Login  
HSRO Home


Search

 Go
Advanced Search


Investigator Resources

Information for Research Participants
Information for Study Teams
Information for Sponsors
Institutional Review Boards
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
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
HIPAA
Translations
Western IRB (WIRB)
About the HSRO


Basic Folder Information

7.2 Recommendations for Review Category


Apoproval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

March 14, 2006

Revised: May 24, 2011

 



7.2 Recommendations for Review Category

As part of the submission process for new or continuing studies, the Principal Investigator shall be asked to recommend whether the study, by its scope and protocol, falls into one of the specific review categories defined in 45 CFR 46 and 21 CFR 56.  These categories are:

1)     Exempt Review (does not apply to studies regulated by the FDA)

2)     Expedited Review 

3)     Convened IRB Review

It is the responsibility of the Principal Investigator to understand and request an appropriate review category for his/her application.  Investigators are urged to consult with HSRO regulatory staff before making their recommendations to the HSRO and the IRB regarding the review category.

The submissions and recommendations by the Principal Investigator are made to the HSRO where they are screened by trained HSRO staff who shall forward the recommendations of Principal Investigators and the recommendations made by them (the staff) on behalf of the HSRO to the IRB.  Final decisions as to the review category of new or continuing studies shall be made by the IRB.

The HSRO recommends and the IRB determines review category on the basis of federal regulations and the guidance provided on the website of the Office for Human Research Protections (OHRP).  Specific information on determining the review category for study applications is provided in subsequent sections of these policies.

Those studies recommended recommended and meeting criteria for exempt or expedited review shall be forwarded to the IRB chair or chair-designee for review.  Chair-designees must be members or alternate members of the IRB.  The IRB chair or chair-designee shall make the final decision as to whether the study may be reviewed within the proposed exempt or expedited category or whether the study should be deferred to the convened IRB.

IRB chairs and chair-designees shall conduct reviews of studies that fit within the exempt or expedited categories on behalf of the IRB.  The applications of those studies that fit under the "Convened IRB Review" category shall be made available to all members of the IRB.  IRB chairs/IRB-designees may determine that studies recommended for exempt or expedited review require convened IRB review.  Conversely, the convened IRB may determine that studies recommended for "Convened IRB Review" require exempt or expedited review.



Footer Block

University of Miami Office of Research UM School of Medicine CITI Program Jackson Health System
 University of Miami logo University of Miami
Human Subjects Research Office

1500 NW 12th Avenue, Ste. 1002, Miami, FL 33136
Tel. 305-243-3195
Copyright, University of Miami, All Rights Reserved
Requests for information. Send technical feedback.
View Privacy statement