July 22, 2011

US Contemplating New Regulations On Human Medical Research

The U.S. Department of Health and Human Services (HHS) announced on Friday that the government is contemplating various ways of enhancing the regulations overseeing research on human subjects.

HHS said in a statement that before making changes to the regulations, the government is seeking the public's input on issues related to the ethics, safety, and oversight of human research.

The changes under consideration were published in the Federal Register. 

"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," Howard K. Koh, MD, MPH, HHS assistant secretary for Health, said in a statement.

"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."

The rules that govern human subject research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions.  Each study took place at only a single site.

HHS said the public's input on the issues will be critically important to the government's efforts to ensure that regulations keep up with the changing research environment.


On the Net: