This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators, 21 CFR part 54. This document is a revision of the Guidance for Industry: Financial Disclosure by Clinical Investigators dated March 20, 2001. In order to address issues raised by the Office of the Inspector General (OIG), Department of Health and Human Services, in its report, OEI-05-07-00730, The Food and Drug Administration’s Oversight of Clinical Investigators’ Financial Information as well as questions FDA has received from industry and the public, FDA issued a revised guidance in draft in May 2011 for public comment. Comments were received from 13 individuals and entities, which were considered in preparing this final guidance. FDA encourages applicants and sponsors to contact the agency for advice concerning specific circumstances regarding financial disclosures that may raise concerns as early in the product development process as possible.
The Financial Disclosure by Clinical Investigators regulation (21 CFR part 54) requires applicants who submit a marketing application for a drug, biological product or device to submit certain information concerning the compensation to, and financial interests and arrangements of, any clinical investigator conducting clinical studies covered by the regulation (see generally the purpose of the regulation at 21 CFR § 54.1). The regulation, which became effective on February 2, 1999, applies to clinical studies submitted in a marketing application, including a supplement or amendment to an original application, that the applicant or FDA relies on to establish that the product is effective, and any study in which a single investigator makes a significant contribution to the demonstration of safety (21 CFR §§ 54.2(e) and 54.3). The regulation requires applicants to certify the absence of certain financial interests and arrangements of clinical investigators that could affect the reliability of data submitted to FDA, or to disclose those financial interests and arrangements to the agency and identify steps taken to minimize the potential for bias (21 CFR § 54.4(a)). If the applicant does not include certification and/or disclosure, or does not certify that it was unable to obtain the information despite exercising due diligence, the agency may refuse to file the application (21 CFR § 54.4(c)).
Under the applicable regulations, an applicant is required to submit to FDA a list of all clinical investigators who conducted covered clinical studies and to identify those who are full-time or part-time employees of the sponsor of each covered study (21 CFR § 54.4). For each clinical investigator who was not a full-time or part-time employee of a sponsor of the clinical study, the applicant must provide either a certification, using FORM FDA 3454, that none of the financial interests or arrangements described in 21 CFR § 54.4(a)(3) (see Section III.B. below) exists, or completely and accurately disclose, using FORM FDA 3455, the nature of those interests and arrangements to the agency and describe any steps taken to minimize the potential for bias resulting from those interests and arrangements (21 CFR § 54.4(a)). If the applicant acts with due diligence to obtain the required information but is unable to do so, the applicant may certify that it acted with due diligence but was unable to obtain the information and include the reason the information could not be obtained (21 CFR § 54.4).
FDA generally expects that applicants will be able to provide this information. Under 21 CFR §§ 312.53(c), 812.20(b)(5) and 812.43(c), a sponsor is required to obtain clinical investigator financial information before allowing the clinical investigator to participate in a covered clinical study. Under 21 CFR § 54.4(b), each clinical investigator who is not a full-time or part-time employee of the sponsor of the covered clinical study is required to provide the sponsor with sufficient accurate financial information to allow for complete disclosure or certification and to update this information if any relevant changes occur during the study and for one year following its completion.