Not seeking ethical approval in developing countries

There are a number of possible reasons why researchers from developed countries may fail to apply for ethical approval in a developing country when they are conducting research there. These include: (a) ignorance, as in the case of the first author of the Smith and Neupane paper; some may assume that a developing country does not have a system or a working system for ethical review; (b) perceptions of cost; some may think that applying for ethical approval in a country is expensive and/or time consuming; (c) perceptions of certain research being exempt, for example, believing that certain health research does not need ethical approval; perhaps because it does not involve patients or health institutions or because it is ‘only’ a student project; and (d) arrogance or paternalism; some may feel that ethical approval from an institution in a developed country is good enough, if not better.

Applying for ethical approval in Nepal

Ten years ago, the Nepal Health Research Council (NHRC) published its ethical guidelines for health research in the country.8 The NHRC was created by an Act of parliament in 1991 to promote scientific study and high quality health research in Nepal. The published ethical guidelines discuss general principles of ethics, and include, among others, checklists for: (a) assessing informed consent; (b) scientific merit of research proposals; and (c) ethical questions. It also sets out eight steps for research which is sponsored and/or funded externally, which are reproduced in the box 1.

The box 1 clearly states that the NHRC expects that the researchers have gained permission to do research from their own institution's ethics committee (called IRB at most universities in the USA) and that they seek approval from the NHRC. It is regrettable that the authors, one of whom is based in Nepal, did not make the last step. The experience of submitting at least a dozen ethical applications in Nepal is that the system is relatively easy to use. The application form is available on the web and applying is not expensive. The comments one receives are generally relevant and helpful and feedback seems to be offered faster than in the UK. Moreover, we have never failed (yet) to gain research ethical approval in Nepal for our maternity care public health studies.

Developing countries such as Nepal often do not have the information systems to create an inventory of on-going health research, which means it is harder to keep an eye on the quantity and quality of such research. It makes it also less likely that research findings are appropriate for the country's needs and that the findings are, or can be, integrated into national health policy. Often, developing countries only have a snapshot overview of the total volume of health research when someone conducts a bibliography review of the published health research literature, for example, recently in Nepal.9 One of the additional reasons of applying for research ethics permission for the NHRC is that it adds that particular study to the register of health research in Nepal.

One wonders what the editors of Social Science & Medicine would have done if the boot had been on the other foot. What if an academic paper was submitted by an author based in Nepal who studied patients in, for example, the UK? If in the submission the author had stated that she had applied for ethical approval to her IRB at her university in Kathmandu to interview pregnant women who were smoking as they step out of an antenatal clinic in Sheffield or Bournemouth and suppose the authors' statement read something like: ‘Kathmandu University's Institutional Review Board exempted the study from review’, would the journal have considered this to be appropriate or sufficient?

Final thoughts

We do not want to imply that Smith and Neupane have conducted unethical or bad research; on the contrary, their research is excellent and timely.7 Moreover, it is the kind of health policy research that a country with limited research capacity desperately needs. Our key point is that resource-poor countries like Nepal will find it very hard to assess and control what health research is conducted within its borders (and when and where and how) if researchers from resource-rich countries do not inform them adequately. And if leading international journals do not enforce this requirement, what incentive is there for the next generation of researchers to go through the extra hoop of applying for in-country ethical permission?

Of course, editors of international journals cannot be expected to be aware of ethical bodies in every country, but perhaps they should start from the assumption that there are appropriate research ethics committees in every country to which researchers should apply. The editors should be convinced by the researchers that there was no appropriate local research ethics committee at the time of the study. In the mean time, it stays the responsibility of individual researchers to establish whether or not there exist an ethics committee in the country where they are planning to conduct their fieldwork/study.