Research Ethics and Compliance Officer Army Human Research Protections Office Falls Church, Virginia, United States
Background: Army institutions that conduct and/or support human subjects research must have a Human Research Protection Program (HRPP) with oversight commensurate to the institution’s research portfolio. To ensure regulatory compliance, Army oversight personnel evaluate Army institutions to determine HRPP needs through relationship building, virtual and on-site education, regulatory support, and assessments.
Program
Description: Site monitoring involves building relationships with Institutional leadership and site personnel to provide support to institutions unfamiliar with HRPP requirements. Or, in the case of institutional changes, monitoring supports an institution that had HRPP oversight, as an example, but may be moved to another command. Phone and/or virtual meetings are part of the initial activities. Results may indicate the need for an on-site visit. Assistance visits may include meetings with institutional stakeholders and departments such as legal, contracting, and public affairs. Following the assistance visit, oversight personnel may conduct document reviews and editing with site personnel to provide further refinement of standard operating procedures, organizational charts, and creation of a Plan of Actions and Milestones (POAM) for further HRPP development actions. To further site involvement, Army sites in-development are invited to HRPP Training and Education meetings where they are encouraged to participate and connect with other HRPP colleagues.
Program
Assessment: Human subjects research (HSR) may involve just a small portion of activities being carried out at an Army institution, therefore ensuring a compliant HRPP includes securing buy-in from Institutional leadership and staff. Army sites are provided a dedicated point of contact (lead) for each institution, and the lead is the initial contact and information provider during the HRPP development process. The lead is responsible for determining whether the HRPP requires an Assurance. This requirement applies if the institution will conduct nonexempt HSR or is forecasted to conduct nonexempt HSR in the near future. As HRPP development progresses, the sites are provided direct training to site individuals designated for certain roles within the HRPP such as the Exempt Determination Official and Human Protections Director. After an HRPP is implemented, the lead conducts periodic touchpoints to enhance compliance and ensure HRPP operations are aligned with the approved HRPP documentation and associated institutional policies and procedures.
Limitations: Personnel changes in military and civilian leadership at Army institutions may impact the mission of the organization and its research portfolio. HRPP oversight may be strained with limited staff or resources and thus may be at increased risk for noncompliance due to inadequate oversight. Required or recommended HRPP actions meant to scale HRPP functions to appropriate levels may not be immediately implemented and thus result in delays of research activities.
Discussion: Site monitoring and HRPP-development through assistance and assessment is easily applied toward ensuring regulatory compliance and oversight, especially where oversight is provided across a large geographic or organizational entity. The effects of noncompliant HSR can harm participants, and can include termination of research, limitations on a site’s research portfolio, and contribute to an erosion of organizational trust. Flexibility in HRPP development is key as there is no one- size-fits all approach. Leveraging technology such as Microsoft TEAMS for virtual assessments, training and document sharing is vital. HRPP tools such as checklists and templates help establish consistent requirements across institutions.
