Strategies for Achieving Regulatory Compliance and Economies in DoD-Supported Research

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1 Strategies for Achieving Regulatory Compliance and Economies in DoD-Supported Research University of Pittsburgh Pittsburgh, Pennsylvania 30 June 2016 Laura Ruse Brosch, RN, PhD Director, Office of Research Protections Headquarters, US Army Medical Research and Materiel Command Fort Detrick, MD

2 These opinions represent those of the presenter, and do not reflect the official views of US Army Medical Research and Materiel Command, the US Army, or the Department of Defense.

3 US Army Medical Research and Materiel Command (USAMRMC) The Army's medical materiel developer, with responsibility for medical research, development, and acquisition and medical logistics management. The Command is headquartered at Fort Detrick, MD, with 12 subordinate commands located throughout the world. Responsively and responsibly create, develop, deliver, and sustain medical capabilities for the Warfighter. Lead the advancement of military medicine Approx staff worldwide overseeing >$2.0B annually 4

4 FY16 USAMRMC Congressionally Directed Medical Research Program (CDMRP) Funding Program $M Program $M Alcohol and Substance Abuse Disorders $4.0 Peer Reviewed Alzheimer s $15.0 Amyotrophic Lateral Sclerosis $7.5 Peer Reviewed Cancer (13 Topics) $50.0 Autism $7.5 Peer Reviewed Medical (39 Topics) $278.7 Bone Marrow Failure $3.0 Peer Reviewed Orthopaedic $30.0 Breast Cancer $120.0 Prostate Cancer $80.0 Duchenne Muscular Dystrophy $3.2 Reconstructive Transplant $12.0 Epilepsy $7.5 Spinal Cord Injury $30.0 Gulf War Illness $20.0 Tick-Borne Disease $5.0 Joint Warfighter Medical* $50.0 Trauma Clinical Research $10.0 Lung Cancer $12.0 Tuberous Sclerosis Complex $6.0 Military Burn $8.0 Vision $10.0 Multiple Sclerosis $6.0 Neurofibromatosis $15.0 Programs Managed on behalf of Others: Neurotoxin Exposure Treatment Parkinson s $16.0 Defense Medical R&D* $299.6 Orthotics and Prosthetics Outcomes $10.0 Defense Medical R&D Restoral* Ovarian Cancer $20.0 Psychological Health and Traumatic Brain Injury* $125.0 * CDMRP is assisting with the management of a specified portion of a larger appropriation(s) TOTAL = $1.468B 4

5 Funding Opportunities Numerous types of award mechanisms Tailored to the goals of each program May vary from year to year Each funding opportunity is made available through a Program Announcement (PA) or program-specific Broad Agency Announcement (BAA) Pre-announcement release CDMRP website and blast Funding Opportunity Postings CDMRP website Grants.gov FedBizOps (BAA)

6 Subscribe, Register & Apply Subscribe to Funding Opportunity Releases Registration and Pre-application Application

7 Note: DoD supported research is subject to a few additional regulatory requirements and review/approval processes Knowledge of requirements and advance planning can streamline the review and approval process

8 USAMRMC Office of Research Protections Oversees USAMRMC supported research involving human subjects or animals, to assure they are conducted in accordance with (IAW) ethical standards and federal, DoD, Army, USAMRMC, local and international regulatory requirements Oversees Army conducted or supported animal live tissue training to ensure that it is conducted IAW DoD requirements Oversees Army-conducted or supported cadaver use to ensure that it is conducted IAW Army-level policy requirements

9 HQ USAMRMC ORP Organization HQ USAMRMC Institutional Review Board Office of Research Protections (ORP) Human Research Protections Animal Welfare Institutional Review Board Office (IRBO) Human Research Protection Office (HRPO) Animal Care and Use Review Office (ACURO) CY15 Oversight for 4445 human research projects Received 1022 new protocols Oversight for 3257 animal use projects Received 1193 new Protocols 1699 Institutions 65 Countries

10 ORP s Support Role in USAMRMC- Supported Extramural Research Executional Management Activity Science Officer (SO) Contracting Officer s (Technical) Representative (COR/COTR) Common Goal Support the Investigators /Institutions Efforts to Complete High Quality, Regulatory Compliant DoD-Supported Research Office of Research Protections Human Subjects Protection Scientist Animal Use Specialist US Army Medical Research Acquisition Activity Contracting Officer Contract Specialist

11 An Overview of DoD Human Research Protections

12 Human Research Protections in the DoD Important DoD contributions Walter Reed (1900) Informed Consent Wilson Memorandum (1953) Implemented Nuremburg Code Operation Whitecoat

13 Human Research Protections in the DoD Checkered past - Atomic Soldiers injurious exposures absence of controls no informed consent poor record-keeping LSD experiments CIA at Fort Detrick Army at Edgewood Incapacitating Agents Army Chemical Center Volunteer participants

14 Human Subjects Research Regulations DHHS 45 CFR 46 Subparts A,B,C,D,E 21 CFR 50,56,312, 812 FDA Guidances OHRP Guidances HIPAA State laws DoD 10 USC CFR CFR 46 Subparts B,C,D DoDI DoDI Component-specific regulations (e.g., Army, Navy, Air Force) State laws International Country-specific laws and regulations Declaration of Helsinki Council for International Organizations of Medical Sciences (CIOMS)

15 Human Subjects Protection Requirements for DoD-Supported Research DoD Instruction (DoDI) (November 2011) = Common Rule + FDA + Local/Host National + DoD requirements Defense Federal Acquisition Regulation Supplement (DFARS) clause for contracted human subjects research or comparable clause for other mechanisms of DoD support for extramural research

16 DoDI Applicability DoD-conducted research DoD-supported research Research involving human subjects for which the Department of Defense is providing at least some of the resources Resources may include but are not limited to funding, facilities, equipment, personnel (investigators or other personnel performing tasks identified in the research protocol), access to or information about DoD personnel for recruitment, or identifiable data or specimens from living individuals

17 The 2011 DoDI Changed the Way DoD Components Review Extramural Research DoDI requires: Federal Assurance for engaged institutions DoD human research protections regulations apply to subcontractors IRB of Record review for non-exempt human subjects research Human Research Protection Official (HRPO) administrative review for compliance with human subjects protection regulatory requirements for all extramural research and select categories of intramural research HRPO review consists of an assessment of the basic human subjects protection regulatory compliance (to include unique DoD requirements) of a USAMRMC supported protocol. HRPO review is not a second DoD IRB review HRPO approval indicates that a protocol has been determined to be in compliance with regulatory requirements

18 DoD-Unique Requirements

19 DoD Unique Human Subject Protections Appointment of a Research Monitor Required for all greater than minimal risk research studies Must be independent of research team Different from a Sponsor s Medical Monitor IRB must approve by name and include description of duties, authorities and responsibilities One research monitor is required, but more than one may be needed based on specific circumstances of the research May be an ombudsman or member of Data Safety Monitoring Board Duties should be based on specific risks and concerns of the research. Should have independent authority to take steps to protect individual subjects

20 DoD Unique Human Subject Protections Strategies for Compliance: Appointment of a Research Monitor Required for all greater than minimal risk research studies Include Must be roles independent and responsibilities of research of the team DoD-required research monitor in the protocol Different to be from approved a Sponsor s by the Medical IRB; identify Monitor by name in roles and responsibilities section IRB must approve by name and include description of duties, authorities and responsibilities Research One research Monitor monitor professional is required, qualifications but more should than be appropriate one may be to the research study needed (e.g., based physician, on specific nurse practitioner circumstances for a vaccine of the research clinical trial; psychiatrist/psychologist for PTSD study; sociologist for socio-behavioral survey) May be an ombudsman or member of Data Safety Monitoring Board Research monitor may not work under the supervision of the Principal Investigator (e.g. Duties Fellows, should junior be faculty based members); on specific Note: risks inclusion and concerns of a paid of the research monitor can research. be considered Should in have budget independent authority to take steps to protect individual subjects Roles can include reviewing SAEs, Unanticipated Problems; may review requests for exceptions or other unique tasks required by the IRB or DoD (e.g., observe consent episodes)

21 10 USC 980: Limitation On Use Of Humans As Experimental Subjects (a) Funds appropriated to the [DOD] may not be used for research involving a human being as an experimental subject unless-- (1) the informed consent of the subject is obtained in advance; or (2) in the case of research intended to be beneficial to the subject, the informed consent of the subject or a legal representative of the subject is obtained in advance. (b) The Secretary of Defense may waive the prohibition in this section with respect to a specific research project to advance the development of a medical product necessary to the armed forces if the research project may directly benefit the subject and is carried out in accordance with all other applicable laws.

22 10 USC 980 Substantive Effects If a subject is unable to consent (e.g., children, the mentally ill, unconscious persons), the legal representative may consent in advance, but only if research is intended to be beneficial to the subject (all subjects, regardless of study arm) Implications for studies with usual care or placebo arms A Secretary of the Army Waiver of the advance informed consent provision of 10 USC 980 is required for studies conducted under 21 CFR 50.24, Exceptions from informed consent for emergency research

23 10 USC 980 Substantive Effects Strategies for Compliance: Requires advance informed consent of the subject When seeking a waiver of informed consent or allowing Legally Authorized Representative If a subject permission unable in lieu to consent of subject (e.g., consent children, in experimental the mentally clinical trials with usual ill, unconscious care, active comparator, persons), or the placebo legal controlled representative arms, Investigators may must articulate consent how in all advance, subjects in but the study only (regardless if research of is study intended arm) may to potentially be benefit from participation. For example, the provision of additional clinical beneficial to the subject (all subjects, regardless of study monitoring, testing, evaluations that are made available to the care providers; potential arm) for earlier intervention due to nature of the study-specific monitoring provided Implications for studies with usual care or placebo arms A Secretary of the Army Waiver of the advance informed consent provision of 10 USC 980 is required for studies conducted under 21 CFR Exceptions from informed consent for emergency research. For all clinical research that require an Exception from Informed Consent for Emergency Care Research (EFIC) under 21 CFR work early and closely with the appropriate DoD component Human Research Protections Office to obtain a Secretarial Waiver can take the action forward after first site is IRB approved for community consultation waiver may take up to 6 months for approval

24 DoD Unique Human Subject Protections Military Personnel (and Federal Employees) Special considerations for recruitment of military personnel in greater than minimal risk (GTMR) studies No Chain of Command involvement in recruitment Ombudsperson Negotiating access required military approvals Limitations in compensation for Service Member or federal employee research participation

25 DoD Unique Human Subject Protections Military Personnel (and Federal Employees) Strategies Minimize for Potential Compliance: for Coercion, Undue Influence due to Rank Structure Special considerations for recruitment of military personnel in populations GTMR studies No Chain of Command involvement in recruitment Ombudsperson Negotiating access required military approvals Limitations in compensation for research participation Collaborate with a military partner to negotiate access to military When recruiting military populations for GTMR studies via group recruitment briefings plan for separate sessions for enlisted Service Members and their Chain of Command (consider time required per session) If multiple military institutions are engaged, request single military IRB review or explore the option of having the military institution rely on your IRB if the military role is secondary to yours! Work with military collaborators to determine under which circumstances Service Member or federal employee research volunteers can be

26 How Does DoD Differ from HHS? IRBs may use expedited review for research involving previously collected data for any purpose (other than for the current research) DoD has adopted subpart B (pregnant women, fetuses, neonates), with modifications The current regulatory language suggests restriction to only important biomedical knowledge The DoDI extends use of subpart B to all generalizable knowledge, including social and behavioral research

27 How Does DoD Differ from HHS? DoD has adopted Subpart C (Prisoners), with modifications For research intended to include prisoners, these include: DoD does not allow expedited procedures to be used DoD expands the subpart C categories of permissible research with prisoners to include: o Epidemiological research meeting specific criteria o Human subjects research that would otherwise be eligible for exemption can be conducted with prisoners, provided that it is approved by a convened IRB in accordance with other provisions of Subpart C and the DoDI NOTE: When a subject in a DoD supported study becomes a prisoner it must be reported to the local IRB and the DoD HRPO

28 How Does DoD Differ from HHS? All detainees are a special population of prisoners Research with detainees is PROHIBITED Detainee is defined in DoDD E as: Any person captured, detained, held, or otherwise under the control of DoD personnel (military, civilian, or contractor employee). It does not include persons being held primarily for law enforcement purposes, except where the United States is the occupying power.

29 How Does DoD Differ from HHS? DoD defines the status of Service Members as adults All active duty members and all Reserve Component members in a Federal duty status are considered to be adults Participation is not subject to additional protections discussed in section 7.d, Children as Subjects of the DoDI Classified non-exempt research requires Secretary of Defense approval (non delegable)

30 Unique Human Subjects Protections USAMRMC Required Consent Form Language A statement that DoD is funding the study A statement that representatives of the DoD are authorized to review research records Representatives of the DoD are an entity to whom protected health information (PHI) can be disclosed in HIPAA Authorization Research Monitor may be named if from outside the HIPAA covered institution

31 HRPO Administrative Review, Approval and Compliance Oversight Criteria for Approval: Appropriate determination (if applicable) e.g., not research, research not involving human subjects, exempt research Appropriate level of IRB review (Full board vs expedited) Risk level determination NSR/SR device study determination Appropriate IND determination Consent form language HIPAA language When do we contact your IRB Office? Clarify nature of your IRB review, e.g., expedited review of a device study Help us understand the risk level determination if we have questions Better understand your position on a variety of issues to include IND/IDE determinations

32 HRPO Administrative Review, Approval and Compliance Oversight We generally communicate directly with the Principal Investigator and Site Principal Investigators (with few exceptions) to ensure all human subjects regulatory requirements are met and DoD-required language is included in the protocol and consent form

33 HRPO Life Cycle Requirements Human research may not be initiated until HRPO approval memo sent to each site (memo specifies reporting requirements) Life Cycle Actions Substantive amendments to the protocol (and Statement of Work) Continuing review reports provided to IRB Final study report provided to IRB HRPO tracks each protocol to closure due to completion or withdrawal, termination, and end of award whichever comes first

34 DoD HRPO Reporting Requirements DoD-supported institutions shall promptly notify the DoD HRPO of the following: when substantive changes to the research protocol are approved by the IRB if the IRB used to review and approve the research changes to a different IRB when the institution is notified by any Federal department or agency or national organization that any part of its HRPP is under investigation for cause involving a DoD-supported research protocol all UPIRTSOs, suspensions, terminations serious or continuing noncompliance regarding DoD-supported research involving human subjects 26

35 Formula for Success Program Announcement The Congressionally Directed Medical Research Program Award Guide for HRPO Information for Investigators Funded Investigators Protocol Submission Forms Program Announcement for the Defense Health Program Defense Medical Research and Development Program Department of Defense Congressionally Directed Medical Research Programs Peer Reviewed Orthopaedic Research Program Clinical Trial Award Funding Opportunity Number: W81XWH-14- PRORP-CTA Catalog of Federal Domestic Assistance Number: SUBMISSION AND REVIEW DATES AND TIMES Pre-Application Deadline: 5:00 p.m. Eastern time (ET), June 27, 2014 Invitation to Submit an Application: August 2014 Application Submission Deadline: 11:59 p.m. ET, October 24, 2014 End of Application Verification Period: 5:00 p.m. ET, October 29, 2014 Peer Review: December 2014 Programmatic Review: February 2015 Design and budget considers all regulatory requirements + + & THE CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS AWARD GUIDE FOR FUNDED INVESTIGATORS March 2014 revision Contact regulatory offices identified in the award guide for early guidance if needed & Follow the directions for a oneway trip through the DoD Component Human Research Protections Office

36 Investigator s Perception of the Regulatory Roadmap Then the DoD process begins... NOT!!!

37 Improved Version - Regulatory Roadmap PI responds to well-written DoD RFP/BAA that includes Regulatory Requirements PI s proposal is funded receives HRPO Guidelines for Investigators and includes all DoD Requirements in wellwritten protocol can call HRPO with questions.submits IRB-approved protocol to HRPO for approval.starts recruitment/enrollment/study

38 In closing... a request for civilian-military research partnerships... We need evidence-based solutions. We depend upon civilian-military research partnerships to advance military (and civilian) health care today and tomorrow.

39 Points of Contact Laura Brosch, RN, PhD Director, Office of Research Protections (ORP) Director, ORP, Human Research Protection Office (HRPO) US Army Medical Research and Materiel Command (USAMRM (301) Kimberly Odam Deputy Director, HRPO USAMRMC (301)

40 Resources US Army URL: Headquarters, US Army Medical Research and Materiel Command URL: US Navy URL: US Air Force + + URL: Office of the Deputy Assistant Secretary of Defense for Force Health Protection and Readiness URL: 31

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