FAQ - Application Submission & IRB Approval Process
What is the difference between full, expedited and exempt review?
- Full-Committee Review
- Studies are reviewed by a fully-convened IRB committee. The committee discusses the study and makes a decision about the approval of the study. This type of review is carried out for studies greater than minimal risk to subjects.
- Expedited Review
- Studies are reviewed by a qualified member of the IRB committee. This member reviews the appropriate materials and consults with the PI if necessary to come to a decision about the approval of the study. This type of review is carried out for studies which involve minimal risk to subjects and fit into an expedited review category of research.
- Exempt review
- The RSPP senior office staff screens studies for exemptions. If a study fits into an exempt category of research and is low risk to subjects, it will not need to go through expedited or full-committee review. If the study is not found exempt, it will need to go through expedited or full-committee review.
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How to answer stipulations from the IRB.
Provide a written response to each of the committee’s stipulations along with the original signature of the PI on the cover letter.
If changes to the consent documents are required, include revised consent/assent forms with changes highlighted. Include a copy of any documents requested by the committee and highlight any changes made in response to stipulations.
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What qualifies as research that can go through the expedited review process?
To qualify for expedited review, a research procedure must be limited to the activities that are federally approved (from 63 FR 60364-60367, November 9, 1998.) for expedited review and incur no more than minimal risk for participants, or be a minor change in previously approved research that involves no additional risk to the research subject.
The activities approved in the federal regulations for expedited review are:
- Clinical studies of drugs and medical devices
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture
- Prospective collection of biological specimens for research purposes by noninvasive means
- Collection of data through noninvasive procedures
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes
- Collection of data from voice, video, digital, or image recordings made for research purposes
- Research on individual or group characteristics or behavior
- Continuing review of research previously approved by the convened IRB
- Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified
See Expedited Review Categories for more info
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What must be reviewed by the IRB?
See:
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When will I hear from the IRB about my study?
The length of time a study will take to be approved and an approval letter received depends on the type or level of review required. Listed below are average times for approval. (days include both weekdays and weekend days)
Exempt Review(from application submission to granting of exemption): 9 days
Expedited Review(from application submission to approval): 22 days
Full-Committee Review(days after a committee meeting): 8 days
Note on approval time: These times are averages for studies that are not assigned stipulations by the IRB committee or require additional information. Studies that are assigned stipulations will take an additional amount of time depending on how fast these stipulations are met and when they can be reviewed, either through expedited review or full-committee review.
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Why does the IRB require signatures of department heads on the application forms?
In keeping with the initiative in sponsored projects management at the University of Minnesota, the roles and responsibilities of researchers, department heads, and institutional officials are being articulated to ensure that all parties understand the extent of their responsibilities for project management. The IRB holds all projects irrespective of funding source to the same standards. Therefore, to ensure that the required local oversight of projects is in effect, all research projects that involve human subjects require the signature of the department head.
It is the IRB's preference that the task of signing the form not be delegated. However, in some circumstances the IRB will consider delegation to an appropriate authority in the departmental structure as long as that person is knowledgeable in the requirements for protecting human subjects and has the authority to sign for the department head in this regard.
When a department head delegates this task, that delegation should be communicated to the IRB in writing and the IRB will consider the substitution and provide written response. The IRB may decline to consider task delegation.
Even when task of signing is delegated, the responsibility for local oversight remains with the department head. In some instances, a department head may be required to provide additional supervision over high-risk projects.
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