Improving human rights for better ethics in research
Bebe Loff is Associate Professor and Head, Human Rights & Bioethics Unit in the Faculty of Medicine, Nursing and Health Sciences at Monash University in Australia. Prof. Loff is an activist who has worked with community based groups locally and internationally, and a lawyer.
In this interview she discusses ethical issues concerning research with vulnerable populations. She suggests that there are parties to research whose behaviour is not properly addressed by traditional research ethics and proposes measures which might be considered with particular relevance to the conduct of research in developing nations.
1. How would you describe ethics in health research?
Ethical issues in research essentially take two forms: the structural (economic and political) and the particular or relational, both of which deserve attention. By the particular I mean the kinds of interactions that take place between researchers and participants and those matters that are the traditional focus of ethical review. Since research ethics adopts a clinical model, this focus seems natural.
I use the term structural to refer to where power rests and who makes decisions about what research is done, why, in whose interests and what and who gets left behind. Far more ethical energy is directed towards the personal, possibly because it seems manageable. Even so, our systems for scrutinising research practice have marginal impact on the ways in which research might be conducted. A great deal depends upon how researchers interpret their responsibilities and the intentions of the funders of research.
2. Why are ethics in health research important, to citizens, or other beneficiaries of health research who are not directly involved in health and health research processes? How can good/ bad health research ethical practices affect society?
Society has an intrinsic interest in ensuring that all human activity is conducted sensitively, in the interest of others, and after a process of informed reflection. The usual sorts of answers to this type of questions are, for example: the results of research which has not been conducted ethically can be unreliable, or bad ethics produces bad science. As we know, in extreme instances, torture has masqueraded as research and has been a manifestation of societies which have come to ignore the humanity of certain groups and who fail to respect the basic rights of all, which is a fundamental entitlement. How people can come to believe that such behaviour is correct or desirable is likely the result of being inured to lesser breaches of ethical standards, such standards having been established to avoid the ill-treatment of others.
3. Who is responsible for addressing these ethical requirements?
States, by virtue of their legislative, economic powers and human rights obligations are responsible for addressing ethical requirements. Multi and bilateral agencies, corporate bodies and others whether private or public are also part of it. The UNESCO Declaration on Bioethics and Human Rights addresses itself to States, individuals, groups, communities, institutions and corporations, public and private. The difficulty is that the ethical obligations that apply beyond the relationship between the researcher and the participant are not well articulated.
4. An increasing amount of clinical research by pharmaceutical corporations is now being conducted in developing countries. How should these companies share positive results of trials with the clinical site country? How can they build the capacity of national research by conducting their trials in a certain way?
While the proportion of clinical research conducted in the developing world is rising, most clinical research is carried out in the United States by pharmaceutical companies.
Another option that governments in developing nations might consider is the imposition of strict legal requirements on investment by foreign corporate entities. This could encompass preconditions such that companies are subject to screening prior to investment and be required to demonstrate that there will be local economic benefits and/or that the investment is in the national interest.
Countries might impose ceilings on allowable foreign equity and limitations on foreign shareholding (ranging from total prohibition to something like 49%). Constraints might be imposed on the number and type of positions that can be held by foreign nationals including membership of boards of directors, and in management. Countries may specify that foreign investment activity is allowable only in the form of joint ventures. Countries might impose requirements for technology transfer.
I have more confidence in the potential impact of regulatory mechanisms such as these than the less specific requirements contained in ethical guidelines. At the same developing countries need to focus attention on educating their own populations so that they are able to take on these responsibilities. Most importantly, the mechanisms that corporate bodies use to transfer capital from State economies to themselves must be investigated by government and regulated.
5. How should research with vulnerable populations such as sex workers, illicit drug users, men who have relations with men, refugee populations, people living in poverty be conducted?
Research of this nature should be conducted very tentatively and with respect. I see vulnerability as the deprivation of basic human rights and/or an inability to exercise those rights. Any research that is done in these populations is highly unlikely to alter their situation of vulnerability and is probably not intended to do so.
The likelihood is that the researcher/ sponsor/ funder is using the participant instrumentally (though not necessarily consciously or intentionally) – and that the researcher/sponsor/funder will prosper in some way as a result of doing the research. Even if the participant derives some sort of benefit, it may not be meaningful to them. The research process may ultimately be burdensome, having failed to produce any sustainable long-term (or even short-term) improvement of basic rights. Even when the participants derive benefit, this does not, in my view, address the inherent moral problem of exploitation in research. Another form of response is required.
6. How else can low and middle income countries safeguard themselves against exploitation in research?
Short of NOT participating in externally funded research, they can’t really. This question is the subject of a paper I and others are working on where we make a few suggestions. Significant will on the part of government is required.
Ultimately for reasons we explain, in order to redress the inherent exploitative nature of such research, the research content and process must direct itself towards lessening the vulnerability of the population by attending to the improvement of their basic rights.
This can only happen by ensuring consistency with a programme of development that is directed towards improvement of human well-being and not simply economic productivity.
7. What ethical capacity is needed for researchers in low and middle income countries? How can governments and research institutions help build this capacity? Can you give examples of specific skills needed by specific professionals in the health research sector?
I would like to reshape the way we think of ethics in research and make all research partners ethically accountable in different ways. Research ethics and our current system of ethical review primarily consider the relationship between the researcher and the participant – and on occasion the participant community.
This is an unnecessarily limited vision and it means that those who really drive what happens in research escape rigorous scrutiny. We all need to go back to the drawing board, and the skill we need is the capacity for critical and informed reflection.