The University of Texas at Dallas’ Post-Approval Monitoring Program (PMP) is designed to ensure the ongoing safety and compliance of research involving human subjects. This program, managed by the Office of Human Subjects Protections (OHSP), conducts thorough reviews of active studies to assess adherence to approved protocols and regulatory requirements. The PMP aims to safeguard participant welfare, provide educational support to researchers, and identify areas for improvement. Reviews may be initiated randomly, at the request of the Principal Investigator (PI), or due to specific concerns about participant risk. Through this proactive approach, UTD maintains high standards of ethical research and continuous quality improvement.
Any active study is subject to a post-approval review via our post-monitoring program (PMP). The PMP assesses the research activities conducted under the University’s Federal Wide Assurance Agreement with the Office of Human Research Protections (OHRP). This program assures human subject safety in research, provides education to research professionals, and identifies strengths and areas for improvement.
Reasons for Monitoring Reviews
- A protocol is randomly selected from a list of currently approved studies;
- The PI or PI’s department may wish to have research studies reviewed proactively;
- The IRB may request OHSP staff to conduct an observational visit for a specific protocol because the study is very complex or involves unusual levels or types of risks to participants; or
- Other reasons primarily related to subjects’ risk and safety.
Areas of review include (but is not limited to) the following:
- IRB records and documentation
- Compliance to IRB approved protocol
- Participant recruitment, selection, and payment procedures
- Participant enrollment and corresponding records
- Informed consent procedures and corresponding records
- Participant payment and corresponding records
- Data storage / retention practices
- Confidentiality and privacy practices and process
Once the PI and research team is notified of the PMP visit, they are encouraged to contact the OHSP with any questions or concerns.
- Notification of a PMP visit is sent by the Office of Human Subjects Protections (OHSP) via email to the Principal Investigator (PI) and Faculty Sponsor (if the PI is a student). OHSP staff will work with the PI to establish a monitoring visit usually within thirty (30) days of notification.
Types Of PMP Reviews
- For Cause/Directed: Occurs when the Office of Human Subjects Protections receives an external request for monitoring or from the IRB or study team.
- Random/Routine: Occur when a study has been randomly selected for monitoring.
- Requested: Occurs when a Principal Investigator requests a review of their study for feedback or to confirm compliance.
Common Deviations
In human subjects research, protocol deviations refer to departures from the procedures outlined in the IRB-approved protocol. Here are a few common types of protocol deviations:
- Exceeding Approved Sample Size/Enrollment Goal:
- Sometimes, researchers enroll more participants than initially approved, leading to a deviation from the planned sample size.
- Privacy & Confidentiality:
- Mishandling of sensitive participant information: storing data on an unsecured server or shared via unencrypted email.
- Sharing data with friends or family members not a part of the study.
- Enrollment of Subjects Not Meeting Inclusion/Exclusion Criteria:
- If participants who don’t meet the predefined criteria are enrolled, it’s considered a deviation.
- Failure to Follow the Study Protocol:
- Any intentional or unintentional deviation from the approved protocol, such as administering treatments differently or skipping required assessments, falls into this category.
- Informed Consent Form (ICF):
- Lack of participant and researcher signatures on ICF (when applicable). When both the participant and researcher do not sign the form, it represents a significant deviation from the standard process.
- Retrospectively dated ICF. This occurs when the date on the ICF is different from the date when the participant initially signed it.
- Equipment and Data Management:
- Uncalibrated equipment: Using equipment that has not been properly calibrated.
- Data entry errors: Incorrectly entering data into study records.
Preventing Deviations
- Training and Education
- Ensure that all study personnel receive the required and recommended training on the study protocol. (e.g., understanding inclusion/exclusion criteria, visit schedules, and procedures).
- Regular Monitoring and Oversight
- Welcome monitoring visits to assess adherence to the protocol. Monitoring helps identify deviations early and allows corrective actions.
- Clear Communication
- Maintain open communication among study team members. Clarify any doubts or uncertainties related to the protocol promptly.
- Standard Operating Procedures (SOP)
- Develop SOPs for study procedures. SOPs provide step-by-step guidance, reducing the likelihood of errors.
- Documentation and Record Keeping
- Maintain accurate and detailed records of study activities. Document deviations, reasons, and corrective actions taken.
Frequently Asked Questions
1. What is the Post-approval Monitoring Program (PMP)?
The PMP is a program set up typically within a human subjects research or protections office that evaluates research activities after IRB approval to ensure compliance, participant safety, and data integrity.
2. Why is PMP important?
Post-approval monitoring helps maintain research quality, identify areas for improvement, and protect participants.
3. Who conducts PMP?
Although it varies by institution, at UTD, an OHSP or Post Monitoring Specialist from the Human Subjects Protection office will perform the Post-approval Monitoring visits.
4. How are protocols selected for PMP?
- Protocols may be randomly or routinely chosen or selected based on complexity, risk, or proactive requests.
- For-Cause or Directed as a result of a complaint by a research participant, lab staff or which raises safety concerns or compliance concerns.
- When continuing review suggest that changes may have occurred without IRB approval.
- When a protocol involves vulnerable populations, or unusual levels of types of risks to subjects.
- Requested by Investigator.
5. Who is notified when a protocol has been selected for a PMP review?
- An email will be sent to the Principal Investigator notifying them of the visit. Primary contacts and lab staff are included in the notification.
- If there is no response, the PI will receive a follow-up email from the PMP Monitor. Should the lack of response persist, the matter will be documented and escalated to the OHSP Director for review and determination.
6. What areas are reviewed during Post-approval Monitoring visits?
IRB records, compliance, participant recruitment, consent, payment, data storage, and confidentiality.
7. What happens if issues are found during PMP?
Corrective actions are recommended, and the PI collaborates with the OHSP office to address them.
8. How often does Post-approval Monitoring occur?
Typically, routine PMP reviews occur once every 12 months. A protocol may be selected for a routine monitoring, for-cause or requested by the Principal Investigator. While the goal of the OHSP to conduct routine reviews annually, it may not be possible to review all PI’s or Labs within this timeframe. Therefore, not all PI’s will be selected for review each year.
9. Can PIs request proactive Post-approval Monitoring?
Yes, PIs can initiate proactive reviews if they have concerns or want feedback.
10. What should PIs do when notified of a Post-approval Monitoring visit?
Promptly respond to the email notification sent out by the OHSP with any questions or concerns.