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Pamela Andanda argues that a court challenge in Kenya over the conduct of trials involving a potential HIV/AIDS vaccine could bring much-needed legal order into an area that currently suffers from 'name and shame' tactics.

Pamela Andanda is an advocate of the High Court of Kenya and a member of the Institute of Certified Public Secretaries of Kenya (ICPSK). She is currently carrying out research on the regulation of clinical research in Kenya and other countries. She lectures on law and biotechnology at the University of the Witwatersrand's Law School, South Africa.

I was pleased to read recent reports that a Kenyan researcher has launched a lawsuit against Oxford University and eight British scientists, alleging fraud and theft of his samples and research materials (see Row over use of data from Kenyan 'AIDS orphans'). Lawsuits of this nature are long overdue in developing countries, if only to clarify some of the issues at stake.

This is especially true at a time when the international community is grappling with issues related to benefit sharing with developing countries — such as Kenya — which experience diseases that attract research funding and collaborative research arrangements with developed countries.

Some previous disputes appear to have been resolved the traditional Kenyan way, namely through "naming and shaming" — and eventually reaching an amicable settlement. Even without going into the merits of the most recent lawsuit, it is clear that, from a policy perspective, an incident of this nature should serve as a wake-up call for Kenya's policymakers and legislators, persuading them to rethink the prevailing situation in the country's clinical research environment.

For such research is not just a national issue, on which decisions can be postponed until an opportune moment. Clinical research is a dynamic and changing field that often involves international regulatory issues, especially when researchers and scientists have obtained funding from other developed countries. Several wake-up calls have been sounded in the past, but other issues seem to have been given priority. It is high time that the regulation of clinical research was itself given urgent priority if we are to protect Kenya's research efforts from collaborators who may not have the country's best interests at heart.

Unheeded wake-up calls

A number of recent incidences have raised the urgency of addressing these issues. One is a set of trials on a potential AIDS vaccine trials being funded by the International AIDS Vaccine Initiative (IAVI). These are being conducted in three locations, namely London (United Kingdom), Nairobi (Kenya) and Entebbe (Uganda). The London trials started in April 2002, when the Uganda trials were already under way. But the Kenyan trials started much later, as a result of delays in the approval process.

One reason given for the delay was that the Kenyan National Council of Science and Technology (NCST) lacked the necessary funds to bring its members together to discuss the application. Indeed researchers have previously complained about the slowness with which the vaccine proposals were cleared by the NCST and the Kenyatta National Hospital's (KNH) ethics and research committee. Another apparent reason for the NCST delay was that its board lacks experts with adequate knowledge of the formulation and operation of the vaccine, requiring it to rely on foreign experts who may not always be easily accessible.

A second example is a dispute between the Department of Microbiology at the University of Nairobi, Kenya, and the Human Immunology Unit of Oxford University, United Kingdom. Researchers in the two institutions are collaborating on vaccine development for AIDS, based on the finding that some Kenyan sex workers from Majengo slum in Nairobi have an immune response to HIV that protects them from the disease.

Extensive studies were carried out on genetic material obtained from the sex workers to see if it could become the basis of an effective vaccine. Disagreement arose when the University of Nairobi scientists protested that their partners at Oxford had patented the HIV vaccine development process without giving them sufficient acknowledgment. The dispute was resolved by drawing up a new memorandum of understanding allowing the research to proceed. But it required several months of what one newspaper described as "name-calling, resignations and agonising moments that threatened the future of the vaccine and its patent ownership."

The most recent case involves another team of researchers from Oxford University that became interested in a nineteen-year-old orphan who was born HIV positive but continued healthy while his fraternal twin brother sickened and eventually died of AIDS. The issue came to public attention when initial results from a study being carried out by the scientists in collaboration with the orphanage were presented at the International AIDS Society meeting in Buenos Aires in 2001. The study was described as likely to contribute immensely towards the fight against HIV/AIDS. But reports in the media, published at a time when the orphanage was already discussing a draft memorandum of understanding with Oxford University, focused on whether the study had received the necessary clearance from government authorities.

The above incidents underline the problems caused by the fact that at present there is no clear national policy or legal framework that appropriately addresses issues and concerns in clinical research in Kenya. The existence of this gap was confirmed by a task force that produced a report to accompany the draft HIV/AIDS Prevention and Control Bill of 2002. This proposed that Kenya should adopt legislation bringing the country in line with international principles on biomedical research involving human participants.

The approval process in place

It is already clear that Kenya's current framework for reviewing research protocols is in urgent need of an overhaul. At present, government authorities, operating through the NCST, usually approve protocols covering clinical research.

KNH also attracts many research proposals owing to its facilities, and to the diversity of patients that are treated there. The hospital's ethics and research committee was formed to take charge of all research conducted within the hospital or the College of Health Sciences at the University of Nairobi.

In addition, the ethical review committee of the Kenya Medical Research Institute (KEMRI) vets all proposals for research that involve humans. The committee is multi-sectoral and multidisciplinary, with most of its members coming from outside the institute, to ensure its independence.

This system is now in need of revision to seal loopholes that may lead to the exploitation of Kenyan researchers, scientists and research participants. One particular concern is the lack of a concise policy or legal framework, especially with regard to the local application of international guidelines governing the international collaborative trials that NCST is often requested to approve.

Most countries with which Kenya collaborates in clinical research, including the United States and the United Kingdom, have statutes and statutory regulations governing clinical research. Kenya's lack of comparable policy and legal frameworks inevitably leads to an uneven playing field.

A glimmer of hope?

Despite this, it is encouraging to note that a specific objective in a five-year strategic plan for Kenya's National Health Sector, covering the period 1999-2004, has been to review, update and harmonise all health-related laws in the country. As the period covered by this strategic plan comes to an end, it is hoped that appropriate policy and legal frameworks will be put in place to effectively regulate clinical research in Kenya.

But a number of issues need to be addressed in order to create an enabling clinical research environment in the country. Firstly, clear guidelines are needed on the selection of research participants. In other words, in what circumstances is it ethically acceptable to propose that a prospective participative should take part in a planned clinical trial?

Secondly, there should be clear guidelines for assessing potential benefits and risks. In the Oxford/Nairobi research on a potential HIV/AIDS vaccine, for example, how should benefits for the participants (the Majengo slum sex workers whose genetic material contributed substantially to the research) be assessed, given that prostitution is a criminal offence? Should, for example, the two institutions agree to set up a community development project in Majengo with some of the profits/benefits that they eventually derive from the vaccine's patent, not only being used to alleviate poverty in the slum, but also to provide community members with a more legal source of income than resorting to prostitution?

Finally, the regulatory framework should include a mechanism for ensuring the local application of broadly-based international research ethics guidelines, such as the Declaration of Helsinki, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects, published by the Council for International Organisations of Medical Sciences. These two international guidance documents leave considerable scope for the formulation of national guidelines to be followed by local ethics review committees. Kenya needs a proactive mechanism that keeps in step with ongoing international debates in research ethics and regulation.

The legal disputes quoted above demonstrate that Kenyans are now sufficiently sensitised to bring research disputes to court, rather than resorting to naming and shaming through the media — never an effective regulatory strategy, apart from its role in setting a political agenda.

It is clear that Kenya's courts need some law to deal with such cases. Gone are the days when the law was seen as primarily a distant follower limping along behind biotechnological advances. Today, law is increasingly recognised as "a primary vehicle for resolving disagreements about public policy and the treatment of real persons." [1] Putting it that way around emphasises the need for our policy makers and legislators to listen to the gentle wake-up call that the latest court case represents.

[1] Dworkin B.R. (1996) Limits: The Role of Law in Bioethical Decision-Making. Indiana University Press, p.2

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