Compensation for Injury Frequently Asked Questions

A sponsor asked me to make changes to the compensation for injury standard paragraphs in the consent form. Who can I contact to review and approve the changes?

The University is committed to the highest regulatory and ethical standards to protect research subjects and has developed these paragraphs to meet these standards. The clinical trial agreements that ORPA negotiates are aligned with these consent statements. Thus, our contracts and consent reflect the level of compensation the University considers to be a minimum for conducting sponsored trails here. Unless the contract is amended because of unusual circumstances, we cannot change the wording. The standard paragraphs were developed to avoid lengthy delays for a case-by-case review of sponsor requests for changes. If the investigator is unable to have the sponsor agree to use the standard wording, OHSP, ORPA and OCMC can become involved to achieve that end.