The Bryan College of Health Sciences Institutional Review Board (IRB) is a federally registered board responsible for the review and approval of all research protocols involving humans as participants. The IRB requires that all research involving human subjects conducted within the College or by faculty, staff, or students affiliated with the College, be reviewed and approved prior to subject recruitment or initiation of data collection.
A human subject is defined as “…a living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual; or 2) Identifiable private information.” (CFR Title 45 Part 46). Therefore, any study/project that collects data about human subjects in any form, requires consideration by the IRB. Only the IRB can determine that such a study/project does not need to be reviewed.
A student class project is a project that is required for completion of a course or series of courses at Bryan College of Health Sciences. The purpose of a class project is for the training and education of students in the use of particular methods, concepts, devices, or equipment with no intent to contribute to generalizable knowledge. A thesis/dissertation is not a class project. IRB waivers for student class projects are obtained by faculty teaching courses that require a student class project as an assignment for completion of a course. Class projects that have been granted an IRB waiver cannot be submitted for publication or be presented at meetings outside Bryan College of Health Sciences without prior IRB approval. Carefully consider the need for IRB review. Retrospective IRB review is NOT possible after data collection has begun for a class project. Once students begin class project data collection, the faculty or student cannot change their mind and submit an IRB Request for Review after the fact. Retroactive IRB approval will not be granted under any circumstance.
Carefully consider the possibility of publication or use of data collected in class projects in future research studies. Please see the College IRB website for the application guidebook, meeting dates, forms/templates, and resources for researchers. Please see the College Manual for bylaws of the Bryan College of Health Sciences IRB.
Case Study Policy
A case study is a detailed description and analysis of one, two, or three individuals for the purpose of providing rich, educational information that may be of value to the health care community. Case studies do not require review by Bryan College of Health Sciences IRB because they are not defined as research according to 45 CFR part 46. A case series (more than 3 cases) meets the definition of human subjects research and requires the approval of the IRB. The author must follow all HIPAA privacy rules when writing case studies.
Authors of case studies must also obtain the permission of the subject or authorized individual prior to writing case studies where journal submission and public or meeting presentations beyond Bryan College of Health Sciences may be required.
Many journals require an IRB approval letter prior to publication. You may request an approval letter from Bryan College of Health Sciences IRB by submitting a written request and a copy of the signed Case Study Authorization Form to IRB@bryanhealthcollege.edu. The Case Study Authorization Form is available in the Graduate Studies Office.