The following AHC IRB news items are posted as a reference for IRB members, investigators and the research community. Please review the website regularly for current news, updates on forms and guidelines, and new IRB related information.

Selected 2006 FDA Rule and Guideline Initiatives

Note: FDA's guidance documents, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

• Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors-Exception from Informed Consent Requirements for Emergency Research (Draft Guidance, September 7, 2006). http://www.fda.gov/cber/gdlns/emergres.htm
• Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers , July 18, 2006. (This document supersedes Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers, issued July 12, 2001). http://www.fda.gov/cdrh/ode/guidance/1381.html
• An interim final rule to amend the Food and Drug Administration (FDA) informed consent regulations to establish a new exception for use of investigational in vitro diagnostic devices in certain circumstances [Medical Devices; Exception From General Requirements for Informed Consent," 21 CFR 50.23(e), June 7, 2006]
  http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-8790.htm
• Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable (April 2006).
  http://www.fda.gov/cdrh/oivd/guidance/1588.pdf
• Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees (March 2006).
  http://www.fda.gov/cber/gdlns/clintrialdmc.htm
• Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials (March 2006).
  http://www.fda.gov/cber/gdlns/irbclintrial.htm
• Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies: (January 2006)
  http://www.fda.gov/cder/guidance/7086fnl.htm
• Waiver of IRB Requirements for Drug and Biological Product Studies (January 2006 update of Sept. 1998 guidance). http://www.fda.gov/cder/guidance/waiver.pdf
• FDA Institutional Review Board Inspections (January 2006; update of Sept. 1998 guidance).
  http://www.fda.gov/oc/ohrt/irbs/reviewboard.pdf
• FDA Inspections of Clinical Investigators, January 2006; update of Sept. 1998 guidance).
  http://www.fda.gov/oc/ohrt/irbs/investigator.pdf
• Frequently Asked Questions about Medical Devices (January 2006; update of Sept. 1998 guidance).
  http://www.fda.gov/oc/ohrt/irbs/irbreview.pdf
• Significant Risk and Non-significant Risk Medical Device Studies (January 2006).
  http://www.fda.gov/oc/ohrt/irbs/devrisk.pdf

Selected 2006 OHRP Guidance Initiatives

• Frequently Asked Questions (and Answers) page (October 25, 2006).
  http://www.hhs.gov/ohrp/faq.html
• Guidance on how to determine whether the HHS regulations at 45 CFR part 46 are applicable to the activities covered by the Food and Drug Administration's interim final rule, "Medical Devices; Exception From General Requirements for Informed Consent" (21 CFR 50.23(e).(June 2006).
  http://www.hhs.gov/ohrp/humansubjects/guidance/invitrodev.html (HTML)
  http://www.hhs.gov/ohrp/humansubjects/guidance/invitrodev.pdf (PDF)
• Guidance on: expiration of FWAs; documentation of approval of FWAs and processing of IRB registrations; FWA and IRB registration & OHRP Electronic Submission System.
  http://www.hhs.gov/ohrp/news/index.html
• New OHRP human subject protections resource page (February 2006).
  http://www.hhs.gov/ohrp/related.html

Back to the top