2013 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 4, 2013 SACHRP Letter to the HHS Secretary

Attachment A: SACHRP comment regarding the June 4, 2013 FDA Request for Comment relating to the availability of masked and de-identified non-summary safety and efficacy data

May 20, 2013 SACHRP Letter to the HHS Secretary

Attachment A: Recommendation on Changes to Expedited Review Applicability and Categories

Attachment B: Considerations and Recommendations concerning Internet Research and Human Subjects Research Regulations, with Revisions

January 10, 2013 SACHRP Letter to the HHS Secretary

Attachment A: Consideration of Local Context with Respect to Increasing Use of Single IRB Review

Attachment B: Comments on OHRP and FDA Draft Guidance Documents Regarding IRB Transfers

Attachment C: Investigator Responsibilities

Attachment D: Informed Consent and Waiver of Consent