1.21 Post-Approval Monitoring of Research

Last Revised: 11/17/2025

1.0. Purpose

The purpose of this policy is to describe the Organization’s requirements for post approval monitoring of research. For the purpose of this policy, “monitoring” encompasses both “not-for-cause” post-approval review of research activities, and “for-cause” audits.

2.0 Policy

It is the policy of the Organization that:

• 2.1. Post approval monitoring (PAM) will be conducted in order to measure and improve compliance of investigators and research teams with applicable organizational policies, regulations, and guidance related to the conduct of human subject research.
• 2.2. PAM will serve to identify the educational needs of the research community, and to provide appropriate training to investigators and research teams regarding applicable organizational policies, regulations, and guidance related to the conduct of human subject research.

3.0 IRB/ORA Responsibilities

• 3.1. The ORA will conduct PAM of approved non-exempt research projects
  • 3.1.1. Not-For-Cause Monitoring of Non-Exempt Research
    • 3.1.1.1. Non-exempt research projects will be randomly selected for Post Approval Monitoring, and will primarily focus on the following categories of research:
      • 3.1.1.1.1. Investigator-initiated research
      • 3.1.1.1.2. Research which would meet the criteria for increased monitoring and/or interim continuing review per HRPP policy 3.1 (Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI).
      • 3.1.1.1.3. Research involving vulnerable populations
      • 3.1.1.1.4. Greater than minimal risk research
    • 3.1.1.2. Selected research must be currently IRB-approved and accruing subjects for at least one year.
    • 3.1.1.3. The ORA will generally conduct “not-for-cause” post-approval monitoring of at least eight non-exempt studies per year.
  • 3.1.2. For-Cause Post Approval Audit
    • 3.1.2.1. “For-Cause” audit will be conducted at the instruction of the IO, IRB Executive Chair, the UNMC IRB, or, in the case of research under the jurisdiction of an outside IRB on which the institution is relying IRB, the instruction of the reviewing IRB.
    • 3.1.2.2. Reasons for “For-Cause” audits include, but are not limited to:
      • 3.1.2.1.1. Noncompliance (as per HRPP policy 8.4: Review of Noncompliance by the PI, Study Team, and/or Subjects).
      • 3.1.2.1.2. Concerns raised by the IRB or the ORA in the course of review of a Continuing Review form, an Incident Report or an Adverse Event report.
      • 3.1.2.1.3. Complaints (as per HRPP policy 8.2: IRB Review of Study Related Complaints).
      • 3.1.2.1.4. Monitoring reports issued by outside agencies (pharmaceutical sponsors, FDA, OHRP or others).
• 3.2. Post Approval Monitoring Process
  • 3.2.1. Prior to all “not-for-cause” monitoring, the PI and research team will have the opportunity to do a self-review of the protocol. The self-report may be used as a focus of the PAM.
  • 3.2.2. The PAM may include observation of the process of informed consent or interviews with subjects if required by the IO, IRB Executive Chair or the IRB. If so, potential subjects must provide their consent to be observed or interviewed.
  • 3.2.3. Failure to comply with the Post Approval Monitoring Request, or failure to cooperate with PAM, or interference with the PAM process may represent serious non-compliance subject to HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel …).
  • 3.2.4. As appropriate, the IRB analyst performing the PAM will present preliminary findings to the PI, obtain additional clarifications and corrections, and provide education concerning IRB requirements as needed.
  • 3.2.5. If PAM suggests noncompliance, or suggests a UP, the investigator will be instructed to submit an Incident Report and Corrective Action Plan as appropriate. Such IR will be handled as per HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel …) or HRPP policy 8.3 (Review of Unanticipated Problems Involving Risk to the Subject or Others).
    • 3.2.5.1. PAM that suggests subjects or other may be placed at unacceptable risk will be referred immediately to the IRB Executive Chair and to the ORA, and may justify suspension or termination of the research in accordance HRPP policy 8.6 (Study Hold, Suspension, and Termination).
  • 3.2.6. After resolution of all issues related to PAM, the IRB Analyst performing the PAM will present a written report of findings and resolution to the PI, the Institutional Official, the IRB Executive Chair and the convened IRB as a notification item.
  • 3.2.7. Based on the evaluation of the PAM report, and (as appropriate) the Corrective Action Plan submitted by the Investigator in response to findings of the PAM, the IRB may require additional follow-up monitoring or audits.
  • 3.2.8. “For-Cause” audits will follow the same procedure as above, except that unannounced visits may occur if authorized by the IO, and all PAM reports will be reviewed by the convened IRB.

4.0. Investigator Responsibilities

• 4.1. The PI and research team must make all reasonable efforts to assist the IRB Analyst performing the PAM by providing access to relevant documents, research personnel, and subjects as appropriate.
• 4.2. If the PAM discloses evidence of noncompliance, the PI will be required to submit an Incident Report which includes a Corrective Action Plan to address plans to reduce risk of further noncompliance.
• 4.3. If the PAM discloses or suggests unauthorized use or disclosure of protected health information (PHI) then the PI will be required to submit a separate report to the Privacy Officer of the involved institution (Nebraska Medicine or Children’s Nebraska).

DOCUMENT HISTORY:

 Written: 12/14/2015 (Approved: 12/14/2015) - original author not recorded (original title “QUALITY IMPROVEMENT ASSESSMENT FOR THE CONDUCT OF RESEARCH”)

 Revised: 2/28/2018 - revision not documented

 Revised 11/17/2025 - Deleted language throughout more appropriate for SOPs; clarified timing of initial and final PAM reports, and responsibilities for review PAM reports; stylistic and format changes