On April 27, 2022, the Parliament of Cameroon adopted a law providing a new framework for medical research involving the “human person.” This law places a particular emphasis on the right to information and the free, informed, and written consent of the participants. It also provides guarantees regarding respect for privacy and confidentiality of personal data and respect for human integrity, dignity, and vulnerability.
Background to the Law
According to Cameroonian press reports, the new law was drafted in reaction to a scandal involving the trial of a preventive treatment for AIDS conducted in 2004 by the American NGO Family Health International on sex workers in Douala “in violation of [their] ethical and deontological rights.” The new law also represents a response to the recent proliferation in Cameroon of clinical trials of COVID-19 treatments conducted without rigorous controls.
Content of the Law
The newly enacted law delimits the scope of consent for medical research involving minors (articles 15 and 16), disabled persons (articles 17 and 18), and pregnant women (articles 19 and 20). It also provides a framework for medical research on in vivo fetuses and in vivo embryos (articles 19 to 22). Finally, the law addresses research conducted on stillborn children (articles 23 and 24) and on the dead (articles 27 and 28).
Article 59 of the law establishes criminal sanctions, providing for a penalty of one to five years’ imprisonment and a fine of 10–50 million Cameroonian francs (approximately US$16,000–$82,000) for anyone who carries out a medical research project
– without having informed the participants of their rights and of the modalities and risks of the research;
– without having obtained the consent of the person concerned or that of other persons [or] authorities designated to authorize the research;
– for conducting such research on a minor or a legally incapable adult without having asked for their consent and the consent of their legal guardian;
– when consent previously given has been withdrawn.
Such consent had already been recognized in the international human rights sphere. Article 7 of the International Covenant on Civic and Political Rights (which Cameroon ratified in 1984) states that “no one shall be subjected without his free consent to medical or scientific experimentation.” In addition, the Council for International Organizations of Medical Sciences, in collaboration with the World Health Organization, had enacted guidelines in 2016 and made it clear that informed consent is of the utmost importance. According to its Guideline 9, “[r]esearchers have a duty to provide potential research participants with the information and the opportunity to give their free and informed consent to participate in research, or to decline to do so.”Prepared by Baptiste Beurrier, Law Library intern, under the supervision of Nicolas Boring, Foreign Law Specialist