Institutional Review Board (IRB)

The IRB's function is to review proposed research in order to insure that the subject's rights are protected and that risk of harm is minimized. University officials may not approve human subject research if it has not been approved by the IRB.

Animal welfare: N/A

Biosafety/Recombinant and Synthetic DNA Molecules:

  • Requires review and approval of use of hazardous materials, infectious agents, etc., if necessary
  • Requires Institutional Biosafety Committe (IBC) approval if necessary

Conflict of interest:

  • Assures that appropriate disclosures are made to research subjects
  • Addresess any apparent financial conflict of interest in the conduct of a research project

Data and safety monitoring:

  • Receives and acts on reports of adverse events according to institutional policy and IRB procedures, and forwards relevant information to DSMBs, sponsors and appropriate federal agencies as required

Education and training:

  • Provides education and training in human subjects protection for all personnel
  • Documents compliance with IRB training requirement for all personnel on a research project

Environmental health and safety:

  • Requires Insitutional Biosafety Committee (IBC) approval if necessary
  • Resolves safety issues in human subjects research if necessary

Financial management of research: N/A

Human gene transfer:

  • Requires Insitutional Biosafety Committee (IBC) review and approval prior to consideration of protocols

Human subjects:

IRB Director and administrators

  • Provide oversight of all IRB activities
  • Oversee compliance with federal, state and local laws, institutional policy and IRB procedures
  • Develop, implement and interpret policy and procedures
  • Provide interpretation and application of federal regulations
  • Supports and facilitates the IRB process
  • Ensures compliance with FWA
  • Ensures training and education of IRB staff, IRB members, and research staff
  • Review proposed advertisement for recruitment of subjects

IRB Administrative Office

  • Provides administrative and clerical support to IRB panels and members

IRB Panels

  • Review proposed research in order to insure that the rights and welfare of human subjects are protected, that risk of harm is minimized, and privacy of the subjects is protected
  • Assist researchers by minimizing hazards or misunderstandings which might lead to damaged reputations or to litigation
  • Determine whether the researcher should obtain and document fully informed consent from the human subjects prior to conducting the research
  • Review existing projects at least annually
  • Review and approve/disapprove proposed amendments to existing projects
  • Review reports of unanticipated problems and adverse events that are unexpected, related to the research, and pose an increased risk to partiicpants and others.
  • Determine what, if any, action(s) need to be taken

Human tissue samples:

  • Requires that consent is obtained for banking of samples, with options for banking with no identifiers, banking with identifiers, or banking with identifiers but future use contingent on donor's consent
  • Requires that potential for financial gain is specified in consent
  • Requires review of projects using human tissue samples from deceased persons

Patents and inventions: N/A

Radiation safety:

  • Requires assurance of approval from Radiological Health Department, as necessary

Sponsored projects administration:

  • Provides assurances of compliance with state, federal, sponsor and University of Utah regulations