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Standard Operating Procedures - Chapter 17

MANAGEMENT OF FDA REGULATED RESEARCH

The U. S. Food and Drug Administration (FDA) regulates clinical studies conducted on drugs, biologics, devices, and diagnostics, hereinafter referred to as “FDA regulated test articles.” All such research studies must be conducted in accordance with FDA requirements for protection of human participants and IRBs, regardless of funding (21 CFR Parts 50 and 56).

When FDA regulated test articles are used in research being conducted at UMASS or funded by another federal agency, more than one set of regulations may apply. For example, clinical trials involving FDA regulated test articles that are supported by the Department of Health and Human Services (DHHS) fall under the jurisdiction of both the FDA and the DHHS Office for Human Research Protections (OHRP). Such trials must comply with the FDA and the DHHS human participant regulations. Where regulations differ, the UMASS IRB will apply the stricter one.

17.1

IRB Review of Research Involving Drugs and Biological Products

17.1 IRB Review of Research Involving Drugs and Biological Products

The UMASS IRB will comply with the requirements of 21 CFR Parts 312 and 600 for the review and approval of research studies involving FDA regulated drugs and biological products.

Studies that involve FDA regulated drugs or biologics that are submitted without a valid investigational new drug ( IND ) number are reviewed with respect to determining the need for an IND. If the IRB determines that the study is exempt from an IND and approves the study, the study may begin without submission of an IND application to FDA. If the IRB determines that an IND is needed, the investigator/sponsor must submit an IND application to the FDA and provide documentation of the outcome of the FDA determination to the IRB before the IRB approves the study.

The IRB may consider a study using a drug product that is lawfully marketed in the United States to be exempt from the requirements for obtaining an IND if all the following apply:

    • The research study is not intended to support a new indication for use nor any other significant change in the labeling for the drug;
    • The research study is not intended to support a significant change in the advertising of the product;
    • The research study 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; and
    • The research is conducted in compliance with the requirements for institutional review and informed consent.

Use of an off-label marketed product in research intended to support a new indication for use, change in labeling or advertising requires IRB review and approval, informed consent and submission of an IND.