Human Research Protection in Human Factors Engineering

1. Human Research Protection in Human Factors Engineering L. Andrew Jones, Ph.D. Department of the Navy Human Research Protection Program Office of Naval Research 703-588-0612 andy.jones@navy.mil

2. Background: National Experience Human subject protection history Nuremberg trial, PHS syphilis study, etc. Prestigious institutions shut down Johns Hopkins, Duke, U of Illinois at Chicago, U Penn Consequences of non-compliance Threat to welfare of subjects, loss of public trust, loss of funding, degraded mission capability, Congressional inquiries, litigation, negative media attention

3. Adverse Events and Non-Compliance in DoD U.S. Government mind control experiments – LSD, MKULTRA, MKDELTA (1950-1970s) The CIA and Army collaborated on research using LSD and other drugs in violation of DoD policies. Research was conducted without informed consent. One known suicide. Human radiation experiments (1940s-1970s) A 1995 Advisory Committee for Human Radiation Experiments (ACHRE) report found that government agencies and Services, kept critical information secret from subjects and failed to obtain informed consent.

4. Projects SHAD, Copper Head, Flower Drum, Shady Grove, Autumn Gold, among others (1963-1970) More than 5,800 Naval shipboard personnel were exposed to nerve agents and biological simulant aerosol spray released by aircraft to test protective clothing, gas masks, and ship vulnerability. Adverse Events and Non-Compliance

5. A Matter of Law Human subject research is governed by federal law and DoD policy: 10 USC 980: Limitation On Use of Humans as Experimental Subjects 32 CFR 219: National Defense Protection of Human Subjects DoDD 3216.02: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

6. Department of DefenseDirective (DoDD) 3216.02 Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research DoD-supported human research is subject to the provisions of DoDD 3216.02 All human subject research supported or conducted by the DoD shall be conducted under an assurance of compliance acceptable to the funding Agency DoD human subject research must comply with 10 USC 980; 32 CFR 219; 45 CFR 46 Subparts B,C,D; 21 CFR 50, 56, 812; and component-specific regulations The involvement of prisoners of war as human research subjects is prohibited All DoD-supported human subject research must undergo a DoD-level human subjects protection review

7. DoD Human Research Protection Program (HRPP)

8. Definition: Research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

9. Definition: Human Subject Research with living individuals about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction that is identifiable private information

10. Military Service Members as Subjects Why they are an attractive population? Available, convenient, organized, predictable, and follow directions They serve in a strict hierarchical culture and Are trained to respect rank Implicitly agree to subordinate their autonomy for the sake of accomplishing the mission Agree to risk personal injury or loss of life, if need be, in compliance with lawful orders of their seniors Ideal “healthy volunteer” population Socio-behaviorally interesting Universal access to health care Limited compensation options Density of conditions (e.g., PTSD)

11. Military Service Members as Subjects Military research subjects: Are susceptible to directives/requests from senior officials Risk potential disqualifying consequences from disclosure of sensitive information Note: This may also be true for civil service employees

12. Research Involving MilitaryPopulations DoDD 3216.02 requires special protections for military personnel Chain of command may not influence service member participation Supervisors and unit leaders shall not be present for recruitment, enrollment, or consent process

13. DoD Regulatory Requirements Each institution engaged in research which is covered by this policy (involving human subjects) and which is conducted or supported by a federal department or agency shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements set forth in this policy Repeat of slide 2 – repeat the regulatory requirement now that all the words have been explicated. Repeat of slide 2 – repeat the regulatory requirement now that all the words have been explicated.

14. Definition: Engaged An Institution is “engaged” when the research is: Conducted or directed by employees or agents (including contractors and subcontractors) Conducted by or under direction of an institution facility Involves release of identifiable information to identify or recruit subjects or release of identifiable data for the research itself

15. Definition: Assurance A formal agreement between an Institutional Official and the Component Designated Official An Assurance is the institution’s commitment and procedures to comply with applicable laws, regulations, policies, and ethical guidelines

16. Not Human Subjects Research Quality improvement Process improvement Quality assurance Program evaluation Public health Surveillance Emergency response

17. Not Human Subjects Research Business process improvement Business process reengineering Capability maturity modeling Hoshin Kanri ISO 9000 Just in time manufacturing Lean manufacturing Performance improvement Process management Lean Six Sigma Theory of constraints Total quality management Trillium modeling Twelve leverage points

18. Proposed DFARS Changes Anticipated changes to the Defense Federal Acquisition Regulations System (DFARS) Part 207 Acquisition Planning 207.172 Human Research Part 235 Research and Development Contracting 235.071 Additional contract clauses Part 252 Solicitation Provisions and Contract Clauses 252.235-7012 Protection of Human Subjects

19. DoD Agency Contacts DDR&E Ms. Patty Decot patty.decot@osd.mil USA COL Julie K. Zadinsky julie.zadinsky@hqda.army.mil USN CAPT Eileen Villasante eileen.villasante@med.navy.mil USAF Lt. Col. Joe Narrigan joe.narrigan@pentagon.af.mil OUSD P&R Ms. Caroline Miner caroline.miner@tma.osd.mil OASD SO/LIC Dr. Gabriel Ramos ramosg@tswg.gov NSA Dr. Glen McWright gmmcwri@lps.umd.edu NGA Dr. Jeff Kretsch jeffrey.l.kretsch@nga.mil DARPA Ms. Riva Meade rmeade@darpa.mil DTRA Mr. Al Graziano al.graziano@dtra.mil JFCOM COL Linda Nye linda.nye@jfcom.mil SOCOM Mr. Robert Clayton claytor@socom.mil

20. Save the Date!  DoD HRPP Training Conference 26 & 27 June 2008 0800 -1630 Marriott Gateway Hotel Crystal City, VA

21. Research Involving Military Populations Ombudsman: For research involving greater than minimal risk During recruitment briefings to a unit where a percentage of the unit is being recruited to participate as a group Ombudsman not affiliated with military unit or research team Stresses and monitors the voluntary nature of participation Ensures information provided is adequate, accurate, and appropriate

22. DoDD 3216.02Additional Safeguard Study Monitor: All DoD conducted or supported research involving greater than minimal risk Independent study monitor Capable of overseeing the progress of research protocols, Independent of the investigative team Shall possess sufficient educational and professional experience to serve as a subject advocate