Ask a Core IRB Reviewer
By: Allison Kampa and Tyler Oates
A couple of our Core IRB reviewers answered common questions about the Institutional Review Board (IRB) process.
If you have any questions that are not answered below, or would like more information about Core IRB services, please feel free to reach out to Core IRB through our website (https://www.corehf.com/services/irb-services) or via email (irb@corehf.com).
Q: What
are the benefits of having my study reviewed by an IRB?
A: An IRB review is useful to ensure that your study is conducted in accordance with Office for Human Research Protections (45 CFR 46) or FDA regulations (21 CFR 50) and that research participants are physically, socially, and psychologically protected from any potential harms they could face while enrolled in the study.
Q: What
are the types of studies that Core IRB reviews?
A: Core IRB specializes in reviewing minimal risk human factors and social/behavioral sciences studies that are conducted in the United States. We can provide expedited or full board reviews of study materials. Although we can review international studies for ethical considerations, we are not able to ensure adherence to various international ethical guidelines.
Q: What
is the difference between an expedited review and a full board review?
A: If your study is minimal risk, it will likely qualify for an expedited review. An expedited review can be completed by one to two members of the IRB. A full board review is necessary for studies that are beyond minimal risk and requires multiple reviewers to look over and discuss the provided document. This means the review process will take longer and the review fee will be higher. We follow the HHS guidelines or FDA guidelines to determine whether the study is appropriate for expedited review. Please reach out to Core IRB if you are unsure whether your study qualifies for expedited review.
Q: What
is the review time for a Core IRB submission?
A: For expedited reviews, Core IRB provides an initial review within two business days of submission. For full board reviews, Core IRB provides an initial response approximately two weeks after the submission is received. Review of materials does not guarantee your submission will be approved. Submitters will be contacted with any questions and/or comments from the IRB. If you have a tight timeline, we encourage you to provide updated documents within one to two business days. Times for approval vary based on the specifics of the study and the submission.
Q: My
study has specific timeline needs, what are my options?
A: Expedited review has an option for recruiting materials to be reviewed separately to allow recruiting to take place in parallel with protocol development. If a project is on a tight deadline, Core IRB offers an accelerated review option which has an 8-hour initial response time but must be coordinated ahead of time with Core IRB.
Q: What
do I need for a complete Core IRB submission?
A: On
the Core IRB submission form, you will be asked to provide the following items:
●
Investigator CVs
●
Study protocol
●
Informed consent form(s)
●
Recruitment materials
● Case Report Form (CRF) or moderator’s guide
Q: How
do I submit a document for review?
A: If this is your first time submitting to Core IRB, fill out the Core IRB Support form: https://www.corehf.com/services/irb-services. A member of Core IRB will provide our submissions guide and answer any questions. If you have already submitted to Core IRB, use the previously provided submission link.
Q: I’ve
made a change to my study plan after the review has been completed. How do I
notify the Core IRB?
A: If your submission has already been approved and you need to submit an updated protocol, Informed Consent Form, or other study-related document for review, you may submit an amendment via the submission portal. If you have questions regarding the scope of an amendment, you can reach out to Core IRB to discuss prior to submitting.