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Investigator Resources

Information for Research Participants
Information for Study Teams
Information for Sponsors
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

University of Miami

Written Policies and Procedures for the
Protection of Human Subjects in Research

Human Subject Research Office/
Institutional Review Boards



For Reference Only

Please note: As of December 9, 2013, the information provided below is for archival and reference purposes only.

For the current UM IRB policies and procedures, please refer to the new eProst site located at https://eprost.med.miami.edu/eprost/ for the current SOPs and Investigator Manual.

 



Documents



Table of Contents

Note: These Policies and Procedures govern the conduct of human subject research.  Click on green hyperlinks to navigate to desired policies.

Table of Contents

1.      Preface

2.      Background Information

2.1 History
2.2 Ethical Principles
2.3 Federal Regulations
2.4 Federalwide Assurance (FWA)
2.5 The University of Miami IP3R Program (Innovative Practices for the Protection of Participants in Research)
2.6 Does a Project Constitute Human Subjects Research?

 3.      Authorities and Responsibilities

3.1 IRB Authority
3.2 HSRO Responsibility
3.3 IRB Policy and Procedure Committee
3.4 Responsibilities of Principal Investigator
3.5 Responsibilities of UM Deans/Department Chairs
3.6 Responsibilities of Students and Faculty Advisors
3.7 CITI Certification

4.      Conflict of Interest

4.1 General Principles
4.2 IRB Members, Alternate Members, Ad Hoc Members and Guests
4.3 Principal Investigators and Key Personnel
4.4 Human Subject Conflict of Interest Committee
4.5 IRB Review and Approval of Conflict Management

5.      Institutional Review Boards

5.1 IRB Membership and Structure
5.2 IRB Chairs and Vice-Chairs
5.3 IRB Members

6.       IRB Meetings

6.1 Agenda
6.2 Minutes
6.3 Reviewer Assignments
6.4 Consultants and Ad Hoc Reviewers
6.5 Confidentiality of IRB Meetings and Guest Policy
6.6 Meetings and Quorum
6.7 Voting

7.       General Principles for IRB Reviews

7.1 Submission of New or Continuing Studies
7.2 Recommendations for Review Category
7.3 Criteria for IRB Approval
7.4 Approval Duration
7.5 Project Verification from Outside Sources
7.6 Notification Letters and Approval Stamps

8.       Definition of IRB Review Types

8.1 Exempt Studies
8.2 Expedited Studies
8.3 Reviews Requiring the Convened IRB
8.4 Multi-year IRB Approval

9.       IRB Review of Initial Studies

9.1 Initial Studies - Exempt
9.2 Initial Studies - Expedited
9.3 Initial Studies - Convened IRB Review

10.     IRB Review of Continuing Studies

10.1 General Principles for Review of Continuing Studies
10.2 Continuing Studies - Expedited
10.3 Continuing Studies - Convened IRB Review

11.     Amendments

11.1 General Principles
11.2 Types of Amendments and Their Review
11.3 Changing Principal Investigators or Co-Investigators
11.4 Informational Materials
11.5 Study Exceptions

12.     Closing Studies and Final Reports

13.     Suspension, Termination and Administrative Closure of IRB-Approved Research

13.1 General Principles
13.2 Administrative Action
13.3 Expedited Action
13.4 Convened IRB Action
13.5 Suspension and Administrative Closure for Lapse in IRB Approval
13.6 Voluntary Suspension by the Principal Investigator or Temporary Withhold by the Institution

14.     Unanticipated Problems and Adverse Events

14.1 Definitions
14.2 Requirements for Reporting Problems (Adverse Events) to the IRB
14.3 Review of Problems or Events that Require Prompt Reporting
14.4 Reportable Problems/Events at Continuing Review
14.5 External Adverse Events and Safety Notices/Reports from Sponsor or Central Site

15.     Study Violations

16.     Compliance Audits

16.1 General Principles
16.2 Reporting Audit Findings and Outcomes

17.     Data Safety Monitoring Boards

18.     Ancillary Committees

18.1 Sylvester Comprehensive Cancer Center Protocol Review Committee (PRC)
 

19.     External IRB's

19.1 The Central IRB (CIRB) of the National Cancer Institute

20.     Policies Specific to Certain Types of Research

20.1 Medical Case Reports
20.2 Retrospective Chart Reviews
20.3 Off-Label Use of Marketed Drugs, Biologics or Medical Devices
20.4 Databases, Registries and Repositories
20.5 Investigational Devices

 

21.     Informed Consent

21.1 General Principles for Informed Consent
21.2 Waivers or Modifications of Informed Consent
21.3 Required Elements of Informed Consent
21.4 Informed Consent Documents
21.5 Language Requirements for Informed Consent
21.6 Informed Consent and Vulnerable Subjects

22.     Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements

22.1 General Principles
22.2 IRB Approval Guidelines

23.     Vulnerable Populations

23.1 General Principles
23.2 IRB Approval and HHS
23.3 Pregnant Women, Human Fetuses, and Neonates
23.4 Prisoners
23.5 Children
23.6 Decisionally Impaired Subjects
23.7 Employees, Students Trainees and others

24.     Privacy, Security, Confidentiality and HIPAA

24.1 Which Policies Must Be Followed
24.2 Definitions
24.3 General Principles of IRB Review of Privacy, Security and Confidentiality
24.4 Privacy (as applicable to ALL studies)
24.5 HIPAA-related Privacy Policies (applicable to studies involving PHI and HIPAA)
24.6 Security
24.7 Confidentiality

25.     Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators

25.1 General Principles
25.2 Subcontracts for non-UM Institutions or Individuals "ENGAGED" in UM Research
25.3 Agreements for non-UM Institutions or Individuals "INVOLVED" in UM Research

26.     International Research

26.1 General Principles
26.2 Engaged in UM-Research
26.3 Involved but not Engaged in UM-Research
26.4 Local Context
26.5 Special Considerations for International Research
26.6 Subcontracts for International Research

27.     Emergency Use

27.1 General Principles
27.2 Emergency Use of Unapproved Medical Devices
27.3 IRB Requirements
27.4 Emergency Use and Informed Consent

28.     Record Retention

28.1 General Principles
28.2 Record/Document Retention Requirements
28.3 Record/Document Storage and Deletion


Other Policies

Genetics Research
Gene Therapy Research
Women and Minorities in Research



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