Baylor IRB Quick-Start Guide
What is IRB?
IRB is a regulatory body that ensures studies with human subjects are conducted ethically and protect the subjects.
Do I need to submit my study to IRB?
Does your study involve human subjects? Then yes! You need to submit a form for either an exempt or board review of your study.
How do I know if my study is IRB exempt?
If your study meets at least one of the following categories, it is IRB exempt. These are summarized and can be found in more detail at HHS.gov.
- Study involves normal educational practices unlikely to impact students’ opportunities and assessments negatively.
- Study involves surveys or exams and no identifying information that can be used to negatively impact the participant is collected.
- Study involves consensual behavioral interventions with documented participant feedback and no identifying information that can be used to negatively impact the participant is collected.
- Study uses information and identifiable information that is already publicly available or conducted for a government agency using existing agency records.
- Study is supported by government agency and designed to examine public service and benefit programs.
- Study is a consumer acceptance study that does not include agricultural chemicals or food ingredients at a higher level than deemed safe by the EPA or FDA.
What is required for an IRB submission if my study is exempt?
You will need to fill out the F-15 Exempt application form which is linked here, and the T-05 Exempt protocol template here. Each of these documents has detailed examples of how to complete the application built into the template.
You will also need to submit the consent form you plan to use for your participants. The blank exempt consent form can be found here, and if you want a more guided example, here.
F-15: This document provides the IRB with an overview of your study. It outlines your study personnel, the funding source, location if outside Baylor, the specific category you are claiming exemption through, how you will be recruiting, how you will be obtaining participant consent, and how you will be protecting participant data. All key personnel – those who aid with the study in any capacity at or greater than consent acquisition from participants – must be listed.
T-05: This document provides the IRB with a more detailed look at the specifics of your study. For this form, you will need to detail how you intend to analyze the data obtained, give examples of assessments, and address any potential risks in addition to explaining the categories from the F-15 form in more detail. This form also includes the rationale for the study, which is critical to your study being approved. If you have started a literature review, highlights from that review should be included here.
What is required for an IRB submission if my study is NOT exempt?
The Baylor Office of the Vice Provost for Research has provided a list of all relevant paperwork here. There are two key documents the F-01overview and T-01 protocol. These are similar in structure to the exempt versions discussed above, but ask for extended information on the data collected, data storage, and personnel involved.
There are also different consent forms for non-exempt studies depending on your study structure; a consent form, assent form, and parental permission form.
How do I submit my study to IRB?
After filling out the proper IRB forms from the link above, they can be processed through IRBnet.org.
- Baylor has a quick start guide which can be found here if you have not yet created an account.
- A step-by-step guide to creating a new study can be found here.
Do I need to submit my study by a certain date?
Yes! The IRB panel meets monthly and your submission must be completed prior to the meeting date to be considered. See this link for the schedule of meetings for Fall 2024 or visit here for more information and specialty cases.
I’m still confused!
Questions concerning IRB can be directed to the Office of Research Compliance at IRB@baylor.edu or (254) 710-3708.
The ATL is also available for consults. To schedule an appointment, please email ATL@baylor.edu.