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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

13.6 Voluntary Suspension by the Principal Investigator or Temporary Withhold by the Institution



Approval Block

Review:

IRB Policy and Procedure Committee

Original Approval:

June 1, 2008

Revised:

April 30, 2012, June 7, 2012

 



Policy

In addition to the actions described above, an IRB-approved study may be voluntarily suspended upon request by the Principal Investigator of that study. The Associate Vice Provost for Human Subject Research may also temporarily withhold permission for a Principal Investigator to conduct a study at any time. Voluntary suspensions and temporary withholds shall be governed by the policies on suspensions defined in this SECTION 13 of the IRB Written Policies and Procedures with regard to enrollment, subject safety, the continuance of treatments, and the collection, evaluation and use of research data and information. These policies include that subject enrollment must cease and that study interventions or interactions with already enrolled subjects should continue only when these are in the best interest and safety of individual subjects as determined by those authorized to make such decisions.

Requests for voluntary study suspension should be directed to the HSRO in writing. Voluntary suspensions require approval by the Associate Vice Provost for Human Subject Research or his designee. Approval of a suspension volunteered by the Principal Investigator is subject to the stipulation that lifting of the voluntary suspension by Principal Investigators must be preceded by written notice to the HSRO at least one full working day prior to the resumption of study activities and/or enrollment. A voluntary suspension of enrollment and/or other study activities by the Principal Investigator without administrative suspension shall not be defined as a "suspension" as per definition in other policies in this section and shall not carry with it the reporting requirements of a suspension for cause.

If the Associate Vice Provost for Human Subject Research temporarily withholds study permission or subsequently reinstates such permission, he/she must inform the Principal Investigator and the HSRO promptly in writing. Such temporary withholds by the Institution shall also not carry the reporting requirements of a suspension for cause, since the withdrawal of permission is temporary and must be unrelated to compliance with human subject research-related federal regulations or UM IRB policies and determinations.

A voluntary suspension shall not be approved for a study that is already in suspension either by administrative action or by determination of the IRB. However, a study under voluntary suspension may be suspended either by administrative action or by IRB determination. If a suspension "for cause" is imposed administratively or by the IRB, this suspension shall override the voluntary suspension or temporary withhold of permission by the Institution and carry with it the reporting requirements defined in other policies in this section.



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