Whose risk/benefit ratio is this, anyway?

It's a good question. An analysis of risks and benefits for study participants is considered central to the ethics of research, but how risks and benefits are determined remains tricky. Part of the job description of research ethics committees is to make such determinations, and the Belmont Report encourages use of quantitative risk data whenever possible, but it is unclear how often that actually happens. Anecdotally, there is a lot of eyeballing and back-of-the-envelope estimation of risks, if not outright speculation and magnification. And as for benefits, there is much disagreement as to what should count as a benefit in the risk/benefit assessment. Compensation and inducements are traditionally thought to be inadmissible; benefits that come with study participation ('inclusion benefits') are permitted in the mix by some, ruled out by others.

The problem of risk/benefit determination is not just a problem about how, but also about who. Traditionally, the work of making such judgments is something reserved for experts: bioethicists, researchers, research ethics committees, policy makers. This is one area in which the whiff of paternalism in research ethics is particularly strong. If anything, the perspectives of research participants and communities are regarded as ethically dangerous and problematic, particularly in cases where communities are poor and the prospective participants are hoping to gain medical benefits by joining research studies. An article in a recent edition of Tropical Medicine and International Health suggests that local communities make their own risk/benefit calculations about particular studies, which go far beyond whatever risks and benefits may be directly connected to study interventions. For example, the thought "How could my participation in this study possibly benefit my family?" is a consideration unlikely to appear in your standard risk/benefit discussions. What could be a benefit for participants may, from the perspective of an ethics committee, be literally invisible.

The authors state that much more research is needed into the complex links between socio-economic vulnerability, access to health care and the freedom to decide on participation in medical research. Seems reasonable. But whether such research will lead to a participant perspectives being more determinative of 'official' assessments of the risks and benefits of health research remains to be seen.

New work on ancillary care responsibilities

Health researchers in low-resource settings -- wherever they are located in the world -- are familiar with the following ethical problem: what if your research participant has a significant health problem that is unrelated or tenuously related to what your research is about? Do you have an ethical responsibility to do something about, and if so, why? Why is it your responsibility, rather than (say) the responsibility of your funder or the local government? And what exactly are you responsible for: giving health advice, giving a referral, or giving medical treatment? If participants in health research were not often poor, or were in better health, or had better access to adequate health care, this sort of thing wouldn't happen. But that is not the world we live in, and so we are left with the ethical conundrum of what is has been dubbed 'ancillary care responsibilities.'

Congolese colleagues of mine and I are convinced that the question of ancillary care responsibilities is a particularly fruitful angle for teaching research ethics in low-resource countries. The topic has a bit of everything, intricately related: the relationship between research and medicine; the problem of undue inducement; community engagement; the roles of research ethics committees; obligations towards research participants versus non-participants; provision of care as obligation versus act of charity; politics of international research priorities; benefiting participants versus concerns about data integrity; the social determinants of ancillary care needs. And so on. Our shared view is that approaching research ethics through the prism of ancillary care rather than the usual approach (history of appalling research abuses followed by discussion of informed consent) is a stimulating and locally relevant option in low-income settings that do not share that history and are not aggressively individualistic. With ancillary care, you can go from very theoretical discussions about the nature of the researcher-participant relationship to practical specifics about what responsibilities may hold for research on a particular condition in a specific setting. And back. A full workout for mind and heart.

The best bioethicists currently working on this issue, in my opinion, are Maria Merritt at John Hopkins University and Henry Richardson at Georgetown University. Merritt has published a number of articles on ancillary care (most recently with Holly Taylor in the Journal of Nutrition) which are models of the best bioethics can offer, both philosophically rigorous and relevant for real world decision-making. Richardson has just published an illuminating, sophisticated, and elegantly written book-length treatment of ancillary care. Critics of bioethics, read them and weep.

Health and Human Rights: new online journal

The journal Health and Human Rights has been around since 1994, and it started out under the editorship of Jonathan Mann. Paul Farmer has took over the reins in 2007, and now it has gone online and open access. The inaugural edition of the journal in this new format has a host of interesting looking articles, but my eye was caught by the piece entitled 'Notes on the rights of a poor woman in a poor country' by Tarek Meguid, Deputy Head of the Department ofObstetrics and Gynecology at Bwaila Hospital and Kamuzu Central Hospital in Lilongwe, Malawi. What is striking about the article is its graphic -- and moving -- description of a vast gap between the human right to health (often in the form of access to basic medical supplies) and what actually happens in health care centers in low-income countries like Malawi. The disjunction between rights and reality can be regarded as a source of inspiration and idealism, in so far as one recognizes the existence of the gap and is committed to narrowing it. But as Dr. Meguid's article illustrates, the commitment and idealism of health care workers in many parts of the world are subject to alarming challenges on every work shift. When the situation on ground is that dire, and the prospects for change seem dim, can the human right to health continue to function as an ideal, rather than a haunting spectre, a biting reminder of failure or source of profound shame?