Marlene Llópiz
President
Mexican Association of Medical Professionals Specialized on the Pharmaceutical Industry
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Global Reach Exposes Ethical Issues in Research

Wed, 09/07/2016 - 11:51

The increasingly global nature of health research, and in particular the conduct of clinical trials involving human subjects, and dealing with pharmaceutical drugs – whether reference drugs, biopharmaceutics, generics, or devices – has highlighted a number of ethical issues. This is especially true in those situations where researchers or research sponsors from one country decide to conduct research in another, in this case in Latin America. The research protocols might simply be one way of helping the host country address a public health problem, or they might reflect a research sponsor ́s assessment that the foreign location is a more convenient, cost-efficient or less troublesome site for conducting a particular clinical trial.

Sometimes, the hosting countries serve as sites where the drugs or devices have not been marketed or the region serves as a zone where trial conduction is less expensive, has a greater number of naïve patients and adequate sites, as well as experienced researchers. It may also be that for registration purposes in other countries, testing drugs/ devices in different regions helps companies accelerate submissions to regulatory authorities in their home countries.

Other studies may serve as a joint effort to address an important health concern faced by both parties, as in the development of vaccines due to the outbreak of an epidemic or a public health issue. In these situations, sponsors and hosting countries rush to solve an emerging problem that requires an immediate solution. Ethical issues should not be left aside, no matter the urgency.

Whatever the reason, as the pace and scope of international collaborative biomedical research have increased during the past decade, long standing questions about the ethics of designing, conducting and following up on international clinical trials have re-emerged. Some of these issues have begun to take center stage because of the concern that research conducted by scientists from more prosperous countries in poorer nations that are more heavily burdened by disease may be seen as imposing ethically inappropriate burdens on the host country and on those who participate 

in the research trials. The potential for such exploitation is cause for a concerted effort to ensure that protections are in place for all persons who participate in international clinical trials. This is heavily enforced by the regulatory agencies and ministries of health in all Latin American countries.

As a first step, in most Latin American countries research protocols are carefully reviewed by ethics committees that may be externally contracted agencies serving as a third party for approving trials or as part of the hospitals/sites where the trials will be conducted.

This is often followed by state or national regulatory agencies dedicated to the detailed review of all trial documents. In some countries, both state and national agencies are in charge of reviewing all paperwork related to a clinical study. After the protocol is reviewed, the most important document that follows is the informed consent form. This special document is reviewed by several entities for the protection of the participants. In countries, such as Mexico, additional paragraphs are added to the informed consent form detailing special law-abiding conditions, as well as the need for two witnesses to sign when participants agree to partake in a trial. This is in addition to requiring insurance for the patients during their participation in a clinical study.

Inversely, scientists from developing countries are becoming more involved as collaborators in research, as many of their home countries have developed their capacity for technical contributions to research projects and for appropriate ethical review of research protocols. Clear examples are researcher-initiated trials. Although the source of funding for such collaborative research is likely to continue to be the wealthier developed countries, collaborators from developing countries are seeking to take part in the research enterprise. These may be through international organizations, pharmaceutical sponsors or government agencies. In either direction, ethical issues have to be carefully reviewed and considered.

The current landscape of international research also reflects the growing importance of clinical trials conducted by pharmaceutical, biotechnology and medical device companies. It seems as if market forces have pressured governmental institutions to become more efficient in reviewing the types of clinical trials that enter the designated countries in the conduct of research. ministries of health in Latin America have become more rigid and careful in analyzing study documents. They are now known for taking their time in reviewing protocols, insuring that patients are not disregarded, are carefully guarded and cared for. Although the extent, relevance and force of these pressures are widely debated, it is clear that such pressures can exist regardless of the funding source.

Complex and important ethical concerns are likely to be more pressing in clinical trials than in many other types of research investigations. Other major topics addressed when reviewing ethical issues are the choice of research designs, especially in situations where a placebo control is proposed when an established effective treatment is known to exist; issues arising in the informed consent process in cultures whose norms of behavior differ; what benefits should be provided to research participants and by whom after their participation in a trial has ended; and what benefits, if any, should be made available to others in the host community or country. Governments often require treatments to be continued and provided free of charge to participating subjects until the patients succumb or the treatment is available for purchasing on the market.

Many issues come into play when dealing with the ethical aspects of clinical research whether sponsored by a pharmaceutical or device company or investigator initiated. Special consideration must be given to trials in children, in the mentally disabled, in the elderly, in the blind, etc. When deciding on conducting a trial in Latin America, careful consideration should be given to the ethical issues involved in protecting participants. It is no different in Latin America, nor should it be.