UNM has a nationally accredited human research protections program (HRPP) that follows rigorous standards for ethics, quality, and protections for human research participants. The UNM Institutional Review Board (IRB) is pleased to serve as the IRB of record for external partners. Our services include:
- Consultations with staff who are experts in human research protections
- Training and education services tailored to your needs
- Specialization in behavioral, educational, survey, and social science research with access to clinical and pharmacy consultants for biomedical based research
- Diverse IRB membership that meets monthly, including prisoner and child representatives
- Minimal risk reviews conducted weekly and administrative reviews conducted daily
- Nationally competitive review turnaround times
- GCP compliant study start up services including quality assurance monitors who work with research staff to provide education and support
- Easy to navigate website
- 24/7 access to Streamlyne 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 efficient IRB review and reporting 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 Mayo, Director, at firstname.lastname@example.org 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 Services 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.
|Human Subjects Research Determinations||$500|
|Just in Time and 118 Determinations||$500|
|Administrative Reviews||No Charge|
|Reportable Events and Unanticipated Problems||No Charge|
|Protocol Deviations||No Charge|
- 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.
- Communicate IRB determinations to the Principal Investigator and others, as applicable.
- Maintain current IRB registration with OHRP in compliance with the Federal Policy and applicable FDA regulations.
- Retain the authority to suspend or terminate the research for failure to comply with conditions of approval or regulatory requirements.
- Notify relying institution of any unanticipated problems, termination or suspension of research.
- 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).
- 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.
- Interview, as necessary, all essential researchers involved in the conduct of human research.
- 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.
- 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.
- 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.
- 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.
- Assume ultimate responsibility for the conduct of all research covered under the IRB Authorization Agreement (IAA).
- Provide local context information to the UNM IRB regarding state laws and institutional requirements that pertain to the review of the deferred study.
- Perform and document a review of the project to determine scientific validity prior to submission to the UNM IRB.
- Accept the UNM IRB decisions and requirements and ensure the PI will not initiate any research or implement changes to approved research without first receiving approval from the UNM IRB.
- Assume responsibility for maintaining an institutional process to monitor, evaluate, and continually improve the protection of human research participants, 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 relying institution will also monitor compliance with the terms and conditions of the IRB’s approval.
- Assure that the researchers disclose potential COI with regard to the research according to the relying institutions policies and procedures and provide relevant information to the UNM IRB.
- Manage any organizational COI that may arise related to the proposed research.
- 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 and notify the UNM IRB should changes occur.
- Ensure that an institutional mechanism exists by which complaints about the research can be made by local research participants or others to a local contact.
- 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.
- Notify, within five (5) business days, the UNM IRB of any events including: 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.
- 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.
- 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.
- Maintain the IAA as part of the institution’s records.
- Assume responsibility for ensuring compliance with the terms of its HHS approved FWA, if applicable.
- Ensure researchers comply with the UNM IRB’s required training(s) and other human research related policies.
- The UNM IRB will report to the company the following:
- Serious or continuing noncompliance;
- Unanticipated problems involving risks to participants 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.
- The relying institution will promptly report to the UNM IRB the following:
- Serious or continuing noncompliance;
- Unanticipated problems involving risks to participants or others;
- Suspension or termination of the institution’s approval of the research;
- Allegations of scientific misconduct involving human research;
- Disclosure of significant COI by the deferring institution’s researchers engaged in research;
- Any agency or organization that initiates any action (including audits, compliance monitoring, and reporting) with regard to the research under UNM IRB oversight;
- Any modification to the FWA or changes to the status of the Assurance documents;
- Changes in the IRB Point of Contact information.
- 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 the institution and/or OHRP as appropriate.
- Contact UNM Office of the IRB (OIRB) at (505) 277-2644 to discuss potential partnership
- Negotiate and execute IRB Services Agreement
- Schedule and conduct new Principal Investigator orientation (in-person or remotely)
- Submit to UNM IRB via Streamlyne Research
- OIRB staff conducts preliminary review within 5 business days (may request clarifications from PI)
- UNM IRB conducts review
- OIRB submits invoice for IRB Services