The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)).  The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use.  The FDA has statutory authority to regulate the development and marketing of these products.

  1. What kind of review process will the IRB conduct if the intent of the research in humans is to develop information about safety and efficacy of drugs or devices for submission to, or inspection by, the FDA?
  2. Type of IRB Review

If a test article does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting.

  1. Drugs, Botanicals, Biologicals, or Other Substances

JHM IRB review of research involving unlicensed or unapproved drugs, botanicals, biologicals, or other substances (e.g., food additives, food derivatives, vitamins, minerals, extracts, etc.) must be conducted at a convened meeting.  The review must include the presence of a P&T IRB member who will make a recommendation concerning the risks and proposed benefits of each product to be used in the study.  The IRB review will address the need for submission of an FDA Investigational New Drug Application (IND) prior to the use of the test article in the research study.  The IRB may determine that an IND is not required if all the conditions set forth in 21 CFR 312.2(b) have been met.  The IRB will determine whether to require submission of an IND, or if appropriate, to require the Primary Investigator (PI) to seek clarification from the FDA about the need for obtaining an IND before the IRB completes its review, and before the research may begin (See: “Investigator Inquiry to the FDA About the Need for an Investigational New Drug Application (IND)“).  Consent forms for IND studies must clearly state that the “test article” is investigational or experimental