The IRB Compliance Program staff conduct pre- and post-approval monitoring of human subjects research at the University of Iowa. All monitoring incorporates a thorough review of the HawkIRB application and attachments to assess investigator and research team members’ compliance with federal regulations and UI policies for the protection of human subjects.

Goals of the IRB Compliance Program:

  1. Assess human subjects research for compliance with federal regulations and institutional policies through:
    • An independent review of the HawkIRB application as well as associated research materials.
    • A personal interview with the Principal Investigator and any affiliated research team members, as applicable.
  2. Provide researchers one-on-one and group educational opportunities regarding human subjects research.
  3. Facilitate communication between the IRB/Human Subjects Office and researchers at the University of Iowa.

Types of IRB Compliance Monitoring Visits

PARR is an educational session that takes place after a study is approved by the IRB, often with new Investigators. During the session, the IRB Compliance and Education Specialist (CES) reviews responsibilities of the investigator and research team members. Responsibilities such as reporting requirements regarding recruitment, consent, and conduct of the study are based on university policies and federal regulations.

PAM and ED monitoring reviews open, IRB-approved human subjects research studies conducted by University of Iowa faculty, staff, or students. During the Pam and Ed process, the IRB Compliance and Education Specialist (CES) reviews the research team’s current study procedures and the current IRB-approved study procedures. They may also review research records (e.g. consents, study logs). After reviewing the study, the CES will provide feedback and education about the study.

The focus of Directed Monitoring is to investigate specific questions identified by an IRB Chair, IRB Full Board, or the HSO Director. This monitoring can also be mandated as a result of information from outside sources (such as subjects or research team members) or information that comes to light during the IRB review of an application or another study. Directed monitoring may provide the IRB with additional information to substantiate or refute a potential incident of noncompliance with the federal regulations or institutional policy.

This type of monitoring focuses on studies that are classified as Exempt or Expedited that are conducted by Student Principal Investigators (PIs).  The IRB Compliance and Education Specialist (CES) sends an online Qualtrics survey to both the Student PI and the Faculty Advisor. They assess the responses for consistency with the IRB-approved study procedures described in the HawkIRB application and attachments.  The CES also compares the responses from the student and faculty surveys to evaluate whether the student is receiving adequate support from the faculty advisor.

DoD-sponsored research monitoring visits deliver investigator education on additional DoD regulatory requirements and document PI and IRB compliance with overall DoD regulations and the regulations, directives and instructions for individual DoD components (Army, Navy, Air Force and Marine Corps). UI investigators conducting DoD-sponsored research should expect to meet with an IRB Education and Compliance Specialist at least once to discuss and document DoD compliance. Additional monitoring activities to deliver education and document compliance may be conducted via email.

VAHCS Monitoring encompasses post-approval monitoring of human subjects research at the Iowa City VAHCS. The IRB Compliance and Education Specialist (CES) provides education about additional VA requirements, reviews IRB determinations, and documents investigator, IRB and institutional compliance with the regulations.

Controlled Substance Monitoring occurs for any study that uses a CS for research purposes that is not stored and dispensed by Pharmacy and Therapeutics (P&T) Investigational Drug Service (IDS). This monitoring visit is intended to help PIs and the “Researcher” on the federal Drug Enforcement Administration (DEA) registration application (if other than the PI) who are authorized to use controlled substances for human subjects research to understand and adhere to all applicable rules and regulations of the DEA and the Iowa Board of Pharmacy Examiners regarding registration, purchase, use, and proper disposal of controlled substances used in their research.

Investigational New Drug studies (IND) or Investigational Device Exemption (IDE) studies where the IND or IDE holder is a University of Iowa Principal Investigator are also identified as potential studies to conduct monitoring visits to ensure FDA regulatory requirements are met.

Where applicable, monitoring visits may include a discussion about (, a public database with information about federally and privately supported clinical trials.  Study details provided in HAWKIRB regarding registration in and the National Clinical trials identifier (NCT) may be covered during the visit.  The Compliance and Education Specialist (CES) may also provide education about the Clinical Trials program.

Monitoring Process

Studies may be selected for monitoring by an IRB chair during a full board review meeting, upon PI/researcher request or randomly based on risk and/or concern. Once selected for monitoring, the Compliance and Education Specialist (CES) will correspond with the PI and research team contacts to schedule a visit. PI’s have one week to respond to the initial email and schedule a visit.  After the monitoring visit, the CES will summarize the visit in a report that will be reviewed by the IRB Chair of Record.  Depending on the findings, the IRB Chair may require a modification to the IRB application to address the findings.  This information and additional instructions will be outlined in the Monitoring Report. Researchers can also use our monitoring handout as a guide to the process.

Annual Report

The Compliance Program generates an annual report capturing compliance related activities that have occurred over the last year.  If you have any questions regarding this report, please contact the Compliance Manager. 


Please contact the IRB Compliance Program with any questions or concerns you have.