When an investigator faces a life-threatening situation, it is important to act quickly and carefully. To ensure safety, the investigator must consider all relevant regulations. This article will discuss the regulations related to the use of an investigational drug in an emergency situation.
Attachment B: Recommendation on Single Patient Use
Attachment B of the 2012 March 30 letter from the Secretary’s Advisory Committee on Human Research Protections provides guidance related to the use of unapproved drugs for single-patient use in a life-threatening situation. According to this regulation, the use of an investigational drug in an emergency situation must be done under the supervision of a licensed practitioner, and the patient must be informed of the potential risks, benefits, and alternatives that may be available to them. Additionally, the investigator must provide information to the Institutional Review Board (IRB) regarding the use of the investigational drug.
Emergency Use of an Investigational Drug or Biologic
The FDA’s regulation on the emergency use of an investigational drug or biologic provides guidance on how to proceed once the use of an experimental drug has been approved. According to the FDA, the investigator must provide the IRB with information about the risks, benefits, and alternatives of the experimental drug, as well as information about the patient’s condition. Additionally, the investigator must obtain a written consent from the patient or legal representative, and the IRB must approve the emergency use of the drug. The investigator must also make sure that the drug is stored and dispensed in a safe manner.
Emergency Use: Institutional Review Board (IRB) Office
If time does not allow for prior IRB review and approval, the FDA’s regulation on emergency use of an investigational drug or biologic allows for the one-time emergency use of a test article for the treatment of a single patient. In this situation, the investigator must still provide the IRB with information about the risks, benefits, and alternatives of the experimental drug, as well as information about the patient’s condition. Additionally, the investigator must obtain a written consent from the patient or legal representative. Finally, the investigator must report the emergency use to the IRB within five working days of the use.
Conclusion
In conclusion, when an investigator is confronted with a life-threatening situation, it is important to act quickly and carefully. To ensure safety, the investigator must consider all relevant regulations, including Attachment B of the 2012 March 30 letter from the Secretary’s Advisory Committee on Human Research Protections, the FDA’s regulation on the emergency use of an investigational drug or biologic, and the regulation on emergency use from the Institutional Review Board (IRB). Following these regulations can help an investigator act quickly and properly in a life-threatening situation.