Subject: Investigational Drugs, Agents, and Biologics

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to require that Investigators comply with all applicable regulations pertaining to investigational drugs and biologics, and that all proposed uses of investigational drugs and biologics must be reviewed and approved by the IRB as defined by Federal regulations.

1. Investigational new drug (IND) use in a clinical investigation.
   1. An investigational new drug may be used in a clinical investigation if the sponsor of the investigation submits an IND for the drug to FDA (including a treatment IND); ^[1] and the Investigator conducts his or her investigation in compliance with the requirements of this and other applicable policies. ^[2], ^[3]
   2. An Investigator shall assure that the IRB will be responsible for the initial and continuing review and approval of any proposed clinical investigation involving an investigational new drug.
   3. The Investigator shall promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others (UPIRTSO), and that he or she will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects. ^[4]
   4. A study subject to an IND may begin thirty days after FDA receives the IND application, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold, or on earlier notification by FDA that the clinical investigations in the IND may begin. ^[5]
2. Emergency Use of an Investigational New Drug.
   1. In certain emergency situations where IND submission and/or IRB approval is not possible, FDA may authorize shipment of the drug for a specified use in advance of submission of an IND.
   2. A request for such authorization may be transmitted to FDA by telephone or other rapid communication means.
   3. 1. For investigational biological drugs, the request should be directed to the Division of Biological Investigational New Drugs (HFB-230), Center for Biologics Evaluation and Research, 8800 Rockville Pike, Bethesda, MD 20892, 301-443-4864.
      2. For all other investigational drugs, the request for authorization should be directed to the Document Management and Reporting Branch (HFD-53), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4320.
      3. After normal working hours, Eastern Standard Time, the request should be directed to the FDA Division of Emergency and Epidemiological Operations, 202-857-8400. ^[6]

^[1] 21 CFR 312.34

^[2] 21 CFR 312.20

^[3] 21 CFR 312.40 (a)

^[4] 21 CFR 312.66

^[5] 21 CFR 312.40 (b)

^[6] 21 CFR 312.36