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 standard Compensation for Injury (subject injury) language in the clinical trial agreement and in the informed consent document. (See Below)
  
  

  Note: The new standard compensation for injury language is for all new studies submitted after Janruary 29, 2008. In order to be consistent with previously approved contract language, we will not incorporate this language for amended or re-approved studies.

If you are directly injured by the drugs [or devices] that are being studied, or by clinical procedures solely required to participate in the study, you may need to pay for treatment of your injuries, but you will be reimbursed for the reasonable and necessary medical expenses for such treatment. You will not be required to pay for emergency medical treatment provided at Strong Memorial Hospital or Highland Hospital. The University may seek payment for treating study related injuries from your health insurer or the study sponsor.

• 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 5 sheets of original 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 in one of the following ways: (1) Submit a hard copy of the sponsor consent with your hand-written changes clearly visible or (2) submit the sponsor consent on disk 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.

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