Chapter 18

Special Considerations for Drug Research: Do You Need an IND

WCG IRB’s Initial Review Submission Form asks for information about an IND. As a general rule, WCG IRB requires that a sponsor or investigator obtain an IND from FDA for clinical investigations involving drugs or dietary supplements. 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:

  1. 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;
  2. 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;
  3. 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;
  4. 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
  5. 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 WCG IRB holds the investigator and/or sponsor responsible for complying with those criteria.  Criterion (iv) is satisfied by the fact that the study has been reviewed by WCG IRB.

WCG IRB will consider whether the conditions for (iii) are met and send a letter to the sponsor addressing that item.

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