US Intends to Revise Its Regulations on Protecting Human Research Subjects

Both the Office of the Secretary of the Department of Health and Human Services (HHS) and the Office of Science and Technology Policy (OSTP) have issued an Advanced Notice of Proposed Rulemaking (ANPRM) for the public to offer their views and ideas on revisions of regulations protecting human research subjects. The main goal of the proposed changes is to enhance the protection of research subjects on one hand, yet reduce the delay, bureaucracy and redundancy of regulations on the other hand.

The proposed changes would address  the following issues:  1) regulations of continued, expedited and exempt reviews; 2) informed consent for bio-specimens;  3) having multiple IRB reviews for multi center research, which  which attempts to reduce unnecessary duplication of review that occurs; and 4) the length  of informed consent forms.

The proposed changes are available for review via the following link  The comments and feedback can be submitted to!home before the  deadline on Monday, the 26th of September, 2011 at 5 pm EST. After the submission of feedback, they would be reviewed and incorporated into the notice of proposed (NPRM) rulemaking which would be open to public review and scrutiny before the final rule is passed.

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