Submitting a Protocol
All studies that fulfill the federal definition of "research" and involve "human subjects" (click for definition) must be reviewed and approved by the IRB before any procedures are initiated. All research must be re-reviewed at least annually, and any changes to an approved protocol require prior review and approval.
Adverse events, protocol violations, complaints, and other new information relevant to the research must be reported to the IRB in a timely fashion as each may alter the assessment of study risks or benefits.
At the time of submission, all studies are assigned a level of review based on risk, subject vulnerability, and to some extent the complexity of the proposed work.
Studies that involve procedures that are "more than minimal risk" can only be approved by the convened IRB, also known as the Full Board.
Minimal risk research and minor changes to approved research studies can be approved by the IRB Chair, or delegated to an IRB member for review and approval. This is referred to as expedited review.
- The PI-IRB utilizes a subcommittee review process for initial review of studies that require final review by the Full Board. The subcommittee also reviews and can approve other, minimal risk research.
Federal regulations and OHRP guidance are quite clear about the requirements for continuing review: all studies need to be reviewed for approval at least annually. Investigators are responsible for tracking each study's approval period. Using the 'My Studies' tab in PRISM to confirm your study's expiration date. The expiration date is also noted on the most recent approval notice and on each page of each approved consent form.
- It is important to note that study approval, not merely the consent form, expires on the last day stamped on the consent from.
- Once approval expires, no further recruitment can occur.
- All research must stop unless doing so would place subjects at risk.
- The regulations do not permit extensions or exceptions beyond the twelve month period.
Continuing review reminder notices
- Continuing review notices are e-mailed to the principal investigator 60 days in advance of expiration.
- Reminders are again e-mailed 30 days later.
- Final notices are e-mailed shortly after expiration, and the study is considered terminated 2 weeks later if no continuing review application is received.
In preparing your application
- Carefully review your study's progress.
- Consider if information arising during the implementation of the study, information from the literature, or new standards of care require a reevaluation of the study risks and benefits or changes to procedures or consent forms.
- Submit a completed Application for Continuing Review of Research (ACAR), via PRISM.
- Check this website for new requirements in advance of submission.
Submission and Review
- For studies first approved at the Full Board, continuing review requires consideration at the Full Board unless subject enrollment has not commenced, the study is completed except for data analysis, or the Full Board has agreed that the study no longer requires Full Board review.
- For those studies requiring Full Board review, please allow sufficient time in advance of the expiration date of your study and submit material a minimum of 2 weeks prior to a scheduled meeting. This allows for scheduling and preparing the material for review by IRB members.
- Studies approved using an expedited process are reviewed at continuation using the expedited procedure. Time your submission accordingly.