Human Research Protections: Minimum Education Requirements Framework - PowerPoint Presentation

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

Overview of the Organization Assurances and Harmonization Minimum Education RequirementsCollaborative Institutional Training Initiative (CITI)Questions Table of Contents 2

Overview of the Organization

Human Research Protection Program 4 August 6, 2014 AT&L ASD(R&E) Army SG Navy SG Air Force SG OUSD(P&R) DASD(FHP&R) Other OSD Agencies Components & Assurance Approving 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

OUSD(P&R) Organization and Leadership August 6, 2014 USD(P&R) PUSD(P&R) Military Deputy Chief of Staff Financial and Resource Mgmt DoD/VA Collaboration Office DoD Human Resources Activity ASD(HA) PDASD(HA) ASD(RA) PDASD(RA) ASD(R&FM) PDASD(R&FM) DASD (Force Health Protection &Readiness) DASD (Clinical & Program Policy) DASD(Warrior Care Policy) DASD (Health Budgets & Financial Policy) President, Uniformed Service University of Health Sciences Defense Health Agency WRNMMC FBCH MILVAX AFHSC METC DASD (Materiel & Facilities) DASD (Resources) DASD (Readiness, Training, & Mobilization) DASD (Reserve Manpower & Personnel) Director (Family & Employer Programs & Policy) DASD (Readiness) DASD (Military Personnel Policy) DASD (Civilian Personnel Policy) DASD (Military Community & Family Policy) Diversity Management & Equal Opportunity Total Force Planning & Requirements Transition to Vets Program Office Defense Commissary Agency DoD Education Activity OSD Staff Element DoD Field Activity Defense Agency = Assured = Non-Assured HRPP Defense Equal Opportunity Mgmt Institute + + + Medical Education and Training Campus Memorandum of Agreement

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

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 Subjects48 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 ResearchDoDI 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 Regulatory Responsibilities 7

Assurances and Harmonization

Institutions engaged in the conduct of non-exempt human subjects research must have an Assured HRPPThe 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)Summary of the Legal Requirements 10

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 researchUSUHS: Dr. Arthur Kellermann WRNMMC: BG Clark Jeffrey Clark Signed by the Component Designated Official leading HRPPOUSD(P&R): Dr. David Smith (DASD[FHP&R])What is an Assurance?

1 October 2014:Defense Health Agency (DHA) established within OUSD(P&R)/HAJTF CapMed disestablished National Capital Region Medical Directorate stood up within the DHACurrent State:USUHS Assurance issued by OUSD(P&R)NCR-MD Assurances issued by the ArmyAUGUST 2014:NCR-MD Assurances expireNCR-MD Assurances to be issued by OUSD(P&R) Assurance Transition & Harmonization 11

Business processes, forms, templates, requirements, etc. across OUSD(P&R) institutionsMHS-wide harmonization effortsMultisite studiesProtocol templates (led by Army OTSG)Business processesProtocol management system DoD-wide efforts Protocol management systemMinimum Education Requirements Framework (MERF)Harmonization Efforts

Minimum Education Requirements

History and Background 1 2 14 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.

Key Components of the MERF 15 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.

10 Categories of Roles in the DoD HRPP 16 Category Role 1 Senior DoD Component Leadership & Institutional Officials (IO) 2 DoD Component HQ Oversight Personnel 3 Institutional Review Board Members & Institutional Review Board Support Staff 4 Advisors to the Institutional Official5 Investigators 6 Research Support Personnel 7 Research Monitors, Ombudsman, Subject Advocates, Data Safety Monitoring Boards (DSMBs) 8 Research Coordinators, Clinical Coordinators, Study Coordinators, Research Administrators 9 Regulatory Oversight of Extramural Human Subject Research 10 Subjects

Educational Topic A. Ethical Principals & Requirements for HRPP L. Identifying & Mitigating Conflicts of Interest B. Defining Human Subjects Research & Applying Exemptions M. Requirements for IRB Review & Approval C. Identifying & Mitigating Subject Risk & Subject SelectionN. IRB Operating RequirementsD. Research with Pregnant Women, Human Fetuses, & NeonatesO. Research with the Department of Veteran’s Affairs (VA)E. Research with Prisoners P. International Research F. Research with Children Q. Internet Research G.. Research in an Educational Setting or with Students R. Records-Based ResearchH. Use of a Research Monitor S. Genetics Research I. Informed Consent T. FDA Regulated Research J. 10 US Code (USC) 980 U. Health Insurance Portability & Accountability Act (HIPPA) Regulated Research K. Privacy and Confidentiality Educational Topics for Key Roles

Educational Topics Required Per HRPP Role 18

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

Collaborative Institutional Training Initiative (CITI)

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.

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

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. Instructions for CITI Learners

Requirements 24 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.

QUESTIONS ?

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