The Institutional Review Board (IRB) supports the scientific community at St. Edward's by providing ethics oversight for human subjects research.
COVID-19 IRB RESEARCH PROTOCOL
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. During this time, face-to-face meetings and interventions must be stopped or replaced with alternatives such as phone or video conferencing using tools such as Skype/Google Hangout/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, face-to-face human research studies are not permitted, 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. By working remotely, the SEU IRB plans to remain fully functional, and you may 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).
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.
St. Edward's University IRB is now in session for the Spring 2021 semester. Please expect a ~20 business day turnaround for all new study submissions. The IRB will continue to review exemption requests, expedited proposals, and studies that qualify for Full Board review. Additionally, if any student or faculty member needs any assistance, feel free to contact or set up a Zoom meeting with our IRB Administrator ( firstname.lastname@example.org)
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 & any research which might produce any type of emotional or psychological distress. Any IRB submission should include crisis resources in consent materials and reflected redundantly throughout the protocol in any recurrent instances. A list of those is included here. They resources can be personalized to fit the unique study.
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
|Friday, January 29th|
|Friday, February 26th|
|Friday, March 26th|
|Friday, April 30th|
Below are frequently asked questions for reference as you prepare your proposal submission.
We have a current turnaround time of 20 business days to review proposals and send investigators feedback. This is a rough estimate, as we try our best to review proposals as quickly as possible. However, this could potentially take longer if revisions are needed.
We have a rough estimate of 10 business days to review exempt requests.
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.
*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 (which is why you should complete this guide first!).
Unless you are submitting for an exemption request, yes you do.
When there are human subjects involved, oversight may be needed. For further details 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 any questions.
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 108: Office of Sponsored Programs
Parent Institution/Organization: IORG0008223 (expires 07/26/2020)
IRB00009859 - St. Edward's University IRB #1 - IRB Committee
Federal Wide Assurance (FWA) - #346307 expires 7/31/2020