Institutional Review Board

All biomedical/biological, social and behavioral research approved by the Institutional Review Board is subject to research related policies and procedures of Thomas University and the Institutional Review Board (IRB). In accordance with federal regulations and IRB policy governances, researchers may not initiate studies involving human participants, animal subjects, biological or biomedical specimens until approval has been granted in writing from the IRB. Institutional Review Board approval may NOT be granted retroactively. Approval of proposed research is valid for one year upon written notification, as indicated within the IRB Response to the Principal Investigator.

 

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 irb@thomasu.edu.

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

• Create a Collaborative Institutional Training Initiative (CITI) account using theThomas University email address assigned and by selecting Thomas University as the affiliated school. CITI is located online at https://www.citiprogram.org
• After the CITI account has been properly established, the researcher should complete the required certification courses for their research subject area as indicated (see Forms, CITI Certifications and Other Resources section for details).

SUBMIT THE IRB APPLICATION

• Following the completion of the CITI courses and the award of the completion certification from CITI, the researcher should login to the Thomas University IRB Application Portal with their assigned Thomas University email address and password and complete the appropriate IRB application. The IRB Application Portal is located online at: https://thomasu.keyusa.net
• NOTE: A copy of the CITI certification documents for the appropriate research area must accompany the IRB application and will not be reviewed without a certificate of completion. When using the IRB Application Portal, the researcher’s certifications will be automatically attached to the application–as long as the researcher selects Thomas University as the affiliated school in their CITI account.
• IACUC (animal subjects) researchers will have to submit an IRB application and CITI course completion certifications as attachments to the IRB at irb@thomasu.edu (see Forms, CITI Certifications and Other Resources section for details).

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 irb@thomasu.edu (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:

• Register at the CITI portal using the below link.
• TU Students and Faculty: Make sure to select Thomas University as the affiliate institution and use your Thomas University email address when registering.
• EXTERNAL Applicants: Make sure to select Thomas University as the affiliate institution so that you will be able to view the required courses. If you have an active certification (i.e., one that has not expired and completed within the last two years) for the courses required by Thomas University, you may submit the active certification for each course with your application.
• Once registered, the list of Thomas University courses outlined per research area will be listed in your portal.
• Complete all outlined courses per research area. Any application submitted without the required completion of CITI courses will be denied.

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	Social-Behavioral-Education (SBE) Comprehensive Social and Behavioral Responsible Conduct of Research Conflicts of Interest (COI) GCP – Social and Behavioral Research Best  Practices for Clinical Research IPS for Researchers
Biomedical/DNA	Humans	Biomedical (Biomed) Comprehensive Biomedical Responsible Conduct of Research Conflicts of Interest (COI) IPS for Researchers
Biomedical Data or Specimens Only Research	No Direct Contact with Humans	Biomedical Data or Specimens Only Research Biomedical Responsible Conduct of Research Conflicts of Interest (COI) IPS for Researchers
Vertebrate Animals	Any Vertebrate Animal	Biomedical (Biomed) Comprehensive Biomedical Responsible Conduct of Research Conflicts of Interest (COI) IPS for Researchers Working with the IACUC Course (Indicate Wildlife Research—if applicable) Select and Complete Appropriate Species Course:   (Frogs, Toads, Other Amphibians; Cats; Cattle; Dogs; Ferrets; Fish; Genetically Modified Mice; Gerbils; Guinea Pigs; Hamsters (Family: Muridae); Horses; Mice (Muridae Cricetidae); Non-Human Primates; Rabbits (Leporidae); Rats (Rattus); Reptiles; Sheep and Goats; Swine or Zebrafish
ADDITIONAL CERTIFICATION REQUIRED FOR RESEARCH SUB-AREAS
Research Involving Educational Data	Direct or No Direct Contact with Humans	Family Educational Rights and Privacy Act (FERPA) FOR RESEARCHERS –in Optional Module
Public Health Research	Direct or No Direct Contact with Humans	Public Health Research
Research Protocol Involving: Clinical Trials with Drugs or Medical Devices	Direct or No Direct Contact with Humans	GCP for Clinical Trials with Investigational Drugs and Medical Devices
Research Protocol Involving: Investigation of Devices	Direct or No Direct Contact with Humans	GCP for Clinical Investigations of Devices
Research Protocol Involving: Clinical Trials with Drugs or Biologics	Direct or No Direct Contact with Humans	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

Applications

• IRB Application for Human Subjects Research at https://thomasu.keyusa.net
• IRB Application for Animal Research
• IRB Application for Biomedical/Biological Research at https://thomasu.keyusa.net
• Animal Research Addendum for Application Modifications
• IRB Statement of Assurances

Additional Forms and Resources

• Animal Welfare Act
• Belmont Report
• NIH Office of Extramural Research
• Federal Regulations (45 CFR 46)
• International Regulations
• NIH OLAW
• IRB Appeal
• IRB Research Misconduct

Research
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
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
Vulnerable populations include minors, pregnant women, human fetuses, human neonates, prisoners (detainees, parolees), institutionalized persons, mentally disabled or handicapped persons.

Minimal Risk
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
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:

• Minor changes in previously approved research during the period (of one year or less) for which approval is authorized (an IRB Addendum or research modification must be submitted); or
• Some or all of the research appearing on the US Department of Health and Human Services Federal Register list of categories of research that may be reviewed by the IRB through an expedited review procedure.

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.