All human subjects research conducted by UNLV faculty, staff, and students must be approved by the UNLV Institutional Review Board (IRB) before the research project may begin.
Additionally, all researchers, including faculty, staff, and students must have completed training on human subjects research provided through the Collaborative Institutional Training Initiative (CITI) prior to their submission of an IRB protocol package. CITI training is valid for five years. To complete training or check the expiration date of your training, visit the CITI training website.
Also, one individual must be designated as the principal investigator (PI). Students are not eligible to fill this role. To determine PI eligibility, please see the Principal Investigator Eligibility Policy.
The PI on any project is ultimately responsible for the ethical conduct of research with human subjects. PIs and their entire team must comply with all UNLV policies and procedures as well as all applicable federal, state, and local regulations for the protection of human subjects in research. These responsibilities include, but are not limited to, the following:
- Obtaining IRB approval prior to involving any human subjects (including their data or tissue) in research studies.
- Only the IRB may determine the level of review of a protocol; investigators may not make the determination of exemption.
- Any recruitment, including obtaining lists of names, is considered research activity with human subjects.
- Ensuring that only qualified personnel conduct the study according to the approved protocol and that each individual performs research activity that is within his/her scope of practice.
- Ensuring that the rights and welfare of each research subject are protected. The subject’s rights and welfare must take precedence over the goals and requirements of the research.
- Implementing no changes in the approved protocol or Informed Consent Form without prior IRB approval, except in an emergency, in order to safeguard the well-being of human subjects.
- Ensuring that anyone obtaining informed consent from research participants has read the protocol and has sufficient knowledge of all information provided in the informed consent document.
- Obtaining legally effective informed consent from human subjects or their legally responsible representative before any research-related screening or intervention commences and using only the currently approved Informed Consent Form when applicable.
- Providing each subject enrolled in the study with a copy of the IRB-approved informed consent document at the time of the consent, unless the IRB has specifically waived this requirement.
- Unless specified otherwise, retaining all signed informed consents and other research-related documents (including, but not limited to, material submitted to and approved by the IRB) for three years after the study is completed/closed with the IRB.
- Reporting progress of approved research to the appropriate IRB, as often as and in the manner prescribed by the IRB on the basis of risks to subjects, but not less than once per year. This includes submitting a closure report to the IRB once the research is completed.
- Completing training as required by the Institutional Review Board.
- Complying with all applicable Food and Drug Administration (FDA) regulations (if the study involves products regulated by the FDA), and fulfilling all investigator responsibilities (or investigator-sponsor responsibilities, when appropriate), including those described at:
- 21 CFR 312: Investigational New Drugs
- 21 CFR 812: Investigational Device Exemptions
- If the PI is unavailable to conduct or direct the research personally, as when on sabbatical, leave, or vacation, arranging for a co-investigator to assume research-related responsibilities in the researcher’s absence and notifying the IRB in writing of this change prior to the absence.
- In the event that employment with the university is discontinued, taking one of the following actions on each approved/active study prior to leaving the university: (1) transferring the study to a new principal investigator, or (2) closing the project. The researcher must notify the IRB in writing with a modification request, which must be submitted prior to the termination of employment.
- Complying with UNLV and federal regulations regarding adverse event reporting . PIs must report any injuries, unanticipated problems, or adverse events to the IRB in writing within five working days of discovery of such an occurrence.
- Complying with UNLV and federal regulations regarding student-initiated research.
- Reviewing the following material:
What to Submit for IRB Review
First, you must have a registered account with IRBNet. Registered users will have access to all the necessary IRB forms. Please be advised that all current versions of forms are available for download from within IRBNet. Older versions of forms will no longer be accepted as of July 1, 2015.
Forms are found in the “Forms and Templates” page after logging in to your IRBNet account. To find the correct forms, please be sure to “Select a Library” that matches the board you are submitting to. Not all of the documents discussed below have an associated form/template, and must instead be created by the researcher.
This is a list of the documents that are needed for IRB review of a research proposal.*
- Protocol Proposal Form or Exempt Research Application Form.
- Informed Consent or Information Sheet for Exempt Research Study.
- Screening tool. If you are screening your subjects for inclusion/exclusion criteria, use of a screening tool is suggested.
- Parent Permission and Child and/or Youth Assent.
- Copies of all surveys and questionnaires.
- Interview guide. The questions that guide interviews are submitted for review; however, the IRB understands that there may be follow-up questions based on the answers to initial questions.
- Focus group questions. The informed consent should state that confidentiality cannot be guaranteed in the focus group setting.
- Data collection sheets, if used.
- Advertisements, including brochures, flyers, posters, recruitment letters, email blasts, or any documents used to inform prospective subjects about the research. At minimum, recruitment materials should include the following:
- UNLV logo or heading
- Statement that this is a “research study”
- Purpose of the research
- Inclusion/exclusion criteria
- Procedures involved in the study
- Time commitment
- Location of the research
- Contact Information
- PI’s name
- Facility authorization letters. Letters must be submitted on the facility’s letterhead.
- Pictures, diagrams, or graphics of research procedures, devices, etc., if they are being used in the research.
- List of references/bibliography.
*Additional materials may be needed, depending on the nature of the research.