2017 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.

December 12, 2017 Letter to the HHS Secretary
Attachment A - Recommendations on the Expedited Review List
Attachment B - Recommendations on the Interpretation and Application of §_.104(d)(4) the “HIPAA Exemption
August 2, 2017 Letter to the HHS Secretary
Attachment A - Recommendations on Compliance Dates and Transition Provisions
Attachment B - Recommendations on Benign Behavioral Intervention
Attachment C - Recommendations for Broad Consent Guidance
Attachment D - Recommendations for a Broad Consent Template
Attachment E - Recommendations on FDA draft Real-World Evidence guidance
Attachment F - Recommendations on Reporting Incidental Findings