Post-Approval Monitoring/Investigator Compliance Reviews

The Human Research Protection Program Quality Assurance (HRPPQA) program is responsible for the management and monitoring of quality assurance activities. The HRPPQA staff aim to help ensure the well-being of humans involved in research. Authorization for researchers to work with humans begins with an approved protocol from MaineHealth’s HRPP/Institutional Review Board (HRPP/IRB) or an authorized external IRB. However, research protections and record retention requirements continue throughout a project and after study closure.

It is critical to regularly monitor ongoing research involving human subjects. MaineHealth’s HRPP/IRB maintains accreditation from a leading research protections organization AAHRPP. The HRPPQA staff is required to maintain this accreditation. The post-approval monitoring process also encourages dialogue and education between the researcher and MaineHealth’s Research Compliance Office. Additionally, the post-approval monitoring process helps maintain compliance with state, local, or institutional requirements related to the protection of human subjects.

For more information about Post-Approval Monitoring, please see the following: For human research, HRPP SOP Section 2.2 – Investigator Compliance Reviews

To preview the forms used during a post-approval monitoring visit, please click on the links below:

Scope of Work Form (Completed by Requestor) Monitoring Form (Completed by HRPPQA)

Post-Approval Monitoring FAQs

Protocols may be selected randomly, for-cause, or by risk-based assessment to ensure proper oversight of approved protocols. These reviews are required to maintain our AAHRPP accreditation. At times when potential concerns or risks are identified, a post-approval monitoring visit may be requested by the IRB and conducted to ensure that study procedures are going as planned. Corrective and preventive action (CAPA) plan effectiveness checks may also occur. A Principal Investigator (PI) may request post-approval monitoring to prepare for upcoming external monitoring or audit visits or to assess how study activities are progressing.

More information appears in the MaineHealth HRPP SOPs. For human research, see HRPP SOP Section 2.2 – Investigator Compliance Reviews

The HRPPQA will contact the PI and the lead study team member(s) to schedule a time for the monitoring visit. This communication typically occurs via email, but could be via phone, mail or other means if the PI is deemed unreachable. The communication will state what type (e.g. random, for-cause, etc.) of review will occur. The HRPPQA will establish a timeline for the review.

The PI and relevant research personnel responsible for data and recordkeeping should be present during the Post-Approval Monitoring visit. The PI is responsible for the activities associated with the study and will be expected to serve as the primary contact.

The HRPPQA will meet with the PI and any identified members of the research team at the beginning and the end of the visit. In most cases, the posted forms (above) will be used for the visit. PIs may view these forms in advance to obtain a better understanding of the questions that will be covered and materials to be reviewed during the visit. Additional meetings may be necessary to convey findings and appropriate resolutions.

Yes, if the research has not started, the HRPPQA may assess the status and help an investigator to determine any next steps.

If the research is ending, the HRPPQA will need to review study records and document retention requirements with the PI and research team.

Once the monitoring visit is complete, the HRPPQA will provide the PI with summarized information (e.g. draft report). Any discrepancies or points to resolve should be noted by the PI to the HRPPQA within 15 business days. Once the HRPPQA receives confirmation that the draft report is accurate, a final report will be issued to the PI and any relevant research personnel. The HRPPQA will remain in close contact with the PI until all actionable observations are resolved. If the IRB requests the review, a summary may be sent to the MaineHealth IRB. If any corrective actions are required, the HRPPQA will inform the PI. The HRPPQA office is available for CAPA plan consultations upon request.

The team anticipates that most visits will be educational and informative based on the common goal to protect human research participants’ welfare.

Perhaps the most effective way to prepare for a Post-Approval Monitoring visit is to carefully and objectively review 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. Any change to a study must be reviewed and approved by the IRB prior to implementation. A modification may seem trivial to a researcher, but it may be of great concern to the IRB, federal regulators, funding agencies, or auditors.

The HRPPQA staff is always willing to assist in answering questions, or to help facilitate modifications to your protocol. HRPPQA staff can be reached at (207) 661-4474 or hrppqa@mainehealth.org.

Suggested areas to examine when assessing your study:

  • How many participants are currently enrolled in the study? Is the number enrolled in line with the number approved? Is a modification to add participants needed?
  • Are key personnel performing duties as described, approved, and documented on the delegation of authority log? Are modifications needed?
  • Have there been early withdrawals from the study? Participant complaints?
  • Have there been any adverse events? Were they reported?
  • Who is responsible for conducting study procedures?
  • Are procedures being conducted in accordance with the IRB protocol?
  • Have any changes been made to the approved materials (recruitment fliers, questionnaires, interview questions, etc.)? Has IRB approval been sought prior to implementing these changes?
  • Who is responsible for training study personnel on IRB-protocol specific procedures? Are records of training maintained?
  • Are all research team members that have contact with participants or the participants’ identified data listed as personnel on the study? Is a personnel modification needed?
  • Are all personnel (i.e., PIs, Co-PIs, research staff) aware of all IRB-approved modifications?
  • Is the informed consent document being used the current version? If applicable, does it have the IRB stamp?
  • If applicable, are you using the IRB stamped recruitment advertisements/flyers?
  • Are study records (e.g., approval letters, informed consent) maintained for 3 years after the close of the study?
  • Are documents, records, and data stored as outlined in the IRB-approved protocol?

Below are examples of common findings from post-approval monitoring visits:

  • The IRB-approved version of the informed consent or assent document is not used.
  • Dates of consent occur prior to IRB approval of study.
  • Informed consent documentation problems (when applicable):
    • No real time signatures by individuals obtaining consent (missing, or postdated).
    • Signatures are illegible; this is particularly important when determining if individual giving consent for minors is authorized to do so (i.e., parent or legal guardian, not a grandma, uncle, aunt, sibling, etc.) OREC recommends “Printed Name” lines in informed consent or parental permission documents.
  • The informed consent document retained by research team is not complete (i.e., only the page containing the signature is on file).
  • Changes have been made to the IRB-approved survey questions or interview questions:
    • Questions have been added prior to IRB review and approval
    • Questions have been removed prior to IRB review and approval
  • Recruitment methods have been changed prior to IRB review and approval
  • Methods have changed (e.g., from paper versions to online versions, individual interviews to group interviews)
  • Compensation plans or amounts have been changed prior to IRB review and approval
    • Study Records
    • Study records are not stored as indicated
  • Persons reviewing study records that are not approved or trained to do so

If you have identified discrepancies between your current practices and those outlined in the approved protocol and these questions, please make the appropriate corrections. This may require submitting a modification to your protocol, or simply implementing better documentation practices.

Remember, the goal of Post-Approval Monitoring represents a friendly way to support the research community in conducting scientifically valid and ethically sound research that benefits the study participants and brings social value to MaineHealth.  The Research Compliance Office has a regulatory mandate to monitor the conduct of projects when MaineHealth is engaged in human research and the QA team works collaboratively with the research to identify and correct any deficiencies.

Research Compliance Office

hrppIRB@mainehealth.org
207.661.4474

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