The HSRO shall notify Principal Investigators and institution leaders (when appropriate) in writing of IRB determinations relative to approval, disapproval, required modifications, suspensions, terminations and other information and matters for which such disclosure is required. Determination letters from the HSRO shall reference or describe the UM IRB number of the study, Principal Investigator, project title, date of the IRB action, the IRB action itself, and other pertinent information. Since the determination letters are generated electronically, language defining the electronic signature shall attest to the fact that these letters were prepared according to IRB and HSRO specifications. Such electronically-generated determination letters are considered by the IRB to be a sufficient statement of approval, disapproval or other IRB decisions and shall serve as official notification documents to sponsors or others.
Letters documenting the approval of initial or continuing studies or study amendments, no matter whether approved by expedited review or by the convened IRB, shall specify conditions and terms of approval. They shall be forwarded to the Principal Investigator with approved consent forms and other documents that require marking by the HSRO with an approval watermark or stamp.
The UM IRB approval watermark/stamp indicates that the document has been reviewed and approved by the IRB and shows the date the approval was granted. The watermark/stamp shall only be applied to finalized documents and shall appear on each page of the consent form. Commonly, the approval watermark/stamp is used for the following types of documents which may only be used with a valid watermark/stamp:
1) Consent documents
2) Consent form addenda
3) Assent documents
4) Information sheets associated with the consent process (as directed by the IRB)
5) Advertising/subject recruitment materials reviewed and approved by the IRB
Letters of approval of initial or continuing studies shall include the following information/instructions when applicable:
1) The Principal Investigator is responsible for compliance with all applicable federal regulations and UM written policies and procedures
2) It is necessary to retain signed consents by all subjects unless a waiver is granted
3) Participants must sign a consent form that has been watermarked/stamped in a manner that indicates IRB approval. Only the currently-approved watermarked/stamped consent forms may be used
4) Any and all modifications (amendments) to the protocol and consent form must be submitted to and approved by the IRB before implementation.
5) Continuing and final reports are required.
Letters of IRB disapproval shall specify any necessary actions required for securing IRB approval, if applicable.
The IRB has authority to modify consent forms and protocols in a manner it deems necessary to secure IRB approval. If such modifications have been made by the IRB and IRB approval is given to the study based in part on these modifications, approval letters shall indicate that modifications have been made. Letters shall also state that the study must be carried out, and the consent forms must contain the modifications, as approved by the IRB. If the Principal Investigator implements the study following notification that the IRB has made modifications, this action shall confirm that the Principal Investigator accepts the IRB modifications and is obligated to carry them out. If the Principal Investigator finds one or more of the IRB's modifications to be unacceptable, he/she shall return the acceptance letter to the HSRO and he/she may appeal the decision to the convened IRB within 30 days. If the Principal Investigator returns the acceptance letter to the HSRO, he/she must not implement the study until such time as IRB approval is given in another letter to the Principal Investigator.