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HHS reviews protections for human research subjects
Federal regulators are seeking public input on how to improve the ethics, safety and oversight of human research.
The Department of Health and Human Services says it is overhauling its 1991 regulations, known as the "Common Rule," to keep current with changes in how research is conducted. While research used to be conducted for the most part at a single site at a university or medical institution, now it's much more fragmented and can involve an array of disciplines and venues.
"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," assistant secretary for Health Howard Koh 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."
• Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk;
• Using a single Institutional Review Board review for all domestic sites of multisite studies;
• Updating the forms and processes used for informed consent;
• Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data;
• Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient;
• Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies; and
• Providing uniform guidance on federal regulations.
