Monday, December 20, 2010

Informed consent in international research: the rationale for different approaches

Krogstad DJ, Diop S, Diallo A, Mzayek F, Keating J, Koita OA, Touré YT.
Am J Trop Med Hyg. 2010 Oct;83(4):743-7.

Abstract: "In developed countries, informed consent is based on the autonomy of the individual, a written description of the studies proposed, and previous experience of the participant with Western medicine. Consent is documented by the signature of the participant and supervised by institutional review boards (IRBs), which have conflicts of interest because they are also responsible for limiting institutional liability. In developing countries, the initial decision-making for informed consent is typically vested in the community rather than the individual, and illiteracy is common-limiting the value of written documents and signatures. The challenges in developing countries are exacerbated by the fact that persons at greatest risk of disease are often illiterate, have limited experience with Western medicine, and have limited understanding of the scientific rationale for the studies proposed. Given these differences, it is unrealistic to expect that consent strategies used in developed countries would be effective in such diverse settings."

Comment: In our concern for human rights we insist that people have the right to decide if they wish to participate in a research project. Indeed, we insist that people have the right to decide which if any treatment they should receive as patients of a medical practitioner. That position is based on the assumption that if provided with information on the risks and potential benefits of each alternative they will make reasonable decisions. For children and others thought by their condition to be unable to understand and decide rationally, we delegate the decision making to others who presumably have the welfare of the subject or patient at heart.

In some cases, of course, we weigh the welfare of the community more than the rights of the individual. We require immunizations against some communicable diseases for children entering school rather than allowing individual decisions by their parents as to whether the child will be immunized. We isolate patients with communicable diseases, refuse permission to market drugs deemed by the government to be dangerous or ineffective, force withdrawal of foods implicated in disease outbreaks, require milk to be pasteurized, and even impose quarantines on occasion.

I think the authors of the paper are helpful in suggesting a careful consideration of the basis of requirements of informed consent in international research. There are differences in cultural concepts of human rights. More important, our assumptions as to the ability of patients and subjects to make informed consent are unlikely to hold in many other societies. I suppose it could be argued that given enough time and effort, a patient or subject could be brought to fully understand the alternatives, but that seems unlikely in any practical system.

When I was involved in the management of international research projects I tended to punt, simply requiring that the project fulfill the informed consent requirements of all the nations involved. Thus an American university working with partners in a foreign nation would be required to meet the more restrictive requirements of both nations. It should be noted that the American policies are not always the most stringent.

Note too that informed consent has different meanings for subjects of biomedical research, for social research, and for economic research.

All in all, this is a very difficult area worthy of serious discussion and debate.

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