Biology Reference
In-Depth Information
Medical research is subject to ethical standards that promote respect for all human sub-
jects and protect their health and rights. Some research populations are particularly
vulnerable and need special protection. These include those who cannot give or refuse
consent for themselves and those who may be vulnerable to coercion or undue influence
(WMA 2008 ).
Through this latest revision, the Declaration of Helsinki's potential to overex-
tend vulnerability has been at least partially reversed. The declaration does not
provide a definition of 'vulnerability', but instead picks out two groups: those who
cannot give or refuse consent and those vulnerable to coercion or undue influence.
In doing so it leaves wide open the question of who is considered vulnerable and
who is not.
Above we cited a list compiled by Samia Hurst of types of populations that
could be regarded as vulnerable. The list gives some idea of the multiplicity of
such groups. It also indicates a tendency to first identify vulnerable groups and
then judge whether individuals are vulnerable on the basis of their membership
of such a group, without identifying any specific potential harm. For example, an
unemployed person in a welfare state such as Sweden is not generally vulnerable
to exploitation in scientific research, whereas an unemployed person in Zimbabwe
is very likely to be. The former does not face any particular risk of exploitation
and is almost certain to enjoy the benefits which result from scientific research
through national health care provision. The latter is much more likely to become a
victim of exploitation because participation in scientific research might be his only
avenue to access health care.
When we have to decide whether someone is vulnerable in the research con-
text, rather than ask whether she belongs to any group previously identified as
vulnerable, we should ask whether there is any substantial probability of identifi-
able harm to her, and whether there is a lack of ability or means for her to pro-
tect herself. We cannot list here every possible harm which could be incurred by
participating in scientific research, but we can describe four basic markers for the
occurrence of harm in the research context:
1. Unfavourable risk-benefit ratio
2. Breach of confidentiality or privacy
3. Invalid consent
4. Lack of access to the benefits of research.
The possible harm in question is not necessarily either physical or psychologi-
cal. It is possible to exploit people without harming them physically or emotion-
ally. It is even possible to exploit research participants without them knowing it,
for example if they do not receive the benefits required by justice and fairness.
Therefore we have to understand possible harm to include violations of rights to
well-being, autonomy and justice.
Let us now look at each of the four markers. First, if there is an unfavoura-
ble risk-benefit ratio, the research participant is suffering harm or is placed at
unnecessary risk as weighed against the potential benefits gained. (Here ben-
efits are understood narrowly as the immediate personal benefits of participating
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