2004 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.

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
July 8, 2004 SACHRP Letter to HHS Secretary on Children's Research
Appendix A: Algorithm for Subpart D Analysis (45 CFR 46 and 21 CFR 50)
Appendix B: Non-FAC Open Panel Model Guidelines
Appendix C: OHRP Procedures for a 407 Panel Process for Multi-Site Research
Response from HHS Secretary to July 8, 2004 letter