IRB News

OHRP posts final guidance on IRB continuing review

The Office for Human Research Protections (OHRP) has posted its updated and finalized guidance on the IRB continuing review process.

Titled, "Guidance on IRB Continuing Review of Research," the guidance document supersedes OHRP's January 15, 2007 guidance entitled "Guidance on Continuing Review." The guidance document finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57487). OHRP officials say the public comments submitted on the draft document were very helpful as the office finalized the document.

To see the final guidance document, visit the OHRP website at http://www.hhs.gov/ohrp/policy/continuingreview2010.html or http://www.hhs.gov/ohrp/policy/continuingreview2010.pdf. The Federal Register notice announcing the availability of this new guidance document can be found at http://edocket.access.gpo.gov/2010/2010-30198.htm or http://edocket.access.gpo.gov/2010/pdf/2010-30198.pdf.

Guidance on IRB approval of research with conditions is finalized

The Office for Human Research Protections (OHRP) has posted on its website a finalized guidance document entitled, "Guidance on IRB Approval of Research with Conditions." The guidance document provides OHRP's first formal guidance on this topic.

The guidance document finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57486).

The finalized guidance document is available on the OHRP website at http://www.hhs.gov/ohrp/policy/conditionalapproval2010.html or URLs http://www.hhs.gov/ohrp/policy/conditionalapproval2010.pdf. The Federal Register notice announcing the availability of this new guidance document can be found at http://edocket.access.gpo.gov/2010/2010-30201.htm or http://edocket.access.gpo.gov/2010/pdf/2010-30201.pdf.