The US Department of Health and Human Services (HHS) is proposing some new regulations aimed at improving the safety for human subjects in scientific experiments. The current regulations, known as The Common Rule have not been changed since 1991. The HHS says it is seeking feedback from the public on a wide range of issues related to safety, oversight and ethics in human research before making the changes.

The proposed changes, which are aimed at enhancing protections for human research participants, can be found in an ANPRM (Advance Notice of Proposed Rulemaking) – Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. It is published in the Federal Register, July 25th.

Howard K. Koh, MD, MPH, HHS assistant secretary for Health, said:

“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. 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.”

Existing regulations were developed when the human research environment was quite different. Studies took place mainly at colleges, universities, and medical centers, and mostly in just one site. Things have changed considerably since then. There are many more multi-site studies, among other things, which have shown that current regulations for research subjects and researchers need updating.

The proposed alterations are expected to improve protections for research participants in several ways.

The HHS is seeking feedback on the following:

  • Evaluate the current risk-based framework so that it calibrates the level of review to the level of risk more accurately.
  • Have all domestic and multi-site studies monitored by a single Institutional Review Board.
  • Have all forms and processes used for informed consent updated.
  • Establish compulsory data security and data protection standards for all trials that involve identifiable or potentially identifiable information.
  • Implement a systematic approach to the gathering and analysis of data on unexpected problems and adverse events across all trials to harmonize the complicated range of definitions and reporting requirements. Also, to improve the efficiency of data collection.
  • Extend federal regulatory protection so that they apply to research carried out at US centers that receive funding from the Common Rule agencies.
  • Provide standardized guidance on federal regulations.

The HHS asks the public to provide feedback, which it is considers as “critically important to the government’s efforts to ensure that regulations keep up with today’s changing research environment.”

Office for Human Research Protections (OHRP)

ANPRM (Advance Notice of Proposed Rulemaking) for Revision to Common Rule

Written by Christian Nordqvist