Frequently Asked Questions
The Institutional Review Board (IRB) is a committee that oversees all research involving human subjects, ensuring compliance with all applicable regulations and policies. The primary role of the IRB is to protect the safety and welfare of human subjects.
Please note that our federal regulations (45 Code of Federal Regulations (CFR) Part 46) have been revised. Any research approved on or after January 19, 2019 is subject to the Revised Common Rule: https://www.hhs.gov/ohrp/sites/default/files/revised-common-rule-reg-text-unofficial-2018-requirements.pdf
Any research approved before January 19, 2019 is subject to the Pre-2018 Common Rule (45 Code of Federal Regulations (CFR) Part 46): http://www.access.gpo.gov/nara/cfr/waisidx_03/45cfr46_03.html
The IRB has the authority to approve, disapprove, or modify research protocols. The committee can also suspend or terminate its approval of research activity at any time.
45 CFR 46.102 (e)(1), defines a “human subject” as a living individual about whom an investigator (whether professional or student) conducting research:
Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
45 CFR Part 46.102 defines “research” as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
If your project is a systematic investigation designed to develop or contribute to generalizable knowledge, involves obtaining identifiable data or private information about living individuals and involves interaction or intervention with the individuals, then it needs to be reviewed by the UTEP IRB.
Research involving human subjects may not proceed until written approval is received by the investigator from the IRB.
Principal Investigators (PIs) submit the protocol form and all other documents to the Human Subjects Research Oversight & Compliance (HROC) office and the Institutional Review Board (IRB) via IRBNet (www.irbnet.org).
The submission will be administratively reviewed by the IRB staff for completeness. When the submission is complete, the type of review will be determined and the project will be reviewed by the IRB.
You will receive an email notification from HROC when the protocol has been reviewed and a determination has been made.
The IRB usually approves a protocol for a two-year period if lower than minimal risk and for one-year if a protocol is greater than minimal risk. Studies approved prior to the revised common rule will continued to be approved for a one-year period.
All changes to the project, as approved, must be submitted for subsequent review prior to implementing any such changes and should not be implemented until a determination is received from the IRB.
There are three categories for IRB review: exempted, expedited, or full board review.
Exempted: Review in this category requires that only the IRB Chairman or designee review the study for approval. The study must fall into 1 of the 8 categories as defined by regulatory guidelines not be higher than minimal risk. Exempt studies are valid for a two-year period. Changes to the study protocol must be submitted to the IRB office prior to implementation. Please note that exemption categories 7 and 8 are not being implemented at this time.
Expedited: This review category does not mean that your submission will be reviewed more rapidly except in the case that your review does not have to wait until the next convened meeting of the IRB. This review category permits selected IRB members to review the study and submit their comments, requirements, and votes individually if it falls into one of the nine federally defined categories. It does not require the IRB to convene a meeting to discuss and vote on the study. Studies subject to the pre-2018 common rule are typically granted a one-year approval whereas studies approved under the revised common rule are typically granted a two-year approval. A renewal request must be submitted or closed upon completion.
Full committee review: Projects assigned to this review category require the IRB to convene a meeting to discuss and vote on the project for approval. Meetings are held on an as need basis, typically the last week of the month. Submissions requiring full board review should be submitted to the IRB office no later than two weeks prior to the scheduled date. Please refer to the posted calendar for tentative dates at https://www.utep.edu/orsp/human-subjects-research/submission/index.html
No. Expedited Review means that my project will be reviewed and approved by individual members of the IRB and review is not required by the convened board.
The PI must submit a renewal request and a progress report via www.irbnet.org at least 4-6 weeks before the protocol’s expiration date.
Amendment requests can be submitted via IRBNet at any time. The proposed changes should be marked in all applicable study documents in red italicalized font. The amendment request form outlining the changes must be included in the submission package. Note, changes can only be implemented after IRB approval.
The PI has the responsibility and must promptly report any injuries, adverse events, unexpected problems or additional risks of harm or discomfort previously unrecognized if encountered during the course of the study and as soon as they occur to the IRB office via phone at 915-747-7693 or 915-747-8841 or email at firstname.lastname@example.org
Recruitment and data collection may begin only after the PI has received formal approval of the project from the IRB.
Data collected in a previously approved study may be used in a current study if the consent covered the subsequent use of data. Please see Exempt category 4 for research with previously collected data by another researcher. If a new PI will be working with the existing data, he/she must submit a new research protocol request to the IRB for review and approval.
Office for Human Research Protections (OHRP)
- The link is: https://www.hhs.gov/ohrp/
US Food and Drug Administration (FDA)
- The link is: https://www.fda.gov/Science-Research
Human Subjects Research Ethics training must be completed. The UTEP IRB Office has now implemented CITI training. It is a more comprehensive training module. Once completed, the training is valid for three years and accepted at most universities across the states.
Please note that Responsible Conduct of Research training does not satisfy the IRB’s requirements for Human Subjects Research Training.
IRB 101 presents an overview of human subjects research and ethics. The workshop materials are intended to provide faculty and student researchers with the “guide/tools” best and responsible research practices. Orientation, navigation and submission processes for IRBNet will also be reviewed. To register for the workshop, please contact Christina Ramirez (747-7693).
A template and guidelines are available in the forms library on the project designer page in IRBNet. Regulations require nine basic elements and nine additional elements of consent that applies based on the study to be conducted.
Data collection must cease the earlier date of the following: when data collection is complete or the expiration date is reached. To extend the approval, a request for renewal and progress report must be submitted via IRBNet.
Student researchers (undergraduate and graduate) may be the PI on a project, however, a faculty advisor must be listed on the student’s protocol and verify their support by reviewing and electronically signing off on the project in IRBNet before the study can eligible for IRB review.
Research staff such as statisticians, secretaries, and others who handle de-identified data or assist with manuscript preparation need not be listed and need not complete the training. The PI, Co-PI(s), and all other research personnel considered engaged in the research project must be listed.
A PI should submit the names of Co-PIs and others who will interact with the subjects, either in the proposal or in the study personnel form, as all investigators must complete the required IRB ethics training. If students are used in interactions with subjects, a study personnel form with changes and the supporting training verification must be submitted as a project amendment when the students are replaced on the project.
The required forms as well as all the supporting guidelines and training information are available on the IRB website. Forms can also be found in the IRBNet reference library.
Data from research that can be linked to the subjects can be used if and only if you have clearly stated this possibility in the consent process and it is included in the consent document signed by the individual subject.