IRB Purpose
UTEP’s Institutional Review Board (IRB) reviews and approves human subject research (HSR) for the purpose of protecting the rights and welfare of those subjects. The Board is charged with the responsibility to formulate and implement procedures to assure UTEP’s compliance with federal, state, and institutional regulations for the safeguarding of the welfare and well-being (physical, mental, social, legal, etc.) of human subjects involved in research projects in which UTEP is engaged or otherwise exercises oversight.
UTEP's HSR program is directed by three basic ethical principles.
Respect for Persons (autonomy)
Involves a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy. Respect for persons underlies the need to obtain informed consent.
Beneficence
An obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. Beneficence underlies the need to engage in a risk/benefit analysis and to minimize risks.
Justice
The benefits and burdens of research are distributed fairly. Justice requires that subjects be selected fairly.
IRB Applicability
All HSR sponsored or sanctioned by UTEP, whether funded or non-funded, conducted by faculty, students, or staff, using UTEP property or facilities, or using non-public information maintained by UTEP to identify or contact HSR subjects will be conducted in compliance with 45 CFR 46. HSR may not be performed unless requirements are satisfied and written certification of the IRB review and approval of the research is obtained.
As per NIH NOT-OD-16-149 and other applicable federal regulations, federally funded clinical trial PIs will register the study with clinicaltrials.gov. Registration is optional for non-funded studies meeting the definition of a clinical trial. The IRB Office will provide support with registration to the site.
IRB Accountability
All HSR is reviewed by UTEP’s IRB. HSR will not begin until the IRB has approved:
- the research protocol
- the informed consent document
- the testing instruments
which are obtained by the Principal Investigator. Previously approved protocols must be reviewed biennially or annually by the IRB. Interim changes to approved protocols must be reviewed and approved by the IRB prior to implementation.
If HSR participants are harmed, including any physical or psychological injury, any adverse events, improper disclosure of private information, economic loss, and other harmful or potentially harmful occurrences, the Principal Investigator must notify the IRB and Research & Innovation immediately. R&I will, in turn, notify the Office of Human Research Protections, Department of Health and Human Services.
IRB Schedule
Please note the following important items:
- These timeframes are based on business days/weeks and may fluctuate if revisions or additional information are requested.
- If your project includes vulnerable populations and/or is higher than minimal risk, this may require full committee review.
If you anticipate that your application will require full board review, please observe the deadlines below.
Application
Submission
Deadline
IRB
Meeting
Date*
*Meeting Date subject to change due to conflict of availability.
An application accepted by the published deadline will generally be assigned to the corresponding meeting, however, there may be circumstances when this is not possible, in which case it will be assigned to the next available committee meeting. Application receipt by submission deadline does not guarantee review at the corresponding meeting.Types of IRB Review
Review Time
10 - 14 days*
*Timeframe varies depending on the completeness or complexity of the project.Only the IRB Chair and/or designee need to review the project. The project must fall into 1 of the 8 categories as defined by 45 CFR 46 and not be higher than minimal risk. Exempt studies are valid for a two-year period. Changes to the project must be submitted to the IRB prior to implementation.
