MinerAlert
MinerAlert
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.
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.
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.
The benefits and burdens of research are distributed fairly. Justice requires that subjects be selected fairly.
Research requires IRB review under Department of Health and Human Services (DHHS) regulations if the project is a systematic investigation designed to develop or contribute to generalizable knowledge AND involves living individuals about whom an investigator:
Additionally, research requires IRB review under FDA regulations if the project meets the definition of a clinical investigation — any experiment that involves one or more human subjects and an FDA-regulated test article (drug, device, biologic, human food additive, electronic product) other than in the course of standard medical practice — AND involves a human subject defined as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may either be a healthy individual or a patient.
If a research project meets either two scenarios above, IRB review and determination is required prior to beginning any research activities involving human subjects.
An IRB review is not required if an activity does not meet the regulatory definition of “research”. Similarly, if an activity is research, but it does not involve human subjects, the research does not require IRB review. Failure to meet either definition means that the activity is not human subjects research.
For help determining if research meets these regulatory definitions before submitting to the IRB, contact the IRB staff at
The principal investigator (PI) of a human research study is the individual with ultimate responsibility for the conduct of the activities described in the IRB submission and for protecting the rights and welfare of human participants involved in the research. The PI must be available to devote adequate time and attention to the study to ensure its responsible conduct.
Timeframe: 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.
Timeframe: 2 - 8 Weeks*
*Timeframe varies depending on the completeness or complexity of the project.The expedited category allows selected IRB members to review your project 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. Projects are typically granted a two-year approval. A renewal request must be submitted or closed upon completion.
Timeframe: 4 - 12 Weeks*
*Timeframe varies depending on the completeness or complexity of the project.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 needed basis, typically the last week of the month. Submissions requiring full board review should be submitted to the IRB office no later than the posted deadline. Refer to the posted calendar for tentative dates.
Please note the following important items:
If you anticipate that your application will require full board review, please observe the deadlines below.
*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.UTEP IRB may permit reliance on another IRB. UTEP IRB may also agree to serve as the reviewing IRB for multi-site projects in which University faculty, staff or students are engaged.
All instances of reliance for non-exempt research will be documented in a reliance agreement that describes the responsibilities of the reviewing and the relying IRB.
Such agreements are signed by the Vice President for Research.
Examples of situations in which UTEP may agree to rely on an external IRB include, but are not limited to:
When a request to rely on another IRB is received, the IRB office will assess whether comparable standards are kept by the other IRB.
UTEP IRB may rely upon AAHRPP accredited institutions or organizations
UTEP IRB may rely upon non-AAHRPP accredited institutions or organizations where reasonable steps have been taken to ensure that subjects are adequately protected (e.g., IRBs will adhere to applicable standards and regulations).
All research in which UTEP faculty, staff, or students are engaged must be submitted to the IRB office, even if another IRB will be named as the reviewing IRB.
The IRB office will conduct a local compliance review of the submission to ensure the project procedures and documents adhere to UTEP policies. The compliance review will include:
Reliance agreements will only be signed when the local compliance review is complete, and any other conditions are satisfied.
The IRB office will work with investigators to prepare materials requested by reviewing IRBs, such as local context information forms.
Once IRB review has been ceded to another IRB, Principal Investigators are responsible for being aware of and adhering to the policies and procedures of the reviewing IRB.
When this institution provides IRB review for other institutions, the IRB will review the research in accordance with established policies and procedures to determine that research is ethically justifiable, according to all applicable laws, including initial review, continuing review, review of modifications to previously approved research and reportable events (e.g., unanticipated problems involving risks to subjects or others, allegations of noncompliance).
The IRB will notify the researcher (and organization) of its decisions regarding initial site approval as well as any unanticipated problem, noncompliance, suspension, or termination determinations, make relevant IRB policies and records available upon request to the relying institution or organization and assign the IRB Administrator to lead communication.
UTEP PI is responsible for communicating to relying PIs relevant policies (e.g., timelines for reporting unanticipated problems), approved study documents and any interim IRB decisions, such as continuing review approvals and protocol changes approved via a modification.
Relying sites are responsible for providing local context information to the UTEP IRB to enable a thorough review. This information is necessary to determine that study conduct at the site is approvable and adheres to any local regulations or policies. The information required will not duplicate information that has already been provided to the UTEP IRB as part of the initial review of the research.
The addition of participating sites is considered a minor modification. These modifications are reviewed by designated reviewers