Categories of IRB Review
In accordance with federal regulations, the IRB offers different categories of review for human subjects research studies. The type of review that a particular study is eligible to receive is dependent on two factors: (1) the level of risk present in the study and (2) the study population.
Regardless of the category of review for which a study is eligible, it is the IRB's goal to work with investigators to ensure that risks to human subjects are minimized and are justified in relation to the potential benefit of the study (to the subjects or to a broader population).
If the IRB determines that a study is human subjects research (see the Request for Determination of IRB Jurisdiction form), it will be reviewed under one of these categories, as appropriate:
Human subjects research that presents no more than minimal risk to subjects, and which is deemed to be exempt from the requirements for full and continuing review by the IRB is classified as exempt research.
The IRB—not the investigator—must make the determination as to whether a particular study meets the exemption criteria. If you believe that your study meets one of more of the exemption criteria, please submit a Request for Exemption template, along with any other required documents.
Requests for exemption are reviewed by one of the IRB co-chairs, or by a designated IRB member. There is no deadline for the submission of requests for exemption; they are accepted and considered on a rolling basis.
Approval Period and Continuing Review: Exempt research is approved for five (5) years, after which time the study will be automatically closed by the IRB. During the 5-year period, no continuing review is required unless modifications are made to the approved protocol, at which point a modification request must be submitted to the IRB (prior to the modifications being implemented).
Human subjects research that presents no more than minimal risk to subjects, but which does not fall within any of the approvable categories of exempt research, is eligible to be reviewed under an expedited process.
In order for a proposal to be reviewable under an expedited process, it must meet the requirements for expedited review outlined in the Federal Register:
Note: The Pacific University IRB generally does not use an expedited review process for any research conducted with vulnerable or protected populations (children, prisoners, etc.). If your research involves such a population, it is advisable to contact the IRB for a consultation as to whether your study is likely to require full board review.
The documentation required and review considerations for an expedited proposal review are exactly the same as those required for a full board review (see below for a description of full board review). However, expedited proposals are reviewed by either one (or both) of the IRB co-chairs, or by two designated IRB members.
There is no deadline for the submission of expedited review proposals; they are accepted and considered on a rolling basis. However, if you are unsure as to whether your proposal will require expedited or full board review, you are advised to submit it in advance of the deadline for the next scheduled IRB meeting.
Approval Period and Continuing Review: Proposals approved under an expedited process are approved for one (1) year. If the investigators wish to continue their study beyond that one year period, they will be required to undergo continuing review and to submit a request to extend the study period. In addition, if during the study period, any modifications are made to the approved protocol, a modification request must be submitted to the IRB (prior to the modifications being implemented).
Human subjects research that is non-exempt and that does not qualify for expedited review will be reviewed by the full IRB at a convened board meeting. Any study that presents greater than minimal risk to subjects will be reviewed by the full board.
In order for a research proposal to be considered at an IRB meeting, it must be received in the office by the submission deadline for that meeting.
Note: A submission will not be considered to be received by the IRB office if it is incomplete in any way. The official date of receipt of the proposal by the IRB corresponds with the date on which the IRB has received all required materials from the investigator.
Approval Period and Continuing Review: Proposals approved by the full board are approved for one (1) year. If the investigators wish to continue their study beyond that one year period, they will be required to undergo continuing review and to submit a request to extend the study period. In addition, if during the study period, any modifications are made to the approved protocol, a modification request must be submitted to the IRB (prior to the modifications being implemented).
The IRB may, at its discretion, require that a study submit to continuing review at intervals more frequent than annually. This requirement is most likely to be placed on studies that present significant risk to subjects or that examine an especially vulnerable population.
Refer to these proposals for examples of well-written submissions. The formatting of these examples adheres to outdated requirements, but the presentation of the content remains extremely helpful as a tool for researchers.
Request for Exemption: