Research Involving Drugs and Biological Products
For studies that involve FDA regulated drugs and biological products the UOP IRB will comply with the requirements of 21 CFR Parts 312 and 600.
Research Involving Unapproved / Investigational Drugs and Biological Products
In general, the submission of an Investigational New Drug (IND) application is required for any clinical research study that proposes the use (e.g., as a research tool to explore a biological phenomena or disease process) or evaluation (i.e. for safety and/or effectiveness) of an unapproved drug or biological product.
For studies that involve investigational drugs or biological products, the IRB shall require evidence that the FDA has issued an Investigational New Drug (IND) number. This confirmation will be made by determining if the IND number provided on the IRB coversheet or the OSIRIS submission matches that recorded on the sponsor protocol, communication from the sponsor, or communication from the FDA.
Research Involving Approved Drugs or Biological Products
For research using an approved drug or biologic, where the investigator has not provided a valid IND number, the IRB shall evaluate the protocol to determine if an IND is required. In general, the submission of an IND is not required for any clinical research study that proposes the use or evaluation (i.e., for safety and/or effectiveness) of an approved drug, provided that:
- The results of the study are not intended to be reported to the FDA in support of a new indication for the use of the drug or to support any other significant change in the labeling of the product;
- The results of the study are not intended to support a significant change in the advertising for the product;
- The study does not involve a route of administration or dosage level, or use in a subject population or other factor that significantly increases the risks (or decreases the acceptability of risks) associated with the use of the product; and
- The study is conducted in compliance with the requirements for IRB review and informed consent.
Dietary supplements are exempt from FDA regulation as “drugs” provided that they are being evaluated and/or are labeled for intended use in affecting the structure or function of the body (i.e., a structure/function claim).1 However, the evaluation of a dietary supplement for the diagnosis, prevention, mitigation, treatment or cure of a specific disease or condition (i.e., a disease claim) requires the prior submission of an IND application.
1 Dietary Supplement Health and Education Act