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UNM IRB Commitments

  1. Perform all of the functions required under 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56 and 45 CFR Parts 46.160 & 164 HIPAA Privacy Rule, and the human subjects protection requirements of a Department of Health and Human Services (HHS) federalwide assurance (FWA) for the review and continuing oversight of human subjects research conducted under the auspices of the IRB approved protocol, where applicable.
  2. Communicate IRB determinations to the Principal Investigator and others, as applicable.
  3. Maintain current IRB registration with OHRP in compliance with the Federal Policy and applicable FDA regulations.
  4. Retain the authority to suspend or terminate the research for failure to comply with conditions of approval or regulatory requirements.
  5. Notify relying institution of any unanticipated problems, termination or suspension of research.
  6. Establish, maintain and make accessible online written procedures for:
    • IRB membership, quorum and review procedures.
    • Requirements for full board, expedited, exempt and minimal risk review of research.
    • Requirements for obtainment and documentation of informed consent/assent.
    • Requirements for reporting the IRB findings and actions to the Principal Investigator and officials at the deferring institution.
    • Determining how often projects require continuing review.
    • Determining which projects need verification from sources other than the researchers that no material changes have occurred since the previous IRB review.
    • Ensuring concordance between any applicable federal grant and the IRB protocol.
    • Ensuring prompt reporting to the IRB of proposed changes in a research activity.
    • Ensuring that changes in approved research, during the period for which IRB approval has already been given, are not initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the participant.
    • Ensuring prompt reporting of any unanticipated problems involving risks to participants or others.
    • Reviewing unanticipated problems and allegations of noncompliance including complaints, protocol deviations and audit reports.
    • Ensuring prompt reporting of any serious or continuing noncompliance.
    • Conducting post approval monitoring including observation of the consent process and conduct of the research by an IRB designee.
    • Obtaining additional approvals from DHHS when necessary (e.g. prisoner certification).
  7. The UNM IRB or its authorized representatives, including HHS to the extent allowed by law, will be permitted to conduct the following:
    • Examine and inspect facilities used for the performance of the studies.
    • Observe the conduct of the studies.
    • Inspect and copy all documents relating to the studies, including research records, informed consent documents, and other study specific data.
  8. Interview, as necessary, all essential researchers involved in the conduct of human research.
  9. Consider applicable conflicts of interest (COI) as identified and determined by the deferring institution’s COI policies and procedures including review of any COI management plans.
  10. Maintain all documents reviewed in connection with the IRB review of the research, including any relevant communication with researchers. The UNM IRB will make its records available upon written request from appropriate officials at the relying institution for studies approved under this agreement. The UNM IRB will maintain electronic IRB records indefinitely in IRBNet.
  11. Cooperate fully with relying institution and make appropriate records available to regulatory and accrediting entities at such time as the Human Research Protection Program (HRPP) of the relying institution is under review, to include making appropriate records available to the reviewers.
  12. Ensure that in the event of termination of this agreement, the UNM IRB will remain responsible for continued oversight of related activities until closure or transfer of oversight.
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