Frequently Asked Questions
Exempted: Review in this category requires that only the IRB Chairman review the study for approval. The study must fall into 1 of the 6 categories as defined by regulatory guidelines (please see Exemption Request Form). Exempt studies are usually given a one year approval. However, it must be resubmitted for review if there are any changes to the study as approved. Upon expiration, a renewal request must be submitted or closed upon completion
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. It does not require the IRB to convene a meeting to discuss and vote on the study.
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 usually held monthly during the fall and spring semesters.
45 CFR 46.102 (f) lists a “human subject” as a living individual about whom an investigator (whether professional or student) conducting research obtains data or any identifiable private information through intervention or interaction with the individual.
The PI must submit a renewal request and a progress report via www.irbnet.org at least two weeks before protocol’s expiration date.
If your project is a systematic investigation designed to develop or contribute to generalizable knowledge, involves obtaining information about living individuals which is identifiable or private, and involves interaction or intervention with the individuals, then it needs to be reviewed by the UTEP IRB.
The PI must promptly report to the IRB office via phone or email any injuries, adverse events, unexpected problems or additional risks of harm or discomfort previously unrecognized if encountered during the course of the study.
Principal Investigators (PIs) submit the protocol form and all other documents to the Office of Research and Sponsored Projects (ORSP) Institutional Review Board (IRB) via IRBNet (www.irbnet.org). The submission will be 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 ORSP when the protocol has been approved.
In your study documents at www.irbnet.org, your memo of determination (approval) will be available to you and your collaborators to be used as needed.
The IRB usually approves a protocol for a one-year period.
All changes to the project, as approved, must be submitted for subsequent review prior to implementing any such changes.
Recruitment and data collection may begin only after the PI has received formal approval of the project from the IRB.
Data collected in a previous approved study may be used in a current study if the consent covered the subsequent use of data.
IRB Ethics training is required every three years for anyone who wishes to conduct research with human subjects. Contact the UTEP Compliance Office at 915 747-6478 or email@example.com to arrange to have the IRB compliance module added to your training set. What you need to request is the module called:
20001--IRB, HUMAN SUBJECT RESEARCH, & ETHICS
Students and non-UTEP employees may download a PowerPoint version of the training and the test in the forms library in IRBNet. Students and non-UTEP employees may submit a copy of the completed test in place of the completion certificate.
A template and guidelines are available in the forms library on the project designer page in IRBNet. Among the elements required (with customary working) are:
- Contact the IRB office for any questions, injuries, or for the names and phone numbers of PIs.
- Participation is voluntary, and the subject may end his/her participation at any time without any penalty
- Space for signature & date by participant (and parent or guardian, if needed) and PI unless a waiver of signed consent has been granted by the IRB.
- A Spanish (or other subjects’ languages) translation of the English version of the informed consent (depending upon the subjects to be included in the research) at the level of language appropriate for those particular subjects.
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 may be the PI on a project. However, the project must be signed by the student's faculty research advisor before it is eligible for review by the IRB.
Research staff such as statisticians, secretaries, and others who handle data or assist with manuscript preparation need not be listed and need not complete the training.
A PI should submit the names of co-PIs and others who will interact with the subjects, either in the proposal or in a separate memo, as all investigators must complete the required IRB Ethics training. If students are used in interactions with subjects, a memo outlining personnel 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 is available at IRBNet in the forms and reference library on the project designer page.
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?
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 Institutional Review Board (IRB) is a committee that oversees all research involving human subjects
Federal law established it: 45 Code of Federal Regulations 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 a research activity at any time.
There are three categories for IRB review: exempted, expedited, or full board review.
45 Code of Federal Regulations Part 46.102 (d) defines “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
The Principal Investigator is responsible and should call the Office of Research and Sponsored Projects (ORSP) at 915-747-8841 to report research-related injuries or problems as soon as they occur.
A--IRB 101 presents an overall view of human subjects research and ethics. The workshop materials are intended to provide faculty and student researchers with the “guide/tools” for the responsible conduct of research. Orientation, navigation and submission processes for IRBNet will also be reviewed. To register for the workshop, please contact Christina Ramirez (747-7693).