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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
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HSRO Forms & Documents
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eProst User Guide
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About the HSRO


Basic Folder Information

9.3 Initial Studies - Convened IRB Review


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

July 24, 2006

Revised: August 17, 2011

 



9.3 Initial Studies - Convened IRB Review

Studies being reviewed by the convened IRB shall be assigned at least one primary and one secondary reviewer.  Primary reviewers shall be prepared to lead the discussion of the study, the complete grant application (as applicable), all other materials related to the study and the risk/benefit ratio.  Primary reviewers are encouraged to seek expertise/consultation as necessary, to conduct informal queries of the Principal Investigator and other experts in order to provide a thorough review, and to coordinate review comments/questions with the secondary reviewer(s) if appropriate.  Primary reviewers shall present specific recommendations for IRB actions, including changes and/or questions for the Principal Investigator. 

Secondary reviewers shall be prepared to serve in the absence of the primary reviewer.  Secondary reviewers are also encouraged to seek expertise/consultation as necessary, to conduct informal queries of the Principal Investigator and other experts in order to provide a thorough review and to coordinate review comments/questions with the primary reviewer(s) if appropriate.  Secondary reviewers may present specific recommendations for IRB actions, including changes and/or questions for the Principal Investigator. 

IRB members shall receive all appropriate study materials with sufficient time for their review prior to scheduled IRB meetings to be prepared to participate in deliberations and voting.  After presentation by the primary and/or secondary reviewers and deliberations at IRB meetings, any IRB member may motion for an action.  For a motion to pass, the majority of voting members present must vote affirmatively.  The convened IRB may approve motions and thereby take any of the actions indicated below:

1)  APPROVED AS SUBMITTED
This motion defines the study as approved as submitted, with no further action required.  In this case, the HSRO shall inform the Principal Investigator in writing of the approval and its duration.  The start date for the study shall be the date of this IRB approval, and the study may begin upon receipt of the letter of approval.

 

2)  APPROVED AS MODIFIED BY THE IRB
This motion defines the study as approved with revisions, clarifications or other changes to the protocol or to the informed consent or other documents made by the IRB.  In this case, the HSRO shall inform the Principal Investigator in writing of the changes made by the IRB and of the IRB approval of the study including those changes and also including the duration of approval.

The letter to the Principal Investigator from the HSRO shall state that the Principal Investigator must conduct the study as modified by the IRB in accordance with the IRB approval.

If the Principal Investigator does not accept the changes made by the IRB, he/she may not initiate the study pursuant to the IRB approval and that IRB approval is to be considered void.  The study may not be started unless/until a new IRB approval is obtained and confirmed in writing to the Principal Investigator by the HSRO.

If the Principal Investigator does not accept the changes made by the IRB, he/she may withdraw the study, appeal to the IRB or make revisions to the study for reevaluation by the IRB.

3)  DEFERRED FOR SUBSEQUENT EXPEDITED REVIEW BY THE IRB CHAIR OR DESIGNEE
This motion defines that the IRB has agreed to approve the study but with conditions that require revisions and/or clarifications that the IRB determined to be nonsubstantive and minor and not directly relevant to the IRB determinations required under 45 CFR 46.111 and/or 21 CFR 56.111.  Such revisions or clarifications may be reviewed and approved by the IRB chair or designee on an expedited basis. 

Required revisions or clarifications must be submitted to the HSRO by the Principal Investigator within 30 calendar days following notification to the Principal Investigator by the HSRO unless the IRB requires a due date that is different from that occurring 30 days following notification. 

Pursuant to this motion, the HSRO shall notify the Principal Investigator that the revisions and/or clarifications shall be reviewed on an expedited basis by the IRB Chair or designee.  The IRB shall clearly specify the action(s) needed and who has the authority to review and approve the revised or requested materials on an expedited basis.  A letter shall be forwarded to the Principal Investigator by the HSRO indicating the specific required action(s) and the fact that the documents may be returned for review on an expedited basis and that another convened IRB review may not be required unless the study is deferred to the convened IRB by the IRB Chair or designee.  The letter shall also define that the study has been deferred and has not received IRB approval and that the study must not be initiated until the IRB Chair or designee has approved it on behalf of the IRB.

If the study is subsequently approved by the IRB Chair or designee, the HSRO shall inform the Principal Investigator of this approval and that the date of approval is the date that the fully-convened IRB deferred the study and set conditions for its expedited re-review rather than the date that the minor changes were approved on an expedited basis by the IRB Chair or IRB-designee.  The study may begin upon receipt of this letter of approval.

If revisions and/or clarifications are submitted after the due date, the Chair/designee may seek an explanation from the Principal Investigator and/or:

a)  Defer the study to the convened IRB for its review and approval/disapproval; OR

b)  Defer the study to the IRB for withdrawal.  If the IRB withdraws the study, the Principal Investigator may re-submit a new application for the study incorporating the revisions and/or clarifications from the prior IRB review; OR

c)   Find the explanation and the revisions and/or clarifications acceptable and  approve the study

 

4)  DEFERRED FOR SUBSEQUENT RE-REVIEW BY THE CONVENED IRB
This motion defines the study as needing revisions or clarifications from the Principal Investigator for subsequent review by the convened IRB.  This motion shall pertain when the convened IRB has determined that the revisions or clarifications are substantive and directly relevant to the IRB determinations required under 45 CFR 46.111 and/or 21 CFR 56.111.  In this case, the Principal Investigator shall be informed by the HSRO in writing of the needed revisions and/or clarifications and the requirement that these revisions or clarifications be submitted within 30 calendar days unless otherwise specified by the IRB.  The letter shall make clear that the study is not approved and the revisions and/or clarifications will be reviewed at a convened IRB meeting.

If the study is subsequently approved by the convened IRB, the HSRO shall inform the Principal Investigator of this approval and that the date of approval is the date that the fully-convened IRB gave final approval to the study.  The study may begin upon receipt of this letter of approval. 

If revisions and/or clarifications are submitted after the due date, the HSRO shall seek an explanation from the Principal Investigator and the IRB may either conduct its review or it may withdraw the study.  If the IRB withdraws the study, the Principal Investigator may re-submit a new application for the study incorporating the revisions and/or clarifications from the prior IRB review.

5)  TABLED
This motion defines the situation if the IRB is unable or unwilling to review and/or vote on a study or other matter.  This may occur if the quorum is lost, pertinent documents are unavailable or the scope of IRB expertise is not considered sufficient for appropriate decision-making.  Although the Principal Investigator may be notified of this motion, no action by the Principal Investigator is required.

 

6)  DISAPPROVED
This motion defines the study as not approved by the IRB for reasons directly relevant to the IRB determinations required under 45 CFR 46.111 and/or 21 CFR 56.111 such as that the study requires major changes or that it is not likely to be feasible without a complete reassessment of the protocol by the Principal Investigator and/or sponsor.  In this case, the HSRO shall inform the Principal Investigator in writing of the disapproval.  The letter shall include a description of the reasons why the IRB has taken this action and shall inform that the Principal Investigator has an opportunity to respond to the IRB in person or in writing.  If the Principal Investigator appeals the disapproval, it is the responsibility of the IRB to ensure that there is a fair hearing of the appeal. 



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