Testing high doses of vitamin A on children
The ministry of health of a West African country receives a grant from a foreign medical institute to collaborate with its investigators on a double-blind study designed to assess the effect of periodic high doses of vitamin A on the incidences of childhood diarrhoea and acute respiratory infections (ARI). High-dose vitamin A capsules or placebo would be admin-istered in a double-blind fashion every 4 months for 1 year to children from 6 months to 5 years. A record of morbidity (diarrhoea and ARI) and mortality data would be measured biweekly and blood samples would be drawn (less than 2cc) at 0, 6, and 12 months to test vitamin A status. The daily affairs of this traditional, rural community are governed by a traditional leader and council of elders but the national government retains control of other municipal affairs, includ-ing tax collection, the police, and the military.
The chief and council call a meeting to inform the community of the proposed study. In a festive environment, the inves-tigators describe the study and answer all questions from members of the community (men, women, and children) and from the council. After a brief meeting, the village chief and council give their approval. Shortly thereafter, in accordance with the guidelines provided by the research ethics commit-tee at the foreign investigators’ institution, the field staff begin to go from house to house to obtain parents’ signatures on the informed consent forms that are necessary to allow their children to participate in the study. The parents, however, say that since the chief has already approved of the study they do not need to sign anything. They also explain to the researchers that 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 is summoned to the chief’s house where they are politely informed that their seeking individual signatures is both unnecessary and insulting. The fact that the chief and coun-cil has approved is enough. When the field staff explain that they are required by the grant agreement to obtain signed informed consent forms, they are told that if they insist on doing so they will have to leave the community.
92 THE CASE STUDIES Voluntary Informed Consent
Questions
1 Is individual informed consent a culturally bound concept (from developed countries) or is it a universal principle that ought not be compromised?
2 May the chief and the council provide informed consent for the community? Should they?
3 How crucial is individual informed consent in this setting?
4 Are there circumstances when individual informed consent is unnecessary?
5 Is the purpose of informed consent to protect the participant and/or the investigator?
6 How should the field team handle this problem? What should the granting institution do?
CASEBOOK ON ETHICAL ISSUES IN INTERNATIONAL HEALTH RESEARCH
