Office for Human Research Protections Request For Information Due Sept. 29, 2008

Posted

The Office for Human Research Protections (OHRP) on July 1 issued a “Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs”. The RFI seeks information and comments from affected entities and individuals about:

  1. Whether OHRP should issue additional guidance recommending that institutions engaged in human subjects research conducted or supported by the Department of Health and Human Services (HHS) implement training and education programs for individuals involved in the conduct, review, or oversight of human subjects research; and
  2. Whether HHS should develop a regulation requiring the implementation of such training and education programs.

The goal of such training and education programs is to help ensure that individuals involved in the conduct or review of human subjects research at institutions holding OHRP-approved Federal-wide Assurances understand and meet their regulatory responsibilities for protecting human subjects. Comments on the information collection are due September 15, 2008.