The Institutional Review Board (IRB) supports the scientific community at St. Edward's by providing ethics oversight for human subjects research. Our mission is to assist University-affiliated investigators in carrying out the most informative research possible while ensuring that it is rendered with the utmost consideration and respect for those involved.
When the COVID-19 pandemic began, investigators conducting human subjects research were notified that all face-to-face human subjects research must be halted to ensure the safety of study participants and researchers. Currently, face-to-face meetings and interventions have been replaced with alternatives such as phone or video conferencing using tools such as Zoom or online survey software, i.e Qualtrics. The IRB, in partnership with OIT, relies on guidance from the CDC, FDA, and NSF on possible online / virtual alternatives with safety, data security and ease of use in mind.
At this time, however, there may be a case where COVID-19 risk can be mitigated to a minimal level, allowing research to resume if a PI has modified the IRB protocol to add the risk of COVID-19 exposure to the procedures and consent form, included necessary safety measures, and re-consented new or continuing participants. Guidance for minimizing the risk of exposure to COVID-19 in human subjects research can be found at CDC, FDA, and NSF. Studies where the COVID-19 risks cannot be mitigated, or are not modified to address risks associated with COVID-19, cannot resume face-to-face procedures at this time. This guidance is in effect for all SEU students and faculty regardless of geographic location.
These guidances are highly dependent on ongoing updates to federal, state, local, and institutional policies related to physical distancing and allowed activities and based on continuous monitoring of the guidelines. Any changes to study procedures must be approved in advance by the IRB. Please contact IRB@stedwards.edu with questions.
All human subjects research at St. Edward's must be sanctioned by the IRB before data collection may begin. This site provides resources in order to guide you through your proposal submission and to help bring your project into compliance with Federal, State, and University policies that are pertinent to the protection of human subjects (see 45 CFR 46).
The IRB reviews exemption requests, expedited proposals, and studies that qualify for Full Board review. Please expect a ~20 business day turnaround for all new study submissions. To set up a meeting for guidance or support with the IRB process, please contact Laura Minnigerode email@example.com, or just stop by Holy Cross Rm 106 during office hours.
In addition to the protocol considerations, protection of risk in human subjects, and vulnerable populations, the IRB maintains an abundance of caution for mental health. We require that research which might produce any type of emotional or psychological distress include crisis resources both in consent materials and reflected frequently throughout the protocol in any recurrent instances. For a list of crisis resources from the National Alliance on Mental Health, please click here.
The IRB will ultimately determine the level of review needed for your study: exempt, expedited or Full Board. Please note that you must formally request an exemption if your research qualifies. Click here for an overview of exemption qualifications.
Be sure to complete your required CITI ethics training prior to any proposal submission OR exemption request.
For Expedited and Full Board Proposals:
Below are Forms and Templates to assist with your IRB submission.
If you are unsure what forms you need, please visit our Guidance Page. Completed forms may be sent as attachments to IRB@stedwards.edu. Failure to submit the appropriate materials may result in delays. Please contact us with any questions.
Templates and Logos
Full Board meeting dates appear below.
IRB Full Board Meetings
Below are frequently asked questions for reference as you prepare your proposal submission.
Currently, the turnaround time is about 20 business days to review proposals and send investigators feedback. This is a rough estimate. We try our best to review proposals as quickly as possible. However, if revisions are needed, the review process is generally longer.
It generally takes 10 business days to receive a response for requests for exemption.
If you are not submitting an exempt request, you will need the following: CITI certificates from all investigators (i.e. anyone who is going to be involved in the research, not just the PI), a consent form, all recruitment materials (including any emails that would be sent out, flyers, etc.), survey materials, and completion of the IRB Application Guide. Also, keep in mind that for requests for exemption, researchers do still need to submit their CITI certificates.
*Make sure that each section of the IRB Application Guide is complete! These are the same questions that will appear on the SEU IRB Portal, where you will submit your study proposal. Once you have completed each section and filled out this guide, you can then copy and paste your answers into the proposal site at bit.ly/SEUIRBPortal. Keep in mind that the SEU IRB Portal does not let you “save as you go.” You must upload everything at once, so be sure to have a response ready for each of the items before you begin your submission.
Unless you are submitting for an exemption request, yes you do.
When there are human subjects involved, oversight is most likely needed. For guidance to help you determine whether or not your research requires IRB oversight, click here. If you need further guidance or are still unsure, please reach out to us at IRB@stedwards.edu.
For classroom projects involving human subjects research, please refer to this guide. If you believe a class assignment qualifies for exemption from IRB oversight, you will need to submit a Request for IRB Exemption of Classroom Projects form. Ultimately, it is the decision of the IRB to determine if your project(s) qualify for exemption or require IRB oversight.
You are welcome to contact our Administrative Team or individual members of the Institutional Review Board (IRB) with questions about your proposal submission.
Laurie Cook Heffron, PhD, LMSW
Shelbee Nguyen, PhD
IRB Vice Chair
Holy Cross Hall Room 106
Parent Institution/Organization: IORG0008223 (expires 02/28/2022)
IRB00009859 - St. Edward's University IRB #1 - IRB Committee
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