63 - Post-Approval Compliance Monitoring in a Military Prison

Background:  In 2023, an Army site conducted its first post–approval compliance monitoring (PACM) in a medium-security correctional facility to ensure that the human subjects research (HSR) was being conducted as required by federal, Department of Defense (DoD), Institutional Review Board (IRB), ethical, regulatory, legal, and logistical standards.

Program

Description:  The PACM involved collaboration among personnel from various offices integrated as a team. Effective preplanning was crucial during the initial stages and prison visit. This included leveraging prison expertise, adhering to regulatory documentation and checklists to ensure compliance, obtaining advanced permission from prison leadership, and actively engaging with the Key Investigator. The IRB provided essential pre-review and PACM input to the Key Investigator. The Army Human Research Protections Office assisted the site with PACM procedures. The ombudsperson, who was present during recruitment as an independent intermediary to ensure adherence to the research protocol and answer participant concerns, was available during the PACM. By utilizing standardized checklists and creating a well-structured agenda that allocated time for specific activities during the monitoring period, the site completed the PACM as planned. Following the PACM, additional interaction ensured that the Key Investigator met corrective requirements.

Program

Assessment:  Accessing a prison poses challenges for both researchers and auditors. On-site access requirements for the PACM team included background checks, security screenings, and a prohibition on electronic devices (no outside computers allowed). Personnel are limited to bringing only essential materials such as paper and pens, and an escort is required at all times for both the PACM team and participants. From the IRB’s perspective, PACM oversight focused on ensuring that study procedures were adhered to and that the risks remained acceptable for participants. For example, the team reviewed the adherence to recruitment and informed consent processes, including data transmission, storage, de-identification of records, and study closure.

To adapt existing PACM procedures for a prison setting, the following activities occurred:
• Meeting with facility leadership and touring the prison.
• Conducting interviews with investigators and the ombudsperson.
• Reviewing master regulatory files and participant records (including informed consent verification and data collection tools).
• Inspecting documentation storage methods for security and privacy.
• Observing study procedures which included two participant groups.

Limitations: No literature specifically addresses DoD PACM in correctional facilities that operate within tightly regulated and closely monitored environments. Successful execution of the PACM visit hinged on factors such as the prison schedule, research time frame, and the availability of prison escorts. Each prison has its unique operational security and compliance requirements. Therefore, it remains unclear whether this PACM activity could occur in a non-DoD prison and if this PACM model is universally applicable.

Discussion:  The stringent operational and security measures combined with identifying prison leaders, correctional officers and staff to assist with PACM likely facilitated execution in the DoD setting. However, this context may not apply in non-DoD settings. When engaging in PACM in a correctional facility, there are a significant number of potential security threats may have been reduced in this setting. PACM coordination extends beyond the ethical, regulatory, and legal oversight and includes significate regulatory constraints during the development and initial approval of prison research. The addition of on-site PACM provides an opportunity to further human subjects protections and ensure regulatory compliance.