Institutional Review Board (IRB)

The IRB supports the St. Edward's 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. A key tenet of the IRB mission is to ensure "respect for persons" during research studies, as outlined in The Belmont Report.

For each research proposal, the IRB endeavors to provide a timely review that evaluates the risks to subjects. Considerations include the sensitivity of information being collected and the level of discomfort or distress participants might experience during the course of the study. The IRB then works with the Principal Investigator to minimize the risks and achieve IRB approval.

The IRB's additional goal is to educate the SEU community about the review process and broader ethical considerations. This is achieved with researchers through one-on-one communications, educational materials, classroom training and faculty workshops at the SEU Teaching Symposium.

• Any research project involving living human subjects, and where the Principal Investigator (PI) OR participant is a St. Edward’s University faculty, staff or student, must be reviewed and approved by the IRB before research can begin.
• After an initial review, depending on the level of risk to participants, the IRB designates a research project Exempt, Expedited or Full Board Review. See this IRB Flowchart for more specifics on the evaluation process.
• The submission process begins at the St. Edward’s University IRB Application Portal. All IRB applications are online, but supporting materials (Informed Consent, Recruitment, etc.) are completed separately and submitted as attachments. See our additional guidance on which documents to prepare and how to submit.

• All researchers should plan (6) six weeks in advance to receive IRB approval. On average, for Exempt and Expedited proposals, the time between submission and approval is 7–21 days. For Full Board Review, approval could take several weeks.

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

• Exempt and Expedited: Proposals that need review before the Christmas break should be submitted approximately two (2) weeks prior to the last day of school. The IRB will make every effort to provide feedback before the holiday, but approval might be delayed until faculty return to campus in mid-January.
• Full Board Review: Research proposals that include vulnerable populations (children, pregnant women, prisoners, and persons with diminished decision-making capacity), or that pose a high risk to participants, must be received at least 14 days before an IRB scheduled monthly meeting (review IRB Full Board Meeting Dates). The Full Board does not meet May through August. To receive feedback before the end of the academic year, these proposals must be received by the April deadline.
• Summer IRB:
  These proposal types will be accepted and reviewed during specific summer months:
  • June and July – Exempt, Expedited and Modifications/Continuing Review. Submission deadline for ALL proposals is July 15, 2024.
  • August — No IRB services.

The St. Edward's University IRB is not responsible for enforcing professional standards beyond those concerning the protections of living, 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.

However, the IRB does require specificity and thoroughness within the proposal's application regarding all research protocols, and particularly on the Consent Form. The IRB Submission Checklist is a useful tool for knowing what is required. The IRB will also sometimes make non-binding recommendations to the PI based on best practices.

All scientific disciplines are subject to the same standards of excellence. 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.

The St. Edward's University IRB is required to 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).

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)).