The University has accountability obligations for all University-sponsored and sponsor-investigator drug, device, or biological research and manufacturing at the University. The primary objective is to promote compliance with Food and Drug Administration (FDA) Investigational New Drug Application (IND) and Investigational Device Exemption (IDE) regulations (Significant Risk and Non-Significant Risk) that apply when individuals serve in the role of sponsor or sponsor-investigator. This policy does not apply to research sponsored by an external entity such as a commercial drug or device company, nor to emergency use INDs/IDEs. The Vice President for Research, who serves as Institutional Official under federal regulations, may place limitations or conditions on the privilege of individuals to serve as sponsors or sponsor-investigators.
University Sponsors and Sponsor-Investigators
When individuals serve as a sponsor or sponsor-investigator, they assume the same sponsor obligations under FDA regulations as a commercial drug or device company. Individuals who serve as sponsors or sponsor-investigators must comply with FDA requirements and do the following:
- register their proposed project with the Human Research Protection Program (HRPP);
- complete appropriate training as designated by the HRPP;
- submit required checklists to HRPP outlining their plan to meet FDA reporting and all other FDA requirements that apply to the study;
- utilize clinical trial monitoring services provided by the University through the Clinical and Translational Science Institute (CTSI) or an equivalent monitoring plan accepted by CTSI; and
- submit copies of all documents relevant to the FDA pre-submission and the IND/IDE application (as outlined below) to the University’s IND/IDE Central File.
These requirements are in addition to the obligations that apply through the Institutional Review Board (IRB), Conflict of Interest (COI) Program, Sponsored Projects Administration (SPA), Molecular and Cellular Therapeutics (MCT) facility, and any other applicable federal, state, local or University requirements.
Activities that Require Additional Review
The Vice President for Research or designee and the Vice President for Clinical Affairs or designee may require that the HRPP submit higher risk sponsor or sponsor investigator activities to their offices for additional review and approval. These activities include, for example, research where the University sponsor or sponsor-investigator is responsible for the conduct of the trial at multiple institutions or responsible for overseeing University manufacturing at the MCT or other University facility or at other academic or non-profit institutions.
IND/IDE Central File Requirements
For each new protocol, whether Non-Significant risk IDE, Significant Risk IDE or IND or an FDA pre-submission, Sponsors and Sponsor-investigators must submit the following to the University’s IND/IDE Central File, as applicable:
- IND/IDE exemption or determinations requests
- IND/IDE pre-submission and application
- Safety reports
- Communications, including transcriptions of calls with the FDA
- Annual report(s)
The registration must be updated if sponsorship is transferred to another sponsor or sponsor-investigator during the course of the study.
Sponsors and sponsor-investigators are responsible for compliance with FDA reporting requirements. Units must send copies of the FDA related documents to the University’s IND/IDE Central File as they are received or sent.
If a sponsor or a sponsor-investigator fails to comply with this policy, the HRPP will notify appropriate institutional leaders and groups including but not limited to the Vice President for Research, the Institutional Review Board (IRB), department head and dean.
The Vice President for Research, who serves as Institutional Official under federal regulations, may place limitations or conditions on the privilege of an individual to serve as sponsors or sponsor-investigators for failure to comply with these requirements. Depending on the nature and extent of non-compliance, individuals also may be subject to regulatory sanctions by the FDA and/or disciplinary action by the University.
This reporting policy does not apply to the more common situation when a faculty member serves only as the principal investigator on an IND or IDE study, whose sponsor is an outside company, institution, organization, or individual. Under federal law, the outside sponsor, not the University, is responsible for interactions with the FDA. The principal investigator, however, remains subject to all other University policies on clinical research.
This policy also does not apply to emergency use INDs/IDEs.
Reason for Policy
This policy promotes compliance with FDA regulations in sponsor-investigator initiated drug, device and biologics studies at the University of Minnesota. The FDA will not directly communicate with the University regarding a sponsor-investigator's pre-submission, IND or IDE interactions. The University, however, is potentially liable for the actions of its faculty members. The requirement for sponsor-investigators to submit copies to the University-wide repository (IND/IDE Central File) will enable the University to monitor the completeness and timeliness of IND/IDE and FDA pre-submission reporting and to respond to inquiries.
This policy also promotes the availability of services to assist sponsor-investigators in interpreting FDA regulations and changes, and communicating with the FDA.