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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

9.2 Initial Studies - Expedited


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

March 31, 2006

 



9.2 Initial Studies - Expedited

The IRB Chair or the Chair’s designee from among the IRB members shall determine whether a study involves no more than minimal risk and may be reviewed and approved within the "expedited category". This decision shall be made according to regulations included in 45 CFR 46.110, 45 CFR 46.111, 21 CFR 56.110, 21 CFR 56.111, and 38 CFR 16.110. 38 CFR 16.111) and according to the UM policy defining these criteria (c.f. Policy 8.2)

[NOTE – See also http://www.hhs.gov/ohrp]

If the IRB Chair or designee disagrees with the applicability of expedited review for a given study, the Chair or designee may refer the study to the convened IRB by notifying the HSRO of this decision. Even if the submission fulfills the criteria for expedited review according to the regulations, the Chair or designee may use his/her discretion as to whether the study should be expedited or referred for convened IRB review.

In conducting an expedited review of an initial study, the IRB Chair or designee may exercise all of the authorities of the IRB with the exception of disapproval of the study. The Chair or designee shall conduct a full, significant and meaningful review of all materials related to the assigned study, inquire of the Principal Investigator and/or other experts as deemed necessary and present clear and concise requirements/recommendations for changes and/or questions in written form (via ePROST) for communication to the Principal Investigator. The Chair or designee may request minor revisions and/or clarifications from the Principal Investigator before approval is granted. The chair or designee may request a second reviewer and/or may seek recommendations from an expert consultant(s) for issues which require expertise beyond, or in addition to, that available on the IRB.

Approval by the IRB chair or IRB-designee of a study under the expedited review process requires:

  1. Confirmation that the research poses no more than minimal risk
  2. Identification of the specific permissible category of expedited review into which the study falls
  3. Determination of the requirement for continuing review and additional requirements
  4. Review of the informed consent process in accordance with regulations
  5. Review of any recruitment procedures involving advertisements
  6. Documentation of the above findings
  7. Consideration of the principles and deliberation criteria defined in Policy 7.3 including:
    1. Research relevance
    2. Minimization of risks
    3. Reasonable risk/benefit ratio
    4. Equitable selection of subjects
    5. Appropriate informed consent process or waiver
    6. Adequate safety monitoring and provisions for privacy and confidentiality
    7. Protection of vulnerable subjects
    8. Conflict of interest
    9. Investigator's educational requirements and certification

If the chair or IRB-designee approves the study on an expedited basis, he/she shall determine the interval to a required continuing review. This interval shall not be greater than one year from the date of the initial IRB approval.

If expedited approval is granted by the IRB Chair or designee, he/she shall:

  1. Document the expedited category(ies) that applies to the study
    [NOTE – A children’s category (under 45 CFR 46 SubPart D and/or 21 CFR 50 SubPart D) must be identified if any minors under the age of 18 years are involved as research participants, and 45 CFR 46 SubPart B must be satisfied if the research involves pregnant women, fetuses, neonates of uncertain viability, placenta, dead fetus, or fetal material. New Studies involving 45 CFR 46 SubPart C (i.e. research involving prisoners) shall not be reviewed in an expedited manner.]
  2. Comment on the review of informed consent (unless a waiver of consent was approved)
  3. Provide required findings if a waiver of consent or alteration of consent (45 CFR 46.116(c) or (d)) or waiver of documentation of informed consent (45 CFR 46.117(c)(1 or 2) is requested/approved.

This documentation shall also include approval period dates (if less than annual continuing review is recommendation) and detail limitations to approval periods (such as limitations to enrollment numbers prior to reporting back for continuing review.

The IRB Chair or IRB-designee shall provide the documentation (above) to the HSRO which is responsible for record-keeping and for creating correspondence to the Principal Investigator. The HSRO shall ensure that notification of expedited review approval is made at the next convened IRB meeting.

If the IRB Chair or designee is not able to approve the study, the Principal Investigator shall be informed of the reasons and may request convened IRB review.

Throughout these studies, the requirements for informed consent (or its waiver or alteration) apply to all studies meeting criteria for approval on an expedited basis.



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