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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

6.4 Consultants and Ad Hoc Reviewers


Approval Date

 

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

March 14, 2006

Revised: May 24, 2011; June 8, 2011

 



6.4 Consultants and Ad Hoc Reviewers

Although IRB members are encouraged to seek informal consultation as a normal part of their review process, care should be given regarding confidentiality issues.

At its discretion, the IRB may invite scientists or non-scientists from within or outside the University, who have special expertise, to function as consultants and ad hoc reviewers of human research studies.  Once a consultant is identified, s/he shall be provided with a confidentiality agreement for signature, and must affirm that s/he has no conflict of interest pursuant to University policy or individual sponsor contact. Contingent upon receipt of the signed confidentiality agreement and the conflict of interest affirmation by the HSRO, the consultant shall be provided with all documents submitted to the IRB relevant to the specific matters under IRB review as will as the questions posed by the IRB for which guidance is being sought.

Guidance/recommendations to the IRB from consultants may be given by personal contact, in writing, by phone, through the internet or other appropriate communication mechanisms. Verbal guidance/recommendations from consultants provided to the IRB chair or designee conducting expedited reviews shall be summarized by the IRB chair or designee and included within the study file. Written guidance/recommendations from consultants provided to the IRB chair or designee shall be added to the study file. Verbal or written guidance/recommendations from consultants provided to the convened IRB shall be presented at the IRB meeting by the member or other receiving entity and summarized in the meeting minutes. If in writing, such guidance/recommendations form consultants shall be added to the study file.

A consultant may advise in the preparation of a presentation to the IRB, may participate at the deliberations as a guest at the request of the IRB and may make recommendations on the project, but s/he may not vote.  

If an IRB member believes that a consultation is required, s/he may identify the consultant and recommend consulting fees to the Associate Vice Provost for Human Subject Research, who is authorized to determine and arrange for reasonable compensation to consultants.



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