2011 SACHRP Recommendations

SACHRP advisory documents are the result of considerable Committee effort, deliberation and consensus building. Once the Committee achieves consensus on an issue, its recommendations are posted on this website and transmitted by the Chair to the Secretary of Health and Human Services, Assistant Secretary for Health, and to the Director of OHRP for their consideration. The content of these documents is advisory and does not represent the official views or policies of OHRP or the Department of Health and Human Services.

October 13, 2011 SACHRP Letter to the HHS Secretary: SACHRP ANPRM Comments - Final
Attachment - ANPRM Biospecimen Minority Report Final
October 13, 2011 SACHRP Letter to the HHS Secretary: Recommendations from SAS & SOH
Attachment A: Approved by SACHRP July 20, 2011 - Guidance on Applying the Regulatory Requirements for Research Consent Forms: What Should and Should Not be Included?
Attachment B: Approved by SACHRP July 20, 2011 - SACHRP Recommendation regarding definition of a minor change in research under 45 CFR 46 and 21 CFR 56
Attachment C: Approved by SACHRP July 20, 2011- SACHRP Recommendation regarding application of 45 CFR 46 and 21 CFR 56 to early processes in research, such as identifying potential subjects, contacting subjects and recruiting subjects
Attachment D: FAQ's Terms and Recommendations on Informed Consent and Research Use of Biospecimens
August 5, 2011 SACHRP Letter to the HHS Secretary (Including recommendations and FAQ's on the topic of parental permission, child assent, and documentation of informed consent)
August 5, 2011 SACHRP Letter to the HHS Secretary (Including comments regarding request for Comments on Human Subjects Protections in Scientific Studies)
August 5, 2011 SACHRP Letter to the HHS Secretary (Including recommendations on HIPAA/HITECH Notice of Proposed Rulemaking)
January 24, 2011 SACHRP Letter to the HHS Secretary: Recommendations Involving Informed Consent and Biospecimens, IRB Membership and Definition of Non-scientist
Attachment A: FAQs, Terms and Recommend. on Informed Consent
Attachment B: Recommendation on IRB Membership and Definition of Non-scientist under 45 CFR 46 and 21 CFR 56