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IRB Services for External Partners

The University of New Mexico (UNM) has a nationally accredited human research protections program (HRPP) that follows rigorous standards for ethics, quality, and protections for human research. The UNM Institutional Review Board (IRB) is pleased to serve as the IRB for external partners. Our services include:

  • Consultations with staff who are experts in human research protection
  • Training and education services available and tailored to your needs
  • Diverse IRB membership that meets monthly
  • Expedited reviews conducted weekly and exempt reviews conducted daily
  • Quality assurance monitors who work with research staff to provide education and support
  • Specialization in behavioral, educational, survey, and social science research with access to medical and pharmacy consultants for biomedical based research
  • GCP compliant study start up services
  • 24/7 access to IRBNet© research software

By using UNM’s IRB services, your organization:

  • Does not have to create, organize, register or maintain an IRB or IRB support office
  • Does not have to coordinate training for IRB members and staff
  • Can ensure IRB review that is compliant with federal regulations
  • Can quickly and inexpensively get research underway

If your organization is interested in working with the UNM IRB, please contact Linda Petree, Director, at petreel@unm.edu or (505) 277-2644. She will discuss your organization’s research portfolio to determine whether working with the UNM IRB is an appropriate fit. An IRB Service Agreement must be negotiated and executed and a specific training and consultation plan will be developed in accordance with your organizational needs.

The infrastructure that supports the IRB is funded by the indirect (F&A) return on expenditures by the University.  That cost is not captured when the funding is run outside of UNM. If studies are receiving funding external to UNM and are using UNM’s IRB, the following fee schedule applies.

New Projects $1,500
Continuations $500
Amendments $500
Human Subjects Research Determinations $500
Other Submissions
Change to Project Team No Charge
Reportable Events No Charge
Protocol Violations No Charge
Closures No Charge
  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.
  1. Assume ultimate responsibility for all research covered under the IRB Authorization Agreement (IAA).
  2. Assume responsibility for maintaining a formal process to monitor, evaluate, and continually improve the protection of human research subjects; dedicating resources sufficient to do so; exercising oversight of research protection; educating researchers about their ethical responsibility to protect research participants; and, when appropriate, providing a mechanism to intervene in research and to respond directly to concerns of research participants.The deferring institution will also monitor compliance with the terms and conditions of the IRB’s approval.
  3. Assure that the researcher’s disclose potential conflicts of interest with regard to the research according to the deferring institutions policies and procedures and that relevant information is provided to the UNM IRB.
  4. Assure and warrant that all researchers conducting human research under the IAA remain members of the institution’s staff in good standing and are credentialed and privileged to perform the procedures outlined in the IRB approved protocol.
  5. Notify, within five (5) business days, the UNM IRB of the termination, suspension, or modification of any research privileges of its Principal Investigators responsible for the oversight of the studies under the purview of the UNM IRB.
  6. Notify, within five (5) business days, the UNM IRB of the any: 1) unanticipated problems involving risks to subjects or others; or 2) any serious or continuing noncompliance with the federal regulations or the requirements or determinations of the UNM IRB.
  7. Notify, within five (5) business days, the UNM IRB of the termination or suspension by the institution of any research under the purview of the UNM IRB.
  8. Inform the UNM IRB of any contact by HHS, or any other persons or entities regarding any of the research under the IAA within five (5) business days of contact. The institution will also notify the UNM IRB within five (5) business days, in the event that a governmental agency issues the institution any Notice of Inspectional Observations, Warning Letters, or other communications citing improper or inadequate research practices with respect to the research.
  9. Maintain the IAA as part of the institution’s records.
  10. Assume responsibility for ensuring compliance with the terms of its HHS approved FWA.
  11. The deferring institution’s researchers will comply with the UNM IRB’s required training(s) and other human research related policies.
  1. The UNM IRB will report to the deferring institution the following:
    • Serious or continuing non-compliance;
    • Unanticipated problems involving risks to subjects or others;
    • Suspensions or terminations of IRB approval;
    • Action initiated by any Oversight agency or other organization (including audits, compliance monitoring, and reporting).
    • Any modification to the FWA or changes to the status of the Assurance documents.
  2. The deferring institution will promptly report to the UNM IRB the following:
    • Serious or continuing non-compliance;
    • Unanticipated problems involving risks to subjects or others;
    • Suspension or termination of the institution’s approval of the research;
    • Allegations of scientific misconduct;
    • Disclosure of significant conflicts of interest by the deferring institution’s researchers engaged in research;
    • Oversight agency or other organization initiates any action (including audits, compliance monitoring, and reporting) with regard to the research under UNM IRB purview;
    • Any modification to the FWA or changes to the status of the Assurance documents;
    • Changes in the IRB Point of Contact information.
  3. The UNM IRB will promptly report (i) unanticipated problems involving risks to subjects or others, (ii) serious or continuing noncompliance, and (iii) suspensions or terminations of previously approved research related to the deferring institution’s FWA to OHRP as appropriate.