the research supported or financed?
• Where and by whom was the study designed?
• Where and by whom will the resulting data be analyzed?
- What interests are created by the financial relationships involved in the situation?
• Do individuals or institutions receive any compensation that may be affected by the
• Do individuals or institutions involved in the research:
• Have any proprietary interests in the product including patents, trademarks,
copyrights, and licensing agreements?
• Have an equity interest in the research sponsor and is it a publicly held company?
• Receive significant payments of other sorts (e.g. grants, compensation in the
form of equipment, retainers for ongoing consultation, and honoraria)?
• Receive payment per participation or incentive payments, and are those
payments within the norm?
- Given the financial relationships involved, is the institution an appropriate site for the research?
- How should financial relationships that potentially create a conflict of interest be managed?
- Reduction of the financial interest;
- Elimination of the financial interest (i.e. severance of the divestiture that caused the conflict of interest);
- Disclosure of the financial interest to prospective subjects (conflict of interest must be disclosed in the consent document);
- Changing of the protocol;
- Separation of responsibilities for financial decisions and research decisions;
- Additional oversight or monitoring of the research;
- Establishment of an independent data and safety monitoring committee or similar monitoring body;
- Modification of role(s) of particular research staff or changes in location for certain research activities (e.g., a change of the person who seeks consent, or a change of investigator);
- Disapproval of investigator’s ability to conduct the research.
III. Investigator Responsibilities
Openness and honesty are indicators of respect for persons, characteristics that promote ethical research and can only strengthen the research process. In order for the IRB to verify that no conflict of interest exists for investigators submitting research studies for review, the following information shall be included in the Research Application:
- A copy of the CHS IRB Financial Disclosure Statement for each investigator. If the sponsor has a Financial Disclosure Statement, the investigator may submit this as well.
- An itemized study budget listing the amounts received for each procedure per participant and the total amount received per participant.
- If an investigator is receiving an enrollment stipend or will in any other way gain financially from participating in the study, this must be disclosed in the consent form.
IV. Member Conflicts
As stipulated in HHS regulations at 45 CFR 46.107(e), no IRB member may participate in the IRB's initial or continuing review of a project in which the member has a conflicting interest, except to provide information requested by the IRB. .
In compliance with OHRP recommendations, IRB members absent themselves from the meeting room during final deliberations and abstain from voting on research in which they have a conflicting interest. This information is noted in the IRB meeting minutes.
Whenever possible, the CHS IRB will avoid the installment of primary IRB members who often have a conflict of interest. These members would need to be excused from deliberations and voting - creating the risk of losing a quorum. For example, researchers who are frequently listed as the primary investigator for studies being reviewed by the IRB are not good candidates for primary IRB membership. However, it is acceptable for such individuals to be alternate members.
COTTAGE HEALTH SYSTEM POLICY
|ORIGINAL POLICY EFFECTIVE DATE:
||4/06, 1/08, 1/09