Paying the price of research

Earlier this year, SciDev.Net ran an essay competition on research ethics. In this, the prize-winning essay, Robyna I. Khan argues that the practice of asking patients to fund the research they take part in is unethical and can lead to serious conflicts of interest for the researcher.

To fulfil the requirement for a fellowship, a resident in anaesthetics conducted research in which she compared two breathing systems. Thirty patients were included in the study, and the research was not externally funded. Patients who were selected and who agreed to participate were those who came to the hospital for treatment of diverse surgical maladies. They paid for their treatment, which included the cost of the research intervention. This scenario — my own experience — is from a teaching university hospital in a non-industrialised country.
 
Research in academia
Undertaking research has become an essential part of academic medicine. Research is either a mandatory part of postgraduate medical training or crucial for climbing academic ladders[1]. There is a palpable pressure on medical academics to publish. Indeed, the career advancement of clinical academics depends more on research output than teaching[2]. This pressure is just as pervasive in developing as is in developed countries. The unfortunate difference is the lack of sufficient resources to sponsor research initiatives in developing countries[3].

Another reality of the non-industrialised world, however, is paying for healthcare in the absence of third party funding. In the context of therapeutic research, the combination of the ‘publish or perish’ culture with the need for patients to pay for healthcare creates a troubling state of affairs — patients recruited as research participants not only pay for their treatment but also fund the research component of their treatment. This practice is unethical because the research participants are bearing the cost of the research and the inherent risks, with little or no additional direct benefits to themselves.   
 
Research by junior scientists in developing countries combines experiment and treatment. It could be the new use of an old drug (or technique), the use of an established drug in a different dosage, or different combinations of existing drugs used for their prescribed purposes. The research is often done to survive and prosper academically, but can sometimes be a mandatory part of postgraduate training. For a physician from a developing country, there is nothing new about the case mentioned above, but the ethical problems involved made me uncomfortable and started me thinking about the ethics of research that is funded by the research participants themselves.

The rationale used by most physicians is that the patients are willing to pay for treatment. If an intervention is used at no extra cost, there is no harm in it. My discomfort was because the participants were not going to achieve any direct additional benefit from the research besides receiving the treatment for their surgical problems. In addition, there were some inherent risks involved with the interventions that I was researching. This is not an isolated incident but an example from a common practice in the non-industrialised world. 

Conflicts of interest
Although patients may not see any extra benefit from being the subject of research, a researcher sees definite benefits in the form of promotions, journal publications and a boost to their curriculum vitae. I had a lot to gain from my research. I went on to write my dissertation and completed my fellowship. This type of situation creates a potential conflict of interest between researchers and research participants. Research participants fund the progress of academics in their professional careers, completely unaware that they are doing so.

Conflicts of interest are not inherently unethical. But they should be recognised and properly dealt with[4]. Declaration of conflict of interests upfront is essential and should be a minimum measure taken to resolve ethical problems. But it should not be the only measure. If the available resources are insufficient to support these research initiatives entirely, efforts should be directed to cover the cost of the experimental components. Universities where research fellows or junior researchers are being trained should take responsibility for providing research funds.

Doctor-patient relationship
Another ethical problem is the vulnerability of research participants and their ability to accept or refuse participation. Hans Jonas in his Philosophical Reflections on Human Experimentation writes about the patient as subject of research: “His physical state, psychic preoccupation, dependent relation to the doctor, the submissive attitude induced by treatment — everything connected with his condition and situation makes the sick person inherently less of a sovereign person than the healthy one”[5]. 

In most developing countries doctors are held in high esteem and it is uncommon to challenge or question their authority[6]. Patients are thus in a vulnerable position. It is difficult, if not impossible, for them to refuse an intervention that is not an essential part of their treatment. Although some patients appreciate that research interventions often carry inherent risks and are not a mandatory part of their treatment, they are unable to refuse the intervention because of this vulnerability. A solution to this dilemma would be the presence of a neutral third party who could intervene in this situation.

Alternatively, providing essential treatment for free could also be judged ‘undue inducement’. Many patients who cannot afford expensive interventions might opt to receive them by being research subjects. Guidelines by the Council for International Organisations of Medical Sciences support free medical services as reimbursement for participation[7].

To further neutralise the concern of undue inducement, the cost of a research intervention could be reimbursed at the patient’s discharge from the hospital. Often the total expenses of hospital stay are substantial, so partial reimbursement for the research component would not be an undue inducement. Ethics review committees are in a good position to assess this.

Recommendations
Recognition of the ethical problems associated with the issue of research participants as sponsors of therapeutic research is an essential first step. Acknowledgement of conflicts of interest and their disclosure when obtaining informed consent should be obligatory. When the participant is in a dependent relationship with the physician, the need for extra caution cannot be overemphasised as there is always a risk of consent under duress. In that case, the informed consent should be obtained by a well-informed physician who is not engaged in the investigation and who is completely independent of this relationship[8].

Parent institutes should take more responsibility for providing funds for the research initiatives of their trainees and physicians. They could do this by incorporating this expense into their institutional budgets or by earmarking a corpus fund from patients’ fees. 
Many teaching institutes and tertiary care centres in the developing world do not have ‘standard management protocols’. Developing these protocols and making them available to patients will make it easier for patients to identify whether some part of the proposed intervention is outside the standard practice.

Lastly, the publish or perish climate needs to change. This belief encourages excessive measures by imposing undue pressure on academia. Douglas G Altman writes: “We need less research, better research, and research done for the right reasons”[9]. Abandoning the idea that the number of publications is a measure of scientific capability would be a start.

The author is a consultant anaesthetist at The Aga Khan University in Karachi, Pakistan.

References
1. Fernandez A.R. (2000) Publication and Promotion: Call for Breaking the Link. Journal of Postgraduate Medicine 46, 163.
2. Stewart P.M. (2002) Academic Medicine: A Faltering Engine. British Medical Journal 324, 437-38.
3. Bhutta ZA. (2003) Practicing Just Medicine in an Unjust World. British Medical Journal 327: 1000-1001.
4. Lemmens T, Singer P.A. (1998) Bioethics for Clinicians: 17. Conflict of Interest in Research, Education and Patient Care. Canadian Medical Association Journal 159, 960-65.
5. Jonas H. (1970) Philosophical Reflections on Experimenting with Human Subjects. In Experiments with human subjects. P Freud, ed. Braziller NY: 1-31.
6. Moazam F. (2000) Families, Patients, and Physicians in Medical Decision Making: A Pakistani Perspective. Hastings Centre Report 30, 28-37.
7. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International Organizations of Medical Sciences. Geneva 2002. [Online] [Accessed 2004 February]. Available from URL:  http://www.cioms.ch/frame_guidelines_nov_2002.htm.
8. Ethical Principles for Medical Research Involving Human Subjects. World Medical Association Declaration of Helsinki. 52nd World Medical Association General Assembly, Edinburgh, Scotland, October 2000. [Online] [Accessed 2004 February]. Available from http://www.wma.net/e/policy/b3.htm.
9. Altman DJ. (1994) The Standard of Poor Medical Research. British Medical Journal 308, 283-84.