Abstract

Conflicts of interest are inherent to the majority of relationships among individuals and of these with companies and institutions and, certainly, research involving human beings is no exception. In relation to clinical research, the main focus of this manuscript, conflicts of interest occur at different levels and usually permeate among them:

• In the pharmaceutical industry in their decisions to invest to develop new products, especially vaccines and drugs, and also in relation to marketing of these products;

• Among the investigators the conflicts may be related to the financial gains to participate in pharma sponsored trials, or to the expected academic career boost attained with the publication of the results of the trials and also to personal interests such as the financial support for trips to international conferences. Often the participation of host country investigators is restricted to performing phase III or IV protocols developed abroad, many times with low scientific relevance, and even lower relevance to public health;

• Universities or research institutes themselves also have conflicts of interest, as the sponsored projects may help increase their budgets, both directly (taxes) and indirectly (e.g., improvement of physical infrastructure of laboratories or out patient clinics);

• For the trial volunteers in developing countries, and Brazil is no exception despite free and universal access to its health system, participation in clinical trials is many times seen as, and can really be, an unique opportunity of receiving better health care, better treatment by the health professionals, easier access to costly lab exams and also to receiving certain medications which would otherwise be difficult to have access to.

In order to handle these conflicts of interest, Brazil has a well-established and respected legal support and ethical normatization. The latter is represented by Resolution 196/96 of the Brazilian National Research Ethics Committee (CONEP). This national system was established in 1996 providing guidance to all research involving human beings and currently there are approximately 500 local research ethical committees certified by CONEP in all States of Brazil. However, there is intense international pressure mainly from the pharmaceutical industry especially to the ethical requirements emanated from the Declaration of Helsinki (DH), aiming to lower the level of ethical requirements in research to be carried out with volunteers from developing countries. Fallacious reasoning includes that the equity stated at the DH, especially the access to the best proven medical care and to the developed products to all volunteers independently of where the trial is being held, would inflate the costs of research and drive the sponsors away from the developing countries. In this line of thought, if the volunteers have not the same rights that would constitute an unacceptable double standard, or in other words, the best for the volunteers from developed countries and whatever is possible for those in developing countries. This manuscript will focus on the various levels where conflict of interest issues are more prone to happen, such as in the actions of pharmaceutical industries, their relation to health professionals, the participation of universities and research institutes, the ethical research committees and their members, including the possible pressures exerted on them by researchers, sponsors and even their institutions. Emphasis will be given to the interrelation between conflicts of interest and vulnerability, and also the causes and possible solutions to lower the risks of exploitation of volunteers in research. It will also emphasize the need to guarantee access to products that are proven efficacious to all individuals who may need them. Possible ways of empowering these volunteers will be evaluated, so that they become aware of their rights and demand for them. It will discuss the need of separating economic interests from the real needs of public health and of demystifying economic arguments used in order to justify the lowering of ethical requirements. And finally it will address the search for or the establishment of real and effective involvement of all stakeholders in an international organism really representing everyone (e.g., WHO) in order to evaluate, debate, and decrease the risks of several conflicts of interest, aiming at the establishment of research projects that can truly contribute to lower the obscene disparities of health between developed and developing countries.

Key-words:

Human experimentation, Clinical trial, Conflict of interest, Vulnerable populations, Brazil.