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

Basic Folder Information

Section 17:  Data Safety Monitoring Boards

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

August 3, 2009

17. Data Safety Monitoring Boards

All studies submitted to the IRB for review must contain a plan for adequately monitoring the data collected to ensure the safety of subjects [c.f. 45 CFR 46.111(a)(6) and 21 CFR 56.111(a)(6)].  Elements of data safety and monitoring plans may vary depending on potential risks, study complexity and type, but all plans must be suitable for the level of risk to be faced by subjects and to the nature of the research involved.  If a study is sponsored by an agency or organization which requires specific data and safety monitoring standards, a copy of these monitoring standards must be attached to the study application and the Principal Investigator must submit to the IRB a plan to meet these standards.

For any study considered by the IRB to involve greater than minimal risk to human subjects, the IRB may require that the data safety and monitoring plan include a Data Safety Monitoring Board (DSMB).  In particular, the IRB may (and usually will) require a DSMB for Phase III multi-site clinical trials involving interventions that entail potential risk to the participants. 

In determining whether a DSMB is required, the IRB shall consider factors suggesting that a DSMB is needed which include:

  1. a large study population
  2. multiple study sites (since it is difficult to recognize unusual problems or patterns of problems when investigators are treating only a fraction of the participants)
  3. highly toxic therapies or dangerous procedures
  4. high expected rates of morbidity or mortality in the study population
  5. high change of early termination of the study especially if there is a reasonable likelihood that the study may be terminated early for reasons of safety, futility or efficacy

DSMB members should be experts in the scientific field of the study who are independent from the study and who may, at the discretion of the IRB, be internal or external to the institution.  DSMB members shall have no professional or financial interest in the outcome of the studies they monitor.  The DSMB shall function as an independent committee to monitor data throughout the duration of the study to determine if continuation of the study is appropriate scientifically and ethically.  Determinations by the DSMB shall be considered as recommendations to the IRB and must be reported by the Principal Investigator to the IRB (through the HSRO) in a timely manner.

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