Full Board Category Review | What is Full Board Review | What are the Criteria | What are some examples | How do I submit a new Project | How will I know that a Protocol has been approved | Who receives these IRB Action Notices
The following are some conditions that define studies under Full Board level of review.
1. Studies that cannot be reviewed and approved at an EXEMPT or EXPEDITED REVIEW level
- EXEMPT Category
Some studies that are “minimal risk” may qualify for EXEMPT category status. These studies have features and procedures that are specifically described by the federal regulations as “exempt” from IRB review. [Click here for descriptions and definitions of what research qualifies as an “exempt” category project].
Recall that, at UNTHSC, all research projects involving human subjects must be reviewed by the OReC to determine if they are truly “exempt” or if they must be reviewed by the IRB. This EXEMPT category of review is conducted by OReC staff and verified by the Executive Director of OReC.
- EXPEDITED Category
Other studies that are “minimal risk“, but that do not meet the strict criteria for EXEMPT category must be reviewed by the IRB.
However, the regulations allow for such minimal-risk studies to be reviewed at an “expedited” level, in which only the IRB Chair, or an IRB member designated by the Chair, may review and approve the project. Federal regulations allow for such reviews for a wide-range of specifically defined studies with certain features. [Click here for descriptions and definitions of what research can be reviewed at an “Expedited” level].
As with Exempt category projects, an Expedited review is initially conducted by an OReC staff member and then verified by the Executive Director of OReC. However, at this level, the IRB Chair (or IRB member designee) must also review and approve the project.
2. Studies which have been determined by IRB Chairperson to be MORE THAN MINIMAL RISK
Federal regulations define “minimal risk” as:
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
45 CFR 46. 102 (i)
Therefore, determination of “more than minimal risk” becomes a judgment call for the IRB who must carefully assess study procedures and its effects on subject risk. At UNTHSC, risk to subject assessment is initially evaluated by the OReC Executive Director and staff. If the OReC Executive Director decides that a project is “more than minimal risk”, it is then sent to the IRB chairperson for further assessment and prepared for Full Board Review for final determination.
3. Studies involving elements, procedures or interventions that require additional provisions or safeguards, as stated by federal regulations and guidance.
- Vulnerable or certain Special Subject Populations (e.g., children, prisoners, incapacitated subjects, etc.)
- Studies taking place in foreign countries particularly those with little or no provisions for protection of human subjects in which the procedures pose more than minimal risk to subjects
- Studies where information may be disclosed that could require reporting, e.g., child or elder abuse, illegal activities, etc.
- Deception studies/studies that are more than minimal risk