What Type of Application Do I Need?
The level of risk to the subject determines the appropriate type of application. The risk level is compared to "minimal risk," as defined by federal regulations:
Minimal Risk means that 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 examination or tests (45 CFR 46.102).
Determine which of the four types is required:
- Full Committee Review
Presents greater than "minimal risk" to subjects
- Randomized double-blind placebo-controlled trials
- Phase I, II, III, IV trials
- Studies using investigational agents
- Behavioral studies
- Compassionate use
- Humanitarian Device Exemptions
- Renewal of studies that are still ongoing
- Expedited Review
Presents no more than "minimal risk" to subjects
- Prospective collection of biological specimens
- Collection of data through noninvasive clinical procedures
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
- Collection of data from voice, digital, or image recordings
- Low risk behavioral research
- Renewal of studies approved under expedited review or undergoing data analysis only; including studies that were originally reviewed by the full committee
Presents less than "minimal risk" to subjects; fits into one of four federally defined categories.
- Biological specimens that have no identifiers
- Data sets that do not include any PHI
- Emergency Use of an Investigational Drug or Device
May be approved in very limited circumstances under three very specific conditions:
Note: Not be confused with "Compassionate Use" which requires full committee review.
- A life-threatening situation
- in which no standard acceptable treatment is available and
- in which there is not sufficient time to obtain IRB approval.
Which Category of IRB Review and Approval is Needed for My Project?
Federal regulations divide research involving human subjects into three categories "Full Committee Review," "Expedited Review," and "Exempt Review" each of which has a corresponding requirement for institutional approval.
Full Committee Review
Any research involving human subjects that does not fall into either "Expedited Review" or ‚"Exempt Review" categories must be submitted for full committee review. This is the most rigorous level of review.
To be eligible for an "Expedited Review," research must qualify as one of the federally-defined categories of "minimal risk research." Federal regulations allow Institutional Review Boards to expedite the review of categories of research as described in 45 CFR 46.110 and 21 CFR 56.110.
Although the category is called "exempt," this type of research nevertheless does require review by the IRB. The exemption review is much less rigorous than an Expedited or Full Committee Review. To be eligible for "Exempt Review," research must fall within one of the six federally-defined categories. These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or publicly-available data, or conduct of the least potentially harmful research experiments. Some examples of "Exempt Review" research include: anonymous surveys, taste sensory panels, retrospective chart reviews, and analysis of discarded pathological specimens without personal identifiers.
Which Forms Do I Use to Submit a Request for Full Committee, Expedited, or Exempt Review?
To submit a request for Exempt Review, you must complete the Application for Exemption. To request a Full Committee Review, you must complete the form entitled Initial Review Submission and adhere to the regularly scheduled IRB deadlines. To request Expedited Review, you must also complete the Initial Review Submission form.