[RIO DE JANEIRO] Brazil's National Health Council (NHC) has approved revised regulations on the ethics of research that, among other provisions, protect the rights of individuals over the genetic information that they provide for research into human genetic variation and gene-related diseases.
Under the new rules, those who provide samples for research from which genetic information is obtained will be able to choose whether or not to be told about any of their own genetic details that are discovered by researchers.
They will also have the right to remove their sample from research databases at any time. The new document also states that under no circumstance can information on an individual gathered through such research be made available to third parties (such as insurance companies, and current or future employers).
The rules — which entered into force on 9 August — were developed by council's National Committee of Research Ethics (NCRE), with the assistance of the Brazilian Society of Genetics.
"It is necessary to ensure people's privacy and right to information about their own genetic profile, and we welcome efforts to do so," says Mayana Zatz, who conducts research on muscular dystrophy at the University of Sao Paulo. "In the case of children, we must guarantee they have the option to decide, when they grow up, whether or not they want to know what's in their genes."
According to the NCRE's president, William Saad Hossne, the new rules update a 1996 law on the ethics of research that is currently difficult to enforce due to a lack of firm legal and technical details specific to genetic research. Previous updates to the 1996 law covered areas such as collaboration with foreign researchers, and scientific exchanges of gene and blood samples with other countries.
The new text repeats ethical concerns expressed in the 1996 law. But it replaces the general guidelines in the earlier law with a more thorough treatment of each aspect of the way samples are obtained, and of what happens to them after they have been collected.
The rules confirm the role of both local and national ethics of research committees, stressing that researchers must seek and respect the committees' decisions before conducting research. Also emphasised is the importance of 'informed consent' agreements that must be signed by each donor to confirm they accept the use of their genetic material by researchers.