- Assume ultimate responsibility for all research covered under the IRB Authorization Agreement (IAA).
- 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.
- 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.
- 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.
- 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 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.
- 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.
- The deferring institution’s researchers will comply with the UNM IRB’s required training(s) and other human research related policies.