qualification will conduct a preliminary screening of the human research applications and supporting documents submitted by researchers. OSP staff may make suggestions to researchers for revisions on the application form before forwarding the application to the IRB. Furthermore, if any of the required documents are missing upon submission, the OSP staff will ask the researchers for the missing documents and will not submit the application for review until all the relevant documents have been provided.
The type of review that a study receives is commensurate with the level and type of risk to participants involved. These risks include the probability and severity of possible harm to the participants' physical, psychological, social, or economic welfare.
Applications that meet exemption criteria will be processed quickly and normally reviewed within a week following receipt. Applications meeting one or more expedited review categories will be processed quickly and normally be reviewed within two weeks following receipt. Applications that require full review by the IRB must be received approximately 30 days in advance of a scheduled IRB meeting.
In cases where a full review is needed, all active voting IRB members will receive all documents submitted by the researchers one week prior to the meeting date. Documents will be distributed electronically by email and/or a file sharing platform.
Additional materials included in the meeting packets will include a copy of the previous meeting's minutes, a list of all determinations of exempt status and expedited actions taken since the previous meeting and a copy of the meeting agenda.
All IRB members will have access to and may review files containing all the applications reviewed in the past year or that are under review. These files will include applications for exemption and expedited review, as well as applications for full review.
According to 45 CFR § 46.104, as of 2023, research activities are exempt from the human research protection regulations when the only involvement of human subjects falls within one of eight categories. The eight exempt categories are as follows: