A grant has been given by a U.S.

university to the research unit of the Ministry of Health of a West African country, for the
purpose of conducting a double blind study to evaluate the impact of periodic doses of high dose Vitamin A on the
incidence of diarrhea and ARI (acute respiratory infections) in children less than five years of age in a particular
community. A traditional leader and council of elders govern the community in its daily affairs, although the national
government retains control of tax collecting, the police, military, etc. The village was called together by the chief and
council to inform the community of the impending study. In a festive environment, the investigators described the study
and answered all questions from members of the community (men, women, and children) and the council. After the
description and the question and answer period, the village chief and council met briefly and gave their approval.

Shortly thereafter, in accordance with the guidelines provided by the Ethical Review Board of the university, the principal
investigator and his field staff began going from house to house to obtain signed informed consent from parents to give
permission for their children to participate in the study. The mothers (usually the parent at home during the visit) said that
since the chief had already approved, they did not need to sign anything. The mothers also explained 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 was summoned to the chief's house where they were politely
informed that approval had been given for the study and it was both unnecessary and unacceptable to seek individual
signatures. The fact that the chief/council had approved was enough. When the field staff said that they were required by
the grant agreement to obtain signed informed consent forms they were told that if they insisted on doing so they would
have to leave the community.

6. How should the field investigator handle this problem? The donor?

As a field investigator, it is important to explain to the community chief and council the importance of having an informed
consent. The field investigator must discuss the benefits of having such a thing done and how it will protect the children
in the community throughout the research process.

The field investigator may also address this problem by translating the documents in the local language of participants
and ensure that it is accurate and of high quality. Also, it is a must that the informed consent is written for a reading level
that the participants in the community can easily understand. Conducting a pilot test to know if the informed consent
materials are appropriate should be done to ensure that it will be easily understand by the participants. The field
researcher may opt to do the pilot testing to the council of elder so that the they can give inputs whether the materials to
be presented to the mothers are appropriate.

However, if the community chief and council still asked the field staff to leave the community, the field investigator
together with the US university funding the research may reassess their options and identify another group, that is similar
to the chosen community, to serve as the new participants of the research. As a researcher, it is important to respect the
decisions of the mothers in the community to not give their consents for the participation of their children in the research.
Also, it is a must to respect the decision the community chief and council.