• A substance recognized by an official pharmacopoeia or formulary.

  • A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

  • A substance (other than food) intended to affect the structure or any function of the body.

  • A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.

  • Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)

 

There must be a prescribing physician or nurse practitioner listed on the IRB application when a prescription drug is used. They should also be involved in the consent process and designated as “participate in the process” or “authorized to obtain consent”.

For non-prescription drugs (i.e. over the counter), you must have investigators listed on the IRB application who are knowledgeable about its use and are administering under the oversight and consultation of a prescriber. Investigators, who arrange with the investigational pharmacy to be exempt from using the investigational pharmacy or are not within the hospital system, are required to submit a plan for drug accountability and storage to the IRB on the drug subform.

Anytime a drug is used outside the course of medical practice (routine activities/standard of care), it needs to be listed on the subform. This includes protocol driven use of investigational drugs, approved drugs used in an unapproved manner, and approved drugs used in an approved manner. An exception is FDA approved medical supplies/products that are not part of the clinical investigation and not being studied. The IRB application has a separate subform for these supplies/products.

  • Package inserts for approved drugs – make sure to upload the most current version. If needed, contact the pharmacy for a copy.
  • Investigator's brochure for investigational drugs

 

Yes. All clinical investigations involving drugs need IDS approval regardless of whether IDS will control or administer the drug. You should work with the IDS pharmacist early to obtain approval. The IRB will obtain IDS approval documentation during its review, but it is highly recommended to get this approval process started early by sending the protocol with drug administration plans, including accountability.

 

Research involving a drug/biologic that is not yet FDA approved or is used off-label and does not qualify for an exemption in the question below, requires an IND application. The IND application is submitted by the sponsor or sponsor-investigator to the FDA.

If the drug is not already legally marketed, the study is not eligible for IND exemption and would require an IND.

IND Application Instructions

A clinical investigation of a drug product that is lawfully marketed in the United States is exempt from the IND requirements if ALL criteria for an exemption in §312.2(b) are met:

  • The investigation does not involve a route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product.
  • Investigators should carefully consider the risk implications of any conditions of use in the study that deviate from the conditions of use described in the drug's labeling, with particular attention to the following:
    • Route of Administration
    • Dose
    • Patient Population
  • The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication and there is no intent to use it to support any other significant change in the labeling of the drug.
  • The investigation is conducted in compliance with the requirements of §312.7 (i.e., the investigation is not intended to promote or commercialize the drug product).
  • In the case of a prescription drug, the investigation is not intended to support a significant change in the advertising for the drug.
  • The investigation is conducted in compliance with the requirements for review by an IRB (21 CFR part 56) and with the requirements for informed consent (21 CFR part 50).

This information is collected on the drug subform for review and consideration. Justification must be provided to determine an IND exemption. Studies that are IND exempt may be reviewed expedited if the IRB determines it can be expedited and involves minimal risk.

Whether an IND is needed for a clinical investigation evaluating a dietary supplement, food, cosmetics, or other substance, is determined by the intent of the clinical investigation. 

If the clinical investigation is intended to evaluate its ability to diagnose, cure, mitigate, treat, or prevent a disease or condition, an IND is required, and it must be listed on the drug subform. If it is not, then it goes on the supplement/food/cosmetic/other subform. See our FAQ on Supplement, Food, Cosmetic or Other.

See additional information from FDA.