Sarah Rule Email and Phone Number

•Serves as a recognized authority and subject matter expert in the area of research ethics and human subjects protection regulations•Provides expertise to military commands, government and non-governmental organizations, and others involved in research concerning the application of Army policies, procedures and regulations for the protection of human subjects•Negotiates and administers Human Research Protection Program (HRPP) plans and Assurances for Department of Defense (DoD) organizations•Conducts assessments of research oversight programs and identified research noncompliance in accordance with 32 Code of Federal Regulations (CFR) 219, 45 CFR 46, U.S. Food and Drug Administration (FDA), Department of Defense Instruction (DoDI) 3216.02, and other federal regulations, policies, procedures and guidelines domestic and international •Monitors progress as corrective action plans are implemented, monitors and evaluates content of facility research compliance programs•Interacts with investigators, research program leaders, commanders, and senior officials to assess needs related to approvals of Assurances and HRPPs•Develops, organizes and implements substantive and meaningful education programs in human subjects research ethics, regulatory compliance, responsible conduct of research, research integrity for Army-wide activities engaged in or supporting human subjects research•Develops effective evaluation tools to determine human subjects protection education and training needs and then develops and delivers educational lectures, workshops, seminars and courses to help Army organizations meet their human subjects protection training requirements

• Consulted regularly with stakeholders and interest groups to respond to human subjects protection research compliance and assurance issues• Triaged and provided regulatory guidance to questions regarding research, regulations, and VA policy • Developed and implemented educational programs for field research personnel including investigators and study staff, facility Research and Development (R&D) office personnel, Institutional Review Board chairs, R&D Committee Chairs, members, and administrators, and other VA facility staff that provide oversight or support to research• Assisted senior level staff in developing national level policies and guidelines

• Served as a recognized authority and subject matter expert in the area of research ethics and human subjects protection regulations• Provided expertise to military commands, government and non-governmental organizations, and others involved in research concerning the application of Army policies, procedures, and regulations for the protection of human subjects• Negotiated and administered Human Research Protection Programs (HRPPs) and Assurances for DoD organizations• Interacted with investigators, research program leaders, commanders, and senior officials to assess needs related to approvals of Assurances and HRPPs• Developed, organized, and implemented substantive and meaningful education programs in human subject research ethics, regulatory compliance, responsible conduct of research, and research integrity for Army-wide activities engaged in or supporting human subjects research• Developed effective evaluation tools to determine human subjects protection education and training needs and then developed and implemented educational lectures, workshops, seminars, and courses to help Army organizations meet their human subjects protection training requirements

•Served as the Chief of Research Department, Human Protections Administrator, Research Oversight and Compliance Officer and an Exempt Determination Official for the military treatment facility (MTF) in accordance with Department of Defense (DoD) Component and Assuring Authority, Office of the Under Secretary of Defense for Personnel and Readiness (OUSD P&R) Human Research Protections (HRPO)•Subject matter expert and consultant for Clinical Investigations for all research conducted at the MTF•Managed the day-to-day operations and oversight of the Human Research Protection Program (HRPP)•Coordinated scientific review of proposals and protocols, facilities information flow and was a liaison between agencies such as Medical Research and Materiel Command (MRMC), Federal and Contractor Principal Investigators and research staff, administrative staff, Institutional Review Boards (IRBs), Institutional Bio-safety Committees (IBCs), research administrative offices, U.S. Food and Drug Administration (FDA), and the Office of Research Protections (OHRP) •Resolved major problems in gaining approval for the research of the institution from scientific review committees to the Institutional Review Board (IRB) of record and other domestic and international institutional and ethical review boards•Accountable for oversight for DoD and Federal Institutional Assurances•Ensured human subjects research (HSR) studies are conducted with applicable sponsor, local, state and federal regulations in areas of research, public health, health outcomes, technology transfer, and health information technology•Assisted in the development and updates of the regulatory and compliance policies, SOPs and requirements for the organization•Established and implements training programs in HSR •Conducted research compliance monitoring •Represented the institution and HSR program at DoD and national conferences•Supervised subordinates

•Reviewed and monitored research protocols to ensure safety and regulatory compliance with federal law, domestic and international regulations, policies and guidelines pertaining to human subjects research •Developed human subjects research protocols aligned with U.S. FDA efforts: Phase I clinical trials, Good Clinical Practices (GCPs), safety and efficacy of novel candidate pharmaceutical, biological and/or medical device as an investigational new product and non-FDA human subjects research •Drafted reports to document research procedures, deviations, research compliance and non-compliance and investigator actions •Drafted and revised institutional policies and standard operating procedures (SOPs) for internal department/institutional use on regulatory compliance per the DoD, Department of the Army, FDA, U.S. Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP) •Prepared and distributed research protocol documents for Institutional Review Board (IRB) meetings•Wrote minutes for IRB actions such as board stipulations, human subjects research regulations, quorum count, votes, and conflicts of interest. •Performed quality checks of memoranda, protocol life cycle action documentation, IRB actions, department Access database entries, and regulatory files of co-workers •Conducted educational training of human subjects protection regulations and quality research documentation of research records for investigators, research support staff and new staff members

• Reviewed research protocols to ensure compliance with federal law, domestic and international regulations, policies and guidelines pertaining to human subjects research • Assisted with human subjects research protocol development for the FDA efforts: Phase I clinical trials, GCPs, safety and efficacy of novel candidate pharmaceutical, biological and/or medical device as an investigational new product and non-FDA human subjects research • Conducted monitoring for research protocols for safety and regulatory compliance• Wrote reports from protocol audits • Revised internal department SOPs and institutional policies on DoD, Department of the Army, FDA, DHHS OHRP human subjects research regulations involving investigational products, and IRB regulation and procedures• Assisted the IRB Administrator with organization and documentation of monthly IRB meeting procedures as per regulation • Provided educational training of human subjects protection regulations and quality research documentation of research records to investigators and research support staff• Assisted CRM Headquarters on proposal writing projects and provided assistance with all job-related progress reports/technical reports

Division of Infectious Diseases, Breast Cancer Research

Graduate Student

National Institute of Health (NIH), Division of AIDS (DAIDS) research contract