- 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.