A recent article in the Lancet argues that very little attention has been devoted to the relationship between external human rights contexts and the ethics of human research. The authors attempt to provide guidance on how to determine human rights conditions in a given region and whether, or under what circumstances, studies may be considered appropriate in regions with poor human and political rights records.
The authors explain how 'research ethics reviews' generally focus on the procedures and study design proposed by investigators e.g. whether participants are consulted or coerced, but that routine questioning about background settings and their effect on the risk/benefit equation of research is rare. They argue that neglecting to examine the pre-existing human rights conditions of participants could result in the approval of investigations with unacceptably high levels of risk. The paper describes how human rights and political considerations might affect the risks and benefits of research in five contexts.
Research into human rights violations
Research into the health effects of rights violations is inherently risky. Breaches of confidentiality could lead to retaliatory measures. Studies cannot proceed that place participants, researchers or monitors at substantial risk. Risk reduction poses challenges. Researchers must find new ways to work. For example, famine conditions in North Korea have been investigated by interviews with Koreans who have fled into China and were therefore not put at risk.
Non-political research, e.g. into malaria vaccines or micronutrient supplementation, is often proposed in settings with a dubious rights record. However, this can also carry risks. For example, in Rwanda census lists of orphanages and boarding schools were enumerated for research purposes. These lists included numbers of children, name, age, sex and ethnic origin. The lists were later gathered by government agents ordered to kill all children with Tutsi names or of Tutsi descent. Researchers must also learn what they can about possible retribution after they leave. Might participants be punished for associating with researchers? Might governments use the study to legitimise their activities to the outside world?
Research findings that could increase risk of violations
In some cases research findings could lead to harm, e.g. existence of a health condition or health practices may stigmatise the population.
Dangerous conditions for research staff
In countries with poor human rights, risks to local and expatriate research staff must be considered, particularly if findings may be construed as critical of government policy. Findings, for example, that show that child mortality is increasing or that malnutrition exists, might be seen by government as criticism of leadership. Local staff may be accused of bringing shame to the country.
Validity of research in certain human rights conditions
Research may be hampered by difficulties in obtaining valid data.
The authors also point out that informed consent is often the corner stone of research ethics. However, assuring that consent is voluntary is also challenging.
Against a backdrop of oppressive limits on individual freedom, citizens may fear reprisal if they do not participate in research, while government authorities may preclude any possibility of voluntary participation.
Ideally, the problems of the most disadvantaged groups should be addressed in research, and if a community is to bear the risk of research, it must also reap future benefits. However, under an oppressive government the most disadvantaged may be least likely to benefit from research findings. Institutional review boards should therefore ask investigators about the implementation plan for their research and steps to ensure that research findings are applied to the most at risk populations.
The authors make the following recommendations.
Researchers must learn about background human rights conditions as a pre-condition to conducting the research. There are several sources of information, e.g. human rights organisations, local NGOs, international media, under-ground movements, etc. These sources may be able to provide information on how particular procedures or questions in a proposed study are likely to be received. They may also be in the position to give guidance on local contacts or human rights organisations whose experiences may help assess the likelihood of successful future interventions in response to research findings. Indeed before initiating a study, investigators might need to consider whether there are barriers to implementation of study findings, such as might have occurred regarding women living under Taliban rule, and to investigate indirect methods of provision of study benefits.
If after completion of the above steps, it seems risks can be managed, adequate consent procedures can be designed and findings applied to the community, then official approval must be considered. Generally, studies have to be reviewed by an ethics board in the host country. Also, the Ministry of Health is normally informed of the study and asked for permission. If such approval is problematic, studies may need to be done clandestinely. An alternative might be to establish an outside international review board, comprised of representatives of a human rights organisation or NGOs to provide independent review. Such a review would be in keeping with the spirit of international regulations, in that a body more familiar with local conditions and most likely to have local citizens' interest at heart should provide permission.
The authors conclude that ultimately, if research does not relate directly to rights violations, researchers must justify why a study ought to be done in that setting as well as assuring protection for participants. Researchers might justify a location in terms of high rates of infection, malnutrition and other health problems, but there is no point conducting the research in situations where the social problems that caused disease will prevent future implementation of aid programmes.
1 Beyer.C and Cass.E (2002): Human rights, politics and reviews of research ethics. The Lancet, vol 360, July 20, pp 246-250