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Human Subjects Division (HSD)

Regulatory Updates

OHRP: Updated Written IRB Procedures Guidance

Jul 5, 2011 at 11:35am

OHRP has updated its Guidance on Written IRB Procedures. The July 1, 2011 guidance document replaces OHRP's January 15, 2007 guidance on this topic. Specifically, the updated document has been changed as follows; updated sections are identified in the parenthetical following each description of the changes:

  1. Guidance related to continuing review has been replaced with content from OHRP's November 10, 2010 document, "Guidance on Continuing Review of Research," and a cross-reference to the continuing review guidance document has been added (see Section A.(2)(b) and Section B.(2)(b)).
  2. A cross-reference to OHRP's January 15, 2007 document, "Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events," has been added (see Section A.(3)).
  3. Guidance related to the approval of research with conditions has been replaced with content from OHRP's November 10, 2010 document, "Guidance on IRB Approval of Research with Conditions," and a cross-reference to the guidance document on approval of research with conditions has been added (see Section A.(5)).
  4. All URLs referenced in the document have been updated to link to OHRP's new website.
  5. A closing paragraph was added to the end of the document to provide OHRP's contact information.