09/27/07 – The FDA Amendments Act was implemented to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. Supporters state that this legislation strikes the proper balance between new drug safety measures and ensuring consumers have access to innovative prescription pharmaceuticals in a timely manner. To view this document, visit http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110

04/17/07 – The FDA published the draft guidance document, "Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting - Improving Human Subject Protection". Click here to view the draft guidance document.

01/15/07 – The Office for Human Research Protection published the final guidance document, "Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events". Click here to view the final guidance document.

08/29/06 – The FDA published the draft guidance document, "Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research". Click here to view the draft guidance document: http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0331-gdl0001.pdf

06/07/06 – FDA issued an interim final rule amending the informed consent rules to add an exception from the general requirements for certain studies involving investigational in vitro diagnostic devices intended to identify chemical, biological, radiological, or nuclear agents. Click here to view the pdf of this document.

06/07/06 – The Office for Human Research Protections (OHRP) issued 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)). Specifically, the document provides guidance on the following: (1) The determination of when institutions conducting activities covered by 21 CFR 50.23(e) would be engaged in non-exempt human subjects research; and (2) The requirements for obtaining or waiving informed consent under 45 CFR 46.116.

This guidance can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/invitrodev.html and http://www.hhs.gov/ohrp/humansubjects/guidance/invitrodev.pdf

05/10/06 – As part of a series of new policy and regulatory developments to strengthen the Agency's oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency's approach to bioresearch monitoring as part of the Critical Path Initiative, the FDA released a draft guidance entitled "Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54 Additional Safeguards for Children in Clinical Investigations". Click here to view the pdf of this document. It is hoped that the Human Subject Protection and Bioresearch Monitoring (HSP /BIMO) Initiative will facilitate the modernization of the regulation of clinical trials and bioresearch monitoring, specifically the protection of human subjects and the integrity of data in clinical trials, and encompasses devices, foods, human drugs, biological drug products and veterinary medicine.

04/25/06 – The FDA released the guidance entitled "Guidance for Sponsors, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable". Click here to view the pdf of this document.

03/27/06 – The FDA published the final guidance for industry, entitled "Establishment and Operation of Clinical Trial Data Monitoring Committees." To view this document, visit http://www.fda.gov/cber/gdlns/clintrialdmc.pdf

03/16/06 – The FDA released a final guidance for industry entitled "Using a Centralized IRB Review Process in Multicenter Clinical Trials". This was published in the Federal Register on 03/16/06. Click here to view the pdf of this document.

Visit the OHRP human subject protections resource page at http://www.hhs.gov/ohrp/related.html. This page provides links to reference documents, historical materials, and Common Rule departments/agencies. Additional materials are added as they become available. OHRP encourages all in the research community to use this reference page.