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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

25.2 Subcontracts for non-UM Institutions or Individuals "ENGAGED" in UM Research


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

September 18, 2006



25.2 Subcontracts for non-UM Institutions or Individuals "ENGAGED" in UM Research

The selection of the appropriate subcontract template from among the five subcontract templates linked within these policies depends upon whether the non-UM institution is engaged or only involved in UM research [NOTE – Non-UM investigators who are collaborating in some way in UM research must always be considered as being "engaged" in the UM research].

A non-UM institution is "engaged" with UM in human subject research when its employees or agents intervene or interact with living individuals for research purposes or when its employees or agents obtain identifiable private information for research purposes [45 CFR 46.102(d),(f); 21 CFR 56.102(c), (e); 21 CFR 50.3(c)(g)].   Examples of engagement may be found in the OHRP Guidance Document "Engagement of Institutions in Research".  Engagement in research is contrasted with being "involved" in research.  Involvement in research occurs when an outside institution and/or its employees or agents are not intervening or interacting with living individuals for research purposes or are not obtaining identifiable private information for research purposes (but research may be ongoing on the premises) [45 CFR 46.102(d),(f); 21 CFR 56.102(c)(e); 21 CFR 50.3(c)(g)].  

Under the UM Federal Wide Assurance, UM must ensure that all institutions and investigators ENGAGED with UM in studies involving human subjects operate under a Federalwide Assurance (FWA) for the protection of human subjects.  If the non-UM institution has an IRB or has access to an IRB, the subcontract generally will require that UM and also the non-UM institution conduct individual IRB reviews and give approval for the study.  If the non-UM institution or individual has no means of access to an IRB, the subcontract may define that UM has agreed to act as the IRB of record for the study for that institution.  The terms by which UM agrees to act as the IRB of record for each individual study require prior approval from the Associate Vice Provost for Human Subject Research. 

For non-UM institutions and/or investigators engaged in UM human subject research, it is expected that the subcontract be constructed from the appropriate one of the following templates.  However, it is recognized that in certain circumstances, these subcontracts/agreements may not be suitable.  In such situations, alternative documentation may be permitted upon review and consultation with the HSRO. 

SUBCONTRACT 1:  (For Template of Subcontract 1, CLICK HERE)
This subcontract shall apply if all of the following apply:

1)  The non-UM institution or investigator is engaged in UM research; and

2)  The study is supported, at least in part, by extramural grants or sponsors

3)  UM is the prime awardee of the extramural funds; and

4)  The non-UM institution has its own FWA on file with OHRP and has its own IRB

It is usual that any non-UM institution with its own FWA designate its own IRB to review the research activity and approve the study in a manner additional to UM IRB review and approval.  In such a dual review situation (i.e. when the UM IRB and a non-UM IRB both exercise authority for review of the study, the following conditions shall apply:

1)  The non-UM institution must have an FWA

2)  The UM IRB must receive reports of all IRB-reportable events occurring both at UM and    at the non-UM facility

3)  All non-UM site consent forms should identify the role of UM in the study

NOTE – In some circumstances, UM may agree, pursuant to an IRB Authorization Agreement,  to act as the IRB of record for a study conducted with a non-UM institution or to designate the IRB for the non-UM institution as the IRB of record for the research.

SUBCONTRACT 2:  (For Template of Subcontract 2,  CLICK HERE)
This subcontract shall apply if:

1)  The non-UM institution or investigator is engaged in UM research; and

2)  The study is supported, at least in part, by extramural grants or sponsors

3)  UM is the prime awardee of the extramural funds; and

4)  The non-UM institution does not have its own FWA on file with OHRP

Non-UM institutions without their own FWA will generally be required to file an FWA and create an IRB for its own review of the collaborative UM study prior to the conduct of the research.  However, there may be circumstances in which the University of Miami agrees either to extend its FWA to the non-UM institution and/or investigator for purposes of reviewing and approving the collaborative research study or to serve as the IRB of record for a non-UM institution that has an FWA but no IRB.  In this circumstance, the non-UM institution must sign an IRB-authorization agreement appointing UM as the IRB of record for the study.  The implementation of this option to extend the UM FWA is included in subcontract 2. 

The option to extend the UM FWA to a non-UM institution requires review by the Associate Vice Provost for Human Subject Research and approval by the Vice Provost for Research.  To acquire this approval, the principal investigator must submit a written request that includes a research synopsis and protocol and a description of the direct supervision and oversight of the research activities at the non-UM institution that will be provided by the UM PI and research staff.  The UM PI should also describe his/her understanding of the local area context or how knowledge will be obtained (i.e. use of consultants).  If the research is ongoing at another institution, the PI should provide a report on research results to date and a summary of all unanticipated problems and/or serious adverse events and other reportable adverse events.  The UM IRB shall review the material and make a recommendation to the Associate Vice Provost regarding the request based upon the justification provided. 

SUBCONTRACT 3:  (For Template of Subcontract 3, CLICK HERE)
This subcontract shall apply if all of the following apply:

1)  The non-UM institution or investigator is engaged in UM research; and

2)  The study is not supported by extramural grants or sponsors

3)  The non-UM institution has its own FWA on file with OHRP and has its own IRB

As in the situation for Subcontract #1, it is expected that non-UM institutions with an FWA and an IRB will conduct their own review of the research activity and to approve the study in a manner additional to UM IRB review and approval.  In such dual review situations (i.e. when the UM IRB and a non-UM IRB both exercise authority for review of the study, the following conditions shall apply:

1)  The non-UM institution must have an FWA

2)  The UM IRB must receive reports of all IRB-reportable events occurring both at UM and    at the non-UM facility

3)  All non-UM site consent forms should identify the role of UM in the study

NOTE – In some circumstances, UM may agree, pursuant to an IRB Authorization Agreement, to act as the IRB of record for an unsponsored study conducted with a non-UM institution or to designate the IRB for the non-UM institution as the IRB of record for the research. 

SUBCONTRACT 4:  (For Template of Subcontract 4, CLICK HERE)
This subcontract shall apply if: 

1)  The non-UM institution or investigator is engaged in UM research; and

2)  The study is not supported by extramural grants or sponsors

3)  The non-UM institution does not have its own FWA on file with OHRP

Non-UM institutions without their own FWA will generally be required to file an FWA and create an IRB for its own review and approval of the collaborative UM-initiated study prior to the conduct of the research.  However, there may be circumstances in which the University of Miami agrees either to extend its FWA to the non-UM institution and/or investigator for purposes of reviewing and approving the collaborative research study or to serve as the IRB of record for a non-UM institution. In this circumstance, the non-UM institution shall sign an IRB-authorization agreement appointing UM as the IRB of record for the study.  The implementation of this option to extend the UM FWA is included in subcontract 4 and requires review by the Associate Vice Provost for Human Subject Research and prior approval by the Vice Provost for Research in the same manner as described for subcontract 2.



Documents

INTERNATIOANAL SUBCONTRACT 1 (7-17-09).doc
Created Date:  4/25/2012 5:33 PM
Type: Word (.doc file)
 
INTERNATIONAL SUBCONTRACT 2 (7-17-09).doc
Created Date:  4/25/2012 5:54 PM
Type: Word (.doc file)
 
International Subcontract 3 (7-17-09).doc
Created Date:  4/25/2012 5:55 PM
Type: Word (.doc file)
 
INTERNATIONAL SUBCONTRACT 4 (7-17-09).doc
Created Date:  4/25/2012 5:55 PM
Type: Word (.doc file)
 


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