Office of the Associate Vice Chancellor for Compliance

News Archive

On January 18, 2007 OHRP posted on its website OHRP’s formal “Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events” (dated January 15, 2007). The guidance can be found by going to the Policy Guidance [by topics] page on the OHRP website at http://www.hhs.gov/ohrp/policy/index.html, and clicking on either “Adverse Events” or “Unanticipated Problems” from the list of guidance topics.

OHRP has also posted newly revised versions of the following two guidance documents:
(1) “Guidance on Continuing Review” (this guidance can be found by clicking on “Continuing Review” from the list of guidance topics at the top of the Policy Guidance [by topics] page on the OHRP website). This guidance has been revised to be consistent with the content of OHRP’s January 15, 2007 “Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events.”

(2) “Guidance on Written IRB Procedures” (this guidance can be found by clicking on “IRBs” from the list of guidance topics at the top of the Policy Guidance [by topics] page on the OHRP website, and then clicking on the last bullet under the heading “IRB (Institutional Review Board).” This guidance has been updated to include the following changes: (1) the content regarding continuing review has been revised to be consistent with the content of OHRP’s January 15, 2007 “Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events;” (2) paragraph A.(4) under “ADDITIONAL OHRP GUIDANCE RELEVANT TO WRITTEN IRB PROCEDURES” has been revised to be consistent with OHRP’s position regarding when IRB’s must defer approval of research; and (3) formatting changes.

OHRP welcomes comments on these guidance documents. Please send any comments to OHRP by e-mail at ohrp@hhs.gov, with citation of the specific document related to the comments in the subject line.

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