Clinical investigators who sponsor research studies ‘sponsor investigators’ may not be well versedin FDA regulatory requirements and may mistakenly assume that these requirements do not apply to investigator-initiated drug studies. For example, some sponsorinvestigators erroneously conclude that an investigator-initiated drug trial does not require an Investigational New Drug application (IND). Federal regulations require the sponsor of a study to obtain an IND not only for clinical trials involving drugs that are not yet approved for marketing, but also for trials involving a new indication, route of administration, or change in dosage for an approved drug. Drug trialsinvolving the latter are exempt from IND requirements only if the study (1) is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use or other significant change in the labeling of the drug; (2) is not intended to support a significant change in the advertising for the product; (3) does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks, or decreases the acceptability of the risks, associated with the use of the drug product; (4) is conducted in compliance with federal IRB review and informed consent requirements; and (5) is conducted in compliance with the requirements for promoting and charging for investigational drugs found at 21 C.F.R. § 312.7. See 21 C.F.R. § 312.2(b) Investigators who normally take part in studies sponsored by a pharmaceutical company or other third-party may be surprised to learn that in investigator-initiated studies the responsibility for obtaining an IND shifts to the investigator. Similar confusion may arise with respect to the Investigational Device Exemption (IDE) requirements that apply to device trials. While some device trials are exempt from IDE requirements, there is no blanket exception for investigator-initiated device trials. The fact that a study is investigator initiated does not itself excuse the study from compliance with either the IND or IDE regulations; rather, the sponsor-investigator has a duty to obtain the IND or IDE if one is required. Sponsor-investigators also sometimes believe that if a drug study does satisfy the IND exemption requirements, the study is not subject to IRB review or the FDA’s informed consent requirements. In fact, a drug study that is otherwise exempt from IND requirements must comply with federal regulations regarding IRB review. In addition, sponsor investigators of drug studies must document, via a signed informed consent form, the informed consent of each research participant or the participant’s legally authorized representative. An IRB may waive the requirement for a signed informed consent form if it finds that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context. In very limited, life-threatening circumstances, an IRB may approve a waiver of informed consent in its entirety pursuant to 21 C.F.R. § 50.23. In short, it is erroneous to assume that an IND-exempt drug study is automatically exempt from other FDA regulatory requirements. If an otherwise IND-exempt drug study fails to obtain IRB review and/or informed consent in accordance with FDA regulations, it will no longer satisfy the IND exemption criteria and will lose its exempt status.
