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hough there were some statements of research ethics dating from the
early 20th century, they did not prevent physicians in Nazi Germany
and elsewhere from performing research on subjects that clearly vio-
lated fundamental human rights. Following World War Two, some of
these physicians were tried and convicted by a special tribunal at Nu-
remberg, Germany. The basis of the judgment is known as the Nu-
remberg Code, which has served as one of the foundational documents
of modern research ethics. Among the ten principles of this Code is
the requirement of voluntary consent if a patient is to serve as a re-
search subject.
The World Medical Association was established in 1947, the
same year that the Nuremberg Code was set forth. Conscious of the
violations of medical ethics before and during World War Two, the
founders of the WMA immediately took steps to ensure that physi-
cians would at least be aware of their ethical obligations. In 1954, af-
ter several years of study, the WMA adopted a set of Principles for
Those in Research and Experimentation. This document was revised
over the next ten years and eventually was adopted as the Declaration
of Helsinki (DoH) in 1964. It was further revised in 1975, 1983, 1989,
1996, and 2000. The DoH is a concise summary of research ethics.
Here is a brief description of the principles, taken primarily from the
DoH:
Ethics Review Committee Approval
“...every proposal for medical research on human subjects must
be reviewed and approved by an independent ethics committee before
it can proceed.”
Scientific Merit
“...medical research involving human subjects must be justifiable
on scientific grounds”. If patients are being asked to participate in a
research project, even where risk or harm is minimal, there should be
an expectation that scientific knowledge will be the result.
Social Value
“...social value has emerged as an important criterion for judging
whether a project should be funded.”