The justice factor must be improved when carrying out health research

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Research in the health sector is particularly notorious for its exploitation of the developing world. Despite the increased developments in the scientific arena, the concept of benefit sharing still remains relatively unexplored.

Benefit sharing ensures that everyone who participates in research gains from it. This does not imply a monetary transaction only. It can be any form of advantage, assistance or upliftment to the participant, community or institution.

The philosophical principle behind it is a matter of justice. Those who contribute to scientific research ought to share in its benefits. But it is not always clear how and with whom benefits should be shared, especially when research is funded by outside sources. The concept is sometimes questioned or resisted when developed countries perform and fund research activities in the developing world.

Bad - and good - examples

Traditionally, developed - or affluent - countries have argued that participating in scientific research should be altruistic in nature. But there are serious concerns about exploitation if this notion is exported into developing countries.

In one instance of exploitation, in the 1990s, a British anaesthetist was arrested and charged with murder for carrying out dangerous human experiments on 500 patients in Zimbabwe without their knowledge or approval from any relevant authorities. Up to six patients allegedly died because of his experiments.

In another case of participant exploitation, in 2001, pharmaceutical giant Pfizer was sued by 30 Nigerian families as a result of trials of the antibiotic Trovan, intended to treat meningitis.

About 200 children were given the drug without informed consent or approval by a local ethics committee. Eleven children died while some survivors suffered permanent brain damage and paralysis. In this case an out of court settlement was reached.

There are at least two benefit sharing agreements and arrangements which were successfully implemented in Africa to the advantage of the communities involved. The first is the case of participants in Majengo, a slum in Mombasa, Kenya. The second is the case of the San in South Africa.

In Majengo, follow up studies were conducted on 850 female sex workers in Kenya for research which could contribute to the development of a vaccine against HIV.

Here the main benefit for the women was access to non-discriminatory health care. The research team set up a clinic for them to freely access. Until then they were forced to use a local treatment centre where services were poor and they were discriminated against. They also received indirect benefits in the form of a “safe haven” by accessing the clinic. This enabled the women to form new relationships, social networks and a sense of solidarity, creating a community environment.

Research publications also gave the women international exposure. This could safeguard their rights to benefits that may accrue from ongoing research activities.

In specific response to the Majengo case, national guidelines for research and development of HIV/AIDS vaccines were developed. These guidelines provided a framework to address issues of financial compensation for research participants.

In the case of the San people, they were acknowledged for their traditional knowledge about the use of hoodia gordonii. This is a moist plant found in the Kalahari desert, which the San people customarily used to limit hunger on their tiring journeys.

At first the San people were unaware that an appetite suppressant was being patented and commercialised using the hoodia plant without their consent. But in 2003, with the help of a non-governmental organisation, one of the first benefit sharing agreements was negotiated. As part of the agreement the San people were provided with a share of the royalties derived from the sale of products containing hoodia.

The agreement is an example of how one of the first benefit sharing agreements was negotiated in South Africa in the absence of an enabling domestic legal environment. Although far from perfect and criticised to some extent, this agreement is an example for future ones where communities are allowed to receive recognition and share in the commercialisation of products based on their traditional knowledge.

Benefit sharing laws and guidelines

There are many international protocols on benefit sharing. These include the Nagoya protocol declaration on the human genome and human rights, the Council for International Organisations and Medical Sciences' international ethical guidelines for biomedical research involving human subjects and the Declaration of Helsinki.

In South Africa, the only legal document that defines and describes benefit sharing and benefit sharing agreements is the Biodiversity Act. It stipulates that the agreement must be approved by the Minister. It also sets out how the agreement should explain the extent to which resources should be used and the benefits shared and provides for regular review of the agreement.

But the Act excludes the use of human material and the benefits that should be derived from it. In addition, the South African National Department of Health’s ethics in health research guidelines also mentions benefit sharing. Although the guidelines refer to human material, they are not legally binding.

Most African countries are signatories to the international ethical guidelines that place a huge emphasis on benefit sharing.

Bridging the gap

To assist researchers with benefit sharing, in 2014 the University of the Witwatersrand approved a comprehensive Material Transfer Agreement template for human biological materials to be used by its researchers.

In this agreement benefits include (but are not limited to):

• the sharing of information,
• use of research results,
• royalties,
• acknowledging the provider as the source of the materials,
• publication rights,
• transfer of technology or materials, and
• capacity building.

Other institutions and the Department of Science and Technology in South Africa have shown interest in the template and its use is open access.

Providing adequate benefit sharing mechanisms will enhance confidence and trust in the research process, which will in turn attempt to restore a balance and ensure a sustainable research environment for research participants, researchers and institutions.

This article is based on a paper published in a special South African Medical Research Council Flagship edition of the South African Journal of Bioethics and Law.

Ian Sanne received funding from the National Institute of Health in the United States and is the CEO of Right to Care, a non profit organisation that supports and delivers prevention, care, and treatment services for HIV and associated diseases.

Safia Mahomed does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond the academic appointment above.