Clinical research is going global. The number of trials conducted in countries like India and China is steadily growing and a significant proportion of marketing applications for new drugs in countries like the US include data drawn from clinical trials conducted in other jurisdictions.
When pharmaceutical companies outsource trials to emerging markets a number of ethical issues come to the fore. Some of these are very similar issues to those that you’d find in research conducted in industrialised countries; the need to ensure that participants provide valid consent and have their personal data protected is as ethically germane in Gabon as it is in Germany. However, when investigators based in high-income countries conduct research in low-income countries certain ethical dilemmas become much more pressing.
One such issue, which has not received much attention until relatively recently, is the question of whether ancillary care should be provided for research participants. Ancillary care is the kind of care that is needed to treat incidental findings – problems found “by accident” in the course of testing – but not injuries caused by the research (side effects from taking a pill for example) or to make research safe or scientifically valid.
Clinical investigators inadvertently uncover conditions unrelated to their research on a regular basis. For example, while conducting a trial of a new diagnostic test for chlamydia it is entirely possible that investigators will detect other sexually transmitted infections like genital warts. In richer countries investigators can easily refer participants for further investigation and treatment. But in poorer countries there is often insufficient provision of affordable healthcare.
It is tempting to think that there is no real ethical dilemma here. Many of the organisations conducting research in poorer countries have very deep pockets and it might be argued that these organisations should simply provide whatever ancillary care is needed. Sadly, it’s not quite so simple.
Researchers are often not well placed to provide care directly. Some investigators are clinically trained, but other are not, and even those with a clinical background don’t have the skills to treat every condition they encounter. A dentist is not qualified to carry out gynaecological procedures. Some treatments also require resources, such as operating theatres or intensive care facilities, that are simply not available in poor, rural, settings. Other conditions, like type 1 diabetes and HIV, can only be properly managed with life-long care. Arguably, research teams could try to provide long-term access to necessary medications after a trial is finished, but supply chain problems and difficulties with follow ups mean that this would be very difficult to achieve.
Given the degree of health need in some countries, if the best available treatment has to be given for every condition the research team encountered, research budgets would be seriously diminished. And this might impact on the team’s ability to carry out their primary goal – discovering new medical knowledge – and reduce the likelihood that sponsors would fund future research. If investigators try to provide extensive care to trial participants this could also disrupt national healthcare strategies and create further inequities.
This is not to say that investigators and their sponsors can simply wash their hands of any duty to provide ancillary care. Far from it. The duty to provide at least some treatment for incidental conditions has been vigorously defended from a number of ethical perspectives. In particular, it has been argued that entrustment and a number of theories of justice underpin claims to such care. An appeal to participants’ human rights to health or to the concept of beneficence could also ground a moral requirement to provide ancillary care.
The really difficult ethical question, then, is not whether the duty exists, but rather how demanding it is. In other words, how much care should be provided (or paid for) by investigators and their sponsors? Needless to say no simple formula exists for an answer. And as is often the case with research ethics, contextual factors are crucial in determining the right outcome. The seriousness of the incidental findings, the cost of providing care and the wealth of the sponsors are all relevant.
What can be said with some confidence is that the discovery of incidental findings in clinical research is predictable and that anyone planning to conduct research in low-income countries has an obligation to think carefully about what they can and what they cannot offer in the form of ancillary care. Research Ethics Committees and Institutional Review Boards, which have to green light all trials, should also make it clear to sponsors and investigators that a failure to provide reasonable amounts of ancillary care will lead to a withdrawal of ethical approval.