Regulations designed to enhance research
Revisions to the Rules Protecting Human Subjects of Research
In a major undertaking, HHS, together with the President’s Office of Science and Technology Policy, is leading the effort to review and revise the Common Rule that over 20 years ago established the guidelines for protecting humans when they are subjects of scientific research. A total of 16 federal departments and agencies also follow this rule. It has, however not kept pace with the evolving human research activity, the proliferation of multi-center clinical trials, the expansion of health services research, and the use of advance technologies.
A revised rule could eliminate unnecessary Institutional Review Board reviews and enable them to better focus their resources on review of research protocols that pose greater than minimal risks to subjects. A revised rule might also improve mechanisms for collecting information to evaluate the effectiveness of research oversight systems and facilitate research by reducing unnecessary burdens on institutions and investigators. Revisions could better protect human subjects while facilitating valuable research and reducing burden, delay, and ambiguity for investigators and research subjects.
HHS published an Advance Notice of Proposed Rulemaking on this topic on July 26, 2011, asking for comment on how HHS might modernize and revise current regulations for protecting human subjects who participate in research to make them more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. Based on the comments it receives in response to the ANPRM, HHS will proceed to develop and publish a proposed rule for additional public comment.
Modifications to the HIPAA Privacy Rule to Streamline Research
In continuing efforts by the Department to harmonize regulations that apply in the research context, OCR proposed modifications to the HIPAA Privacy Rule to streamline the research authorization requirements to better align with the requirements for informed consent under the Common Rule. These changes will provide increased flexibility for researchers and reduce paperwork and burden. OCR is working to finalize changes in this area as part of a broader rulemaking that includes final modifications to the HIPAA Rules pursuant to the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act, as well as a final Breach Notification Rule.
Peer Review of Research Grants and Contracts
In an additional effort to enhance research, NIH intends to review its regulations pertaining to Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects. NIH anticipates that review of this peer review regulation could result in a unified set of peer review regulations for all HHS agencies that would provide greater flexibility and reduce regulatory and administrative burdens.