Part I of a series on proposed changes to the common rule: Introduction

The U.S. Department of Health and Human Services has announced an Advanced Notice of Proposed Rulemaking regarding the common rule.  The common rule, originally published in 1991, regulates informed consent and Institutional Review Boardss for human subject research.  This post serves as the first of a series that will address issues raised by this topic, including the notion that written informed consent is required for biospecimen research even when the biospecimen is de-identified and standardizing informed consent.

“The adoption of the Common Rule two decades ago was a landmark event to ensure ethical practices and the safety of those individuals who participate in research,” said Howard K. Koh, MD, MPH, HHS assistant secretary for Health. “This regulatory review effort is primarily about enhancing protections for human subjects. The changes under consideration offer the promise of updating and enhancing those protections to keep pace with current challenges.”

Highlights of the proposed changes include:

• Revising risk assessment rules

• Multi-site trials must have a single IRB of record

• Updating the informed consent process

• Establishing mandatory data security standards

• Improved and standardized adverse event reporting and collection techniques

• Extending Federal regulatory protections to all institutions that receive funding from Common Rule agencies

• Providing uniform guidance on federal regulations

HHS is requesting public comment on these proposed changes, with the comment period closing on October 26, 2011.

– Kim Child