Finalized Investigator Guidance Emphasizes Spouses, Children

Final FDA guidance on clinical investigator financial disclosures underscores that the term “clinical investigator” includes the spouse and children of the investigator, as well as subinvestigators, participating in a study.

It also makes the distinction that an applicant is the party that submitted the marketing application, which may or may not be the sponsor.

The guidance discusses financial conflicts of interest that clinical investigators must disclose to sponsors, what disclosures the applicant needs to provide the FDA and what actions the agency can take if those requirements are not met.

Marketing applications should include a list of all clinical investigators who conducted the supporting studies and disclose the following financial interests, arrangements and payments:

• Compensations made to the investigator by the sponsor where the value of the compensation could affect the study outcome;
• Any proprietary interest in the drug or device being studied, such as a patent, trademark, copyright or licensing agreement;
• Any equity interests sponsors may have, such as ownership interests and stock options;
• Any equity interests sponsors that are publicly held companies might have that exceed $50,000; and
• Other significant payments made by the sponsor to the investigator or the investigator’s institution for amounts exceeding $25,000 in total during the study and up to one year after the study is completed.

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