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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 (where applicable), 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.
  2. Retain the authority to suspend or terminate the research for failure to comply with conditions of approval or regulatory requirements.
  3. Consider applicable conflicts of interest and confirm, where appropriate, that the application or proposal for human subject research submitted to DHHS is congruent with the protocol submitted for IRB approval.
  4. Notify deferring institution of any unanticipated problems, termination or suspension of research.
  5. Establish and maintain written procedures for:
    • IRB membership, quorum and review procedures.
    • Requirements for full board and expedited 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 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 subjects or others.
    • Ensuring prompt reporting of any serious or continuing noncompliance.
    • Observation of the consent process and conduct of the research by an IRB designee.
  6. 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.
  7. Interview, as necessary, all essential researchers involved in the conduct of human subject research.
  8. 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 deferring institution for studies approved under this agreement. The UNM IRB will maintain IRB records indefinitely.
  9. Cooperate fully with deferring institution and make appropriate records available to regulatory and accrediting entities at such time as the Human Research Protection Program (HRPP) of the deferring institution is under review, to include making appropriate records available to the reviewers.
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