Human Research Quality Assurance Program (HRQA)

Supports the university's expectations of high quality research. HRQA monitors active research protocols to ensure the protection of human subjects and confirm that research is conducted in compliance with federal regulations and university policies.

Jeneane Braden

Assistant Vice Chancellor for Research Integrity & Ethics

Andrea Morris

Manager, Human Research Quality Assurance/Quality Improvement (HRQA/QI)

  • Phone: 314-747-5525
  • Email: morrisam@wustl.edu
  • Office: Human Research Quality Assurance Program (HRQA)

Associated Topic: Human Subjects Research

Contacts

Andrea Morris
morrisAM@wustl.edu
314-747-5525

Susan George Kienzle
s.george@wustl.edu
314-747-6588

Melissa Tsvirko
tsvirkoM@wustl.edu
314-747-5526

FAQs

What research protocols are subject to review by the program?

All open research protocols involving human participants at the Medical School and the Danforth Campus are subject to review by the program. Research subject to monitoring by other mechanism will not be reviewed except in for-cause circumstances.

How will I be notified that my research is selected for monitoring?

The Principal Investigator will be notified in writing that a particular study has been selected for review. The monitoring staff will then call to make a mutually agreeable appointment for on-site review, typically within 7-10 days of notification.

Does the principal investigator need to be present for the entire process?

After a short general discussion of the research protocol, the analyst will need a place to work and access to the requested files. Someone who is able to answer questions (either the PI or research coordinator) should be available by phone.

What will be reviewed?

All of the regulatory documents related to the study will be reviewed on-site. In addition, the analyst will request specific subject records (the number will depend on the accrual to date). Review of subject records will include the informed consent process, the inclusion/exclusion criteria, the records of the research intervention and any follow-up. Adverse event and unexpected occurrence records will be reviewed. The analyst may contact subjects who have participated in the study in order to review their understanding of the consent process, the research project and their impressions of participation in the research process.

Who will receive the results of the monitoring activity?

The Faculty Committee will review the results of the analyst’s report. Minor concerns will be addressed with the Principal Investigator and research staff. Serious concerns will be reported to the Vice Chancellor for Research. Educational efforts to address general concerns will be developed as they arise.

Key Elements for Monitoring Adherence

The five key elements for maintaining quality research are:

I. Informed Consent

  • Is the correct, up-to-date consent form, including all amendments and risk assessments, appropriately signed and witnessed by each participant?
  • When participants are contacted, do they agree that the consent process adequately prepared them for what their participation actually entailed?

II. Confidentiality

  • Are there appropriate measures in place to ensure the confidentiality of research data?
    • Paper records
    • Computer

III. Safety Monitoring/Adverse Events

  • What safety monitoring is performed?
  • How is performance of safety monitoring documented?
  • When safety issues are identified, how are they addressed?
    • When adverse events are identified, are they reported appropriately?

IV. Withdrawal/Accrual Statistics

  • How many (what fraction of) participants have withdrawn from the study?
  • Are the reasons for withdrawals recorded?
  • Do these reasons suggest any issues with the consent process or safety monitoring?
  • Are accrual goals being met?

V. Experimental Design

  • Is eligibility (inclusion/exclusion criteria) of each participant documented?
  • Was the specified intervention/observation performed?
  • Were the specified outcome measured recorded?