Over the past few months, I’ve fielded a number of questions from faculty members interested in conducting scientific research while on a Clinic Abroad trip. In each case, I have had to discuss the challenges of doing so, because the conduct of human subject research in foreign settings is fraught with legal, moral and ethical issues. And as much as I truly hate being the bearer of bad news- for after all, my role is in part to enhance research scholarship- there are good reasons to raise those challenges. I thought I would use this entry to briefly discuss the ethics of international research.
As human activity globalizes, there has been increasing concern about international research ethics since a significant amount of drug research now occurs in third-world and developing nations. Not all of this has been without controversy. In the United States, our research ethics has been guided by the Belmont Report (1), which itself was based on the Declaration of Helsinki (2) [which was itself based on the Nuremburg Code (3) that developed immediately after the end of World War II]. While these codes and accords began with the protection of subjects involved in non-therapeutic research (that is , research that provided no benefit to the subject), it has been universalized to those who also participate in therapeutic research ( where there is a potential for subject benefit, not a guarantee). Arising from this is the key bioethical precept of informed consent. Quoting my former instructor Dr. Erin Egan, “Informed consent in research is a complex issue even in the United States, and research in other countries adds several levels of complexity.”(4) Beyond that, other areas of concern include (a) Vulnerable populations issues, (b) Informed consent issues, and (c) Social justice and societal benefits issues.
Vulnerable Populations: Major pharmaceutical companies look to overseas regions because it is cheaper and they might be able to use study designs that would not be approved for use in the United States. Costs are lower because potential participants are likely to accept far less monies that subjects in the US would, and because poverty may ultimately override their normal caution in considering participation. If you obtain participants because of poverty and desperation, this can be problematic; it is not unethical in and of itself to simply offer lower costs and payments. And consider this: if you do an AIDS trial in, say, Mozambique because the design you are using is not ethical in the US, and you are not offering any care once the trial is done, and the people of Mozambique will not be able to use the drug under development because it will cost too much; you are taking advantage of the population since they will never benefit from the results, and you are then using them to help develop a drug to be sold in the US alone. I think we can see the problem here. The current standard is that all research participants are entitled to the worldwide best standard of care (as opposed to the standard of care as offered in that country, said standard of which may be no care at all).
Informed Consent: This is hard to address in the USA as it is; it is even harder when you factor in language and cultural issues, as well as lack of education. How can we translate our English language consent forms into another language and retain the nuances of the document, and ensure it is written at an appropriate level? How well do we understand the culture itself? Do we need to involve community leaders or tribal elders? How do ensure that women are not coerced, without our knowledge, into participating or not participating?
Social Justice and Societal Benefits: There now exists both national and international guidelines about what comprises acceptable research in foreign populations. These are designed to help limit the concerns we might have about using one population of subjects for the primary benefit of another more advantaged population. Thus, one stipulation of this consensus is that the research must benefit the population studied; it makes sense, for example, to study Malaria in a country where it is endemic, though it might be less ethical to study the effects of a new drug for obesity in such populations. A second issue is that of subsequent care- you should not come into an area, conduct research and then leave without considering providing some consideration of the subsequent health needs of the community. This may seem less critical for chiropractic care, since it is not generally addressing life-threatening diseases, but it is still no less true. In countries with poor infrastructure, how do ensure this happens?
There is also one other consideration, and that is ethics review. We have a Palmer IRB which reviews research conducted by Palmer faculty and researchers. When working in another country, we need to follow their laws as well as our own, and this means we need to have IRB review done by both the Palmer IRB and a local IRB in the country of interest. We need to be sensitive to the health ministry and its regulations as well. This needs to be studied, since it varies by country. The National Bioethics Advisory Committee has said this on this issue: “Recommendation 5.2: The U.S. government should not sponsor or conduct clinical trials in developing countries unless such trials have received prior approval by an ethics review committee in the host country and by a U.S. Institutional Review Board. However, if the human participants protection system of the host country or a particular host country institution has been determined by the U.S. government to achieve all the substantive ethical protections outlined in Recommendation 1.1, then review by a host country ethics review committee alone is sufficient.” (5)
Given all these considerations, I hope you can see why I have been so cautious about the development of foreign-based projects during Clinic Abroad trips. This is not to say we cannot consider such research, but it will take significant planning to be able to develop such a project successfully.
1. http://ohsr.od.nih.gov/guidelines/belmont.html, accessed April 27, 2010
2. http://www.wma.net/en/30publications/10policies/b3/index.html, accessed April 27, 2010
3. http://ohsr.od.nih.gov/guidelines/nuremberg.html, accessed April 27, 2010
4. Egan E. Course notes, week 11, Research Ethics. Loyola University, Nieswanger Institute of Ethics, 2009
5. National Bioethics Advisory Committee. Ethical and policy issues in international research: clinical trials in developing countries. Bethesda, MD, 2001