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Investigator Resources

Information for Research Participants
Information for Study Teams
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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

11.1 General Principles


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

February 21, 2006

Revised:

February 13, 2012

 



11.1 General Principles

Prior to their implementation, all modifications to an ongoing study must be submitted to the HSRO and approved by the IRB pursuant to regulations and these policies. Examples of study modifications include those related to the protocol or informed consent documents or process, staffing, advertisements, number of subjects to be enrolled, questionnaires, etc.

The only case where a change can be made to an approved study without prior IRB approval is when the change is necessary to eliminate apparent immediate hazards to human subjects [45 CFR 46.103(b)(4)(iii), 21 CFR 56.108(a)(3) and (4)].  In this case, the Principal Investigator must notify the IRB of such changes in writing within ten (10) working days of the occurrence.  This notification should be on the amendment forms supplied by the HSRO.

To obtain IRB approval for study amendments, the Principal Investigator must submit to an amendment application via eProst describing all proposed modifications.  Upon receipt of this form, an HSRO staff member will recommend into which category the amendment fits (c.f. Section 11.2) and forward the amendment for further review pursuant to that category.  Any significant new findings that arise from the review process and that might decrease participants' willingness to continue participation must be provided to participants through the re-consenting or other process as determined by the IRB. All members of the IRB will be informed of amendments that are approved using the expedited review process.

Amendments will only be approved for studies with active IRB approval.  Approval of a study amendment shall not extend the length of study approval or the expiration date of that approval.

Upon final approval of amendments, modified consent/assent materials or recruitment/advertising materials will receive a stamp/watermark of approval and correspondence will be sent to the Principal investigator indicating what modified documents were approved.



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