Recommendations Directed to other HHS Agencies

NIH Genomic Data Sharing Policy: NIH Request for Public Comments
Attachment D: SACHRP Recommendations on Revisions to “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules,” Appendix M
Attachment C: SACHRP Recommendations on Benchmarking
Attachment B: Recommendations Regarding Application of the Common Rule to Clinical Data Registries under the Medicare Access and CHIP Reauthorization Act of 2015
Attachment C: Return of Individual Results and Special Consideration of Issues Arising from Amendments of HIPAA and CLIA
Attachment F: Recommendations Regarding the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-site Research
Attachment B: Recommendations on Certificates of Confidentiality
Attachment A: SACHRP Models of Compound Authorization
Appendix I: Clarify scope of the public health reporting exception
Appendix H: Clarify in guidance that IRB alteration of HIPAA's authorization requirement may be sought and granted for international research
Appendix G: HIPAA's transition provisions exempting research where informed consent was obtained are not helpful
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 D: Application of the Privacy Rule to research databases and repositories needs further refining to align it with existing Common Rule requirements
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 B: Reconsider the de-identification standard, reduce the number of data categories, and focus on safeguards in recording and publishing data
Appendix A: Research disclosures should be exempted from the accounting