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Obtaining informed consent in an illiterate population.

Mahnaz Alaei1, Akram Pourshams2, Najmeh Altaha3

  • 1Departement of Pediatrics, Mofid Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

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Summary

Informed consent for a large esophageal cancer study in Iran was successfully obtained from 50,045 participants, including many illiterate individuals. This innovative awareness method ensured ethical participation in vulnerable populations.

Keywords:
IlliterateInformed consentMedical ethicOld age

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Area of Science:

  • Epidemiology
  • Public Health
  • Medical Ethics

Background:

  • Esophageal cancer presents a significant health challenge among the Turkman population in Northeastern Iran.
  • A prospective cohort study involving 50,000+ individuals over 40 is underway to investigate cancer etiology.
  • The high illiteracy rate in the study population complicates the crucial process of obtaining informed consent.

Purpose of the Study:

  • To evaluate the etiology of esophageal cancer in a high-prevalence region.
  • To establish an effective and ethical method for obtaining informed consent from illiterate and elderly populations in research studies.
  • To facilitate participation in a large-scale prospective cohort study.

Main Methods:

  • Engaged community leaders and health officials to explain study aims and methods.
  • Provided comprehensive information about the research process to potential participants in their homes one week before consent.
  • Allowed ample time for participants to consider the study, consult with various community members, and observe the research firsthand.

Main Results:

  • Achieved a participation rate of 50,045 individuals, with 70% being illiterate.
  • Successfully obtained informed consent without any refusals related to medical ethics.
  • Demonstrated the feasibility of the awareness method in a large-scale epidemiological study.

Conclusions:

  • The implemented awareness strategy is a valuable model for research involving elderly and illiterate participants.
  • This approach can be adapted for ethical research conduct in similar populations globally.
  • Effective communication and community engagement are key to overcoming barriers in research participation.