Why the FDA’s Draft Informed Consent Guidance Matters

The FDA’s 2024 draft guidance on “Key Information and Facilitating Understanding in Informed Consent” sends a clear message: informed consent should support understanding—not just documentation.

That matters because consent often occurs in the context of a real power imbalance. Clinical trial participants typically have less familiarity with medical terminology, limited experience interpreting scientific risk, and a natural tendency to defer to clinical authority. In that environment, “consent” can quietly become compliance.

Health literacy compounds the challenge. Even highly educated adults may struggle to understand complex medical concepts—especially when information is dense, technical, or delivered under stress. Long, jargon-heavy consent forms don’t clarify risk; they obscure it.

Poor consent is also a business risk. It can drive protocol deviations, withdrawals, complaints, inspection findings, delayed approvals, reputational damage, and loss of trust—outcomes no company can afford. Failing to align with FDA expectations doesn’t just undermine clinical trial participants; it undermines the trial program.

The draft guidance is an important step because it names the problem. But compliance will require more than revised templates. It requires rethinking how key information is written, structured, and delivered—so it actually works in practice.

Clear consent isn’t about lowering standards. It’s about aligning process with reality.

Link to guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/key-information-and-facilitating-understanding-informed-consent-guidance-sponsors-investigators-and

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