Dr Henry Silverman, the director of the MERETI program and a Professor at the University of Maryland gave a very interesting talk about the ethical debates in international research, especially in situations where investigators or research sponsors wish to conduct research in a resource-limited country.
Dr. Silverman began his presentation by noting the increase of clinical trials that have occured in the developing world during the past decade. Such an increase has been mirrored in Cairo University Medical School, whose REC received double the number of studies compared to last year. Half of these studies were international multi center trials. The issue is that the ethics has lagged behind this increase in clinical trials. In fact, the Al Jazeera Network did a commentary on this issue last Spring, please click here.
Dr Henry Silverman highlighted a number of ethical issues and questions related to the design, the operation and the follow up of international clinical trials. The first issue he discussed was related to the determination of the standard of care for the control group when research was conducted in resource-limited countries. The exact issue was whether placebo trials are ethical if there was an existing universal standard therapy that was not available in the host country. Dr. Silverman pointed out the specific clause from the Declaration of Helsinki 2008 stating that a new method should be tested against the best proven current methods. But, the guideline does not state whether that best proven current method represents the one administered locally in the host country or in the sponsor’s country.
This issue was highlighted by the AZT placebo trial, in which a short course of AZT (given to decrease maternal-fetal transmission of HIV) was compared with placebo, even though the new universal standard of care was long course AZT, which was not available in the host country. The argument against using the universal standard of care for the control group in resource-limited countries is that the cost of such treatment would be prohibitive.
Dr. Silverman then discussed the issues around informed consent, which respects individuals’ autonomy and decision making capacity. Obtaining a valid informed consent has been made difficult in resource-limited countries due to existence of illiteracy, poverty and lack of access to basic medicines. Dr Silverman concluded that even if individuals give their informed consent, this does not prevent exploitation in such situations, as vulnerable parties will typically consent to an unfair distribution of benefits, so long as the transaction represents the best available option.
The last part of the talk was about exploitation of human subjects in research and how this concern is raised in an unjust world. Dr Silverman showed how Helsinki as well as CIOMS guidelines justified medical research in developing countries if only any product developed will be “reasonably available” to the host community. But this is not applicable for all research settings. For example, if the study drug is expensive, then the population will not be able to afford it even if proven to be the best practice. Hence, commentators have advocated for a fair benefits approach, in which it is not “what” is given to the host countries, but rather “how much”. However, Dr Silverman raised an important question regarding “mutually advantageous exploitation” where the victim is treated unfairly, but is left better off than in the absence of the exploitative transaction, which is why the victim accepts the exploitative transaction. Hence, the question is to what extent can such “mutually advantageous exploitative” be accepted? Dr. Silverman then discussed that research should be regarded as a “social” institution that plays a large role in enhancing the human development of the country and hence, the benefits of reseach should ensure should be those that advances this goal.