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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
Other Policies
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HSRO Forms & Documents
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Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
Western IRB (WIRB)
About the HSRO

Basic Folder Information

23.7 Employees, Students, Trainees and others

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

April 24, 2006

23.7 Employees, Students, Trainees and others

The following policies apply to employees, students, trainees and others who shall be considered as vulnerable populations. It shall be recognized that some individuals for whom the following policies apply may also be included in other categories of vulnerable populations such as pregnant women, prisoners or children. Additional policies for these individuals have been defined in other sections of this document. When subjects fall within two or more vulnerable population categories, the total of regulations and policies apply to these subjects.

Employees, students and trainees/fellows of the University of Miami or Jackson Health System or affiliates may be considered vulnerable subjects, depending on the context of the specific research study proposed. This is because of the potential for perceived coercion due to the relationships to the institutions and to the researchers (regardless of the researcher's intentions) especially if there is a power differential between the researcher and the prospective subjects. If the proposed subjects are part of a research team, there may also be inherent conflicts of interest in their participation.

As do others considered within vulnerable populations in federal regulations and these policies, employees, students and trainees/fellows shall have rights to participate in human subject research. The IRB shall ensure that all of the following conditions are met in determining whether such individuals may participate as subjects:

1)  Participation in the research may not bestow upon the subject-employees, students or trainees/fellows any competitive academic or occupational advantage over other employees, students or trainees/fellows who do not volunteer to participate in the study

2)  Investigators or others may not impose any academic or occupational penalty on those employees, students or trainees/fellows who do not volunteer.

3)  Employees, students or trainees/fellows participating in research may not be systematically treated differently from subjects in the study who are not employees, students or trainees/fellows

Due to the potential for perceived or real coercion to participate in research studies, employees, students or trainees/fellows may not participate as subjects in studies in which the principal investigator or anyone listed as key personnel has direct supervisory responsibilities over the employee, student or trainee/fellow. The Principal Investigator may request, and the IRB may approve, a waiver of this prohibition if the following conditions are documented to apply:

1)  Participation in the study is reasonably likely to provide direct and significant benefit to the subjects; AND

2)  Risks to the subjects have been eliminated or have been minimized to the satisfaction of the subjects; AND

3)  The study has reasonable scientific merit

Other vulnerable subjects: The IRB shall take into account subject vulnerability from such factors as socioeconomic circumstances, cultural or religious background and personal or family circumstances. Examples of concerns that should be considered by the IRB include:

1)  Financial compensation offered to impoverished subjects for participation in research may be interpreted as exploitative

2)  Local cultural leaders may urge participation in a study which may be perceived as exploitative

3)  Individuals in the midst of traumatic or emergency situations may be under emotional distress and increased vulnerability

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University of Miami Office of Research UM School of Medicine CITI Program Jackson Health System
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Human Subjects Research Office

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