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.
The IRB, a volunteer service committee, actively seeks to provide ethical guidance to our University's scientific community in order to help affiliated investigators engage in work that, above all else, (1) honors the rights and dignity of every human participant, and, (2) complies with federal regulations. In keeping with the larger mission of St. Edward's University -- which emphasizes educational opportunities for all students, faculty, and staff -- the Institutional Review Board (IRB) endeavors to proactively educate our research community through classroom and Institutional training initiatives that emphasize a high standard of respect for participants in the human subjects research discipline. We seek to communicate consistently with investigators in order that these important ethical standards should remain exemplified throughout each scientific endeavor.
The St. Edward's University Institutional Review Board (IRB) serves to protect the rights and dignity of participants in Human Subjects Research that is undertaken by (or with) members of the St. Edward's University community. The St. Edward's IRB is responsible for ensuring that University-affiliated research is compliant with the human subjects laws of the State of Texas as well as the federal guidelines that are defined -- in conjunction -- 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)] .
The St. Edward's University IRB recognizes that human subjects research constitutes a broad range of activities, and thus the committee’s interpretation of state and federal guidelines may require some dialogue within reason to enforce these guidelines over the commonly accepted practices of distinct disciplines.
It should be noted that the St. Edward's University IRB is not responsible for enforcing professional standards beyond those concerning the protection of human subjects. While some research activities may raise questions beyond this purview, for example, questions pertaining to the quality of the research methodology or the topic's accordance with the University mission, it should be noted that the IRB is charged specifically with determining the foreseeable risks and benefits posed to human participants taking part in University-affiliated research. The Institutional Review Board recognizes the limitations of this charge, yet we wish to remind all University-affiliated researchers that the scientific discipline as a whole is subject to the same standards of excellence that accompany any professional endeavor and, thus, all affiliates are expected to maintain excellence in conduct throughout their scientific investigations, even in those areas that extend beyond the purview of the IRB.
St. Edward's University uses the SMART IRB online reliance system.
As is the case with almost every college and university, St. Edward's University has agreed to the OHRP Federalwide 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)).