Página 63 - Dimensiones éticas de las regulaciones en salud

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In response to these concerns there has been an evolutionary growth in
guidelines to assist in the assessment of the ethical conduct of human
research. Notable among these are the Nuremberg Code, which is a very
brief code, to much more complex documents that have evolved over the
years including the Helsinki Declaration and the CIOMS Guidelines,
among others. Of note is the 1979 Belmont Report, which enshrined a
principle based approach to research ethics in the US context, eventually
forming the basis of the common rule. Currently, there is a proliferation
of guidelines and of different regimes for oversight. Many countries are
developing guidelines for ethical oversight and review, as are professions.
Central to these mechanisms is some form of review board, variably called,
institutional review boards (IRB’s) or research ethics boards (REB’s).
These review boards have the authority to approve, disapprove, propose
modifications to, or terminate any proposed or ongoing research involv-
ing human subjects. It is recommended that such boards adopt a propor-
tionate approach to research ethics review based on the principle that the
more potentially invasive or harmful the research, the more care should
be taken in its review.
These guidelines are meant to adhere to and uphold the moral impera-
tive of respect for human dignity and autonomous choice. This translates
into a series of correlative ethical principles such as respect for free and
informed consent, respect for vulnerable persons, respect for privacy and
confidentiality, respect for justice and inclusiveness, and balancing harms
and benefits. In a published article in the Journal of the American Medical
Association Ezekiel Emanuel and colleagues synthesized these principles
and created seven requirements for determining whether a clinical re-
search study is ethical(1). Their requirements state that research involving
humans should posses social or scientific value, that it be scientifically
valid, that it adhere to fair subject selection, that there be a favourable risk-
benefit ratio, that such research be independently reviewed, that informed
consent be obtained, and that respect for potential and excluded subjects
be adhered to. Emanuel et al. provided a series of benchmarks for these