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IRB Basics- Human Subjects Research and the UNT IRB
Offered at the beginning of each fall and spring semester. For information regarding availability of an IRB Basics presentation as part of a regular academic class, contact Boyd Herndon, Director of Research Compliance, at email@example.com.
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
Rights of research subjects violated due to improper informed consent process during a Havasupai tribe study
Feds say study ethically flawed because risks were not identified in the informed consent form
Chinese researchers, co-authors in an American study, lose jobs due to lack of approvals in research involving children
How do I know if I am conducting research with human subjects?
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:
Only projects meeting both definitions (research and human subjects) come under the jurisdiction of the IRB.
Why is my research subject to review?
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.
How do I decide which application to use?
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.
What training am I required to do before submitting my application?
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.
Where can I get assistance?
You can get assistance with your application by contacting a Research Compliance Analyst at firstname.lastname@example.org or by phone at 940-565-4643 (for Expedited or Full Board questions) or 940-565-4258 (for Minimal Review questions). 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.
How do I submit my application for review by the IRB?
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 email@example.com.
When do I submit my application?
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.
How will my application be reviewed?
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.
Who will review my application?
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.
What if my research will be conducted at another institution?
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.
What if I am not a UNT faculty member, but I want to conduct my research at UNT?
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.
What happens if I don’t comply with UNT policy or federal regulations?
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.