human rights and legislation who resource book on mental health

The MI Principles <strong>and</strong> CIOMS Guidelines thus allow research involving persons <strong>who</strong> are lacking
capacity to consent if: i) the research is necessary to promote the health of the population
represented; ii) this research cannot instead be performed on persons <strong>who</strong> have the capacity to
consent; <strong>and</strong> iii) adequate procedural safeguards are followed.
It has been argued that although the ICCPR is legally binding on the governments that have
ratified it, whereas the CIOMS Guidelines <strong>and</strong> the MI Principles are not, in certain circumstances
it could be advantageous for people affected by particular conditions to allow research or
experimentation without consent, where this involves minimal risk of harm to the person; for
example, people with conditions (whether current or likely to present in the future) where all
affected are unable, due to their condition, to give informed consent. In such circumstances, the
consequence of not undertaking research with this group may be a reduced likelihood of ever
finding treatments or interventions that could cure or prevent the condition.
If countries do decide to legislate in favour of research or experimentation involving persons
unable to give informed consent, the CIOMS guidelines should be carefully followed.
Clinical & experimental research: Key issues
• Informed consent for participation in clinical or experimental research must be obtained
from all patients <strong>who</strong> have the capacity to consent. This is applicable to both voluntary <strong>and</strong>
involuntary patients.
In countries where clinical <strong>and</strong> experimental research is permitted with patients <strong>who</strong> are unable
to consent, <strong>legislation</strong> should include the following safeguards:
1. When patients are lacking capacity to give informed consent, they may participate in
clinical <strong>and</strong> experimental research, provided that proxy consent is obtained from legally
appointed guardians <strong>and</strong>/or family members <strong>and</strong>/or personal representatives, or by
obtaining consent from an independent review body specifically constituted for this
purpose.
2. Participation of patients <strong>who</strong> are lacking capacity to consent, by obtaining consent from
proxies or an independent review body, should only be considered when:
a) this research cannot be performed on patients <strong>who</strong> are capable of giving consent;
b) the research is necessary to promote the health of the individual patient <strong>and</strong> the
population represented;
c) adequate procedural safeguards are followed.
13. Oversight <strong>and</strong> review mechanisms
Most modern mental health <strong>legislation</strong> contains statutory safeguards providing for the creation
of review bodies to protect the <strong>human</strong> <strong>rights</strong> of persons with mental disorders. Such bodies fall
into two broad categories: (i) oversight <strong>and</strong> review of the processes regarding people <strong>who</strong> are
admitted/treated involuntarily; <strong>and</strong> (ii) oversight <strong>and</strong> review of the well-being of people with
mental disorders, within <strong>and</strong> outside mental health facilities. The former is a judicial or quasijudicial
function. The latter, although it may be provided in law, <strong>and</strong> penalties for not carrying out
its instructions enforced in some instances, does not operate as a “court” that can impose
restrictions on the liberty of individuals or decide that involuntary patients should be discharged,
for example. In many countries these two bodies are completely independent of each other, have
members with different expertise <strong>and</strong> have unique powers <strong>and</strong> functions; however, in other
countries one body may be legislated to carry out the full range of functions.
Whether one or two bodies are set up, independence is crucial. All review bodies should make
decisions purely on the merits of the situation before them, <strong>and</strong> should not be influenced by
political or departmental pressures or by health service providers.
Legislation should make provision for the composition, powers <strong>and</strong> <strong>resource</strong>s of these
authoritative bodies. It is also necessary to decide whether to have a body with national
jurisdiction or to have a number of review bodies functioning at local, district or regional levels
based on existing administrative boundaries.
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