ANPRM for Revision to Common Rule

By Jerome Reiter posted 09-01-2011 16:32

  
The Dept. of Health and Human Services (HHS) is asking for comments on proposed revisions to the Common Rule via an ANPRM (advance notice of proposed rulemaking).  Many topics that affect statisticians and others who work with human subjects data are in scope, including informed consent, privacy and confidentiality, data security, roles of IRBs and the nature of exempt research, and more.  HHS is accepting comments until October 26 (a recent extension).

See  http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html   for details.

The ANPRM represents an opportunity for ASA members to affect policy making.  The ASA Privacy and Confidentiality Committee is preparing a set of comments on the proposed revisions to the privacy and confidentiality sections of the Common Rule.  We will post our comments on the Committee web page once they are finished.

Jerry Reiter
Duke University
1 comment
37 views

Comments

10-26-2011 15:57

The Privacy and Confidentiality Committee's comments were submitted on October 19 with Committee Chair Jerry Reiter and ASA Executive Director Ron Wasserstein signing the cover letter: http://www.amstat.org/outreach/pdfs/CommonRuleANPRM_wCover.pdf.