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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review, August 16, 2013 - Special Edition, New SOPs, Tools and Policies

Aug 16, 2013 at 11:37am

HSD Changes are Here!

Welcome to Part 2 (of 4) of the HSD eNews Special Editions.

NEW SOPs, Tools, and Policies

This spring HSD started a major project to write and/or revise IRB and HSD standard operating procedures (SOPs). This was prompted by two major federal audits. The project is also driven by the desire to increase clarity about requirements, IRB review consistency,and efficiency in training HSD staff and IRB members. It is also an opportunity to change some policies and develop some new tools. The first group of SOPs were posted and implemented at the end of June. The second group of SOPs were implemented and posted on August 9th. Most of them are completely new. Look for Parts 3 and 4 of our new SOPs in October and November.

Summary of Changes

Form Changes

A few revisions were required because of the new SOPs. They are effective immediately, but no changes need to be made to already-approved applications or consent forms. Main IRB application form. The changes are:
  • New question about the use of the UW versus the Cancer Consortium IRB, for UW Cancer Consortium members.
  • New questions in the consent section, asking for a description of:
    • The consent process
    • The assent process (when the research participants include children)
    • Any translations or interpretation
Consent template. Minor changes in wording, to more clearly address certain required elements of consent.

Consent

Of the new SOPs, these are the ones of greatest relevance to researchers. NEW Consent. Describes:
  • The regulatory and UW requirements for obtaining consent
  • The required elements of consent
  • Waivers of consent, and the criteria for granting them
  • How the IRB reviews the consent process
  • Procedures for obtaining consent from non-English speaking or illiterate participants
  • Situations for which re-consenting may be necessary
NEW Consent Documentation. Describes:
  • The regulatory and UW requirements for documenting consent (e.g., consent forms)
  • Waiver of documentation of consent, and the criteria for granting it
  • How the IRB reviews the consent document
  • Procedures for obtaining consent documentation from non-English speaking or illiterate participants
NEW Legally Authorized Representative (LAR). Describes requirements and procedures associated with obtaining consent from a legally authorized representative instead of the participant. REVISED Translation and Interpretation. Describes requirements and procedures, including new specific criteria used by the IRB to assess the method of translation or interpretation. Also includes new references to translation and interpretation resources.

IRB Review

This group completes the set of SOPs that describe the basics of the IRB review process. In June, we posted the SOPs about Minimal Risk Review (also called Expedited Review), Modifications, and Status Reports (also called Continuing Review). Highlights of this group include: NEW IRB Review. Describes the basic requirements and procedures for how the IRB conducts a review of any type (initial, modification, status report, etc.) NEW CHECKLIST Criteria for IRB Approval. This two page checklist is a new tool that is being used by the IRBs to guide and improve documentation of the review process. Researchers may find it useful to see the specific criteria that the IRBs are required to consider. NEW IRB Actions. Describes the actions the IRB is authorized to take (by regulation or by UW policy). Includes the procedures associated with the actions as well as the impact on researchers. Examples: approval; conditional approval; suspension. REVISED Certificates of Confidentiality. Several previous documents have been combined into one document to provide researchers and the IRB with a single place to go for information about this important mechanism for protecting participant confidentiality in sensitive research. It includes a "To Do" list for researchers, accompanied by a supporting flow chart. It also includes some minor policy changes:
  • Increased flexibility in the consent language used to describe the Certificate protections
  • Consistency about the timing of IRB approval relative to the timing of obtaining a Certificate

IRB Operations

This group of required SOPs describes IRB operations and logistics. We are posting them on our public website to de-mystify the behind-the-scenes process that supports IRB review.