Consent Forms in Context: How Long is Long?

Mark Hochhauser, Ph.D., Readability Consultant/IRB Member, Golden Valley, MN

Abstract: As the science and regulatory requirements behind clinical trials have evolved over the past few decades, consent forms have become very long. This article compares the word count of some oncology consent forms with other documents, and shows that those consent forms are longer than ethical guidelines and federal regulatory documents. Because too many consent comprehension tests and health literacy measures are not psychometrically sound (and of limited value), efforts to improve comprehension and health literacy continue to be serious problems now and in the future.

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Informed Consent and the Human Experience

Cheryl B. Thomas, MS, CGC, Research Subjectinformed consent Advocate, Mayo Clinic


Going “beyond the regulations” that govern informed consent and understanding the perspective of research participants is crucial to obtaining truly informed consent. This article describes the aspects of informed consent that involve human experience and interactions. Positive and negative feedback from research participants is reviewed to illustrate common issues in participation in clinical research. Participant suggestions for improving comprehension and the overall informed consent experience are shared.

Disclaimers: The author is sharing her own views based on conversations with many research participants. The federal regulations are not reviewed because many of the problems with informed consent arise even when the study team follows the regulations.

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