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.

July 31, 2023 - Letter to the HHS Secretary
SACHRP Recommendations on OHRP Draft Guidance “Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions”
SACHRP Recommendations on “Decentralized Clinical Trials for Drugs, Biological Products, and Devices - Guidance for Industry, Investigators, and Other Stakeholders”
April 4, 2023 Letter to the HHS Secretary
SACHRP Recommendations on Draft Guidance “Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs”
October 21, 2022 Letter to the HHS Secretary
IRB Considerations on the Use of Artificial Intelligence in Human Subjects Research
Recommendations on 87 FR 58733: Protection of Human Subjects and Institutional Review Boards
Recommendations on 87 FR 58752: Institutional Review Boards; Cooperative Research
Use of Social Media by Research Subjects: Ethical and Regulatory Considerations for the Protection of Human Research Subjects
July 25, 2022 Letter to the HHS Secretary
A New Interpretation of the “Engaged in Research” Standard
Considerations for IRB Review of Research Involving Artificial Intelligence
DRAFT Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data
Interpretation of the Definition of “Support” in the HHS Regulations
Recommendations on the Draft Guidance for Use of Single Institutional Review Board for Cooperative Research
March 17, 2022 Letter to the HHS Secretary
NIH Genomic Data Sharing Policy: NIH Request for Public Comments
The Protection of Non-Subjects from Research Harm
July 22, 2021 - Letter to the HHS Secretary
Consideration of the Principle of Justice 45 CFR part 46
March 29, 2021 - Letter to the HHS Secretary
Attachment A - IRB Authority to Restrict Use of Data Collected and Developed in Research
Attachment B - New Challenges in Interactions among Sponsors, Clinical Trial Sites, and Study Subjects
October 26, 2020 - Letter to the HHS Secretary
Attachment A -Public Health Authority and Surveillance Activities
August 12, 2020 - Letter to the HHS Secretary
Attachment A - NIH Data Sharing Policy
Attachment B - Deceased Donor Intervention Research 45 CFR part 46
April 7, 2020 - Letter to the HHS Secretary
Attachment A - New Information Provided to Previously Enrolled Research Subjects
Attachment A1 - Reconsent Appendix 1
Attachment A2 - Reconsent Appendix 2
Attachment B - Clarifying Requirements in Digital Health Technologies Research
November 20, 2019 - Letter to the HHS Secretary
Attachment A - Charging Subjects for Clinical Trial Participation
September 30, 2019 Letter to the HHS Secretary
Attachment A - Addressing Ethical Concerns Offers of Payment to Research Participants
November 13, 2018 Letter to the HHS Secretary
Attachment A - Response Off. Inspector Gen. Report, July 7, 2017
Attachment B - Interpretation Revised Common Rule Exemptions
Attachment C -New "Key Information" Informed Consent Requirements
Attachment D - Parental Permission in Research involving Children
Attachment E - Transition Provisions and Informed Consent Req.
August 9, 2018 Letter to the HHS Secretary
Attachment A - Modif. Prev. Approved Expedited List No. 12
Attachment B -Prev.Approved Rec. Implem.EU GDPR (SACHRP Mar.2018)
April 11, 2018 Letter to the HHS Secretary
Attachment A - FAQs Relating to Recommendations on Broad Consent
Attachment B - European Union's General Data Protection Regulations
Attachment C - Updated FAQs on Informed Consent for Use of Biospecimens and Data
Attachment D - Granting Exceptions or Single IRB Review for Multi-Site Research
December 12, 2017 Letter to the HHS Secretary
Attachment A - Recommendations on the Expedited Review List
Attachment B - Recommendations on the Interpretation and Application of §_.104(d)(4) the “HIPAA Exemption
August 2, 2017 Letter to the HHS Secretary
Attachment A - Recommendations on Compliance Dates and Transition Provisions
Attachment B - Recommendations on Benign Behavioral Intervention
Attachment C - Recommendations for Broad Consent Guidance
Attachment D - Recommendations for a Broad Consent Template
Attachment E - Recommendations on FDA draft Real-World Evidence guidance
Attachment F - Recommendations on Reporting Incidental Findings
November 2, 2016 SACHRP Letter to the HHS Secretary
Attachment A: Initial Considerations for Single IRB Review: Points to Consider
Attachment B: Recommendations on Regulatory Issues in Cluster Randomized Studies
Attachment C: SACHRP Recommendations on Benchmarking
Attachment D: SACHRP Recommendations on Revisions to “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules,” Appendix M
Attachment E: Recommendations on OHRP/FDA draft guidance “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs"
July 21, 2016 SACHRP Letter to the HHS Secretary
Attachment A: Minimal Risk Informed Consent Models
Attachment B: Return of Individual Research Results
January 5, 2016 SACHRP Letter to the HHS Secretary
Attachment A: Recommendations NPRM
November 3, 2015 SACHRP Letter to the HHS Secretary
September 28, 2015 SACHRP Letter to the HHS Secretary
Attachment A: Recommended Guidance on Minimal Risk Research and Informed Consent
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
April 24, 2015 SACHRP Letter to the HHS Secretary
Attachment A: Human Subjects Research Implications of “Big Data” Studies
Attachment B: Commentary on FDA Draft Guidance, “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products,” released December 9, 2014, docket number FDA-2013-D-1275-0002
Attachment C: SACHRP Comments on FDA draft guidance “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers”
Attachment D: Recommendations Regarding Return of General Research Results
Attachment E: Recommendations Regarding Research Uses of Newborn Dried Bloodspots and the Newborn Screening Saves Lives Reauthorization Act of 2014
Attachment F: Recommendations Regarding the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-site Research
February 11, 2015 SACHRP Letter to the HHS Secretary
Attachment A: SACHRP Commentary on the FDA Draft Guidance Entitled, "Informed Consent Information Sheet; Guidance for IRBs, Clinical Investigators and Sponsors," released July 15, 2014, docket number FDA-2006-D-0031
July 3, 2014 SACHRP Letter to the HHS Secretary
Attachment A: Recommendations on Assurances and Engagement
Attachment B: Recommendations on Certificates of Confidentiality
Attachment C: Recommendations on Regulatory Issues in Cluster Studies
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
March 30, 2012 SACHRP Letter to the HHS Secretary
Attachment A: Recommendation on Applicability of FDA Regulations for IRBs
Attachment B: Recommendation on Single Patient Treatment Use
Attachment C: Recommendation on Protocol Deviations
Attachment D: Recommendation Regarding Oversight of Research Misconduct and Regulatory Noncompliance
October 13, 2011 SACHRP Letter to the HHS Secretary: SACHRP ANPRM Comments - Final
Attachment - ANPRM Biospecimen Minority Report Final
October 13, 2011 SACHRP Letter to the HHS Secretary: Recommendations from SAS & SOH
Attachment A: Approved by SACHRP July 20, 2011 - 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 - 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- 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
August 5, 2011 SACHRP Letter to the HHS Secretary (Including recommendations and FAQ's on the topic of parental permission, child assent, and documentation of informed consent)
August 5, 2011 SACHRP Letter to the HHS Secretary (Including comments regarding request for Comments on Human Subjects Protections in Scientific Studies)
August 5, 2011 SACHRP Letter to the HHS Secretary (Including recommendations on HIPAA/HITECH Notice of Proposed Rulemaking)
January 24, 2011 SACHRP Letter to the HHS Secretary: Recommendations Involving Informed Consent and Biospecimens, IRB Membership and Definition of Non-scientist
Attachment A: FAQs, Terms and Recommend. on Informed Consent
Attachment B: Recommendation on IRB Membership and Definition of Non-scientist under 45 CFR 46 and 21 CFR 56
November 23, 2010 SACHRP Letter to HHS Secretary on HITECH Proposed Rule
Attachment A: SACHRP Models of Compound Authorization
March 24, 2010 SACHRP Letter to HHS Secretary: Recommendations regarding IRB accountability, establishing SACHRP Subcommittee on Harmonization, Financial Conflicts of Interest, IRB member training
July 15, 2009 SACHRP letter to HHS Secretary
Attachment: Recommendations Regarding Research Involving Individuals with Impaired Decision-making
February 4, 2009 SACHRP referencing OHRP resources, and socio-behavioral research in subpart B
September 18, 2008 SACHRP letter to HHS Secretary Recommendations regarding regulatory exemptions, institutional responsibilities, tribal authority, research in disaster situations, review of the human subjects protection system
Attachment: Institutional official responsibilities - draft example of guidance to be developed
January 31, 2008 SACHRP letter to HHS Secretary: Recommendations related to waiver of informed consent and interpretation of “minimal risk”
Appendix: Understanding Minimal Risk
June 15, 2007 SACHRP letter to HHS Secretary: Recommendations related to the training of individuals involved in the review, oversight, or conduct of human subjects research
Response letter from the Secretary
March 14, 2007 SACHRP letter to HHS Secretary: Recommendations regarding continuing review and expedited review of research by IRBs
Response letter from the Secretary
November 9, 2006 SACHRP letter to HHS Secretary on Children's Research
Appendix A: Recommendations relative to research involving children
August 8, 2007 Response letter from Secretary
July 28, 2005 SACHRP Chair Letter to HHS Secretary Regarding Recommendations
Appendix A: Who is a “prisoner” under Subpart C, Research Protections for the “Subsequently Incarcerated,” identification of prisoner representative, prisoner representative on IRBs in multi-site studies
Appendix B: Recommendations regarding risk in research involving children
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