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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
HIPAA
Translations
Western IRB (WIRB)
About the HSRO


Basic Folder Information

13.1 General Principles


Approval Date

Review:

IRB Policy and Procedure Committee

Original Approval Date:

April 24, 2007

Revised:

April 30, 2012

 



13.1 General Principles

The IRB and/or members of University Administration (Executive Vice President and Provost, Vice Provost for Research, Associate Vice Provost for Human Subject Research and his/her designees) have the authority to suspend, administratively close or terminate approval of human subject research studies (c.f. 45 CFR 46.113/21 CFR 56.113). Such "for cause" suspension or termination may be implemented by administrative action, expedited action or action of the convened IRB for reasons including that:

  1. The research is not being conducted in accordance with University of Miami policies and/or procedures for research
  2. There is serious or continuing non-compliance with IRB requirements, IRB determinations or federal regulations
  3. A serious incident has occurred involving injury or any other serious unanticipated problem involving risk to subjects or others
  4. IRB approval has lapsed and the study is in suspension

NOTE – The unmodified term "suspension" is commonly used to describe suspensions that occur "for cause" (as the result of an action by University administration or the IRB) and suspensions that occur automatically as the result of a lapse in IRB approval. Sections 13.2-13.4 of this policy pertain to "for cause" suspensions. Section 13.5 pertains to suspensions due to lapse in IRB approval.

Any suspension for lapse in IRB approval or any suspension or termination for cause shall be documented by the suspending/terminating authority in writing with a statement of the reasons for this action. Notification of the suspension or termination shall be provided in a timely manner to the HSRO which shall be responsible for informing the principal investigator and appropriate institutional officials (including the Associate Vice Provost for Human Subject Research, the Vice Provost for Research and the Chair of the investigator's academic department), and sponsoring agencies (if applicable). The Associate Vice Provost for Human Subject Research shall inform the Vice Provost for Research who will report the "for cause" suspension or termination to OHRP and/or the FDA (pursuant to 45 CFR 46.103(b), 45 CFR 46.113, 21 CFR 56.108(b) and 21 CFR 56.113) and to any applicable funding agency as required by the agency.

The communication to the principal investigator should explain the reasons for this action and the consequences of a suspension or termination. This letter should inform the principal investigator that he/she has an opportunity to appeal to the convened IRB about the suspension or termination. A Principal Investigator may appeal to the IRB about a decision to suspend or terminate a study. This appeal must be made in writing within 10 working days following receipt of the written notice of suspension or termination unless these stipulations are waived by the Associate Vice Provost for Human Subject Research or the Chair of the IRB providing study oversight.

If the principal investigator chooses to appeal the suspension/termination to the convened IRB, the principal investigator should provide a plan for ensuring that the rights and welfare of all currently enrolled and previously enrolled participants are protected and a plan to ensure that future participants will be protected if the study receives IRB approval to continue.

During a study suspension, either "for cause" or due to lapse in IRB approval, new subjects may no longer be enrolled, and a decision as to whether currently enrolled subjects must continue to receive study-related interventions due to safety concerns shall be communicated to the principal investigator. Study interventions or interactions with already enrolled subjects should only continue when these are in the best interest and safety of individual subjects. Those authorized to make decisions on the safety of individual subjects are the Associate Vice Provost for Human Subject Research, Assistant Provost for IRB Affairs, the IRB Chair or designee or the convened IRB who may seek information from the Principal Investigator as required. The decision on subject safety shall be forwarded to the HSRO for communication to the principal investigator.

For studies suspended "for cause," the IRB or suspending administrator shall consider the effect of the suspension on the rights and welfare of current participants and shall require that the principal investigator provide a plan outlining what action shall be taken for those participants currently enrolled in the study and how the participants shall be informed, if applicable. If a study is terminated, the IRB or terminating administrator must consider the effect of the termination on the rights and welfare of current participants. New subjects may not be enrolled and all study-related activities including interventions with currently enrolled subjects and data analysis must cease. The IRB or terminating administrator may require specific steps that must be taken by the Principal Investigator to implement the termination.

Whether a study is suspended or terminated by administrative, expedited or IRB action, the convened IRB shall determine and inform the HSRO which shall inform the principal investigator if other actions must be taken. Such actions may include:

  1. Notifying currently enrolled subjects in writing that the study has been suspended or terminated. Written communications to subjects shall usually come from the Principal Investigator and must be reviewed and approved by the IRB prior to its distribution to subjects; however, the IRB may require that written communication be provided to subjects from another source such as the academic department chair or the HSRO. Such communication also requires approval by the IRB prior to its distribution to subjects.
  2. Implementing procedures for withdrawal of subjects that consider the rights and welfare of those subjects
  3. Informing subjects of any follow-up procedures permitted or required by the IRB for their safety [NOTE – If decided by the IRB, this may be included in the communication notifying subjects of the suspension or termination –see above]

The lifting of a "for cause" suspension may not occur by expedited action but requires approval by the convened IRB and by the Associate Vice Provost for Human Subject Research. The lifting of a suspension for lapse of IRB approval shall occur upon approval of the continuing report either by expedited review/approval by the IRB Chair or designee (if the study meets the eligibility criteria for such review/approval) or by review and approval by the convened IRB.



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