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Secretarial Communications

Secretary's Advisory Committee on Human Research Protections (SACHRP)

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.

19. March 30, 2012 SACHRP Letter to the HHS Secretary
Recommendations from the Subcommittee on Harmonization and Recommendations on Component Analysis
[PDF 3617KB]

18. October 13, 2011 SACHRP Letter to the HHS Secretary: SACHRP ANPRM Comments - Final (PDF 494KB)
Attachment - ANPRM Biospecimen Minority Report Final (PDF 47KB)

17. October 13, 2011 SACHRP Letter to the HHS Secretary: Recommendations from SAS & SOH (PDF 84KB)
     Attachment A: Approved by SACHRP July 20, 2011 (PDF 94KB)
     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 (PDF 57KB)
     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 (PDF 60KB)
     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 (PDF 181KB)
     The Secretary's Advisory Committee on Human Research Protections (SACHRP) July 20, 2010

16. August 5, 2011 SACHRP Letter to the HHS Secretary (PDF 4KB)
Recommendations on HIPAA/HITECH Notice of Proposed Rulemaking

15. August 5, 2011 SACHRP Letter to the HHS Secretary (PDF 4KB)
Comments regarding request for Comments on Human Subjects Protections in Scientific Studies

14. August 5, 2011 SACHRP Letter to the HHS Secretary (PDF 4KB)
Recommendations and FAQ's on the topic of parental permission, child assent, and documentation of
informed consent

13. January 24, 2011 SACHRP Letter to the HHS Secretary
Attachment A: Informed Consent and Biospecimen Frequently Asked Questions
Attachment B: Recommendation on IRB Membership and Definition of Non-scientist

12. November 23, 2010 SACHRP Letter to HHS Secretary on HITECH Proposed Rule
Attachment A: SACHRP Models of Compound Authorization

11. March 24, 2010 SACHRP Letter to HHS Secretary [PDF - 93KB]

10. July 15, 2009 SACHRP letter to HHS Secretary [PDF - 2.63MB]
Attachment to July 15, 2009 SACHRP Letter [PDF - 90KB]

9. February 4, 2009 SACHRP letter to HHS Secretary [PDF - 19KB]

8. September 18, 2008 SACHRP letter to HHS Secretary [PDF - 65KB]
Attachment to September 18, 2008 SACHRP letter [PDF - 18KB]

7. January 31, 2008 SACHRP letter to HHS Secretary [PDF - 27KB]
Appendix - Understanding Minimal Risk [PDF - 61KB]

6. June 15, 2007 SACHRP letter to HHS Secretary [PDF - 1MB]
Response letter from the Secretary to June 15, 2007 letter [PDF - 318KB]

5. March 14, 2007 SACHRP letter to HHS Secretary [PDF - 2.14MB]
Response letter from the Secretary to March 14, 2007 letter [PDF - 343KB]

4. November 9, 2006 SACHRP letter to HHS Secretary on Children's Research [PDF - 2.60MB]

Appendix A [PDF - 4.97MB]

Response letter from Secretary to November 9, 2006 letter [PDF - 330KB]

3. July 28, 2005 SACHRP Chair Letter to HHS Secretary Regarding Recommendations

Response from HHS Secretary to July 28, 2005 letter [ - 51KB]

2. September 27, 2004 SACHRP chair letter to HHS Secretary on HIPAA - (Health Insurance Portability and Accountability Act) and attachments

Response from HHS Secretary to September 27, 2004 letter [PDF - 27.4KB]

1. July 8, 2004 SACHRP Letter to HHS Secretary on Children's Research [PDF - 322KB]

Appendix A: Algorithm for Subpart D Analysis (45 CFR 46 and 21 CFR 50) [PDF - 94KB]
Appendix B: Non-FAC Open Panel Model Guidelines [PDF - 59KB]
Appendix C: OHRP Procedures for a 407 Panel Process for Multi-Site Research [PDF - 110KB]

Response from HHS Secretary to July 8, 2004 letter [PDF - 28KB]