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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
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Basic Folder Information

7.6 Notification Letters and Approval Stamps


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

February 25, 2009

Revised: May 24, 2011

 



7.6 Notification Letters and Approval Stamps

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.



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