informed consent

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On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the Common Rule (45 C.F.R. Part 46). Under the current regulations, the Common Rule applies to all research involving human subjects that is conducted or supported by a federal department or agency that has adopted the policy. Subject to only specified exemptions, the proposed rule extends the Common Rule’s requirements to all clinical trials regardless of funding source if: (1) the clinical trial is not regulated by the FDA, and (2) is performed at a US institution that receives any support from a federal agency. Other major changes introduced in the proposed rule include:
Continue Reading Agencies Release Proposed Overhaul of the Common Rule

Earlier this summer, the Food and Drug Administration (FDA) issued a draft 42-page “Informed Consent Information Sheet” that provides guidance for institutional review boards (IRBs), clinical investigators, and clinical trial sponsors on complying with the Agency’s informed consent regulations. Once finalized, the draft guidance will supersede FDA’s previous Information Sheet on this topic, “A Guide to Informed Consent,” which was last updated over 15 years ago, in 1998.  The guidance, which is a compilation of FDA’s regulations and past guidances on informed consent, also reflects the Agency’s coordinated efforts with the Department of Health and Human Services (HHS) to facilitate consistency across informed consent requirements and policies among federal government agencies.

Broadly, the new guidance indicates FDA policy shifting towards enhanced informed consent processes. More narrowly, the draft guidance explains the various and often caveated elements of informed consent (including providing patients with a description of the trial, its risks, benefits, alternative treatments, confidentiality and compensation in the event of injury), depicts the detailed responsibilities of IRBs, clinical investigators and sponsors of clinical trials (including compliance with the process, elements and documentation of informed consent), and provides examples of recommended language to assist industry parties in complying with FDA’s informed consent regulations. FDA accomplishes this task by clarifying some aspects of existing guidance and creating additional guidance in new areas.

The following provides an overview of some of the draft guidance’s notable new and revised provisions.Continue Reading FDA Seeks Comments to Updated Guidance on Informed Consent in Clinical Trials

The Department of Health and Human Services (HHS) is seeking input on how institutional review boards (IRBs) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects as part…

This post was written by Erin A. Janssen.

FDA has issued guidance in the form of a Small Entity Compliance Guide entitled “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).” This guidance is intended to help sponsors, investigators and Institutional Review Boards better understand new informed consent requirements. In…

This post was written by Erin Janssen and Areta Kupchyk.

The HHS Office for Human Subject Protections (OHRP) and the Food and Drug Administration (FDA) are seeking comments on a joint draft document entitled “Guidance on Exculpatory Language in Informed Consent.” Among other things, the draft document:

  • Provides guidance on the regulatory prohibition

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