What role do IRBs play when investigational drugs are used for treatment? PHRP Advisory Board Member and longtime FDA and HHS leader Richard Klein and Lisa Kearns, Senior Research Associate in the division of Medical Ethics at NYU's Grossman School of Medicine, provide clarity on the ethical and regulatory frameworks behind expanded access, Right to Try laws, and the pivotal function of informed consent.

Show Notes:

Richard and Lisa explore IRB considerations for compassionate use and treatment under expanded access programs. Their key takeaways include:

Expanded Access Explained: Expanded access, or compassionate use, allows seriously ill patients to access investigational drugs outside clinical trials when no satisfactory alternatives exist.

The IRB’s Role: Even though expanded access is for treatment, IRB oversight is required due to the investigational nature of the drugs, ensuring proper informed consent and ethical safeguards.

Informed Consent Challenges: Patients pursuing expanded access may be in vulnerable states, making it crucial for IRBs to ensure they understand the risks, benefits, and experimental nature of treatments.

Regulatory Nuances: Single-patient expanded access can proceed with IRB chair approval rather than full board review, streamlining the process for critically ill individuals.

Expanded Access vs. Right to Try: Right to Try laws are distinct from expanded access. They bypass FDA and IRB oversight, but have seen minimal uptake due to ethical concerns and sponsor hesitation.

Learn more about PHRP Advisory Board Member Richard Klein

Resources:

FDA Guidance: Expanded Access | Information for Institutional Review Boards (IRBs)

FDA Guidance: Expanded Access to Investigational Drugs for Treatment Use Questions and Answers Guidance for Industry

FDA's Expanded Access Regulations – 21 CFR 312 Subpart I

FDA's Informed Consent of Human Subjects Regulations – 21 CFR Part 50, Subpart B

The Reagan-Udall Foundation for the Food and Drug Administration is developing

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