On behalf of Thomas University, the primary role of the Thomas University Institutional Review Board (IRB) is to serve as the designated body to review and monitor IRB approved research studies involving the use of humans as subjects, animals as subjects, and biological or biomedical research. The IRB is responsible for safeguarding the rights and welfare of human subjects involved in any IRB approved research related activity, and for assuring proper laboratory practices, and the proper care of animals used in laboratory research conducted by Thomas University faculty and students, or research conducted on behalf of Thomas University in partnership with other universities, external entities, and/or independent researchers associated with Thomas University through project approval.
Thomas University Institutional Review Board (IRB) requires all students submitting an IRB application to conduct research involving human subjects, animals, biological or biomedical specimens to complete the online Collaborative Institutional Training Initiative (CITI) certification courses for the appropriate research area. All required courses are available on the CITI training website for Thomas University students. The courses or course modules appear in the student’s CITI portal after the student creates a CITI account and the selects Thomas University as the affiliate institution. Please review the Thomas University CITI Certification Requirement section for complete details.
IACUC (Animal Subjects) Researchers: Please submit ALL CITI training certificates along with your completed IRB application by emailing all documents as attachments to email@example.com.
Professional (Non-Student) Researchers: Please note you are only required to submit the comprehensive CITI certification for your research area along with the CITI Conflict of Interest certification. For example: Professional researchers proposing to conduct an investigation within the research area of Social, Behavioral or Education with human subjects would submit the CITI Social-Behavioral-Education (SBE) Comprehensive and CITI Conflict of Interest Certifications.
To submit an IRB Application, the researcher must perform the following steps.
COMPLETE CITI COURSE MODULES
SUBMIT THE IRB APPLICATION
All Thomas University student applications must contain the authorization of the student’s Assigned Faculty Sponsor prior to submission. Please fill out all questions completely in order to ensure the review of the application. Incomplete applications will not be reviewed by the IRB.
EXTERNAL RESEARCHERS & IRB APPLICATION SUBMISSIONS
External Researchers (Human Subjects/Biological/Biomedical): If a researcher is not affiliated with Thomas University as a faculty member, student, or staff member, the researcher must first obtain a Guest email account from the Information Technology Director before they can access the IRB Application Portal. After receiving the guest credentials, the researcher must complete the aforementioned steps to submit an IRB application. Additionally, external researchers must also complete and submit IRB Statement of Assurances for External Persons, as an attachment document in the IRB Application Portal.
To receive a Guest email account, submit a ticket notifying IT at the following link: http://thomasu.keyusa.net. Select “Student Technology Help Desk” and include a message stating a Guest account is needed to submit an IRB application.
External IACUC (animal subjects) researchers must submit an IRB application, CITI course completion certifications, and IRB Statement of Assurances for External Persons document as attachments via email to the IRB at firstname.lastname@example.org (see Forms, CITI Certifications and Other Resources section for details).
The full Institutional Review Board meets each second and fourth Monday of the month during the Fall and Spring semester periods. During the Summer semester, the IRB convenes as needed. To have an IRB application, modification, or addendum reviewed during the regularly scheduled meeting day, the document must be submitted by the Friday before the scheduled meeting day (i.e., Friday prior to the second Monday of the month, or Friday prior to fourth Monday of the month).
In accordance with IRB policy and procedures, all researchers are asked to please allow up to two weeks (10 business days) for Exempt and Expedited IRB application reviews, and up to 4 weeks (20 business days) for a Full IRB Committee review of proposed research. All decisions of the IRB will be returned to the principal investigator in writing in accordance to IRB policy and procedures.
CITI Certification Requirement
All Thomas University students, faculty, and external applicants are required to complete CITI certification courses aligned with the area of proposed research before submitting an IRB Application. These areas include research proposing the use of humans as subjects, vertebrate animals as subjects, and biomedical research (including specimens only research).
To complete this requirement:
CITI – Thomas University Registration Portal (Register using your Thomas University email account). For support with CITI registration or login, contact CITI support at 1-888-529-5929.
Thomas University IRB Required CITI Course Certifications:
|Protocol/Discipline||Proposed Research Subjects||Required CITI Courses|
|Social, Behavioral, Education||Humans||
|Biomedical Data or Specimens Only Research||No Direct Contact with Humans||
|Vertebrate Animals||Any Vertebrate Animal||
|ADDITIONAL CERTIFICATION REQUIRED FOR RESEARCH SUB-AREAS|
|Research Involving Educational Data||Direct or No Direct Contact
|Family Educational Rights and Privacy Act (FERPA) FOR RESEARCHERS –in Optional Module|
|Public Health Research||Direct or No Direct Contact
|Public Health Research|
|Research Protocol Involving: Clinical Trials with Drugs or Medical Devices||Direct or No Direct Contact
|GCP for Clinical Trials with Investigational Drugs and Medical Devices|
|Research Protocol Involving: Investigation of Devices||Direct or No Direct Contact
|GCP for Clinical Investigations of Devices|
|Research Protocol Involving: Clinical Trials with Drugs or Biologics||Direct or No Direct Contact
|GCP for Clinical Trials with Investigational Drugs and Biologics|
|Vertebrate Animals Research Involving Distress: Mice or Rats||Mice or Rats as Subjects||Minimizing Pain and Distress|
Additional Forms and Resources
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of these regulations, whether or not they are supported or funded under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.(45 CFR 46.102 d).
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual; and/or identifiable private information (45 CFR 46.102f).
Vulnerable populations include minors, pregnant women, human fetuses, human neonates, prisoners (detainees, parolees), institutionalized persons, mentally disabled or handicapped persons.
Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. That is, the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45 CFR 46.102 (i) and 46.303 (d)
IRB approval means the determination of the Thomas University Institutional Review Board that the research that has been proposed and reviewed may be conducted at the institution or within the proposed venue external to Thomas University as described in the proposal (as subject to the approval of the usage of the proposed external venue by the external venue’s governing body) within the constraints set forth by the Thomas University Institutional Review Board and by other institutional or federal, state, or local regulations or requirements as they relate specifically to the research under scrutiny.
Full Committee Review
A full committee review is a procedure for research that does not qualify for an expedited review (see definition) that occurs during convened Institutional Review Board meetings at which the majority of IRB members (a quorum) are present, including at least one member whose primary concerns are in non-scientific areas. In order for the research to be approved, it will receive the approval of the majority of those members present at the meeting. (45 CFR 46.108 a-b)
Expedited Review Defined
An expedited review is a procedure for certain kinds of research involving no more than minimal risk to subjects that participate in the research study or project under scrutiny. The expedited review procedure is used to review one or both of the following types of research or similar activities:
Direct recruitment of students, faculty, staff or affiliated partners by any individual is not permitted by Thomas University or the Thomas University IRB Policy for any research study without express written permission from the Thomas University IRB Chairman or appointed administrator. All recruitment conducted at Thomas University for approved human subjects research (or any form of approved research) is facilitated through the Thomas University IRB’s Research 101 digital system.
To send announcements requesting participation for an approved IRB research study, the Principal Investigator (PI) of the approved study must forward an announcement in the form of email text, along with the approved TU IRB Application Number and the PI’s contact information to the email: Research101@thomasu.edu. An electronic communication will be distributed to the student body or the appropriate Thomas University population containing the PI’s email message. Those who want to participate in the approved study will contact the PI directly or access participation information as described in the email content provided by the PI.