Special considerations for Drug Research: Do you need an IND?

The WIRB Initial Review Submission Form asks for information about an IND. As a general rule, WIRB requires that a sponsor or investigator obtain an IND from FDA for clinical investigations involving drugs. However, if the investigation uses a marketed drug, the sponsor or investigator may propose that the investigation is exempt from an IND under 21 CFR § 312.2(b), which states:

(b) Exemptions. (1) The clinical investigation of a drug product that is lawfully marketed in the United States is exempt from the requirements of this part if all the following apply:

(i) The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;

(ii) If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;

(iii) The investigation 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;

(iv) The investigation is conducted in compliance with the requirements for institutional review set forth in part 56 and with the requirements for informed consent set forth in part 50; and

(v) The investigation is conducted in compliance with the requirements of Sec. 312.7. [regarding marketing and promotion]

Criteria (i), (ii), and (v) are under the control of the investigator and/or sponsor, and WIRB holds the investigator and/or sponsor responsible for complying with those criteria. Item (iv) is satisfied by the fact that the study has been reviewed by WIRB.

WIRB will consider whether the conditions of item 3 are met, and send a letter to the investigator addressing that item.

For clinical investigations using a dietary supplement, WIRB will require that the sponsor or investigator obtain an IND if the protocol is designed to provide information on a health claim. However, WIRB will accept a written statement from FDA that an IND is not necessary for a given clinical investigation of a dietary supplement.

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