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Investigator Resources

Information for Research Participants
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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
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Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
HIPAA
Translations
Western IRB (WIRB)
About the HSRO


Basic Folder Information

25.1 General Principles


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

September 18, 2006



25.1 General Principles

UM-initiated human subject research may take place at, or otherwise involve, a non-UM institution and/or investigator.  Unless such studies are considered exempt under 45 CFR 46.101 and/or 21 CFR 56.104(d) by the UM IRB, the involvement of a non-UM institution and/or investigator in UM-initiated human studies requires that the study approval process include an agreement or subcontract with the non-UM institution or investigator.  If an agreement or subcontract is required, this agreement or subcontract must be signed by the appr3opriate institutional officials prior to IRB approval of the study and shall be submitted by the principal investigator to the IRB as part of the study materials available for IRB deliberations. 

The requirement for a subcontract/agreement applies to studies with human subjects that include a non-UM institution and/or investigator regardless of source or plans for funding.

Unless other arrangements are approved by the Associate Vice Provost for Human Subject Research to ensure research oversight at collaborating institutions, it is the responsibility of the UM IRB to review UM studies that take place at, or otherwise involve non-UM institutions and/or investigators and to determine whether these studies and the subcontract/agreement ensure optimal human subject protection.   It is the responsibility of the HSRO and the Associate Vice Provost for Human Subject Research to monitor this policy and facilitate subcontracts/agreements that are required for approval of this research. 

For purposes of this policy, UM-initiated studies are those which fit any of the following criteria: 

1)  The University of Miami and the UM principal investigator are recipients of the prime award (i.e. the grant supporting the research)

2)  The University of Miami and the UM principal investigator are prime recipients of the funds from sponsors supporting the research

3)  The University of Miami and the UM principal investigator have initiated the research and/or provide the research leadership

NOTE – In situations where UM is a subcontractor of a study initiated by another institution, UM IRB review and approval is still required.  Documentation relating to the conduct of the study with regard to human subjects must be submitted to the HSRO.

For purposes of this policy, a non-UM institution is defined as an institution (or an employee or   agent of the institution) that is not under the authority of UM and is located within the    United States or a United States territory.  Examples include clinics, schools, other universities, consulting firms or other institutions where activities include interaction or intervention with human subjects and/or the collection or analysis of identifiable data. 

For purposes of this policy a non-UM investigator is someone not employed by or under the legal authority of UM. 

This policy does not apply to non-UM institutions or facilities that are located outside of the United States and for which the "International Research Policy Involving Foreign Institutions in UM Human Subject Research" shall apply.



25.1(a) Responsibilities of the Principal Investigator

25.1(a) Responsibilities of the Principal Investigator

 

For studies involving a non-UM institution and/or investigator, it is the responsibility of the principal investigator to:

1)  Select and ensure completion and approval of an appropriate subcontract from among the five template subcontracts referenced in this policy [NOTE - See links to these subcontracts in the text below].  These templates are suggested but may be modified to meet specific circumstances

2)  Ensure that the study application with protocol that is submitted to the UM IRB for review and approval describes the activities to be carried out at the non-UM institution

3)  Ensure that adequate resources will be available at the non-UM institution to conduct the research safely and effectively in full accordance with the approved protocol

4)  Ensure that all persons interacting with human subjects and/or with their identifiable data are adequately trained in the protection of human subjects, regardless of their employment status with UM

5)  Ensure that the UM IRB receives complete reports of all IRB-reportable events occurring both at UM and at the non-UM institution

6)  Ensure that consent forms fairly and accurately represent the involvement of UM in the research and the decisions of all responsible IRBs reviewing the research

Although IRB policies do not require a subcontract/agreement for exempt research involving a non-UM institution, such research may require a subcontract or other agreement from other institutional departments (e.g. UM Research Administration).  It is the responsibility of the Principal Investigator to comply with such requirements. 

The HSRO suggests that the UM principal investigator of an exempt study obtain a letter of permission to conduct the research activity at the non-UM institution and/or to use the resources of the non-UM institution.  This documentation may be requested by the IRB during the exempt review process.



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