Research with Human Subjects
TU Research Programs
Northrup Hall 341
One Trinity Place
San Antonio, Texas 78212-7200
(210) 999-8234 fax
Institutional Review Board
The Institutional Review Board (IRB) has the responsibility of reviewing and approving all research at Trinity that involves the use of human subjects, including student student projects and theses. This includes interviews, questionnaire research and participant observation. Projects are subject to IRB review regardless of funding status.
Policies and procedures governing the use of human subjects are outlined in the Faculty/Staff Handbook. Trinity subscribes to the Belmont Report ethical principles and guidelines for the protection of human subjects of research.
Faculty, staff, and students who plan to conduct research projects involving the use of human subjects should plan to submit their research protocol so that it may be considered by the IRB at one of its monthly meetings. Research protocols should demonstrate that research subjects have given their consent to participate.
The IRB is currently comprised of the following individuals:
Acting Chair: Harry Wallace (faculty)
Administration: Mark Brodl (AVP Academic Affairs: Budget & Research)
Faculty members: Aaron Delwiche, Steven Luper, Amy Stone, Jane CHilders (on leave)
Community members: Randall Osherow, Abraham Alecozay, M.D.
Student member: to be determined
Fall 2013 IRB Meetings
- Wed 9/25 4pm in NH 303
- Wed 10/23 4pm NH 303
- Wed 11/20 4pm NH 303
- Wed 12/18 4pm NH 303
Apply for IRB Approval
Students: If your project is for a class where numerous students or groups are completing projects, please consult with your instructor. Course instructors are responsible for collecting student research protocols and submitting them as a group to firstname.lastname@example.org. If you are carrying out an individual project (e.g. thesis, independent study, student organization research project), please follow the instructions below.
Step One: Please complete the IRB approval form online to determine whether your project is exempt from review.
Step Two: If your project is NOT exempt from board review, please also send your research protocol, questionnaire or other instruments, consent form (sample) and other relevant information to IRB@trinity.edu.
Human Subjects Education
Investigators who are new to research involving human subjects are asked to complete an online course to familiarize themselves with proper procedures.
Policy on Continuing Review
All IRB approved studies must provide within one year of approval, a status report on the progress of the study.
A member of the IRB, usually the Chair, will review the status report, including the informed consent materials and summarize the report for the full Board in writing. The review and any IRB actions will be noted in the IRB minutes. The full IRB can and should discuss and take action on any review that might be a cause of concern (especially with respect to risks). The final decision for any action rests with the full Board.
In addition, investigators must contact and report to either the IRB Chair or Administrator, any unforeseen incidents that might indicate that risks to participants are higher than originally assumed (see OHRP guidance on unanticipated problems and adverse events) at the time the investigator learns of the incident.
Rationale for a one year review: Most Trinity studies are very low risk, are approved by expedited means, and last for a year or less. A shorter review report cycle will be used for studies if the full Board requires it.
All studies must make at least one status report, either on an annual basis, or at the end of the study. For student projects associated with courses, one report by the instructor at the end of the course, covering all projects, is sufficient.
Setting a review date or cycle time will be part of the approval process. Investigators who have not provided status reports may be denied IRB approval on subsequent applications.