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.
- Phone: 314-747-5525
- Email: email@example.com
- Phone: 314-747-5525
- Email: firstname.lastname@example.org
- Office: Human Research Quality Assurance Program (HRQA)
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?
- Are there appropriate measures in place to ensure the confidentiality of research data?
- Paper records
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?
Stratification of Potential Risk to Human Subjects
Based on risk to participants and to the institution, the QA Faculty Committee developed a stratification of the types of research projects that would be subject to the QA monitoring process. The monitoring staff concentrates its efforts on projects primarily in Groups III and IV. High enrolling studies with minimal risk are also subject to consent review.
- Teaching/Focus Group
- Retrospective Chart Review
- Designated by IRB as “minimal risk”
- Non-invasive diagnostic procedures
- Venipuncture for blood sample (less than five percent total blood volume per month)
- Approved device for approved indication
- Approved pharmaceuticals at approved dose for approved indication
- Vulnerable populations
- Students, prisoners, children, pregnant women, cognitively impaired individuals
- Studies collecting sensitive information
- Non-approved drug
- Approved drug – new indication, new dose, new population
- Non-approved device
- Approved device – new indication, new dose, new population
- Gene Therapy
- Principal investigators with more than 10 protocols open
- Investigators with managed conflicts of interest
- SAE attributed to study
- Excessive SAEs reported
- Will not be monitored unless requested by the Vice Chancellor for Research.
- Cancer Center (subject to QASM review)
- Research using Intensive Research Unit (subject to Patient Advocate Review)
- External monitoring reports will be reviewed. Additional monitoring will be at the discretion of the Committee.
- Industry-sponsored trials
- Studies with (Data Safety Monitoring Board) DSMBs