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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.

22. December 4, 2013 SACHRP Letter to the HHS Secretary (PDF - 169 KB)
      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 (PDF - 179KB)

21. May 20, 2013 SACHRP Letter to the HHS Secretary (PDF - 172KB)
      Attachment A:  Recommendation on Changes to Expedited Review Applicability and Categories (PDF - 182KB)
      Attachment B:  Considerations and Recommendations concerning Internet Research and Human Subjects Research
      Regulations, with Revisions (PDF - 409KB)

20. January 20, 2013 SACHRP Letter to the HHS Secretary (PDF - 104KB)
     Attachment A:  Consideration of Local Context with Respect to Increasing Use of Single IRB Review (PDF - 62KB)
     Attachment B:  Comments on OHRP and FDA Draft Guidance Documents Regarding IRB Transfers (PDF - 72KB)
     Attachment C:  Investigator Responsibilities (PDF - 56KB)
     Attachment D:  Informed Consent and Waiver of Consent (PDF - 75KB)

 

 19. March 30, 2012 SACHRP Letter to the HHS Secretary (PDF - 3617KB)
      (Including recommendations from the Subcommittee on Harmonization and Recommendations on Component 
     Analysis  

 

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, 2011

 

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

 

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

 

14. August 5, 2011 SACHRP Letter to the HHS Secretary (PDF - 4KB)
      (Including 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)
    August 8, 2007 response letter from the Secretary  (PDF - 318KB)

 

5. March 14, 2007 SACHRP letter to HHS Secretary (PDF - 2.14MB)
    June 18, 2007 response letter from the Secretary  (PDF - 343KB)

 

4. November 9, 2006 SACHRP letter to HHS Secretary on Children's Research [PDF - 2.60MB]
    Appendix A [PDF - 4.97MB]
    August 8, 2007 response letter from Secretary  (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)


Content last reviewed on May 4, 2010