Our mission is to support the University's expectations of high quality research via quality assurance (QA) and quality improvement (QI) activities.
- Phone: 314-747-5525
- Email: HRQA@wustl.edu
- Phone: 314-747-4152
- Email: email@example.com
- Offices: Human Research Quality Assurance Program (HRQA)
Institutional Animal Care and Use Committee (IACUC)
Office of Research Integrity & Ethics (ORIE)
Conflicts of Interest (COI)
Associated Topic: Human Subjects Research
HRQA monitors and reviews active research protocols to ensure that the participants’ rights, safety and welfare are protected and that the research is conducted in accordance with the approved research plan and complies with all applicable Federal regulations and University policies.
The QA review process is an essential element of our accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Washington University in Saint Louis (WUSTL) and AAHRPP recognize that the commitment to human research participation does not end with the approval of the project by the Institutional Review Board (IRB).
As an outgrowth of the monitoring activities, the HRQA program provides Quality Improvement support via tailored education, guidance and resources that will assist in the performance of high quality research.
Susan George Kienzle
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 mechanisms are not usually reviewed except in for-cause circumstances.
How will I be notified that my research is selected for monitoring?
The Principal Investigator will be notified via email that a particular study has been selected for review. The HRQA staff will then make arrangements to schedule 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 and how the research files are organized, the HRQA staff will need a place to work and access to the requested files.
The Principal Investigator (PI) will need to meet with the HRQA staff at some point during or after the review process. It is not necessary for the PI or a research team member to be available throughout the entire review. Generally, someone who is able to answer questions should be available via phone or email.
What will be reviewed?
The HRQA staff will need access to ALL participants’ electronic and hardcopy research records, regulatory documentation, and if applicable, specimens and specimen collection records. A sampling of the participants’ records will be reviewed based on the accrual to date and will span the course of enrollment.
The review will assess whether compliance standards have been met in the following 8 categories: 1) Study Enrollment Status; 2) Execution of Informed Consent/Assent; 3) Maintenance of Privacy & Confidentiality; 4) Participant Eligibility; 5) Documentation of Interventions/Observations and Study Procedures; 6) Safety Monitoring; 7) Regulatory Documentation/Multisite Management; 8) Required Education and HIPAA Training.
The HRQA staff 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 HRQA staff will first meet with the PI and designated research staff to review the findings from the visit and provide customized education and guidance based on the review findings. A copy of the HRQA report is then sent electronically to the PI and designated research staff for review and response.
The HRQA Faculty Committee will review the report and the PI’s response to the findings, and assess whether compliance standards have been met. A copy of the report, PI response, and the HRQA Committee’s Assessment will be shared with the PI and designated research team members, the department and/or division head, the Human Research Protection Office (HRPO), the Office of the Vice Chancellor for Research (OVCR), and other compliance offices as appropriate.
Please note: Serious concerns may need to be reported directly to OVCR, HRPO, and/or other compliance offices prior to HRQA Faculty Committee Review.
Key Elements for Monitoring Adherence
There 8 key elements to consider when maintaining quality research:
I. Study Enrollment Status
- Is there adequate tracking and reporting of research participant involvement in a research study?
- Has enrollment information and participant status been reported appropriately to HRPO?
- Has tracking of participant withdrawal or screen-fail been documented appropriately
- Are screening, enrollment, and master logs being maintained accurately and in line with your approved application & protocol?
II. Execution of Informed Consent/Assent
- Has informed consent/assent been obtained/documented according to the process approved in the myIRB application?
- Did the informed consent/assent document contain errors, including but not limited to:
- Outdated or expired documents
- Invalid or missing documents
- Answerable items left blank
- Study procedures executed prior to or without consent
- Lack of full execution of signature boxes
- Signature date discrepancies
- Consent not obtained by appropriate Legally Authorized Representative (LAR) or Legal Parent/Guardian
- Consent obtained by non-HRPO-approved person
III. Maintaining Privacy/Confidentiality
- Has the participants’ private information and study data been used, maintained, and/ or disclosed appropriately?
- Are study records being retained according to University Record Retention Policies (minimum of 7 years post study closure in myIRB)?
- Have there been any HIPAA breaches?
- Is study data being maintained according to protocol
IV. Participant Eligibility
- Have there been any deficiencies identified with the tracking, documentation, and/or enrollment of research participants? This includes but is not limited to:
- Lack or inconsistent documentation of inclusion/exclusion criteria,
- Enrollment of ineligible participants
- Lack of documentation of the source inclusion/exclusion were verified from (per the participant, per EMR on XX/XX/XXXX value X, per interview/survey, etc.)
- Duplicate enrollment without HRPO Approval
- Enrollment of a non-HRPO approved population
V. Documentation of Interventions/Observations & Study Procedures
- Have there been any deficiencies identified with how the investigational plan was implemented and/or documented in the research record? This includes, but is not limited to:
- Deviations from the approved protocol/study plan
- Errors in study documentation (incomplete CRFs, lack of good documentation practices, etc.)
- Inconsistent or lack of documentation of study procedures
- Lack of documentation of research team member/PI involvement and oversight
VI. Safety Monitoring/Adverse Events
- Have there been deficiencies identified with the monitoring, tracking, and reporting of participant safety? This includes, but is not limited to:
- Safety monitoring not conducted or documented according to protocol
- Errors in the monitoring and/or collection of adverse and serious adverse events
- Lack of adherence to safety reporting requirements
- Lack of adherence to HRPO safety reporting requirements
VII. Regulatory Documentation/Multisite Study Management
- Have there been deficiencies identified with the maintenance of essential regulatory documentation at the local site or multisite level? This includes, but is not limited to:
- Failure to maintain essential regulatory documentation
- Discrepancies within essential regulatory documentation
- Participant payment discrepancies
VIII. Required Research Education/HIPAA Training
- Have all research team members completed the required research education (CITI Human Subjects Training, Good Clinical Practice Training, and HIPAA 101) as applicable?