2015 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.

November 3, 2015 SACHRP Letter to the HHS Secretary
September 28, 2015 SACHRP Letter to the HHS Secretary
Attachment A: Recommended Guidance on Minimal Risk Research and Informed Consent
Attachment B: Recommendations Regarding Application of the Common Rule to Clinical Data Registries under the Medicare Access and CHIP Reauthorization Act of 2015
Attachment C: Return of Individual Results and Special Consideration of Issues Arising from Amendments of HIPAA and CLIA
April 24, 2015 SACHRP Letter to the HHS Secretary
Attachment A: Human Subjects Research Implications of “Big Data” Studies
Attachment B: Commentary on FDA Draft Guidance, “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products,” released December 9, 2014, docket number FDA-2013-D-1275-0002
Attachment C: SACHRP Comments on FDA draft guidance “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers”
Attachment D: Recommendations Regarding Return of General Research Results
Attachment E: Recommendations Regarding Research Uses of Newborn Dried Bloodspots and the Newborn Screening Saves Lives Reauthorization Act of 2014
Attachment F: Recommendations Regarding the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-site Research
February 11, 2015 SACHRP Letter to the HHS Secretary
Attachment A: SACHRP Commentary on the FDA Draft Guidance Entitled, "Informed Consent Information Sheet; Guidance for IRBs, Clinical Investigators and Sponsors," released July 15, 2014, docket number FDA-2006-D-0031