ABSTRACT
The aim of this paper is to stimulate debate on the agency (principal-agent) in health-related biotechnology research. It attempts to answer the following questions: What is health-related biotechnology and biotechnology research? What is an agency? What factors are likely to undermine the principal's capacity to exercise informed consent? When might the principal-agency problem arise? How could the agency in biotechnology transfer be strengthened in Sub-Saharan Africa (SSA)? The transfer of health-related biotechnology to SSA ought to be preceded by research to ascertain the effectiveness of such technologies on population health. In that process, the national ethical review committee (REC), as an agent of every human research subject (principal), ought to ensure that international principles (e.g. beneficence, non-malfeasance, autonomy, justice, dignity, truthfulness and honesty) for human experimentation are observed by biotechnology researchers in order to satisfy moral, ethical and legal requirements. The key factors that undermine principals' sovereignty in exercising their right to informed consent to participate in biotechnology trials are discussed. The paper ends with a list of activities that can strengthen the agency, e.g. legislative requirement that all health-related biotechnology transfer should be preceded by rigorous evaluation; continuous update of the agents knowledge of the contents of the international ethical guidelines; and education of potential and actual principals on their human rights; among others.
