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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

4.3 Principal Investigators and Key Personnel


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

October 27, 2006



4.3 Principal Investigators and Key Personnel

The IRB shall be concerned about the potential for biased judgment and/or other abuse when investigators or study staff have a financial obligation or interest that may pose a conflict of interest which competes with the obligation to protect the rights and welfare of human subjects.  The primary goal of this conflict of interest policy is to prevent conflicting interests from adversely affecting the protection of subjects and/or the credibility of the UM human subject protection program if publicly disclosed.  The process to manage conflicts of interest (whether real or perceived) shall not vary according to funding source and shall involve three steps: 

Conflicts of interest (which may include those of the Principal Investigator, key personnel or the University or affiliated institutions) must be disclosed to the HSRO by the Principal Investigator or any individual listed as "Key Personnel" within the study. 

If the conflict exists prior to IRB review of the study, the conflict must be disclosed prior to the IRB deliberation.  If the conflict is initiated after IRB review, the conflict must be disclosed to the HSRO within 10 days after its onset.   

To ensure the reporting of conflicts in applications for new studies, the IRB shall require that the Principal Investigator and all key personnel, and each member of the faculty and study staff who has contact with potential or consented subjects, disclose, in signed statements within their application, all potential financial conflicts of interest on the part of investigators or institution.  With this disclosure, Principal Investigators may recommend to the IRB how the potential conflict of interest should be minimized or resolved.

Among personal financial conflicts of interest that are related to the sponsoring agency(s), any entity allied with the sponsoring agency(s) or other interested entities and that must be disclosed are:

1.  Salary, consulting fees, honoraria, royalty payments, dividends, loans or other compensation for services, payments or consideration with value that exceed $10,000 in any preceding 12 month period or in an anticipated 12 month period

2.  Serving in a management position such as director, officer, partner or trustee

3.  Having an ownership interest, equity in the form of stock, stock options or any other investment equal to or exceeding $10,000 (current market value) or a 5% or greater ownership interest

4.  Having any intellectual property rights such as patents (actual, planned or applied for), licensing agreements or a copyright or royalties with the study or the sponsoring agency(s)

5.  Having any intellectual property rights not directly involved in the study but that may benefit from the study

Principal Investigators must also recognize that financial conflicts of interest may arise that are not directly related to the Principal Investigator but are related to the University or affiliated institutions.  Among such potential conflicts that must be disclosed by the Principal Investigator are:

1.  The research involves a drug, device or other invention created at the University or affiliated institution or by an employee currently or formally at the University or affiliated institution who is not the Principal Investigator or key personnel of the study

2.  The research involves a drug, device or other invention created by someone other than the Principal Investigator or key personnel for which the University or affiliated institution holds a financial interest and/or may derive financial benefit

3.  The research involves a drug, device or other invention for which someone who is a colleague of the Principal Investigator or key personnel is creator and/or holds a financial interest



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