1 / 32

SACHRP Task Force Report: Prioritization of SACHRP Recommendations

SACHRP Task Force Report: Prioritization of SACHRP Recommendations. Barbara E. Bierer, MD SACHRP March 3-4, 2009. Outline. Review of SACHRP Charter: Purpose and Function Charge to Task Force SACHRP Task Force Process Brief review and Synthesis of Recommendations Next steps

bliss
Download Presentation

SACHRP Task Force Report: Prioritization of SACHRP Recommendations

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. SACHRP Task Force Report:Prioritization of SACHRP Recommendations Barbara E. Bierer, MD SACHRP March 3-4, 2009

  2. Outline • Review of SACHRP Charter: Purpose and Function • Charge to Task Force • SACHRP Task Force Process • Brief review and Synthesis of Recommendations • Next steps • Questions and discussion

  3. SACHRP Charter: Purpose Purpose: The Secretary is responsible for regulatory oversight of the system for the protection of human subjects in biomedical and behavioral research supported or conducted by the Department of Health and Human Services. The Secretary’s Advisory Committee on Human Research Protections shall provide expert advice and recommendations to the Secretary and the Assistant Secretary for Health (ASH) on issues and topics pertaining to or associated with the protections of human research subjects. The Committee will work to advise the Secretary as to how to improve the quality of the system of human research protection programs, including the responsibilities of investigators, institutional review boards, administrators, and institutional officials, and the role of the Office of Human Research Protections and other offices within the Department of Health and Human Services. Formerly known as NHRPAC, Initial Charter: October 1, 2002 Last Renewed: October, 2008

  4. SACHRP Charter Function: The Committee shall advise, consult with, and make recommendations on matters pertaining to the continuance and improvement of functions within the authority of the Department of Health and Human Services (HHS) directed toward protections for human subjects in research. Specifically, examples include but are not limited to advice relating to the responsible conduct of research involving human subjects with particular emphasis on: Special populations, such as neonates and children, prisoners, and the decisionally impaired; Pregnant women, embryos, and fetuses; Individuals and populations in international studies; Populations in which there are individually identifiable samples, data, or information; and Investigator conflicts of interest. Formerly known as NHRPAC, Initial Charter: October 1, 2002 Last Renewed: October, 2008

  5. SACHRP Charter Function: In addition, the Committee shall be responsible for reviewing selected ongoing work and planned activities of the Office of Human Research Protections (OHRP) and other offices/agencies within HHS responsible for human subjects protection. These evaluations may include but are not limited to a review of assurance systems, the application of minimal research risk standards, the granting of waivers, education programs sponsored by OHRP, and the ongoing monitoring and oversight of institutional review boards (IRBs) and the institutions that sponsor research. Formerly known as NHRPAC, Initial Charter: October 1, 2002 Last Renewed: October, 2008

  6. SACHRP Principles • Help the research community maintain the highest possible standard of human subject protection while advancing knowledge for the benefit of society • Improve the effectiveness, quality, and efficiency of the informed consent and the protocol review and monitoring process • Reduce regulatory burden that does not contribute meaningfully to human subject protection • Uphold public trust in the integrity of research conduct

  7. 147 recommendations, grouped into topic areas, were reviewed at SACHRP on October 27, 2009 • Research involving children and subpart D of 45 CFR part 46 (38) • Accreditation of human research protection programs (HRPPs) (5) • Adverse event reporting (1) • Research involving pregnant women and subpart B of 45 CFR part 46 (1) • HIPAA Privacy Rule (9) • Research involving prisoners and subpart C of 45 CFR part 46 (9) • OHRP/NIH/FDA workshop on central IRB review mechanisms (1) • Subpart A of 45 CFR part 46 (79) • Tribal authority over research involving American Indian or Alaska Native populations (1) • Research in disaster settings (2) • Review of the human subjects protection system (1) Total number of recommendations: 147

  8. Task Force The SACHRP Task Force was endorsed at the October 27-28, 2008 meeting of SACHRP following a recommendation by Dr. Myron Genel SACHRP will establish an ad hoc committee to review and prioritize pending SACHRP recommendations to the Department of HHS, with a report to be presented to SACHRP at its next meeting (March 3-4). Letters of Recommendations to the Secretary:http://www.hhs.gov/ohrp/sachrp/commsec.html

  9. Task Force Process Membership • Elizabeth Bankert • Barbara Bierer • Jeff Bodkin • Myron Genel • Stephen Shodeke • David Strauss With participation and support from: • Julia Gorey • Jerry Menikoff • Ivor Pritchard

  10. Task Force Process • Process • 2 conference calls • Receipt and review of OHRP input • Review with Subcommittees: • SAS • SIIIDR • Prioritization sent to SACHRP members, past chairs, past subcommittee chairs for input • Input collated and recommendations re-ordered • Summary and presentation to SACHRP March 3-4, 2009

  11. SACHRP Criteria for Prioritization • Enhance protection of human subjects • Reduce regulatory burdens that do not contribute to the protection of human subjects • Clarify confusing or apparently inconsistent regulatory language Importance vs Ease of Execution (“Low-hanging fruit”) Individuals were encouraged to apply their own criteria and were not asked to explain ranking

  12. Recommendations requiring prioritization as requested by OHRP Topics for OHRP regulatory action/policy or guidance development requiring substantial investment by OHRP (n= # recommendations) • A. Children (38) • B. Prisoners (9) • C. Research Involving Pregnant Women (1) • D. Continuing Review (14) • E. Expedited Review (6) • F. Training and Education (4) • G. Waiver of Informed Consent (6) • H. “Minimal Risk”(6) • I. Waiver of Documentation of Informed Consent (5) • J. Exemptions (27) • K. Roles of Institutional Officials (5) • L. Submission of Membership Rosters (5)

  13. Recommendations requiring prioritization as requested by OHRP Topics for OHRP regulatory action/policy or guidance development requiring substantial investment by OHRP (n= # recommendations) • A. Children (38) (A-C Enhance protections of human subjects) • B. Prisoners (9) • C. Research Involving Pregnant Women (1) • D. Continuing Review (14) • E. Expedited Review (6) • F. Training and Education (4) • G. Waiver of Informed Consent (6) • H. “Minimal Risk”(6) • I. Waiver of Documentation of Informed Consent (5) • J. Exemptions (27) • K. Roles of Institutional Officials (5) • L. Submission of Membership Rosters (5)

  14. Recommendations requiring prioritization as requested by OHRP Topics for OHRP regulatory action/policy or guidance development requiring substantial investment by OHRP (n= # recommendations) • A. Children (38) (A-C Enhance protections of human subjects) • B. Prisoners (9) • C. Research Involving Pregnant Women (1) • D. Continuing Review (14) (D-L Reduce regulatory burdens, Clarify confusing or apparently inconsistent regulatory language • E. Expedited Review (6) • F. Training and Education (4) • G. Waiver of Informed Consent (6) • H. “Minimal Risk”(6) • I. Waiver of Documentation of Informed Consent (5) • J. Exemptions (27) • K. Roles of Institutional Officials (5) • L. Submission of Membership Rosters (5) Importance vs Ease of Execution (“Low-hanging fruit”)

  15. Recommendations requiring prioritization as requested by OHRP Topics for OHRP regulatory action/policy or guidance development requiring substantial investment by OHRP (n= # recommendations) • A. Children (38) • B. Prisoners (9) • C. Research Involving Pregnant Women (1) • D. Continuing Review (14) • E. Expedited Review (6) • F. Training and Education (4) • G. Waiver of Informed Consent (6) (G-L Secretary acknowedgement pending) • H. “Minimal Risk”(6) • I. Waiver of Documentation of Informed Consent (5) • J. Exemptions (27) • K. Roles of Institutional Officials (5) • L. Submission of Membership Rosters (5)

  16. Recommendations suggested to be “moot” and not recommended for further action by OHRP Recommendation topics where prioritization for regulatory action/policy guidance development is Moot A. Adverse Event Reporting (1) B. Central/Alternative IRB mechanisms (1) C. HIPAA Privacy Rule (9) D. Accreditation of HRPPS (5) E. Tribal Authority over Research Involving American Indian or Alaska Native Populations (1) F. Demonstration Projects related to system-level changes in the Human Subjects Protection System (1)

  17. Recommendations suggested to be “moot” and not recommended for further action by OHRP Recommendation topics where prioritization for regulatory action/policy guidance development is Moot A. Adverse Event Reporting (1) • Guidance finalized by OHRP; FDA final guidance issued January, 2009 B. Central/Alternative IRB mechanisms (1) • Workshops held and report generated C. HIPAA Privacy Rule (9) • Office for Civil Rights has responsibility for HIPAA privacy rule D. Accreditation of HRPPS (5) • No recommendation suggested; no guidance required E. Tribal Authority over Research Involving American Indian or Alaska Native Populations (1) • Referred to Secretary for action F. Demonstration Projects related to system-level changes in the Human Subjects Protection System (1) • No regulatory action/policy guidance development needed

  18. Recommendations suggested to be “moot” and not recommended for further action by OHRP Recommendation topics where prioritization for regulatory action/policy guidance development is Moot A. Adverse Event Reporting (1) • Guidance finalized by OHRP; FDA final guidance issued January, 2009 B. Central/Alternative IRB mechanisms (1) • Workshops held and report generated C. HIPAA Privacy Rule (9) • Office for Civil Rights has responsibility for HIPAA privacy rule D. Accreditation of HRPPS (5) • No recommendation suggested; no guidance required E. Tribal Authority over Research Involving American Indian or Alaska Native Populations (1) • Referred to Secretary for action F. Demonstration Projects related to system-level changes in the Human Subjects Protection System (1) • No regulatory action/policy guidance development needed

  19. SACHRP PRIORITIES Recommendation Topics for OHRP regulatory action/policy guidance development requiring substantial investment by OHRP • Children (38)A • Expedited Review (5) E1,2,4 are guidance, E3 regulatory, E5 started • Waiver of Informed Consent and Documentation of IC (11) G and I combined • Continuing Review (14) D1, D3-14 guidance, D2 regulatory, • Membership Roster (2) L • Minimal risk (6) H (6-8 Similarly Ranked) • Exemptions (27) J • Institutional Officials (5) K • Training and Education (4) F FR notice posted, process started • Prisoners (9) B • Research involving Pregnant Women and Subpart B (1)

  20. Recommendations: 1. Children 1. Children (38) ｧ46.407: Majority of (6) recommendations implemented via OHRP’s May 26, 2005 guidance on the 407 review process and OHRP’s and FDA’s implementation of a joint review process for research regulated by both agencies. FDA issued guidance on its process under 21 CFR 50.54. Algorithm for analysis under subpart D (part of recommendation I) still under consideration by OHRP. Recommendation regarding a SACHRP subcommittee assessing aspects of 407 process implementation and making annual reports (part of recommendation VI) not implemented.

  21. Recommendations: 1. Children 1. Children (38) ｧ 46.404: research not involving greater than minimal risk (7)*** ｧ 46.405: research involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects (5)*** ｧ 46.406: research involving greater than minimal risk and no prospect of direct benefit, but likely to yield generalizable knowledge about the subject’s disorder or condition (4)*** ｧ 46.402: child assent (3) ｧ 46.408c: parental permission and its waiver for research designed for conditions for which parental or guardian permission is not a reasonable requirement to protect subjects (3)*** ｧ 46.409: research involving children who are wards (6)** ｧ 46.116(d) vis-a-vis waiver of parental permission (4)*

  22. Recommendations:2. Expedited Review 2. Expedited Review (6) 3 calling for revised OHRP and FDA guidance on expedited review: solely clerical or administrative by qualified IRB staff IRBs may give qualified staff authority for clerical/administrative IRBs may develop “stipulation mechanisms” for verifying required change 1 calling for revision of the regulations by changing “Expedited review” to “Delegated review” (Harmonization with FDA encouraged) 1 calling for specific revisions to expedited category 7 regarding behavioral research, and 1 calling for OHRP review of the expedited categories every 5 years, harmonizing list of categories with FDA

  23. Recommendations:3. Waiver of, and Waiver of Documentation of, Informed Consent 3. Waiver of, and Waiver of Documentation of, Informed Consent (11) 6 recommendations regarding the interpretation of the provisions under ｧ 46.116(d) for waiver of the requirements for obtaining informed consent. 5 recommendations regarding waiver under ｧ 46.117(c) of the requirements for documenting informed consent

  24. Recommendations:4. Continuing Review 4. Continuing Review (14) Revision of OHRP’s guidance regarding continuing review (13) Duration and stipulations of CR required after data collection (1) Simplified criteria and content of CR depending on study risk (1) *(similar action called for by FDA) Expedited review for no additional risks, interventions, or activities at any sites and expanded examples of expedited review (2) Responsibility for literature review by investigator, not IRB (1) No requirement for ongoing review of exempt protocols (1) Guidance on substance and timing of CR (4) Continued participation of already enrolled subjects if lapse in IRB CR Clarity of “protocol summary” (1) Qualified IRB staff may accomplish review of protocol (1) Advance Notice of Proposed Rulemaking: 46.109(e)proposal to allow continuing review to occur less frequently than once per year, but not less than every 2 years (1)

  25. Recommendations:5. Membership rosters 5. Submission of Membership Rosters (5) On January, 2009, OHRP (and FDA) published Subpart E largely defining requirement for electronic and, if necessary, written registration of IRBs. Relevant to Assurance stipulation discussed at this meeting

  26. Recommendations:6 Minimal Risk and 7. Exemptions 6. “Minimal Risk”(6) 6 recommendations regarding the interpretation of the definition of minimal risk at ｧ 46.102(i) 7. Exemptions (27) 27 recommendations regarding the exemptions.

  27. Recommendations:8. IOs and 9. Training and Education 8. Roles of Institutional Officials (5) 5 recommendations regarding roles of institutional officials in protecting human subjects. 9. Training and Education (4) 4 recommendations calling for new regulations requiring initial and continuing training: IRB members (1) IRB staff (1) Institutional Officials and Human Protection Administrator (1) Investigators and research team (1) OHRP published a Federal Register notice seeking information and comment

  28. Recommendations:Prisoners • Prisoners (9) 1 recommendation calling for extensive revision of subpart C. 8 recommendations regarding interpretation of current provisions of subpart C.(July 28, 2005) (One recommendation, that a prisoner representative should be a reviewer when research involving prisoners is reviewed by an IRB under an expedited review procedure, has been incorporated into OHRP FAQs. All other recommendations would require development of new guidance or revision of subpart C regulations and are under consideration by OHRP, along with many other recommendations made by the IOM.

  29. Recommendations:Research involving Pregnant Women • Research Involving Pregnant Women and Subpart B (1) Recommendation: OHRP should develop guidance on subpart B regarding how to interpret “Biomedical knowledge” in broadest possible sense, and the requirement that data cannot be collected by any means other than by enrolling pregnant women. The guidance should stress the appropriate use of the exemption clause.

  30. SACHRP PRIORITIES Recommendation Topics for OHRP regulatory action/policy guidance development requiring substantial investment by OHRP • Children (38)A • Expedited Review (5) E1,2,4 are guidance, E3 regulatory, E5 started • Waiver of Informed Consent and Documentation of IC (11) G and I combined • Continuing Review (14) D1, D3-14 guidance, D2 regulatory • Membership Roster (2) L • Minimal risk (6) H (6-8 Similarly ranked) • Exemptions (27) J • Institutional Officials (5) K • Training and Education (4) F FR notice posted, process started • Prisoners (9) B • Research involving Pregnant Women and Subpart B (1)

  31. Refinement Subpart A

  32. Comments and Discussion

More Related