Accountability – Executive Management ofClinical Investigation Programs    Mr. John E. Baker    General Counsel    Uniform...
Clinical Investigation   •   What are we talking about?       • Research – Systematic investigation designed to develop or...
Objectives    •   Identify the regulations regarding the conduct of clinical investigations        research in medical act...
Objective 1     •   Identify the regulations regarding the conduct of clinical         investigations research in medical ...
Basic Principles     •   Belmont Report          • Respect for persons          • Beneficence          • Justice     •   T...
Office for Human Research Protections (OHRP)     •   Public Health Service Act 1974     •   Common Rule – 45 C.F.R. Part 4...
References    •   CFRs:         • 45 CFR 46.101 (definitions and explanations of IRBs,           assurances, informed cons...
References    •   Army:        • AR 40-38 (clinical investigation program)        • AR 70-25 (use of volunteers as researc...
References    •   Navy:        • SECNAVINST 3900.39C (Protection of Human Subjects)        • BUMEDINST 6000.12A (Clinical ...
References    •   Air Force:        • AFPD 40-4 (Clinical Investigation and Human Use in          Medical Research)       ...
Objective 2     •   Demonstrate the function, role, and responsibilities of an         Institutional Review Board (IRB)
Protocol Approval Process    •   Assurances    •   Protocols    •   Scientific Review    •   Human Use
Institutional Review Boards (IRB)    •   Duties: Approve, Disapprove, Modify         • Monitor, Continuing Review         ...
Institutional Review Boards (IRB)    •   Composition:         • Minimum 5 Members         • Both Genders         • Scienti...
IRB Issues    •   Research Subject Selection/Recruitment    •   Compensation of Subjects         • 24 U.S.C. § 30    •   M...
IRB Issues    •   Overseas    •   Special Subjects         • Children (Assent)         • Prisoners         • “Emergency” R...
IRB Process    •   Greater than Minimal Risk    •   Expedited Review    •   Exempt Research (32 C.F.R. 219.101)         • ...
Objective 3     •   Understand the issues regarding informed consent in clinical         research
Informed Consent•   Research Acknowledgement   • Alternatives•   Purpose of Study           • Compensation•   Describe Pro...
Objective 4     •   Understand the future challenges in clinical research
Command Issues    •   Outside Sponsorship    •   Technology Transfer         • CRADAs    •   “Sensitive” Research    •   C...
On The Horizon    •   Recommendations for Reform:        • Recast IRB Requirements        • Strengthen Continuing Protecti...
Individual Accountability    •   Researcher Charged With Negligent Homicide (Criminal        Liability)    •   IRB Chair N...
Institutional Liability     •   U.S. Halts Research on Humans at Duke University     •   Johns Hopkins: Healthy Volunteer ...
The Bottom Line    •   Leadership    •   Visibility    •   Good People    •   Support
Questions/Answers    •   Your Team (Research Director, IRB Chair, IRB Administrator,        Legal Advisor)    •   Technica...
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Online Session Accountability

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USUHS, Medical Executive Skills Course, online session

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  • Critical Decision Making for Medical Executives: Keys to Improving Healthcare Delivery
  • Online Session Accountability

    1. 1. Accountability – Executive Management ofClinical Investigation Programs Mr. John E. Baker General Counsel Uniformed Services University of the Health Sciences jbaker@usuhs.mil Ms. Carol Cooper Associate General Counsel TRICARE Management Activity carol.cooper@tma.osd.mil
    2. 2. Clinical Investigation • What are we talking about? • Research – Systematic investigation designed to develop or contribute to generalizable knowledge – 32 C.F.R. 219.102(d) • Why? • “Cutting Edge” Care, Training, Mission • Who’s accountable? • Individual researchers and health care providers, IRBs, facility commanders/staffs, the services, DoD • What are we accountable for? • Adherence to all applicable laws and statutes, ethical decision-making and judgment
    3. 3. Objectives • Identify the regulations regarding the conduct of clinical investigations research in medical activities • Demonstrate the function, role, and responsibilities of an Institutional Review Board (IRB) • Understand the issues regarding informed consent in clinical research • Understand the future challenges in clinical research
    4. 4. Objective 1 • Identify the regulations regarding the conduct of clinical investigations research in medical activities
    5. 5. Basic Principles • Belmont Report • Respect for persons • Beneficence • Justice • The Technical Stuff Matters Too • “t”s and “i”s
    6. 6. Office for Human Research Protections (OHRP) • Public Health Service Act 1974 • Common Rule – 45 C.F.R. Part 46 • 16 Federal Agencies + HHS • Ethical Principles • Prospective Review by IRBs
    7. 7. References • CFRs: • 45 CFR 46.101 (definitions and explanations of IRBs, assurances, informed consent) • 32 CFR 219.101-124 • DoD: • DODDIR 3216.2 (Protection of Human Subjects)
    8. 8. References • Army: • AR 40-38 (clinical investigation program) • AR 70-25 (use of volunteers as research subjects)
    9. 9. References • Navy: • SECNAVINST 3900.39C (Protection of Human Subjects) • BUMEDINST 6000.12A (Clinical Investigation Program) • BUMEDINST 3900.6B (Protection of Human Subjects)
    10. 10. References • Air Force: • AFPD 40-4 (Clinical Investigation and Human Use in Medical Research) • AFI 40-402 (Protection of Human Subjects in Biomedical and Behavioral Research)
    11. 11. Objective 2 • Demonstrate the function, role, and responsibilities of an Institutional Review Board (IRB)
    12. 12. Protocol Approval Process • Assurances • Protocols • Scientific Review • Human Use
    13. 13. Institutional Review Boards (IRB) • Duties: Approve, Disapprove, Modify • Monitor, Continuing Review • Suspend, Terminate • For each Protocol: • Risk/Benefit Analysis • Plan to minimize Risks • Informed Consent • Privacy/Confidentiality
    14. 14. Institutional Review Boards (IRB) • Composition: • Minimum 5 Members • Both Genders • Scientific/Nonscientific • Nonaffiliated with Institution • Diversity in Experience and Expertise • Sensitive to Community • Knowledgeable of Applicable Regulations
    15. 15. IRB Issues • Research Subject Selection/Recruitment • Compensation of Subjects • 24 U.S.C. § 30 • Minimizing Risks • Medical Monitor • Military Unique Environments • Conflicts of Interest
    16. 16. IRB Issues • Overseas • Special Subjects • Children (Assent) • Prisoners • “Emergency” Research
    17. 17. IRB Process • Greater than Minimal Risk • Expedited Review • Exempt Research (32 C.F.R. 219.101) • Educational Practices, Tests & Surveys • Existing Data • Elected Officials • Public Benefit Service Programs • Consumer Acceptance • Continuing Review
    18. 18. Objective 3 • Understand the issues regarding informed consent in clinical research
    19. 19. Informed Consent• Research Acknowledgement • Alternatives• Purpose of Study • Compensation• Describe Procedures • Medical Care for Injuries • Duration • Experimental • Voluntary Nature• Potential Risks – Withdrawal• Potential Benefits • POC for Questions
    20. 20. Objective 4 • Understand the future challenges in clinical research
    21. 21. Command Issues • Outside Sponsorship • Technology Transfer • CRADAs • “Sensitive” Research • Cooperative Research • Joint IRBs • Publication
    22. 22. On The Horizon • Recommendations for Reform: • Recast IRB Requirements • Strengthen Continuing Protections • Enact Educational Requirements • Insulate IRBs from Conflicts • Recognize Workload Pressures • Reengineer Federal Oversight Process
    23. 23. Individual Accountability • Researcher Charged With Negligent Homicide (Criminal Liability) • IRB Chair Named in Million $$ Lawsuit (Civil Liability) • Commander Relieved (Malfeasance, Nonfeasance, Administrative Action) • 15-6 Investigation for Research Misconduct Clears Lab Personnel
    24. 24. Institutional Liability • U.S. Halts Research on Humans at Duke University • Johns Hopkins: Healthy Volunteer in Asthma Trial Dies After Inhaling Drug • DOD Grounds Medical Research Program at ________________
    25. 25. The Bottom Line • Leadership • Visibility • Good People • Support
    26. 26. Questions/Answers • Your Team (Research Director, IRB Chair, IRB Administrator, Legal Advisor) • Technical Chain (DCS-Research/SG Legal Advisor) • http://www.bioethics.gov • jbaker@usuhs.mil • carol.cooper@tma.osd.mil

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