- Principal Investigator (PI) Handbook
- Effort Certification & Cost Allowability Briefing
- PI, Co-PI, and Research Participant Briefing
- Office of Grants & Contracts Administration
- Research Integrity & Compliance
- ORI-supported Intramural Grants & Awards
- Innovation and Commercialization
Use of Humans in Research (IRB)
Institutional Review Board (IRB)
Frequently Asked Questions
- How do I know if I am conducting research with human subjects?
- Why is my research subject to review?
- How do I decide which application to use?
- What training am I required to do before submitting my application?
- Where can I get assistance?
- How do I submit my application for review by the IRB?
- When do I submit my application?
- How will my application be reviewed?
- Who will review my application?
- What if my research project will be conducted at another institution?
- What if I am not a UNT faculty member, but I want to conduct my research at UNT?
- What happens if I don’t comply with UNT policy or federal regulations?
- IRB Guidelines
- Administration of the UNT IRB
- UNT IRB Full Board Calendar
- IRB Guidance about Data and Safety Monitoring Plans
- Texas Attorney General Guide in Reporting Suspected Child Abuse or Neglect
- Contact Us
Required Training for Investigators & Key Personnel
- Brief Summary of Training Requirement
- NIH On-Line Training Course: Protecting Human Research Participants
- or CITI On-line Training Course: Human Subjects Research (Social & Behavioral Research Investigators)
- Template A: Faculty/Staff Investigator and Adult Subjects
- Template B: Faculty/Staff Investigator and Minor Subjects
- Template C: Student Investigator and Adult Subjects
- Template D: Student Investigator and Minor Subjects
- Template E: Informed Consent Notice — Faculty/Staff Investigator and Adult Subjects
- Template F: Informed Consent Notice — Student Investigator and Adult Subjects
- Template G: Faculty/Staff Investigator with HIPAA Authorization
- Template H: Student Investigator with HIPAA Authorization
Institutional Review Board Members
Chad Trulson, Ph.D., IRB Chair, Criminal Justice
Amyn Amlani, Ph.D., Speech and Hearing Sciences
Kathleen Duffy, Community Member
Rebecca Glover, Ph.D., Educational Psychology
Lisa Henry, Ph.D., Anthropology
Patricia Kaminski, Ph.D., IRB Vice Chair, Psychology
Debbie Rohwer, Ph.D., Music Education
Richard Smith, Ph.D., Behavior Analysis
Mark Vosvick, Ph.D., Psychology
- Federal Regulations: 45 CFR Part 46, Protection of Human Subjects
- The Belmont Report
- Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services
- HIPAA Guidance – Use of Protected Health Information in Human Subjects Research at UNT
IRB in the News
- Professors' Research Project Stirs Political Outrage in Montana
Political scientists investigated for potentially swaying non-partisan election votes
- Inidan Tribe Wins Fight to Limit Research of Its DNA
Rights of research subjects violated due to improper informed consent process during a Havasupai tribe study
- Another Study of Preemies Blasted Over Ethical Concerns by Richard Knox
Feds say study ethically flawed because risks were not identified in the informed consent form
- In A Grain Of Golden Rice, A World Of Controversy Over GMO Foods by Dan Charles
Chinese researchers, co-authors in an American study, lose jobs due to lack of approvals in research involving children
Frequently Asked Questions
The federal regulations define research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The regulations further clarify that “activities which meet this definition constitute research...whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.”
Human subjects are living individuals “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.” The following additional guidance is included in the regulations to help determine whether the research involves human subjects:
- Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between Investigator and subject.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the Investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.)
Only projects meeting both definitions (research and human subjects) come under the jurisdiction of the IRB.
The federal Office for Human Research Protections (OHRP) has issued a Federalwide Assurance (FWA) to UNT. The terms of this assurance require UNT to reasonably ensure that the rights and welfare of human subjects are adequately protected in all human subjects research conducted at UNT or at any location by UNT faculty, staff, or students.
There are three (3) types of IRB review. You should first complete the Application Flow Chart to determine which application you should use: Minimal Review (also known as Exempt from Further Review) or Expedited/Full Board Review. Each level of review is described below.
All Investigators, Co-Investigators and key personnel must complete an instructional program before submitting an IRB application. Key personnel are persons who are responsible for the design, conduct or reporting of your study.
There are currently 2 options to complete the required training. The first is the NIH's "Protecting Human Research Participants" course accessible at http://phrp.nihtraining.com/users/login.php. This course can be completed in approximately one and a half hours. The second option is CITI's "Human Subjects Research (Social & Behavioral Research Investigators)" course that can be accessed by following these directions. This course can be completed in approximately three hours.
When you have successfully completed one of the two courses, print the “completion certificate” and include it with your IRB application. The Investigator is responsible for submitting completion certificates for each of the key personnel.
You can get assistance with your application by contacting a Research Compliance Analyst at email@example.com or by phone at 940-565-4643. The initial application review is conducted by a Research Compliance Analyst who will contact you if clarification or additional information is required. Additional review is conducted by the IRB Chair and the IRB Full Board as applicable.
There are two applications that the UNT IRB uses to review proposed research studies that will involve human subjects: a Minimal Review Application and an Expedited/Full Board Application. Save the application as a Word document, answer all the questions, and transmit the completed application and all supplementary documents to firstname.lastname@example.org.
Applications requiring full board review must be submitted and will be reviewed according to the IRB Full Board calendar.
Expedited and Minimal Review applications may be submitted at any time; however, it is imperative that you submit the applications at least three (3) weeks before the intended start day of your research. Applications that are complete when submitted will receive initial review (the first communication to you from the IRB) within 10 business days of receipt.
Your application will be reviewed for completeness, minimizing risks to subjects, ensuring voluntary participation, verifying that selection of subjects is equitable, ensuring informed consent, protecting privacy and confidentiality, and other requirements in the federal regulations.
All applications receive preliminary review by a Research Compliance Analyst. The Research Compliance Analyst may request additional information required for completion before forwarding it to the IRB Chair. Projects eligible for Minimal Review or Expedited Review are reviewed for approval by the IRB Chair. All other applications must be reviewed by the full board.
UNT faculty wishing to conduct research at another institution must provide the IRB with a copy of the protocol approval letter from that institution’s IRB including the original application submitted to that institution.
Persons wishing to conduct a research project at UNT should identify a UNT faculty member to serve as the project Investigator and take responsibility for submitting the UNT IRB application and any related documents as well as the use of human subjects in research.
If non-compliance is alleged, the IRB Chair will initiate an investigation. The researcher will be informed of the allegations and given time to respond. The Chair will present relevant information to the IRB which will recommend appropriate actions to the UNT Vice President for Research and Economic Development. Possible corrective actions include but are not limited to: destruction of all data improperly collected; required additional training for Investigator and key personnel; temporary suspension of the Investigator's eligibility to conduct human subjects research; notification to subjects regarding the non-compliance; and letters of reprimand to persons involved in the non-compliance.
Non-compliance can have serious consequences for both the Investigator and UNT, including termination of project approval and the UNT’s loss of all federal or other funding related to research activities. If the Vice President for Research & Economic Development determines the non-compliance to be serious or continuing, it must be reported to the federal Office for Human Research Protections (OHRP) and, if it relates to a sponsored project, to the sponsoring agency or entity.
Many juried journals require the author of an article submitted for publication to provide proof of IRB approval for any human subjects research data discussed in the article. Failure to obtain prior IRB approval may prevent presentation and/or publication of research results.
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