Post Approval Monitoring
Researcher interactions with the IRB are not limited to submitting paperwork for review and approval. Once a project is approved, it is under IRB oversight as long as participant interactions continue, identifiers are linked to data, and/or the project is not closed. Post approval monitoring (PAM) is a program that monitors active projects to confirm that the research is being conducted as approved, thus ensuring compliance with the federal regulations, policies and guidelines that govern the protection of study participants.
UNM’s PAM program has three goals: 1) Enhance protection of research participants 2) Improve quality of human research data 3) To serve as a training opportunity for researchers as they conduct their research. To assist researchers with establishing their projects and monitor them over time, study administration tools are available on the OIRB website. Additionally, the OIRB may contact the researcher in order to assess the project in real time through a full assessment, self-assessment, consent document review, consent process review, or other activity. For more information about the PAM program, see SOP 409 Post Approval Monitoring.
Upon selection, the OIRB notifies the PI in writing regarding the selection of their project for PAM. OIRB staff provide the PI and student investigator (if applicable) the monitoring tool to be completed and a return by date (typically 30 days). Lack of response by the PI will be considered noncompliance with this policy and may result in a process hold on future submission(s), full audit or involvement of the Department Chair, Director or Associate Dean for Research.
On Site Assessments
On-site assessments are conducted by a qualified OIRB staff member. The OIRB staff member’s role is to observe the research activity, to assist and educate the principal investigator (PI) in identifying any deviations from the approved protocol and in implementing any required changes, and to document the findings of the PAM assessment.
If selected for an onsite assessment, the various areas of a research project - i.e., the protocol, personnel, study procedures, informed consent process, data confidentiality measures, and general record keeping - are all subject to review. Questions included in the PI Self-Assessment can help PIs and student researchers evaluate their own research programs and identify potential noncompliance issues before they become serious and/or reportable problems.
The OIRB will contact the PI and student researcher (if applicable) via email and ask for the following: availability of the PI and an allocation of resources, such as files, private space, and/or access to electronic records. On the day of review, the study files will be reviewed and interviews may be conducted with project team members.
Perhaps the most effective way to prepare for a PAM visit is to carefully and objectively read your approved protocol and make sure that you and your staff are performing the research activities as described and approved by the IRB. Many variables can play into the need for adjustment in the design, procedures, etc., of your protocol. The main thing to remember is any changes to the IRB-approved protocol must be approved by the IRB prior to implementation. It is easy to be caught up in the progress of research and forget to submit an amendment. Likewise, an issue may seem trivial to a researcher, but it may be of great concern to the IRB, federal regulators, or auditors. Remember, the goal of post approval monitoring is not to “catch” you doing something you aren’t supposed to be doing. Rather, it is designed to facilitate research by making sure it is conducted in a manner where the conditions of federal regulations and University policy are met and by assisting researchers to identify and correct any deficiencies.
Upon completion of a PAM activity, OIRB will prepare a report that will be published in IRBNet. This letter 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 for consideration of non-compliance findings
If a concern or compliant about the conduct of a project is discovered or reported to the OIRB staff, any member of the IRB, or other administrative official, an audit for cause may be initiated. The determination of the need for an audit for cause shall be made by the IRB Chair in consultation with the OIRB Director. Audits for cause may occur at any time. An audit may be project-oriented (focused on a specific project) or researcher-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.
The self-assessment is a tool for researchers to conduct a review of their IRB approved projects to ensure they are being conducted in compliance with the approved procedures and IRB regulations and policies. If you receive a request to complete a self-assessment, this can be completed at a time that is convenient to you and should be returned to our office within 30 days via IRBNet. The UNM IRB encourages researchers to conduct self-assessments at least annually. The IRB may also request that self-assessments be conducted and reported to the UNM IRB. Please keep copies of completed assessments with your IRB related records. If needed, use additional pages for notes.
- No informed consent obtained prior to study procedures.
- The informed consent document on file is not complete (i.e., only the page containing the signature is on file).
- The IRB-approved version of the informed consent or assent document was not used.
- Dates on informed consent document for participant and researcher are not the same.
- CITI training for study personnel is expired or is not on file.
- Study personnel do not have a current conflict of interest disclosure on file with the COI office (required annually for all UNM researchers).
- Study documents not stored as indicated in the approved protocol OR stored with linking list.
How are the research protocols selected?
All active human research studies that have received approval from UNM OIRB may be randomly selected for post approval monitoring.
What happens once a study is selected for PAM review?
The study team will receive notification, in writing, that their study has been selected for post approval monitoring. OIRB staff provide the PI and student investigator (if applicable) the monitoring tool to be completed and a return by date (typically 30 days). Lack of response by the PI will be considered noncompliance with this policy and may result in a process hold on future submission(s), full audit or involvement of the Department Chair, Director or Associate Dean for Research.
What are some of the benefits that an investigator may gain from the PAM process?
Some of the possible benefits that may be gained from a review include but are not limited to:
- Increased understanding of the regulations that guide all of our research projects
- Increased communication concerning updates to Federal and University regulations
- Access to resources and individuals to clarify the Federal and University regulations