The Institutional Review Board (IRB) is a St. Edward's University ethics committee comprised of several faculty members, one administrative support person, and one member outside of SEU. The IRB's goal is to provide required, ethical oversight for all research projects involving living, human subjects.

Mission and Vision

The IRB supports the SEU scientific community by reviewing individual research proposals so that they (1) comply with federal regulations and (2) ensure the basic rights and dignities of every human participant.

In keeping with the larger mission of St. Edward's University—respect for all persons—the IRB's additional goal is to educate the SEU community about the IRB's review protocols and broader ethical considerations. This is achieved one-on-one with researchers or in the form of educational materials and classroom training initiatives.

The IRB endeavors to review each research proposal in a timely manner to evaluate its level of risk factors. Considerations include issues of privacy, confidentiality, and the level of potential discomfort or harm participants might experience during the course of the study. The IRB then works with the Principal Investigator to improve the research protocols in order to achieve full, ethical compliance and IRB approval.

Overview

  • Any research project involving living human subjects, and where the Principal Investigator or participant is a St. Edward's University faculty, staff, or student, must be reviewed and approved by the SEU IRB before research can begin.
     
  • After an initial review, the IRB will designate a research project Exempt, Expedited or Full Board Review, depending on the level of risk to participants.
     
  • All researchers should plan (6) six weeks in advance to receive IRB approval. Generally, for Exempt and Expedited proposals, the time from submission date to approval date is between 10-21 days. For proposals needing Full Board review, approval could take several weeks.

    Note: Submissions received during finals week or before holiday breaks could further delay the approval process.

  • Proposals that likely need a Full Board Review—research that poses a greater-than-minimal risk to participants—must be received at least 14 days prior to an IRB scheduled monthly meeting. See the IRB Full Board Meeting Dates here.
     
  • The IRB does not review proposals from May through August. Limited reviews for Exempt proposals only might be conducted during the summer months depending on faculty availability. Contact IRB@stedwards.edu in advance if your research project will need summer review.
     
  • The IRB submission process is all online, either via the St. Edward's University IRB Application Portal* or through IRB@stedwards.edu. Refer to the IRB web pages for additional guidance on which documents to prepare and how to submit.

Please note: The St. Edward's University IRB is not responsible for enforcing professional standards beyond those concerning the protections of human subjects. For example, the IRB does not evaluate the quality of the research methodology or the topic's compliance with the University mission. The IRB is only concerned with the foreseeable risks and benefits for participants in University-affiliated research projects.

All scientific disciplines are subject to the same standards of excellence, and therefore St. Edward's University researchers are expected to maintain professional conduct and adhere to these standards throughout their scientific investigations, even in areas beyond the purview of the IRB.

Federal Laws

The St. Edward's University IRB must ensure that University-affiliated research complies with the current laws of the State of Texas, as well as federal guidelines as defined by the Office for Human Research Protections (OHRP) (45 CFR 46) and the U.S. Food and Drug Administration (FDA) (21 CFR 50), both divisions of the U.S. Department of Health and Human Services (DHHS).

In short, St. Edward's University has agreed to the OHRP Federal Wide Assurance (FWA) dictating that human subjects research will adhere to the Department of Health and Human Services Code of Federal Regulations (CFR) title 45 part 46. 

According to these guidelines, "Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d)). Likewise, "A human subject is a living individual about whom an investigator (professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information" (45 CFR 46.102(f)).


*St. Edward's University uses the Smartsheet Management System for secure, IRB research proposal submissions.