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Upholding ethics, human rights in biomedical study

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One of the first South African Oxford vaccine trialists looks on as a medical worker injects him with the clinical trial for a potential vaccine against the coronavirus at the Baragwanath hospital in Soweto, South Africa, on June 24 ,2020. PHOTO | AFP

Countries in the world are rallying to find vaccines and a cure for Covid-19 with several tests happening. This involves a lot of biomedical research and raises a lot of ethical questions. Scientists and medical researchers are exploring the possibility of using various methods such as gene editing. In undertaking biomedical research, trials and vaccines may need to be undertaken on human beings.

While Kenya does not have a standalone law on biomedical research providing for issues such as the rights of the targets of the research, issues of biomedical ethics are contained in several laws. These would have to be adhered to by any scientists or institution that seeks to explore a biomedical research on Covid- 19. Some of the laws are international, for example the Universal Declaration On Bioethics And Human Rights.

Over the course of history, biomedical research has often been conducted in an inhumane manner. The Nuremburg trials by the Nazis is an example of gross violations of human rights in scientific research. Often the targets of this research had their human rights abused and ended up dying. This is because there was no regulation of control in the way such exercise was conducted.

Fortunately, today there is a lot of regulation concerning human trial vaccines and research such that rights are upheld.

In Kenya, the first law that guarantees the human rights of the targets is the Constitution. The Bill of Rights contains several provisions that would guarantee the rights of human targets. One such right is the right to life. It would be illegal to conduct a research that is obviously life threatening or conduct a research that would involve taking the lives of human targets.

The study should also not obviously endanger the health of the targets. All due care ought to be taken to safeguard the health of the individuals, inasmuch as there may be some risk involved. No research can be undertaken on a person without first seeking and procuring his consent. One cannot be forced into biomedical research.

Similarly it would be illegal to deceitfully or cunningly involve a person in biomedical research without first getting his consent. For example it would be wrong to inject a target with research substances without informing him or having misrepresented to him that the injection is something else. Forced trials for vaccination are illegal. The targets 'personal health data must be kept private as they have a right to privacy. It would be illegal to disclose their health information without consent.

The above represent some of the Constitutional rights which must be adhered to when conducting Covid-19 research and trial runs in Kenya where the same involve human beings.

The Science, Technology And Innovation Act also regulates on the conduct of a biomedical research in Kenya. This law regulates all research done in Kenya and this includes biomedical research.

The first thing to note is that the research itself must be licensed. Any research undertaken on Covid-19 in Kenya must be licensed. About a month ago there was talks of some vaccine trials being tested in Kenya. The law is clear, such a test cannot be done within Kenya without a licence being issued (even if the same is done by a foreign entity).

A biomedical research such as Covid- 19 must be undertaken by an accredited institution. The Science Technology And Innovation Act has more details on the conduct of such a research in Kenya.