DONATE HERE
Institutional Review Board

NEW STUDY SUBMISSION REQUIREMENTS

UNLV Faculty, Staff and Students
(Including residents and fellows)

As our relationship with UNLV/ UNLV School of Medicine evolves please be advised that in addition to submission and approval from the UMC IRB it is also required to go through IRB review from the UNLV IRB. The UMC IRB requires that either UNLV IRB approval or acknowledgement documentation be provided with the study submission prior to releasing/granting study approval.

Further, all projects having any UNLV student, resident and/or fellow conducted at UMC are required to have a UNLV faculty member be the PI on the study. UNLV PI’s must meet the PI eligibility criteria set in UNLV IRB policy located here: https://www.unlv.edu/research/policies/pi-eligibility

For questions please contact the UMC IRB at umcirb@umcsn.com

 

UMC IRB Meeting Dates and Submission Deadlines

Full Board & Expedited Review

  • eIRB Login
  • Clinical Trials Office Research Application (CTO)
  • Study Protocol (See Forms & Templates page)

    The study protocol should include a clear description of the study objectives, procedures, risks and benefits, recruitment and consent processes, and procedures to maintain confidentiality. Researchers should minimize risks to study participants by using procedures that are consistent with sound study design.

  • Informed Consent Form and/or Assent Form (See Forms & Templates page)
  • Study Team Member qualification items for all Investigators

Exempt Review

Other Support Documents

Depending on the type of your study the following documents may apply:

  • Recruitment Materials (advertisements, scripts, press releases, etc.)
  • Data Collection Forms
  • Request for Waiver of Informed Consent or Elements of Informed Consent

    Description:
    This waiver applies when the IRB determines that investigators need not obtain the subjects’ informed consent to participate in research in special circumstances. The IRB may approve research where investigators leave out or alter elements of informed consent, so long as the research meets all applicable regulations.

    HHS regulations allow the IRB to waive the requirement for obtaining informed consent or parental permission or to approve a consent procedure that leaves out or alters some or all of the elements of informed consent otherwise required under the regulations.
    The FDA does not allow a waiver or alteration of the requirements for obtaining informed consent except in special circumstances.

    Situation when it is used: The IRB often grants a waiver of informed consent for retrospective chart review studies/analysis of existing data or in rare cases where secondary subjects may be involved and it would either be prohibitive or potentially dangerous to obtain consent.

  • Request for Access & Use of Protected Health Information (PHI) (Waiver of HIPAA Authorization)

    If you plan to use or share protected health information (PHI) when conducting your research, you must conduct your study in accordance with the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA).

    This means that when applying for a waiver of consent, you will also have to request a Waiver or Alteration of HIPAA Authorization. The IRB can grant a waiver or alteration if all the required 3 criteria are met.

    A list of the 18 identifiers that must be removed to make health information de-identified are found on the Request for Access & Use of PHI form and also on the Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
This translation is provided by Google Translate. University Medical Center of Southern Nevada makes no representations or warranties of any kind,
whether express or implied, regarding the accuracy of the translation provided above.