University of North Texas 
Deadlines:
Material requiring full board review must be submitted on or before the first of the month to be reviewed at that month's meeting. UNT IRB Full Board meetings are generally scheduled for the last week of the month, pending holidays and scheduling conflicts. Due to the Federal Quorum requirements, meeting dates and times are subject to change.
Plan Ahead:
Investigators are encouraged to submit in advance of the deadline date to allow for sufficient time for questions to be asked prior to the board meeting. Deadlines for application submission applies to protocols requiring full board review only. Deadlines do not apply to exempt or expedited protocols.
Please contact untirb@unt.edu if you have questions related to the review level of your study. It is important to note that categories are determined at the discretion of the reviewers and it will be difficult to provide a category of review without the IRB submission available for review. Additionally, regulations allow for escalation of projects to a more rigorous category at the discretion of the reviewers.
Review Categories
- All UNT “Human Subjects Research” studies must undergo review and approval by an IRB prior to initiation of research activities.
- Definitions for what is considered “Human Subjects Research” are located at 45CFR46.102.
- All research is required to be closed after 3 years' time and to be resubmitted if continuation is desired.
- All required fields for all categories of submissions are located on the submission guidance document.
There are 3 categories of review starting with the most rigorous, Full Board Review. It is possible to qualify for a less rigorous Expedited Review, if you meet certain qualifications noted below. It is also possible to qualify for a less extensive review called the Exempt Review, and to qualify for this review you need to meet the expectations noted below.
In all cases, all human subjects research studies must undergo a review and approval by IRB before any initiation of research begins. *Examples noted below are not meant to be inclusive of all possibilities.
| Review Category | Qualifications | Review Process | Examples* |
|---|---|---|---|
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Full Board |
More than minimal risk studies, as determined by the IRB Chair. Also, any human subjects research study that does not fit into one of the federal categories for Exempt or Expedited. |
Reviewed monthly at Board Meeting. Must be submitted prior to the first of the month to be reviewed at that month's meeting. |
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Expedited |
To qualify for review at an “expedited” level, the study must be no more than “minimal risk” (definition found at 45CFR46.102) and fit in one of the federally designated expedited review categories (45CFR46.110 and 21 CFR 56.110). |
Expedited reviews are conducted by the Research Integrity and Compliance staff and a single member of the IRB committee. They may or may not require annual review, which will be listed on your approval letter. Modifications must be submitted. |
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Exempt |
To qualify for review at the exempt level, the research must not be greater than “minimal risk” (definition found at 45CFR46.102) and must fall into one or more of the exempt categories (45CFR46.104). |
Exempt reviews are conducted typically by only one reviewer within the Research Integrity and Compliance Office. Typically, no annual renewal is required to be submitted. Modifications must be submitted. |
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Gabe Ignatow, PhD, Sociology, Chairperson
Cynthia Hermann, MD, Student Health and Wellness Center, Vice Chair
Charles Blankson, PhD, Marketing and Logistics
Heidemarie Blumenthal, PhD, Psychology
Case Cagle, JD, Community Member
Darrell Hull, PhD, Education Psychology
Reece Leonard, JD, Community Member (Alternate)
Bradley McDaniels, PhD, Rehabilitation and Health Services (Alternate)
Gayle Prybutok, BSN, MBA, PhD, Rehabilitation and Health Services
Catherine Ragland, PhD, Music History, Theory, and Ethnomusicology
Jennifer Rowe, MLS, Library
Chad Trulson, PhD, Criminal Justice (Alternate; Prisoner Representative)
Scott Warren, PhD, Learning Technologies
Justin Watts, PhD, Rehabilitation and Health Services
The Common Rule regulations specify that the UNT IRB must have at least five members. Members must represent a variety of backgrounds in order to promote complete and adequate review of the research activities commonly conducted by the institution. Also, the IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
In addition to possessing the professional competence necessary to review specific research activities, the IRB must be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. Therefore, the UNT IRB must include persons knowledgeable in these areas. The IRB must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. It must also include at least one member who is not otherwise affiliated with UNT and who is not part of the immediate family of a person who is affiliated with the institution. The nonaffiliated member(s) should be knowledgeable about the local community and be willing and able to discuss issues and research from that perspective. When selecting the nonaffiliated member(s), consideration should be given to the type of community from which UNT will draw its research subjects.
Initial and continuing reviews of research requiring Full Board approval must be reviewed at a convened meeting of the IRB at which a majority of the voting members are present, including at least one non-scientific member. Every nondiscriminatory effort is made to ensure that the IRB does not consist entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. The IRB may not consist entirely of members of one profession. The IRB is authorized to invite individuals with expertise in specific areas to assist in the review of issues that require expertise or perspective beyond or in addition to that available on the IRB. Although these individuals may attend meetings and take part in the discussion of research protocols, they may not vote.
Prospective IRB members may also be invited to attend one IRB meeting to learn about the IRB review process, but they may not vote at that meeting. An investigator may be invited by the Chair to present additional information to the IRB members about a proposed study, but the investigator may not remain in the meeting for the deliberation and vote. Due to the confidential nature of the IRB proceedings, the IRB members, the IRB staff, an invited investigator, an ad hoc member invited for special expertise, and invited prospective IRB members are the only persons authorized to attend any convened meetings of the UNT IRB.
The UNT Vice President for Research and Innovation appoints IRB members to serve for 3 year terms and appoints one of the members to serve as Chair. Newly appointed IRB members receive training about how to review proposed research projects and their responsibilities as members of the IRB. The IRB Chair should be a highly respected individual fully capable of managing the IRB and the matters brought before it with fairness and impartiality. The task of ensuring that the IRB is a respected part of the UNT community will fall primarily to this individual. The IRB must be fair and impartial and immune from pressure either from UNT's administration, investigators whose protocols are brought before it, or external sponsors of research.