Investigator-initiated trials (IITs) provide an innovative pathway for scientific
advancements that Augusta University strives to support. The Research Ethics and Compliance
Monitoring Service was created to proactively provide risk-based oversight for IITs,
and other human research studies, as a method for building a robust network of institutional
and investigational compliance.
The Research Ethics and Compliance Monitoring Service aims to:
Monitoring reviews will be implemented routinely throughout the course of human research studies at Augusta University, with the highest priority being given to IITs, particularly those without independent monitors. For FDA-regulated trials, monitoring will often begin once the first subject is enrolled.
This program is complimentary to and does not replace the essential roles of AU’s Human Research Protection Program or the Institutional Review Board (IRB) of record for your study. Furthermore, these reviews are not intended to replace standard quality assurance reviews by the PI and their research team.
SUBJECT CASE REVIEW
In the United States, the Food and Drug Administration (FDA) is charged with the governance, oversight, and regulation of clinical trial conduct and public health protection. The agency’s regulations and guidance aim to promote safe and effective development and approval of medical drugs, biologics, and devices. A key component of these goals surrounds the approval processes for investigational drugs and devices. Investigational drugs and investigational devices are approved for experimental use by the FDA under 21 CFR 312 (Investigational New Drug Application) or 21 CFR 812 (Investigational Device Exemptions).
Below outlines current FDA regulations governing human subject protection and the conduct of clinical trials:
DRUGS OR DEVICES
DRUGS OR BIOLOGICS
A sponsor-investigator is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug or device is administered or dispensed. Sponsor investigators are responsible for satisfying the regulatory requirements of both an investigator and a sponsor.
How are research studies selected for Research Ethics and Compliance review?
The REC Monitoring Service will prioritize research studies with high-risk characteristics. Highest priority will be given to IITs without independent monitors. Other studies that may be prioritized include studies where investigators hold the IND/IDE, phase I clinical trials, high enrolling clinical trials, multi-site clinical trials, studies with vulnerable populations, and federally funded studies without external monitoring. REC Monitoring is applicable to all human research studies conducted at Augusta University but is not required to include all studies meeting criteria for possible review.
What will an investigator gain from Research Ethics and Compliance review?
REC reviews aim is to build a robust network of institutional and investigational compliance. REC monitor(s) apply a regulatory and compliance perspective during these reviews creating an environment for increased knowledge and understanding of applicable human subjects research regulations and Augusta University policies.
How should an investigator prepare for a Research Ethics and Compliance review?
REC monitor(s) will contact the principal investigator (PI) to schedule an REC review. The PI should make every effort to schedule the review with timely responses. After the review has been scheduled, the PI will be notified of the necessary review preparations. Briefly, study records will need to be assembled for review. For remote reviews, REC monitor(s) will need to be able to access required documents. For in-person reviews, the PI/study team will need to reserve a quiet space for the review to occur.
What should an investigator expect for a Research Ethics and Compliance review?
The scope of REC reviews may vary and will be tailored to the scope, nature, and complexity of the research studies being reviewed. A study representative should be available to respond in a timely manner during the review. A close-out meeting will be held to discuss any findings and the PI will receive a copy of the final report. The PI is responsible for correcting any identified items and submitting the appropriate notifications of protocol deviations or violations to the IRB of record. Please note: REC review is not intended to be comprehensive for all subjects and all items, and it does not replace standard quality assurance reviews by the PI and their research team.
Is the Research Ethics and Compliance Monitoring Service part of the IRB?
No, the REC Monitoring Service is independent of the IRB. This program is complimentary to and does not replace the essential roles of the IRB of record for your study, or AU’s Human Research Protection Program. The Monitoring Service is designed to provide early-intervention and proactive monitoring for human subjects research at Augusta University.