ENACCT Responds to HHS Request for Comment Regarding Proposed Regulations for Human Subjects Research

The Department of Health and Human Services (HHS) released a request for comment on Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators [Docket ID Number: HHS–OPHS–2011–0005-0001].

Comments will be used to help with the modernization and revision of current policies around human subjects research that have failed to keep pace with the current "research enterprise." 

The proposed HHS regulation changes can be viewed HERE

ENACCT supports HHS in its work to improve current guidelines, particularly in regards to the informed consent process. ENACCT believes this process, which goes beyond merely the consent form, must be simplified to maximize enrollment opportunities for ALL trial eligible patients. 

ENACCT's comments can be viewed HERE