Human Research Protections: Minimum Education Requirements Framework

1. Human Research Protections: Minimum Education Requirements Framework Office of the Under Secretary of Defense (Personnel and Readiness) Force Health Protection & Readiness Programs, Office of the Assistant Secretary of Defense (Health Affairs) CAPT John Eckert, Acting Program Director

2. Table of Contents • Overview of the Organization • Assurances and Harmonization • Minimum Education Requirements • Collaborative Institutional Training Initiative (CITI) • Questions 2

3. Overview of the Organization

4. Human Research Protection Program Components & Assurance Approving Agencies AT&L ASD(R&E) Army SG Navy SG Air Force SG OUSD(P&R) DASD(FHP&R) Other OSD Agencies AT&L: Under Secretary of Defense for Acquisition, Technology and Logistics ASD(R&E): ASD Research and Engineering P&R: Under Secretary of Defense for Personnel and Readiness DASD(FHP&R): Deputy ASD for Force Health Protection & Readiness SG: Surgeon General

5. OUSD(P&R) Organization and Leadership USD(P&R) PUSD(P&R) Military Deputy DoD/VA Collaboration Office OSD Staff Element DoD Field Activity Financial and Resource Mgmt Chief of Staff DoD Human Resources Activity Defense Agency Memorandum of Agreement ASD(HA) PDASD(HA) ASD(RA) PDASD(RA) ASD(R&FM) PDASD(R&FM) + Medical Education and Training Campus DASD (Force Health Protection &Readiness) DASD (Materiel & Facilities) DASD (Readiness) DASD (Military Personnel Policy) DASD (Clinical & Program Policy) DASD (Resources) DASD (Civilian Personnel Policy) DASD (Warrior Care Policy) DASD (Readiness, Training, & Mobilization) + DASD (Military Community & Family Policy) Defense Equal Opportunity Mgmt Institute Diversity Management & Equal Opportunity DASD (Health Budgets & Financial Policy) DASD (Reserve Manpower & Personnel) = Assured Total Force Planning & Requirements + = Non-Assured HRPP President, Uniformed Service University of Health Sciences Director (Family & Employer Programs & Policy) Transition to Vets Program Office Defense Health Agency WRNMMC FBCH MILVAX AFHSC METC Defense Commissary Agency DoD Education Activity

6. R2O2 Staff Members • Acting Director: John Eckert, PhD, CIP, CAPT, USPHS • Deputy: Brandi Ritter, Maj, USAF, BSC, MPAS • Oversight Consultants: • Francine Jones, CIP (Human Research Oversight) • Kendra Orjada, MPH (Research Integrity and Misconduct) • Shealyn Clinger, MA (Animal Regulatory Oversight) 6

7. Regulatory Responsibilities • Responsible for oversight of compliance with the following: • 10 USC 980 – Limitation on Use of Humans as Experimental Subjects (requirements for informed consent when DoD-appropriated funds are used & humans as experimental subjects) • 32 CFR 219 – Protection of Human Subjects • 48 CFR 207, 235, and 252, “Defense Federal Acquisition Regulation supplement; protection of human subjects in research projects. • DoDI 3216.02 – Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research • DoDI 3216.01 – Use of Animals in DoD Programs • DoDI 3210.07 – Research Integrity and Misconduct • Minimum Education Requirements Framework • Regulatory oversight for all OUSD(P&R) offices/institutions • Provide HRP training to Institutional Officials, Human Protection Administrators at each P&R institution, Investigators, other regulatory program offices • Conduct Assurance compliance audits and assistance visits of P&R Institutions 7

8. Assurances and Harmonization

9. Summary of the Legal Requirements • Institutions engaged in the conduct of non-exempt human subjects research must have an Assured HRPP • The USD(P&R) has the authority to issue P&R Assurances and approve non-Assured HRPPs • Authority delegated to the DASD(FHP&R) by the USD(P&R) through the ASD(HA) 10

10. What is an Assurance? • Formal mechanism through which institutions that engage in Federally-funded, non-exempt human subjects research acknowledge that officials at the institution understand and will comply with statutes, Federal regulations and DoD policies concerning the protection of the human subjects who volunteer to participate in studies. • Signed by the Institutional Official (or designee) who is the lead for local oversight of research • USUHS: Dr. Arthur Kellermann • WRNMMC: BG Clark Jeffrey Clark • Signed by the Component Designated Official leading HRPP • OUSD(P&R): Dr. David Smith (DASD[FHP&R])

11. Assurance Transition & Harmonization 1 October 2014: • Defense Health Agency (DHA) established within OUSD(P&R)/HA • JTF CapMed disestablished • National Capital Region Medical Directorate stood up within the DHA Current State: • USUHS Assurance issued by OUSD(P&R) • NCR-MD Assurances issued by the Army AUGUST 2014: • NCR-MD Assurances expire • NCR-MD Assurances to be issued by OUSD(P&R) 11

12. Harmonization Efforts • Business processes, forms, templates, requirements, etc. across OUSD(P&R) institutions • MHS-wide harmonization efforts • Multisite studies • Protocol templates (led by Army OTSG) • Business processes • Protocol management system • DoD-wide efforts • Protocol management system • Minimum Education Requirements Framework (MERF)

13. Minimum Education Requirements

14. History and Background SUBJECT: Minimum Education Requirements for DoD Personnel Involved In Human Subjects Research References: DoD 3216.02 Purpose: “Establish a framework for educational training requirements for DoD personnel in key roles” of a human research protection program (HRPP). This framework sets the baseline for minimum education requirements for DoD personnel involved in human subjects research. Goals: To standardize education across DoD components. 1 2 14

15. Key Components of the MERF • Groups the HRPP roles into 10 Categories of key roles based on similar duties and responsibilities for the conduct, review, approval, or oversight of research. • Identifies and includes a brief description of the minimum educational topics for the key roles. • Identifies which education topics are required for which HRPP role categories. • Offers a standard DoD education certificate template for use among HRPP personnel of different DoD Components. 15

16. 10 Categories of Roles in the DoD HRPP 16

17. Educational Topics for Key Roles

18. Educational Topics Required Per HRPP Role 18

19. DoD Education Certificate Template DoD Human Research Protection Program (HRPP) Summary of Education [Print name] has completed the education requirements for the HRPP role category(s) indicated below and has completed the education requirements in the special topic(s) indicated below. Date Training Completed: _______________________________ This certificate expires on: _______________________________ Individual validating the education record: Signature: ________________________________ Date: ______________________ Printed Name: ____________________________ E-mail: __________________________________ Phone: _____________________ Completion of Required Educational Topics in the Following Role(s) (check all that apply) ____ Senior DoD Component Leaders & IOs ____ Research Support Personnel ____ DoD Component HQ Oversight Personnel ____ Research Monitors, Ombudsman, Subject Advocates, DSMBs ____ IRB Members, Consultants, & Staff ____ Research Coordinators, Clinical

20. Collaborative Institutional Training Initiative (CITI)

21. Educational Content • www.citiprogram.org • CITI offers content in the following areas: • Animal Care and Use (ACU) • Biosafety and Biosecurity (BSS) • Export Control (EC) • Good Clinical Practice (GCP) • Human Subjects Research (HSR) • Information Privacy and Security (IPS) • Responsible Conduct of Research (RCR) • This content has been customized to fit the needs of OUSD(P&R) while meeting the MERF requirements.

22. Creating a New Account • To create a new account go to www.citiprogram.organd click the “Register” button to follow the system prompts.

23. Instructions for CITI Learners • The curriculum for your course in the protection of human subjects has been defined by your institution according to your role in human subjects research.  • Complete all required modules and their associated quizzes. • The minimum "passing" aggregate score for the quizzes has been set by the R2O2 office.  • The Basic Course will require 4-6 hours to complete. • Print a copy of your completion report to keep for your records. Your institution’s administrative office will automatically be notified of your completion of the training.

24. Requirements • DoD personnel will complete the required Minimum Education Framework topics before assuming their DoD HRPP duties. • If conducting research under a P&R assurance, personnel must take the updated required CITI modules. • The required educational topics shall be repeated every three years. • CITI Refresher training will not be accepted as completed training. • DoD Components must document HRPP training. 24

25. QUESTIONS ?

26. Protecting Human Subjects – A Shared Responsibility CAPT John Eckert Acting Program Director Research Regulatory Oversight Office (R2O2) for the OUSD (Personnel and Readiness) Force Health, Protection & Readiness Programs 21