Biology Reference
In-Depth Information
3.7 Brazilian National Guidelines on Post-trial Obligations
In addition to the international guidelines outlined above, some countries (e.g.
Brazil, Uganda and India) have introduced binding national law on benefit sharing
with human research participants. The Brazilian legal provisions on post-trial obli-
gations are described here as an example of such national measures.
3.7.1 Brazil's National Health Council
In 1996, the Brazilian National Health Council issued a resolution (No.196/96),
which emphasized the importance of post-study obligations. According to this res-
olution, research undertaken on Brazilian subjects
must
result in benefits for them.
Research involving human subjects, regardless of the field of knowledge, must … ensure
the research subjects the benefits resulting from the research project, in terms of social
return, access to procedures, products or research agents … (National Health Council
1996
: article III.3(p))
Through this resolution, the Brazilian government imposes a substantial obliga-
tion to provide post-study access to drugs and other successfully tested medical
interventions. It was initially unclear on whom the obligation rested, but this was
clarified later (see below).
The resolution also requires research involving human subjects
to guarantee that, whenever possible, research in communities is translated into benefits whose
effects continue to be felt after the research is concluded. The project must analyze the needs of
each of the members of the community and existing differences among them, and make clear
how such differences will be respected … (National Health Council
1996
: article III.3(m))
Such research must also
guarantee the individuals and communities where the research was undertaken a return
on the benefits obtained in the research. When it is really beneficial to foster or encourage
changes in practices or behaviors in the interest of a community, the research protocol
must include, whenever possible, provisions to communicate such benefits to the individu-
als and/or communities … (National Health Council
1996
: article III.3(n))
Section IV of the resolution, which sets out the terms of the freely given and
informed consent to be obtained from research subjects, states that they must be
informed of
any foreseeable risks or discomfort to the subject, as well as benefits that might reasona-
bly be expected, associated with participation in the research … (National Health Council
1996
: article IV.1(a))
One could assume here that the term 'benefits' includes post-study benefits,
but this is not explicit. An explanation of potential benefits (e.g. of a therapeutic
or diagnostic nature) is, however, always part of an informed consent process. In
addition, the resolution requires research subjects to be informed about
