Institutional Review Board

All biomedical, social and behavioral research including projects conducted by the Thomas University faculty, staff and students are subject to policies procedures of institutional review board review.  In accordance with federal regulations or IRB policy governances, researchers may not initiate studies involving human participants, vertebrate animal subjects, biological or biomedical until approval has been granted  in writing. 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 letter.

 

Thomas University Institutional Review Board (IRB) requires that all students conducting research involving human subjects, vertebrate animals, biological or biomedical research 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 after selecting Thomas University as the affiliate institution. Please review the Thomas University CITI Certification Requirement section for complete details. 

Please submit ALL training certificates with your IRB application by emailing the documents as attachments to irb@thomasu.edu.

The researcher should first complete the Collaborative Institutional Training Initiative (CITI) certification courses for the appropriate subject area prior to submission of their IRB application. A copy of a certificate of completion for the appropriate research area must accompany the IRB application and will not be reviewed without a certificate of completion.

Following the completion of the CITI certification courses, an IRB applicant should submit the appropriate IRB application that corresponds to their particular proposed study. A digital copy of the completed application should be emailed to the Thomas University IRB as an attachment along with the CITI certification document. Please email the application to: irb@thomasu.edu. All Thomas University student applications must contain the original signature of the student’s Division Chairperson or Assigned Faculty Sponsor prior to submission. Please fill out all questions completely in order to expedite review of the application. Incomplete applications will not be reviewed by the IRB.

Faculty Researchers and External Researchers: If the principal researcher is a Thomas University Faculty or an external researcher (including doctoral student candidates), they should submit their application directly to the IRB via email at irb@thomasu.edu. Additionally, external researchers must also complete and submit IRB Statement of Assurances for External Persons, along with their IRB application and CITI certification document.

The Thomas University IRB meets each second and fourth Monday of the month. To have an IRB application, modification, or addendum reviewed during the 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).

Though the IRB employs a state of rigor when reviewing all applications, we do so in a timely and expedient fashion, regardless of the type of research proposed and in accordance to IRB policy and procedures. To that end, 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.

Please email all applications to the Thomas University IRB via irb@thomasu.edu.

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
• IRB Application for Vertebrate Research
• IRB Application for DNA Research
• IRB 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. All approved research will receive IRB Certification (see definition) of that approval.

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 (See Addendum and Amendment form for IRB Research Proposal and Application); 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.