Endocrine Insider
June 3, 2009

The Office for Human Research Protections (OHRP) requested feedback from the clinical research community on proposed changes to accountability requirements for certain federal regulations.  The Office proposes to shift responsibility for adherence to some regulations governing human research subjects protections from the institution engaged in HSR to the institutional review board (IRB) or the entity operating the IRB.  In so doing, OHRP hopes to facilitate the use of central or common IRBs for multi-site studies.  This purpose is in line with the consensus reached by participants in the Society’s November 2008 workshop on regulatory burden, co-hosted by Lawson Wilkins Pediatric Endocrine Society.

In its response to OHRP, The Endocrine Society commends the Office for addressing the institutional perception of risk when delegating review responsibilities to outside IRBs.  The Society states its support for the proposed changes in accountability and encourages OHRP to clearly outline the responsibilities of the institution and those of the IRB to alleviate any miscommunication.  The Society also recommends that IRBs be accredited to ensure quality and adherence to regulations, which should further assuage institutional concerns.

To read the Society’s comments to OHRP on IRB accountability, click here.