The past few years have seen various attempts to reduce bureaucracy. As part of this, Brazilian human and social scientists have pushed for changes in the ethical and legal framework of all types of research involving human beings, an issue that has caused discontent among these researchers.
The issue is not that they oppose the ethical principles, such as respect for human dignity and the protection of research subjects, which guide these regulations. Rather the point is that the rules, created primarily to regulate biomedical research, do not meet the specific needs of social science.
The main concern is that the system imposes the same rules for two different kinds of research: research into human beings, for example to develop and test new drugs, and research with human beings, which uses ethnography, observation and interviews to understand social behaviour.
The situation is aggravated by the entire system falling under the remit of the National Health Council, part of the ministry of health. Both the council and ministry are made up mainly of representatives from the medical sciences. As well as judging the ethical implications of research projects, the council has been judging their scientific merit too, and this includes projects outside the medical field and so outside their expertise.
“The problem is that the rules and guidelines, with adjustments here and there, were extended to all research involving humans, without taking into account the very different research traditions these have.”
These incompatibilities result in complicated and embarrassing situations. For example, an anthropologist who studies Kanamari Indians would need to get a document signed by this tribe — who do not have written culture — saying that they agree to participate in the study, which, by current ethics rules, is itself considered high risk simply because it involves indigenous people.
The first question to consider is why the debate about, and decisions on, the ethics of scientific research involving human beings mainly occur in the health and biomedical sectors. The second is why the specific rules of those fields are considered applicable to research that is completely different in nature.
The answers to these questions lie partly in history. After the end of the Second World War, discussions on research ethics began in response to crimes committed during the war in the name of medical progress. These included using mosquitoes to infect healthy people with malaria, and studying gangrene by withholding treatment from injured people. It was in this context that the Nuremberg Code of 1947 was drawn up, the first document to set out international rules based on universal ethical principles to protect participants in scientific experiments.
After this came global agreements and national rules that had similar intentions, although they have not always succeeded in preventing further atrocities. In the early 1970s, for example, news of the Tuskegee scandal broke — an experiment in the southern United States, where treatment was withheld from 400 poor African Americans with syphilis, in order to observe the disease’s natural progression. This made it clear that the rules on ethics in human research needed to be strengthened and properly enforced.
Brazilian legislation on human research is based on the general principles of these ethical rules. The problem is that the rules and guidelines, with adjustments here and there, were extended to all research involving humans, without taking into account the very different research traditions these have.
The third question that arises is more complex: why is it so hard to change this legislation? There is no lack of will and effort on the part of social scientists. Through different organisations and associations, they have called for the system governing research ethics to be adapted to the specifics of their fields.
There was an important victory last month, when the National Health Council approved a resolution on ethical standards to be followed by researchers in the human and social sciences. This was the result of a working group established by the National Commission for Research Ethics — the main body of the system regulating research ethics — to discuss the issue. The new rules would see an evaluation system to assess the ethics of research projects and to judge their specific degrees of risk, enabling research projects of very different types to then follow different approval procedures. This makes much more sense and is considered an important achievement. Other improvements include restricting the evaluation system only to the ethical dimensions of projects, rather than their scientific merit, and requiring equal numbers of biomedical and social science researchers on their boards.
However, such improvements will only come when the project gets final sign off from the ministry of health, and, given the political changes and ministry shake-ups the country is undergoing, there are concerns this could prove elusive. There is also no forecast for when the body needed to implement the new guidelines will be established, nor any date for when the debate within the National Commission for Research Ethics and its working groups on the degree of risk will take place.
So there is still a long way to go.
Part of the problem is that dialogue between the biomedical institutions at the forefront of the existing research ethics system and the human and social science organisations that want to change the situation has not been very calm at all.
And here comes a reflection on my third question. For biomedical researchers, the regulatory framework works relatively well despite bureaucratic obstacles, and constrain the power they hold in the system. Why, then, would they want to transfer some of that power to the human and social sciences?
The impression all this leaves is that the issue of regulatory frameworks on research ethics involving human beings in Brazil goes beyond the typical problems of bureaucracy. It is about power and power struggles in Latin America, and exposes the gap between the two science cultures.
Carla Almeida is a Brazilian journalist specialising in science and a researcher in science communication and public understanding of science. She has collaborated with SciDev.Net since 2005.
This is a version of a piece produced by SciDev.Net’s Latin America & Caribbean desk.