What FDA Warning Letters on Informed Consent Are Telling Us

About this session

Informed consent violations appear in FDA Warning Letters year after year. These mistakes rarely stem from bad intentions; they often result from process gaps, time pressure, and operational conditions at sites across the country.

This session presents a practitioner-level analysis of real FDA Warning Letters, examined through the lens of a clinical research nurse. Rather than reviewing informed consent regulations in the abstract, this session grounds the requirements of 21 CFR Part 50 and ICH E6(R3) in the site-level realities that produce violations.

Attendees will leave with a clear picture of the most common ICF failure patterns documented in FDA letters, an understanding of the operational conditions that produce them, and practical frameworks that sites, CROs, and sponsors can implement to prevent them.

After completing this session, attendees will be able to:

Identify the most common informed consent violation patterns documented in FDA Warning Letters

Describe site-level operational conditions that contribute to ICF violations

Apply a practical prevention framework at the site, CRO, and sponsor levels to address ICF process gaps before they result in PDs or regulatory findings

Utilize FDA Warning Letters as an ongoing quality improvement and professional development resource

Speakers

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  Kelsey Bratton

  Portfolio Director · Flourish Research

  Speaker

• MB

  Margaret Bussineau

  Clinical Research Nurse · Academic Health System In Philadelphia

  Speaker