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SACHRP Recommendations

SACHRP Recommendations

SACHRP advisory documents were the result of considerable Committee effort, deliberation, and consensus building. Once the Committee reached consensus on an issue, its recommendations were posted online and transmitted by the Chair to the Secretary of Health and Human Services, the Assistant Secretary for Health, and the Director of OHRP for their consideration. The content of these documents was advisory and did not represent the official views or policies of OHRP or the Department of Health and Human Services. Following SACHRP’s termination on March 31, 2025, PRIM&R has undertaken the responsibility of archiving these publicly available materials to ensure continued access for the research oversight community. By maintaining this collection, PRIM&R seeks to preserve the Committee’s valuable contributions and support professionals who rely on SACHRP’s work to inform ethical and regulatory decision-making in human subjects research.

2024 SACHRP Recommendations

2023 SACHRP Recommendations

2022 SACHRP Recommendations

2021 SACHRP Recommendations

2020 SACHRP Recommendations

2019 SACHRP Recommendations

2018 SACHRP Recommendations

2017 SACHRP Recommendations

2016 SACHRP Recommendations

2015 SACHRP Recommendations

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Attachment B: Commentary on FDA Draft Guidance, “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products,” released December 9, 2014, docket number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Attachment C: SACHRP Comments on FDA draft guidance “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers”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

2014 SACHRP Recommendations

2013 SACHRP Recommendations

2012 SACHRP Recommendations

2011 SACHRP Recommendations

2010 SACHRP Recommendations

2009 SACHRP Recommendations

2008 SACHRP Recommendations

2007 SACHRP Recommendations

2006 SACHRP Recommendations

2005 SACHRP Recommendations

2004 SACHRP Recommendations

September 27, 2004 SACHRP chair letter to HHS Secretary on HIPAA - Health Insurance Portability and Accountability Act

Appendix A: Research disclosures should be exempted from the accounting

Appendix B: Reconsider the de-identification standard, reduce the number of data categories, and focus on safeguards in recording and publishing data

Appendix C: Clarify that the February 2004 Guidance addresses only what is permissible under the HIPAA Privacy Rule not a "best practices" standard for recruitment methods

Appendix D: Application of the Privacy Rule to research databases and repositories needs further refining to align it with existing Common Rule requirements

Appendix E: HIPAA's compound authorization requirements elevate form over substance, confuse subjects, and diminish the informed nature of their consent and authorization

Appendix F: Administrative burden of IRB waiver of the authorization requirement for research not required to receive IRB review is unnecessary

Appendix G: HIPAA's transition provisions exempting research where informed consent was obtained are not helpful

Appendix H: Clarify in guidance that IRB alteration of HIPAA's authorization requirement may be sought and granted for international research

Appendix I: Clarify scope of the public health reporting exception

Response from HHS Secretary to September 27, 2004 letter

Summary Table of Recommendations on the HIPAA Privacy Rule