Case Study 3: Issues in Informed Consent

A grant has been given by a US university to the research unit of a Ministry of Health of a West African Country to conduct a double blind study to evaluate the impact of periodic doses of high dose Vitamin A on the incidence of diarrhea and ARI in children less than five years of age.  A traditional leader and council of elders governs the community in its daily affairs though the national government retains control of tax collecting, the police, military, etc. To inform the community of the impending study the village was called together by the chief and council. In a festive environment, the investigators described the study and answered all question from members of the community and council.  After the description, and q1uestion and answer period, the village chief and council met briefly and gave their approval.  Shortly thereafter, in accordance with the guidelines provided by the Institution Review Board of the university, the principal investigator and his field staff began going house to house to obtain signed informed consent from the parents giving permission for their children to participate in the study.  The mothers (usually the one at home during the visit) said that the chief had already approved and therefor they did not need to sign anything; besides they usually do not sign anything because they cannot read what they are signing.  On the second day, the field team making the home visits was summoned to the chief's house where they were politely informed that approval had been give for the study and that it was both unnecessary and unacceptable to seek individual signatures.  That the chief/council had approved was enough.  When the field staff said that they were required by the grant agreement obtain signed informed consent form, they were told that, if they insisted on doing so, they would be required to leave the community.

A summary of the study design is as follows: high dose vitamin A capsules or placebo would be administered in a double blind fashion every four months for one year to children from 6 months to 5 years. A record of morbidity (diarrhea and ARI) and mortality data would be measured by weekly and blood samples would be drawn (less than 2cc) at 0, 6, and 12 months for Vitamin A status.

The following questions are some of those that you should be prepared to discuss:

• How should this problem be handled by the field investigator? The donor?
• How critical is informed consent in this setting?
• Is informed consent culturally bound or is it a universal principal that cannot be compromised?
• Are there circumstances when informed consent is unnecessary?
• Does it protect the investigator and/or the subject?