Human Subjects Protection

Principal investigator:

  • Adheres to federal regulations, state and local laws, institutional policies and IRB procedures regarding the safety and protection of human subjects
  • Assures the performance of the Informed Consent process
  • Reports adverse events to the IRB according to institutional policy and IRB procedures, and to DSMBs, sponsors and appropriate federal agencies as required
  • Audits the research process on a regular basis, and documents this audit
  • Acts as a liaison between the IRB and the sponsor
  • Maintains documents as required by federal, state and UU policies/procedures
  • Ensures that the IRB protocol is identical to the proposal for funding for extramural or intramural support, informs the IRB of any updates or modifications to the protocol and ensures that they are in compliance with federal, state and UU regulations and policy
  • Completes training on federal regulations, UU policies and procedures and compliance expectations
  • Ensures that all personnel on the sponsored project complete all required human subjects training

Other research personnel:

  • Adhere to federal regulations, state and local laws, institutional policies and IRB procedures regarding the safety and protection of human subjects
  • Complete training on federal regulations, UU policies and procedures and compliance expectations

Department/center/project financial officer: N/A

Department chair/center director:

  • Assures that project is in compliance with federal, state, sponsor and University of Utah regulations regarding the safety and welfare of human subjects
  • Promotes compliance with federal, state, sponsor and University of Utah regulations regarding the safety and welfare of human subjects

Deans office/designee:

  • Promotes compliance with federal, state, sponsor and University of Utah regulations regarding the safety and welfare of human subjects

Executive administration:

  • Promotes University compliance efforts and programs
  • Ensures that University of Utah policies and procedures are effectively applied in compliance with the FWA, OHRP, FDA and NIH
  • Maintains/approves updates to FWA
  • Takes action on non-compliance with these policies, as necessary
  • The Vice President for Research is responsible for matters of policy regarding protection of human subjects and operation of the IRB

Conflict of Interest committee:

  • IRB Director serves on Conflict of Interest Committee
  • Reports Conflict of Interest disclosures to IRB

Environmental Health and Safety, Department:

  • Refers safety issues regarding human subjects research to the IRB as they arise

Governmental Accounting and Support Services: N/A

Institutional Animal Care and Use Committee / Animal Resource Center: N/A

Institutional Review Board:

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 participants or others.
  • Determine what, if any, action(s) need to be taken

Office of Internal Audit:

  • Recommends, as necessary, actions to improve the internal controls over subject payments
  • Examines, assesses and reports on accountability and controls

Radiological Health, Department:

  • Evaluates and approves/disapproves all proposed uses of ionizing radiation sources in or on humans for investigational or non-clinical uses

Institutional Biosafety Committee:

  • Reviews research for compliance with NIH Guidelines for Research with recombinant and synthetic DNA molecules
  • Provides any information requested by IRB to facilitate review and approval

Office of Sponsored Projects:

  • Verifies IRB review and approval as per agency requirements and University policies
  • Provides assurances of compliance with agency requirements and University policies regarding human subjects

Technology Transfer Office: N/A