Conflict of Interest

Federal regulations require the establishment of policies to manage conflicts of interest as they relate to human subjects research. The IRB recognizes that many research projects have the potential for actual or perceived conflicts of interest. The IRB is mandated to protect subjects from financial conflict of interest which may predispose coercive enrollment practices or the possibility of reporting biased or inaccurate data. The intent of the following guidelines is to protect research subjects and their families and to delineate the responsibilities of the researcher.

Guidelines for researchers.

Researchers must include with their application materials all information about a financial relationship with a sponsor. This includes a copy of a grant award, contract, budget and equity interest documentation.

The consent form must include a statement to inform the subject and family that the researcher will benefit financially from the research and from whom they may request additional information, other than from the researcher, about the nature of this benefit.

If the contract, budget or equity interest changes during the research project, the researcher must notify the IRB. This includes the termination of a contract, a supplement to a contract, or an extension.

A researcher's financial relationship can include stipends, compensation for enrolling subjects (finder's fee) or any other monetary or non-monetary benefit such as stock, licenses or patents, equipment, supplies, samples, computers, gifts, contracts or use of space or property. The consent form must disclose that the researcher has some financial relationship or compensation involved in the research project.

Payments to subjects:

Financial disclosure also includes the proposed payment or reimbursement of research subjects. If you propose to provide an incentive for participation or to reimburse subjects for expenses of participation, you must include this information with a budget explication. Payment to research subjects for participation in studies is not considered a benefit, it is a recruitment incentive. The amount and schedule of all payments should be presented to the IRB at the time of initial review. The IRB will review both the amount of payment and the proposed method and timing of disbursement.

Any payment should accrue and be paid as the study progresses and not be contingent upon the subject completing the entire study. While the entire payment should not be contingent upon completion of the entire study, payment of a small portion as an incentive for completion of the study is acceptable, providing that such incentive is not coercive. All information concerning payment to subjects, including the amount and schedule of payment(s) should be set forth in the consent form.

The role of the IRB is to determine if the proposed payments of research subject may be so excessive as to constitute a coercive inducement to the target population. If the IRB believes the payments are coercive, we will request you to consider an alternative.

Questions requiring a written response:

If a researcher will receive some form of compensation or incentive, the following questions will assist researchers in providing full disclosure. Please provide written responses to these questions with your application:

1. Do you or your family have any financial relationship (as described in #4 above) or an agreement (written or verbal) regarding any form of financial compensation which you or your family will receive for your involvement in a research project?
____No ____Yes

2. If yes, please describe.

3. If you expect to receive any financial or non-monetary benefit, to what extent do you think it affects your objectivity in the consent process with subjects?

4. Describe how you will minimize the potential for coercive enrollment.