Investigators serving as sponsors

The Florida Department of Health does not allow researchers conducting research involving DOH to serve as "sponsor-investigators" (21 CFR 312.50). A Sponsor-Investigator is an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug is being administered or dispensed. A researcher becomes a sponsor investigator when they initiate a clinical investigation of a new drug or device seeking approval from the Food and Drug Administration (21 CFR 312.20). DOH investigators who create an Investigational New Drug application with FDA and thereby become sponsor-investigators must retain the services of a contract research organization (21 CFR 312.52) to fulfill the sponsor responsibilities for monitoring and documentation of records for clinical investigations in which the Department is engaged.

• Example: A DOH researcher proposes to apply to FDA for a new use of a drug already licensed by FDA. Suppose the new use would require that the DOH researcher create an application for an Investigational New Drug with FDA. By initiating a study, and filing an application for an investigational new drug with the FDA, the researcher becomes a "sponsor-investigator." DOH does not allow sponsor-investigators, unless they retain the services of a contract-research organization. The researcher would need to retain, and pay for, the services of a contract research organization to supervise and monitor the study, and fulfill all the other responsibilities required by FDA for oversight of clinical investigations.
• Example: A researcher in a DOH clinic seeks to evaluate the use of a different dose and schedule of a licensed vaccine, and is not conducting the study through an affiliation with a drug company. The study is consistent with recommendations by CDC, but involves a dose and schedule that are different from the licensed indication for the vaccine. Since the dose and schedule are different from the licensed indication approved by FDA, the researcher contacted FDA to inquire whether an IND is necessary. FDA's opinion in the case is that the study is probably exempt from the requirements of an IND. The DOH IRB would need to find that the study meets the conditions of exemption from the terms of the IND (see 21 CFR 312.2(b)). If the IRB finds the study is exempt from requirements for an IND, then the researcher would not be a sponsor-investigator, because the particular study is exempt from the requirements of an IND, including sponsor responsibilities. Even if the study is exempt from FDA's requirements for an IND, the study would still require review and approval by the DOH IRB.
• Example: A DOH medical officer fulfilling public health responsibilities determines that the most effective treatment for a particular patient is a drug that is only available in the United States through an "individual-patient-use IND" through an arrangement between the drug manufacturer and HHS. In this case, the DOH medical officer is not functioning as a sponsor-investigator (See DOH Policy on Emergency Use of FDA-Regulated Products)

Researchers should contact the Ethics and Human Research Protection Program office for assistance in interpreting FDA regulations concerning sponsor responsibilities for research involving investigational new drugs.