Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review. This is the most rigorous level of review and, accordingly, is reserved for research projects that present more than minimal risks to subjects. For more information on the different types of review, please visit the Types of IRB Review web page.
Please be aware of the different submission schedules for Full Board Review and meet all requirements in a timely manner. This will ensure that your protocol is placed onto the agenda for an upcoming Full Board IRB Meeting.
Research that Commonly Undergoes Full Board Review
Projects that do not meet the Expedited Review criteria will automatically require Full Board Review. Common examples of projects that typically require Full Board Review include:
- Research projects involving more than minimal risk
- Research projects involving clinical trials and/or clinical interventions
- Research projects that have special concerns or involves vulnerable populations
- Research involving children, pregnant women or fetuses, prisoners, or people with mental impairment (depending on the nature of the study)
- Research projects that involve the use of a medical device (in most cases)
- Projects that involve possible coercion or undue influence that induces or entices consent (e.g., excessive compensation, inequitable relationship, etc.)
- Sensitive information is being gathered (e.g., child abuse, violence, sexual conduct/misconduct, mental health/status information, AIDS, alcohol, compulsive disorders, etc.)
- Projects involving deception (e.g., intentionally misleading subjects about their status, giving false information about the researchers or the research purpose)
Full Board Review Submissions
Social and Behavioral IRB (SB-IRB) Submissions: Submit a complete IRB Approval Form application through the online TOPAZ Electronic Protocol Submission System by the due dates referenced on the IRB Meeting Schedule web page. Submission by the due dates allows appropriate time for your protocol to be reviewed by the Office of Research Integrity staff and the IRB members prior to a convened Full Board Meeting.
Health Sciences IRB (HS-IRB) Submissions: Submit a complete IRB Approval Form application through the online TOPAZ Electronic Protocol Submission System by the due dates referenced on the IRB Meeting Schedule web page. Submission by the due dates allows appropriate time for your protocol to be reviewed by the Office of Research Integrity staff and the IRB members prior to a convened Full Board Meeting.
Full Board Renewals
Any active protocol that previously received a full board review must come back to the Full Board for its yearly renewal. However, a protocol that previously received Full Board review can go through an Expedited review (Category #8), so long as it meets one of the following three requirements:
- the research is permanently closed to the enrollment of new subjects;
- all subjects have completed all research-related interventions; and
- the research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis