USUHS, Medical Executive Skills Course, online session

1. Accountability – Executive Management of
Clinical 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. 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. 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. Objective 1
• Identify the regulations regarding the conduct of clinical
investigations research in medical activities

5. Basic Principles
• Belmont Report
• Respect for persons
• Beneficence
• Justice
• The Technical Stuff Matters Too
• “t”s and “i”s

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. 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. References
• Army:
• AR 40-38 (clinical investigation program)
• AR 70-25 (use of volunteers as research subjects)

9. References
• Navy:
• SECNAVINST 3900.39C (Protection of Human Subjects)
• BUMEDINST 6000.12A (Clinical Investigation Program)
• BUMEDINST 3900.6B (Protection of Human Subjects)

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. Objective 2
• Demonstrate the function, role, and responsibilities of an
Institutional Review Board (IRB)

12. Protocol Approval Process
• Assurances
• Protocols
• Scientific Review
• Human Use

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. 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. 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. IRB Issues
• Overseas
• Special Subjects
• Children (Assent)
• Prisoners
• “Emergency” Research

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. Objective 3
• Understand the issues regarding informed consent in clinical
research

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. Objective 4
• Understand the future challenges in clinical research

21. Command Issues
• Outside Sponsorship
• Technology Transfer
• CRADAs
• “Sensitive” Research
• Cooperative Research
• Joint IRBs
• Publication

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. 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. 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. The Bottom Line
• Leadership
• Visibility
• Good People
• Support

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