Aerial view of the 猎奇重口 campus and buildings around UM's Oval in Missoula, MT.

Research Compliance

Post Approval Monitoring

Post Approval Monitoring (PAM), or compliance monitoring, is an internal IRB program that monitors research projects to confirm that research is being conducted in accordance with applicable federal regulations, state laws, and institutional policies, and as outlined in the approved IRB protocol. The purpose of PAM is to ensure that ethical and regulatory requirements are followed by investigators. This program is also designed to improve the quality of research by ensuring congruence between what is described in the research protocol and what is occurring during the actual performance of research activities. PAMs also give researchers an opportunity to ask questions and receive information about regulations and issues regarding the protection of human subjects. The ultimate goal of post approval monitoring at UM is to ensure the well-being of human subjects in research.

During a PAM evaluation, IRB staff will assess research activities, identify areas of concern, provide guidance in implementing corrective actions or best practice recommendations, and prepare a final observations report. The IRB office uses post approval monitoring checklists (which contain important elements from pertinent regulations) to complete evaluations. All PAM checklists are available to study teams and can be found on the IRB website. The IRB will receive reports on the activities and findings of the PAM program at monthly committee meetings. 

Receiving notification that a study has been selected for PAM does not imply that wrongdoing has occurred or that it is suspected in the conduct of the study. PAM is not designed to “catch” individuals and IRB staff are not the research police; rather, PAM is meant to verify that research is being conducted as approved and to contribute to an overall culture of compliance and research integrity at UM.

Protocol Selection

All studies, even those determined to be Exempt status, are subject to PAM. Post Approval Monitoring visits will primarily be randomly selected; however, an emphasis may be placed on monitoring studies that are more than minimal risk or have unusual risks; involve vulnerable populations; involve investigational new drugs or devices; or require more than frequent than annual reviews by the IRB.

A PI may also request a PAM review to help keep records and procedures in compliance with federal regulations and institutional policies, or to help prepare for an external audit by a sponsor or federal agency. We also encourage study teams to regularly complete their own internal PAM reviews any time during the lifecycle of a protocol.

The PI and their research personnel must fully cooperate with all monitoring conducted by the IRB, regulatory agencies, funding agencies, and study sponsors. In addition, the PI must implement the appropriate corrective and preventative actions to resolve any observations and ensure that their research aligns with applicable federal regulations, state laws, and institutional policies. Failure to complete PAM may result in being reported to Office of Research and Creative Scholarship. If your study is federally funded OHRP/FDA may be notified for noncompliance.

Types of Monitoring Activities

  • A Self-Assessment PAM is conducted by the research team, usually the PI. The UM IRB office will send the project PI a self-assessment checklist to be completed within a set period of time (usually 30 days). The investigator self-assessment is meant to monitor adherence to the IRB-approved protocol, including but not limited to the retention of study records and participant files, compliance with investigator training requirements, the recruitment and selection process, the informed consent process, the conduction of the research procedures, and evaluation of other research activities.

  • The IRB office may also request that an investigator complete a Consent Document Review checklist as part of its PAM procedures. During this process, the PI is required to provide information about their consenting process and may be asked to submit all signed consent/assent signature pages for all enrolled participants within a specified period. This type of PAM is more likely to occur with studies that enroll many participants.

  • During a Consent Process Review, the PI will be asked to complete a checklist during an active consent process with participants. This type of PAM is usually conducted when a project has been issued a waiver of documentation of consent, and/or when there are multiple research team members consenting participants. Consent Process Reviews are a good opportunity for investigators to ensure that consent is being collected and documented (if applicable) properly and according to the approved IRB protocol.

    In some cases, IRB staff may request to observe a project’s consent process.

  • Another PAM procedure that the IRB office uses to ensure compliance is random training audits. Once a month, an active study will be randomly selected and asked to provide current training certificates for all team members listed on the IRB protocol.

  • A Full Site Assessment PAM consists of a full audit of all records and processes for a human subjects research project. This includes, but is not limited to:

    • Regulatory and IRB documentation
    • Protocol adherence, including investigator training records
    • Participant recruitment and selection procedures
    • Participant enrollment and corresponding records
    • Informed consent procedures
    • Participant payment
    • Document and data retention and storage practices
    • Confidentiality and privacy practices and processes
    • Clinical trial requirements (if applicable)

    Full Site Assessments are generally reserved for complex protocols, protocols that involve vulnerable populations, protocols that are deemed more than minimal risk, and/or protocols that are federally funded; however, the UM IRB may randomly do an on-site assessment for any active protocol.

  • If a concern or complaint about the conduct of a project is discovered or reported to IRB staff, any member of the IRB, or other administrative official, an audit for cause may be initiated. Audits for cause may occur at any time. The determination of the need for an audit for cause shall be made by the IRB Manager, IRB Chair, and/or the Office of Research and Creative Scholarship. An audit may be project-oriented (focused on a specific project) or research-oriented (focused on all the projects of a particular researcher). The PI of a project that has been selected for an audit for cause shall be notified at least one (1) working day in advance of the audit.

Preparing for a Monitoring Assessment

When a study is selected for Post Approval Monitoring, a UM IRB staff member will reach out to the Principal Investigator and primary study contact (if applicable) to inform them that their study was selected to undergo a PAM review. For Self-Assessments, Consent Document Reviews, and Consent Process Reviews, the IRB office will ask the PI to review their study records within 30 days of the initial notification and return their findings, in the form of a completed checklist(s), for review. For Training Audits, the PI will have 30 days from receipt of the initial notification to provide current (unexpired) training documentation for all study team members.

For in-person PAM visits, the IRB office will notify the PI and their designee (if applicable) that their study has been selected for post-approval monitoring and schedule an assessment. We will do our best to accommodate everyone’s schedules. Once scheduled, the UM IRB office will provide the PI with a checklist so that the study team can do a self-assessment of the project before the visit. During an in-person assessment, the IRB asks that the following information be made available: access to study files and regulatory documentation; access to participant records; space in which to review study documents; and sufficient time to discuss the project with the PI or a designated team member.

In preparation for addressing PAM questions, it is important for the PI to carefully and objectively review the approved protocol and ensure that all staff are carefully following all activities as described and approved by the IRB. All IRB study procedures must be followed and if any changes are needed to the approved protocol, an amendment must be submitted and approved. The HRPP cannot stress the importance of following the approved protocol. Even small changes from the approved protocol may be of great concern to the IRB, federal regulatory agencies, and internal and external auditors.

The goal of PAM is to help support the research team, and facilitate research by ensuring that the approved IRB protocol and University Policy are being followed.  The HRPP can also help researchers by identifying deficiencies so that the research team can put a plan in place for success and correct any deficiencies.

IRB Actions After a PAM Review

Upon completion of a PAM activity, the IRB office will prepare a case report that will be sent to the investigator within ten (10) business days via email. The case report will provide study teams with an overview of the findings and any potential follow-up actions that may be needed. Findings may include:

  • No issues found and no action required.
  • Recommendations or suggestions for consideration by the PI, such as sharing current best practices.
  • Additional education for the principal investigator and/or study staff.
  • Items requiring action – a request that an amendment or unanticipated problem be submitted.
  • Forwarding to IRB Chair and/or Committee for consideration of non-compliance findings. Please refer to the IRB’s Noncompliance policy for what constitutes research noncompliance.