Payment to Participants

POLICY

Federal regulations and the various codes of ethics governing human subject research require that no "undue inducements" be offered potential research subjects in order to secure their participation in a study. IRB reviewers consider the following regarding costs and compensation for subjects participating in research studies:

1. Subjects should not incur additional financial burdens as a result of participation in a research activity.
2. Subjects should not be induced to participate in research primarily by the prospect of financial gain.
3. There must be equality in compensation for completion of research activities whether patients, controls or active participants.
4. Credit for payment should accrue as the study progresses and should not be contingent upon the participant completing the entire study.
5. Any amount paid as bonus for completion should be reasonable and not be so large as to unduly induce participants to stay in the study when they would have otherwise withdrawn.
6. An investigator may reimburse subjects for any expenses incurred as a result of their participation in a study. This payment may include reimbursement for such items as transportation to and from the research site, parking, meals and baby sitter services.
7. An investigator may offer reimbursement for time expended by subjects participating in a research activity in keeping with the CPHS belief that a subject should be able to volunteer without incurring undue burdens.

Research related injuries: For industry sponsored trials involving investigational drugs or devices, the sponsor of this study must pay for reasonable and necessary medical expenses if the injury is a direct result of taking the study medicine or undergoing study procedures, and not due to the natural course of any underlying disease or treatment process unless otherwise determined by the IRB.

Investigational devices: The IDE regulations allow sponsors to charge a reasonable price for an investigational device.

PROCEDURE

The initial application form includes questions on payment to participants. Consent templates have a section on costs and compensation to participants. Information regarding payment, including amount and schedule of payment should be included in the consent document. IRB reviewers consider payments to participants in the review process.

REFERENCE TO OTHER POLICIES

1. Initial Review

ATTACHMENTS

1. Initial IRB Application
2. Consent Template

If you find errors in this document, contact cp[email protected]