There are four primary goals of Post Approval Monitoring (PAM) or compliance monitoring:
- To confirm by observation, documentation comparison, and direct communication with the Primary Investigator (PI) and study team that all approved research is being conducted in accordance with the IRB approved protocol, federal, and state regulations. In the event of noncompliance, the Institutional Review Board (IRB) and the IRB staff will provide guidance for self-reporting deviations or unapproved changes to the study protocol, and implementing any necessary actions such as submitting a protocol modification.
- To provide education in identified areas of need. During reviews the IRB is able to explain the IRB process, the importance of following the IRB approved protocol, what is expected from investigators and study team members, and best practices for conducting compliant human subjects research.
- To ensure the well-being of human subjects in research.
- In some cases, to help PIs and study teams prepare for external audits by granting, regulatory, and accreditation agencies.
ROLES IN THE PAM PROCESS
The IRB has the authority to approve, require modifications, disapprove, suspend, or terminate all human subjects research activities conducted at Binghamton University. As such, the IRB may determine whether a PAM visit is needed. The IRB is administratively housed within the Division of Research under the oversight of the Assistant Vice President for Research Compliance who serves as the Institutional Official (IO).
To achieve the objective stated above the IRB monitoring representative will work with PIs and their study teams to arrange for observations and confirmation of procedures for an approved study protocol.
The IRB monitoring representative will observe the research activities, prepare reports, provide recommendations for maintaining compliance, provide training, if needed, and, if appropriate, assist in the execution of corrective and/or preventative actions.
The IRB Associate Director and the IRB Chair will jointly provide oversight and management of the PAM program and will assure that reports or updates on items of concern are communicated to the IO.
PROTOCOL SELECTION/CATEGORIES OF AUDITS
All non-exempt studies are subject to post-approval monitoring. Nonetheless, emphasis will be placed on monitoring studies involving:
- Vulnerable Populations
- Confidentiality Concerns
- More than Minimal Risk to Subjects
There are three primary types of monitoring visits:
- Routine/Not-For-Cause Audits: The IRB will randomly select studies to audit based on the list of approved, expedited and full-board protocols. This includes studies with and without a required continuing review. In addition, the IRB may opt to select specific topics for auditing across multiple protocols such as recruitment or informed consent procedures, participant procedures, or maintenance of study records. Note: The IRB will make an effort not to select multiple studies from the same PI within the same calendar year for PAM review.
- For-Cause Audits: Monitoring visits may also be conducted at the discretion of the IRB Associate Director, IRB Chair, or the IO as deemed necessary. These reviews are performed when concerns regarding compliance, protocol adherence, or subject safety are brought to the attention of the IRB. This includes review of any or all study-related activities.
- Investigator Initiated Audits: A PI may request an on-site review to audit records and procedures to ensure compliance with federal and state regulations, institutional policies, and/or to prepare for an external audit by a sponsor or federal agency.
PAM visits are not designed to “catch” individuals. Rather, they are conducted to verify that research is being carried out as approved. The IRB recognizes that if noncompliance is detected, it may be a result of a lack of understanding or inadequate training.
ELEMENTS OF A PAM VISIT
Before the monitoring visit:
An IRB monitoring representative will schedule the visit with the PI and study team members (if necessary), making every attempt to accommodate schedules. Prior to the visit, the IRB monitoring representative will collect and thoroughly review all approved documents in preparation for the visit. Once the visit is scheduled, the PI is provided a copy of the “PI Self-Assessment” form to use to prepare for the visit. Note that more than one IRB member may participate in the PAM visit. When there is more than one IRB member, a lead monitoring representative will be designated.
During the Monitoring Visit:
The IRB monitoring representative will compare procedures being conducted in the study area with those listed in the approved protocol and any approved modifications. Documented discrepancies between observed and approved activities will be brought to the attention of the PI. As needed during the visit, the IRB monitoring representative will provide recommendations on compliance related issues. Documents pertaining to research will remain strictly confidential.
At PAM visits the IRB monitoring representative will review and assess areas such as, but not limited to, the following:
- Consent processes
- Current enrollment and verification of informed consent
- Participant payment
- Privacy and confidentiality issues
- Publications from the study
- Recruitment procedures
- Reports of adverse events
- Research team composition and training
- Screening procedures
- Storage of study documents and data
- Study procedures
After the Monitoring Visit is Complete:
- The IRB monitoring representative will prepare a written report which will be sent to the PI within 10 business days via email.
- If necessary, the IRB monitoring representative will meet with the PI and the study team to provide a brief summary of any findings.
- Within 10 business days of receiving the written summary report the PI will respond in writing to the IRB addressing each indication of non-compliance and providing a plan of corrective action.
- Once sufficient corrective actions have been taken by the PI and communicated in writing to the IRB, the IRB will send a PAM close-out email to the PI.
PREPARING FOR A PAM VISIT / PI SELF-ASSESSMENT
The most effective way for a PI to prepare for a PAM visit is to carefully and objectively read the approved study protocol and to make sure that all study staff are performing the research activities as described and approved by the IRB. There are many reasons why adjustments will need to be made to the design, procedures, etc. of a protocol. The key thing to remember is that any changes to the IRB approved protocol must be formally submitted to the IRB as modification(s) via PACS and approved by the IRB prior to implementation.
PIs can prepare for the monitoring visit by reviewing the checklist of questions here (note that not all items on the checklist apply to all research studies).
INFORMATION SHARING PROCESS AND MONITORING VISIT FOLLOW-UP
A written report that includes a detailed summary of the review of findings and any recommendations for improvement will be sent to the PI within 10 business days after the review has been completed. Within 10 business days of receiving the report, the PI will respond in writing to the IRB addressing each indication of non-compliance and providing a plan of corrective action.
Findings of non-compliance will be reported to the IRB at its next fully convened meeting and a determination will be made if additional follow-up is needed.
It is anticipated that in most cases serious violations involving risk of injury to participants will have already been reported to the IRB. However, if a review demonstrates that a serious protocol violation was not reported, it will be reported immediately to the IRB Chair and the IO.
If PIs disagree with IRB findings from the PAM visit or required corrective actions, they are invited to address these concerns with the IRB monitoring representative who conducted the review within 10 business days of being sent the findings report. If a satisfactory resolution cannot be determined, the PI may then contact the IRB Associate Director and/or the IRB Chair within 5 business days of speaking with the IRB monitoring representative. If at that point no satisfactory resolution is agreed upon, the PI may address the IRB committee directly at the next full-board meeting. If at that point a satisfactory resolution is still not agreed upon, the PI may address any concerns with the IO within five business days of the full-board meeting.
A copy of the PAM visit report and the PAM close-out email will be kept on file indefinitely by the IRB in PACS. Additional documentation including the monitoring visit checklist, email correspondence, and any relevant study files, will be kept in a corresponding electronic folder by the IRB staff for at least three years after the study is closed. Records may be kept longer if other requirements apply (i.e., VA requirements, HIPAA requirements, sponsor requirements).
The staff of the IRB are always willing to assist in answering questions or to help facilitate modification to your protocol. They can be reached at 607-777-3818 or email@example.com.