Expedited vs Full Board Review
When conducting clinical research, ensuring participants rights, safety and welfare should be top priority for research teams. One way to safeguard these factors is through working with an institutional review board (IRB). Their role is to evaluate ethical and scientific aspects of research studies.
However, not all research is reviewed exactly the same. Different studies may qualify for different levels of review. Some studies may be able to undergo an expedited process, while others may necessitate a review with all members of an IRB. This blog outlines two common types of IRB review, including what types of studies qualify for each level.
A Brief IRB Overview
An IRB is in place to protect the rights, safety and welfare of all volunteers participating in a clinical trial. There are many ethical guidelines and federal regulations in place for IRBs to abide by. This is so participants are protected at all times for however long they are volunteering with the study.
There are members who serve on an IRB and review every single study their institution is involved in. Per 45 CFR 46.107, an IRB must have at least five members with varying backgrounds, including at least one member with scientific expertise, at least one with non-scientific expertise, and at least one member who is not affiliated with the institution. All of these parameters are set in place to ensure every study is reviewed fairly and objectively.
Why Are There Different Levels of Review?
While there may be very similar studies currently running, the fact is not one study is running exactly the same as another one. Because of this, there are different levels of risk involved for each individual trial.
This is where IRBs come in. They are the ones assessing the risk level, which enables them to determine the appropriate type of review. Since not all studies pose the same level of risk, there will need to be different types of review for a study. Two common types of review: expedited and full board.
What is an Expedited Review?
Expedited review is a unique review type; not all studies can automatically qualify as such. There are some parameters around whether or not a study necessitates this type of review. In order for a study to be considered for expedited review, it must involve minimal risk.
Understanding Minimal Risk
Minimal risk is defined in 45 CFR 46.102 as “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.”
With this in mind, a study may qualify for expedited review if it meets the definition of minimal risk. However, per 45 CFR 46.110, it also needs to fit into one of the nine categories published in the 1998 List of Categories of Research That May be Reviewed Through an Expedited Review Procedure (1998 List).
If a study meets minimal risk requirements and qualifies for expedited review, it will be analyzed thoroughly. However, expedited review only necessitates the IRB chairperson or one or more experienced reviewers designated by the chairperson to review the study, rather than the entire board getting together to review the study.
It’s important to note: “expedited” review is not equivalent to “faster” review. The study and all necessary documentation will still be reviewed in full. The “expedited” terminology only refers to the designated reviewer(s) rather than the full convened board. While this might result in a faster review because fewer reviewers are involved, that’s not always the case. Expedited reviews also need to be carefully reviewed to ensure the participants’ rights, safety and welfare are upheld.
What is a Full Board Review?
A full board review is a standard IRB review most researchers expect when it comes to getting their trial examined. The types of trials necessitating full board review include:
- New drug trials
- Research involving vulnerable populations
- Complex trial designs
- Any trial involving more than minimal risk
While this is not an all-encompassing list, if there’s any doubt on whether or not a trial qualifies for full board versus expedited review, an IRB can clear up any confusion.
When a full board review occurs, all IRB members need to congregate to review it. This is also known as a convened review. During a full review, the board will either approve, require modifications to secure approval for, or disapprove the study before it moves forward.
Since a full board review is for more complex trials, it will take longer. This is due to all of the IRB members needing to be present, and the care they need to take in order to ensure participants are protected at all angles in that specific trial.
How Does This Impact Stakeholders?
Understanding the different types of review and when they are relevant impacts everyone involved in a research study.
- For researchers, knowing the type of review needed can help them plan their timelines and understand what resources they may need
- For participants, this ensures they receive appropriate oversight for safety and ethics related to the trial
- For institutions, having different levels of review can still enable them to support compliance and integrity in research
No matter the type of review, whether full board or expedited, research must be conducted in such a way that participants rights, safety and welfare are protected at all times. While each of these review types are different, their outcome is the same: providing review for studies with the hopes of advancing research, one study at a time.
Trust Sabai With Any IRB Review
At Sabai, we are a central IRB that offers ethical review services, no matter the type of review we are doing. We are dedicated to delivering protection and oversight for participants involved in clinical research. Our goal is to foster safe, ethical and compliant clinical trials. Partner with us today as we continue to advance therapies and medicine.
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