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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

16.2 Reporting Audit Findings and Outcomes


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

March 27, 2009

Revised:

March 18, 2013

 



16.2 Reporting Audit Findings and Outcomes

Pursuant to regulations [45 CFR 46.103(a) and 45 CFR 46.103(b)(5)] and in accordance with the terms of the UM FWA, the Associate Vice Provost for Human Subjects Research will inform the Vice Provost for Research in writing of such matters that require reporting. The Vice Provost for Research shall report to the Office of Human Research Protections (OHRP):

1)  Unanticipated problems involving risks to human subjects or others;

2)  Any serious or continuing non-compliance with federal regulations or the requirements or determinations of the IRB

3)  All study suspensions [with the exception of those that occur as the result of lapses of IRB approval] or terminations of IRB approval

Pursuant to regulations [21 CFR 56.108(b)] and in accordance with the terms of the UM FWA, the Vice Provost for Research shall report any of the following events involving FDA regulated products to the FDA:

1)  Unanticipated problems involving risks to subjects or others

2)  Serious or continuing non-compliance with federal regulations or IRB determinations or requirements

3)  Any suspension [with the exception of those that occur as the result of lapses of IRB approval] or termination of IRB approval

The above events shall be reported to the FDA as follows: a) Division of Scientific Investigations (for drug products); b) Bioresearch Monitoring Branch (for biologic products); c) Division of Bioresearch Monitoring (for medical Devices).

The Vice Provost for Research shall also report to the OHRP or FDA as appropriate any findings of serious or continuing non-compliance by the IRB. All reports to the OHRP and/or FDA shall be made promptly depending on the seriousness of the non-compliance. Investigations or implementation of corrective actions need not be completed prior to the reporting of non-compliance.  If a report is provided prior to the completion of an investigation or the implementation of a corrective action plan, the Vice Provost shall provide a follow-up report to include the latter information.

Although regulations do not define “serious” or “continuing”, the IRB shall advise the HSRO when they believe that non-compliance with IRB determinations or federal regulations is “serious or continuing”.  Examples of non-compliance that shall be considered 'serious' by the IRB, the Associate Vice Provost for Human Subject Research and the Vice Provost for Research shall include but not be limited to the following:

1)  Non-compliant actions that increase risk to participants and/or adversely affect their rights and welfare

2)  Non-compliance that has harmed research participants or that may cause injury (physical, psychological, emotional etc)

3)  Non-compliance that has compromised privacy and confidentiality of research participants or ethical principles

4)  Non-compliant actions that decrease potential benefits or compromise the integrity or validity of the research

5)  Conducting non-exempt human subject research without IRB review and approval

6)  Substantive modifications to IRB-approved research being carried out without IRB approval

7)  Enrollment of subjects who fail to meet the inclusion or exclusion criteria of the protocol resulting in increased risk to the subject

8)  Enrollment of research subjects while study approval has lapsed

9)  Enrollment of research subjects without approved informed consent

10)Willful or knowing misconduct by the principal investigator or key personnel

Examples of non-compliance that shall be considered 'continuing' by the IRB, the Associate Vice Provost for Human Subject Research and the Vice Provost for Research shall include but not be limited to the following:

1)  Repeated instances of failure to follow federal regulations and/or IRB policies and procedures particularly after the IRB has informed the principal investigator and his/her key personnel of the problem(s) and that corrective actions needs to be taken

2)  The principal investigator has multiple problems with non-compliance over a long period of time or has a problem with multiple existing or previously approved studies

3)  A pattern of minor non-compliances with multiple studies by the same investigator(s) that reflect a lack of knowledge, unwillingness or a lack of commitment by the investigator and/or study team that, if unaddressed, may compromise the integrity of the human research or the protection program

4)  Actions that suggest a likelihood that non-compliance will continue without intervention

In addition to federal agencies as required, serious or continuing non-compliance shall be reported by the Vice Provost for Research to the Dean(s) and academic department chair(s) of the Principal Investigator and other key faculty members involved in the research, to the Executive Vice President and Provost of the University and, if applicable, to the sponsors of the studies in which such non-compliance occurred.



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