Beyond ethics: biomed research and the poor
Takafira Mduluza says ethics are only part of what makes biomedical research work in poor countries — insight and compensation are as vital.
Biomedical research must adhere to ethical norms, but in poorer countries there are considerations above and beyond them. In particular, attention must be given to understanding community hierarchies and the need for adequate compensation, financial or otherwise, as well as the role of researchers in improving local health education.
Involving the right people
When designing a clinical study in the developing world, ethical approval must be obtained from governing research ethics committees. But many researchers overlook how important it is to engage local communities themselves in the approval process.
Communities must be able to determine what they want to get out of participating in a study, if only to safeguard future participation. Local institutional review boards protecting resource-poor participants should involve local leaders in determining from the outset the rewards due to the whole community within the study budget. This will improve local people's confidence in the study.
Understanding community hierarchies is also essential when making contact with that community. Resource-poor communities are often communally 'owned', with certain sectors empowered to make decisions for the whole village. Yet sometimes researchers' efforts concentrate solely on obtaining an individual's consent. Local leaders can stop a community from participating in a study, regardless of any approval granted from external committees — and even if some individuals have already agreed to take part.
The most effective way to involve the community is to inform its 'gatekeepers' of the gains expected from the study, and give them some responsibilities in deciding appropriate compensation.
A fair level of compensation
Indeed, the lack of such compensation or incentives for participants is perhaps the biggest problem facing clinical trials in resource-poor settings. Denying study participants their dues may make working with them on future studies particularly difficult.
Safeguarding the ethical norms of a study population is the responsibility of regional research ethics committees or institutional review boards. Ethical approval through these bodies usually focuses on getting individuals to give informed consent to participate in the study. But ethics committees and boards should also be responsible for ensuring appropriate compensation to individuals and communities alike.
Most biomedical studies involving biological or pharmacological trials consider the potential contribution to science as the major incentive. But in resource-poor settings like Africa, compensation could more realistically be made as financial donations to local institutes or organisations, or take the form of cash, goods, food or housing benefits for individual participants.
Payment can also be made to the community as a whole. For example, communities that agree to participate in malaria control and vaccine trials in Tanzania and Mozambique are issued with free bednets.
A lack of clear guidelines makes it difficult for review boards to clearly determine at the outset of a study what the appropriate level of compensation should be. A payment of sorts is clearly necessary. But standards are needed to make sure that any payment made is not coercive and does not present undue influence.
And unless there is a clear need for communal development — as identified by community gatekeepers, not local bureaucrats — compensation needs to be targeted at individuals. Governments also need to ensure that any tax collected from foreign trials does not impede compensation to individuals and local communities.
Promoting better understanding
One often-overlooked potential benefit of a clinical trial or study is local improvements in health education. Participants in resource-poor countries often want to learn about the health problems afflicting their communities and are normally eager to contribute to understanding disease mechanisms. Researchers have a duty to sensitise communities by providing information on the need for and potential benefit from the study. For example, it is not enough just to provide bednets to members of a malaria-stricken village — researchers must instruct local residents on how to use them and why they are important.
Local researchers have a unique relationship with participants in most of rural Africa, where they are trusted and held in high regard, especially if they speak the local language. Local people will often do what the researchers want, without question. Such relationships are open to abuse. To guard against this, researchers should engage in public meetings to map out local needs and promote understanding of the study. Local media can also help raise awareness of a trial and what it's for.
Resource poor-settings already have personnel sufficiently well-versed in the ethical concerns of protecting and safeguarding participants. It is the principles of remuneration that are lacking. But as resource-poor populations become increasingly aware of their rights as participants in biomedical studies and the contrasting compensatory attitude practised in developed countries, there will be no hiding away from the need for appropriate compensation.
Takafira Mduluza is a biochemistry researcher in the University of Zimbabwe.