The purpose of the Human Oversight & Outreach Program is to improve the quality of the human subjects’ protection program through education, training, and post approval monitoring of research studies. This program is intended to be proactive, not punitive, and focuses on educating investigators and research staff about their ethical and regulatory responsibilities in the conduct of research.
What is the relationship between the IRB and the Oversight & Outreach Program (O&O)?
The IRB and O&O are both components of the Human Research Protection Program (HRPP). The O&O is charged with evaluating and enhancing human research protections through education, training, and monitoring. The IRB is charged with reviewing and overseeing human research to ensure protection of research participants. The feedback received from Oversight & Outreach reviews provides a way for the IRB to improve these activities.
Post Approval Monitoring (PAM) Reviews
The purpose of the Oversight & Outreach (O&O) review is to ensure the safety, rights, and welfare of the research subjects and that subjects are not put at unnecessary risk. The monitoring review evaluates the study data separate and independent from external monitoring by entities including the federal government, study sponsor, and contract research organizations. During each monitoring review, the trial conduct, procedure, and processes will be evaluated.
Learn more about the monitoring and oversight (M&O) review and the selection process for human research studies.
Reason for Oversight & Outreach Review
Through monitoring, the O&O Specialist can assess the study staff’s knowledge and compliance with the OHRP and FDA regulations as well as GCP guidelines. The specialist will also assess any training needs of the study staff. Any deficiencies with the staff and/or study will be identified and a corrective plan will be designed.
Unanticipated Problems/Protocol Deviations
An unanticipated problem is any occurrence that is unexpected (in terms of nature, severity, or frequency) given the research procedures described in the protocol and informed consent document and/or the characteristics of the subject population being studied that is related or possibly related to participation in the research and suggests that the research places subjects or others at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
A protocol deviation is any departure from the procedures approved in the protocol approved by the IRB.
Wake Forest Research teams are required to report all unanticipated problems and major protocol deviations to the Wake Forest IRB within 7 days of any member of the study team becoming aware of the event.
The Office of Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA) both conduct site inspections to ensure compliance with the regulations that govern human subject research. OHRP has jurisdiction over all Public Health Service funded human subjects research, while the FDA’s Bioresearch Monitoring Program (BIMO) focuses on research that involves drugs, biologics, and devices used in the diagnosis, cure, mitigation, treatment, or prevention of disease. The links below document common findings of noncompliance discovered during routine and for cause audits.
Department of Health and Human Services (DHHS) Regulations
- Title 45 CFR 46: Protection of Human Subjects (The Common Rule)
- Title 45 CFR 164 Health Insurance Portability and Accountability Act (HIPAA) of 1996
Food and Drug Administration (FDA) Regulations
- Title 21 CFR 11: (Electronic records; electronic signature)
- Title 21 CFR 50: (Protection of human subjects)
- Title 21 CFR 54 : (Financial disclosure by clinical investigators)
- Title 21 CFR 56: (Institutional review boards)
- Title 21 CFR 312: (Investigational new drug application)
- Title 21 CFR 314: (FDA Approval to market a new drug)
- Title 21 CFR 600: (Biological products)
- Title 21 CFR 601: (Licensing)
- Title 21 CFR 812: (Investigational device exemptions)
- Title 21 CFR 814: (Pre-market approvals of medical devices)
- ICH Good Clinical Practice (GCP) Guidelines