Overview
University of North Carolina at Asheville is committed to the protection of human subjects involved in research studies. In pursuit of our commitment to conduct ethical research, a Human Research Subject Post Monitoring Program was initiated in 2018. The purpose of this program is to assess the research activities conducted under the University’s Federal Wide Assurance Agreement with the Office of Human Research Protections (ORHP). The concept of our program is to ensure the University conducts ethical human subject by providing oversight and educational opportunities while providing the IRB with an instrument to identifying and improve institutional practices.
The purpose of the program is to provide internal oversight on compliance issues relating to the performance of human research studies. The emphasis of the program is:
- To ensure the rights and well-being of research subjects and the quality and integrity of the research.
- To identify educational and research support needs.
To ensure compliance with federal, state, local and institutional regulations and guidelines. - To identify areas of strength and needs of improvement in research policies and practice.
Categories of Monitoring
- Routine: The Office of Research and Sponsored Programs collaborates with the IRB Chair to select studies for monitoring. Selection may include monitoring only certain elements of the research, such as observation of the informed consent process, study procedures, or study records.
- Informed consent: This type of monitoring is intended to support researchers in conducting the informed consent process. It may include observation of the consent process and/or a thorough review of the process. Monitoring also includes reviewing the process of how Principal Investigators train study personnel on administering consent to participants.
- Investigator Initiated: An investigator may request an on-site review to help keep records and procedures in compliance with federal regulations and institutional policies, or to prepare for an external audit by a sponsor or federal agency.
- For-cause: Under 45 CFR 46.113 requirements, this review is performed when concerns regarding compliance, protocol adherence, or subject safety are brought to the attention of the IRB or the Office of Research and Sponsored Programs. This includes a review of all or any related study activities.
Additional Information
The Institutional Review Board recommends that all members of the research team review the University’s post-approval monitoring standard operating procedure. This document addresses notification of review, process of conducting the audit and disposition of outcomes