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Cognitive interviewing as a tool for improving the informed consent process.

Gordon Willis1

  • 1National Cancer Institute, National Institutes of Health.

Journal of Empirical Research on Human Research Ethics : JERHRE
|April 24, 2009
PubMed
Summary

Researchers can use cognitive interviewing to improve how people understand informed consent documents. This method helps assess comprehension and decision-making for research participation, ensuring truly informed consent.

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Area of Science:

  • Bioethics
  • Clinical Research Methodology
  • Cognitive Psychology

Background:

  • Informed consent documents often contain complex language and legal jargon, hindering true comprehension.
  • Difficulties in understanding consent materials can compromise the ethical integrity of research participation.
  • Current methods for evaluating consent materials may not fully capture subject comprehension or decision-making processes.

Purpose of the Study:

  • To propose the adaptation of cognitive interviewing for evaluating the understandability of informed consent materials.
  • To explore how cognitive interviewing can illuminate the thought processes subjects use when making participation decisions.
  • To demonstrate the utility of cognitive interviewing in enhancing the quality of informed consent.

Main Methods:

  • Cognitive interviewing, typically used for survey pretesting, is adapted for consent material evaluation.
  • Involves intensive probing of small samples of volunteer subjects.
  • Focuses on elucidating the hidden thought processes related to consent comprehension and decision-making.

Main Results:

  • Cognitive interviewing effectively reveals barriers to understanding in consent materials.
  • It provides insights into how subjects interpret and utilize information when deciding to participate.
  • The method can identify specific areas of confusion or misinterpretation.

Conclusions:

  • Adapting cognitive interviewing offers a robust approach to assessing and improving the understandability of informed consent.
  • This technique can enhance the basic science of informed consent and its practical application in research.
  • Cognitive interviewing serves as a valuable tool for pretesting materials and embedded assessment of subject comprehension.