Depending on the type of project that you are submitting, you may need exempt, expedited or full board review. The type of review is determined by risk level and categories defined by the federal regulations. Minimal risk is defined by the federal regulations in the following way:
Minimal risk is 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(j)]
Exempt Review
The Federal Code at 45 CFR 46 identifies several different categories of minimal risk research as being exempt from the regulations. This does not mean that they are exempt from IRB review, just that some of the federal requirements that apply to non-exempt studies are not applicable to studies deemed exempt. For example, exempt studies are not required to obtain written informed consent, do not need to be reviewed annually, and are not required to submit modifications prior to implementation (unless they may affect the exempt status of the study).
Exempt reviews are performed administratively by the IRB Exempt/Expedited Team. For detailed information on the exempt categories and exempt submissions, refer to the Exempt Review page. FDA regulated studies are not eligible for exemption under these categories.
Please email askirb@pitt.edu with questions or to set up a consultation. Include an abstract or PittPRO study number (if you have one) along with your questions so that we may properly assign an IRB Analyst.
Expedited Review
Unlike exempt review, expedited review falls under the full protection of regulations and are reviewed administratively by the IRB Exempt/Expedited Team. Expedited studies must fall into one of the Expedited Review Categories and must meet all of the following conditions, at a minimum:
- Presents no more than minimal risk to subjects
- Falls into one of the expedited categories authorized by 46 CFR 46 and 21 CFR 56 (FDA regulations). Inclusion of an activity on the list does not automatically deem it to be minimal risk
- Identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal
- Research is not classified
All expedited studies must adhere to the requirements for informed consent or its waiver or alteration. Expedited studies may or may not be required to undergo annual review. All modifications must be approved by the IRB prior to their implementation, unless they are necessary for the immediate safety of subjects.
Please email askirb@pitt.edu with questions or to set up a consultation. Include an abstract or PittPRO study number (if you have one) along with your questions so that we may properly assign an IRB Analyst.
Full Board
Studies that are not eligible for expedited review (do not meet the definition of minimal risk and/or do not fit into an expedited category) must be reviewed by the convened IRB.
All full board studies must adhere to the requirements for informed consent or its waiver or alteration. Full board studies must undergo annual review. All modifications must be approved by the IRB prior to their implementation, unless they are necessary for the immediate safety of subjects.
The University of Pittsburgh IRB convenes six meetings per month. Each committee is run by a Vice Chair and IRB Analyst and is made up of multi-disciplinary faculty, staff, and community members. Protocols are assigned to the first available committee with expertise in the specialty under study.
Please email askirb@pitt.edu with questions or to set up a consultation. Include an abstract or PittPRO study number (if you have one) along with your questions so that we may properly assign an IRB Analyst.