RSRB Feedback Form
Institutional Guidance and Additional Information
- University's Compensation for Injury Policy: A copy of the subject injury language from the contract is no longer required as a part of your submission documentation. An agreement between ORPA (Office of Research and Project Administration) and the OHSP (Office for Human Subject Protection) provides for u>standard
Compensation for Injury (subject injury) language in the
clinical trial agreement and in the informed consent document.
Compensation for Injury:
Note: The new standard compensation for injury language is for all new studies submitted after January 29, 2008. In order to be consistent with previously approved contract language, we will not incorporate this language for amended or re-approved studies.
- Source of Funding: University of Rochester informed consent documents for new studies will now include a Source of Funding section. This section will contain the following statement: The University of Rochester is receiving payment from [sponsor's name] to conduct this study.
- Submission of Departmental Letterhead: WIRB® has requested the inclusion of electronic departmental letterhead with each new study submission. This is an effort to ensure that current letterhead is used for consent forms.
- Consent Form Submission: WIRB® prefers that you submit sponsor consent forms electronically with your changes highlighted in red-lined format. WIRB® often already has an approved sponsor consent template. If your submitted changes are simply standard UR items, the consent may qualify for expedited review.