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. 

A tablet computer sitting atop a small stack of books

Announcements

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 ( jblue@stedwards.edu)

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.
 

Does my research need review? What type of submission should I prepare?

Click here for an overview of exemption qualifications. Note that the IRB will ultimately determine the level of review needed for your study (i.e., exempt, expedited or Full Board). Also, note that you must formally request an exemption if your research qualifies.

  • All new, non-exempt human research proposals should be submitted through the IRB Submission Portal.
  • Before continuing, you may wish to review the IRB Application Guide or visit our Guidance Page.
  • Be sure to complete your required CITI ethics training prior to any proposal submissions or Exemption Requests.
  • Expect a ~20 business-day turnaround for all IRB submissions except for those needing Full Board review.
  • Proposals that are likely to need Full Board review must be received at least 14 days prior to a scheduled meeting (dates listed below). All other requests may be submitted anytime. NOTE: The IRB does not meet May through August.
  • General inquiries may be sent to IRB@stedwards.edu. We are available to assist you!

Request an Exemption

IRB Submission Form for Expedited and Full Board Proposals

Request a Revision or Continuation