Table Of ContentY a 16 Min
TS ten
i INTRODUCTION
1.1 The purpose of this paper is not to give legal advice, but to clarify and update
the Commission’s position and policy on research involving detained patients’
and the capacity of such patients to give informed consent to participation in
medical research. While this paper concentrates on the position of detained
patients, it is recognised that research involving such patients may have
commenced before they were detained, raising separate issues which are not
addressed here. The Commission’s policy seeks to incorporate and commend
good practice. However, the Commission does not seek to endorse any
particular procedure or to offer any formal advice on how to conduct clinical
trials on detained patients.
1.2 The issue of involvement in research by detained patients is approached on the
basis and understanding that each and every patient detained under the Mental
Health Act 1983 (the 1983 Act) should receive the best and most appropriate
medical treatment.
1.3. There is a fundamental difference between the position of the detained patient
and of other members of the community. Patients who are not detained have
the right not to receive treatment - they have a common Jaw right not to be
assaulted, or otherwise subjected to coercive and intrusive measures. On the
other hand, the detained patient, on admission to hospital, loses the nght not to
receive treatment. Part IV of the 1983 Act creates a regime both for
establishing the existence of consent to treatment and for allowing the
requirement for consent to be overridden, so that treatment can be given without
consent and contrary to the express wishes of the patient and his/her family.
2. DEFINITION OF RESEARCH
2.1 EWneg litsahk e Dais coounra rde:f inition of “research” the following from the Shorter Oxford
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; 225015484 84
The reference here to “detained patients” is to patients detained under any section of the Mental Health
Act 1983, and includes patients “liable to be detaingd”. be
W© rit
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‘An investigation directed to the discovery of some fact by
careful study of the subject; a course of critical or scientific
inquiry’”:
FA We are here principally concerned with research related to the patient’s mental
condition, (including associated subject-matter), rather than research into
treatment in relation to physical problems. Further, “research” can be broken
down into 2 broad categories, based on the intention of the researcher:
i. research which is an integral part of, or consequent upon, medical treatment
- SO, in the case of a detained patient, this means treatment which has been
prescribed and/or approved by the patient’s RMO and falling within Part IV
of the 1983 Act: (we propose to adopt the traditional distinction and
terminology and refer to such research as “therapeutic research”); and
il. research where the principal intention or motive is for information gathering
purposes, whereby the patient is treated as no more than a source of that
information (referred to as “non-therapeutic research”). :
Ze Although these are generally accepted definitions (see, for example, Assessment
of Mental Capacity - Guidance for Doctors and Lawyers, Chapter 11”), it is to
be noted that strict categorisation can raise its own problems of inclusion and
exclusion. We have included drug trials in our consideration of therapeutic
research; however, double blind or placebo controlled trials may fall into either
category depending on various factors such as:
@ the stage of development of the use of the drug;
@ =the intention and motive of those using the drug;
@ =~ whether or not a placebo is being used.
It is not, of course, to be assumed that research on, or involving, a detained
patient is harmful, non-beneficial, or even unethical.
GENERAL CONSIDERATIONS
a2 The law relating to research (both therapeutic and non-therapeutic) conceming
persons who are not detained patients is reasonably well settled. Research is
monitored and regulated (although without the force of law) by local ethics
committees: The lawfulness of research will depend on (1) consent by or on
behalf of the patient and (2) whether or not research is consistent with the duty
of care arising from the relationship of doctor and patient. There may well be
other factors. Where the patient is not detained under the 1983 Act, butis.
2
Published in 1995 by the Law Society and the B.MA..
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incompetent to give informed or real consent, then the difficult questions of
' authorisation and approval for the proposed treatment or involvement in research
arise*. It is neither necessary nor appropriate to consideri n this documént the
position of non-detained patients (whether or not mentally incapacitated) in
detail*. It has already been considered by the Law Commission®, which
recognising the distinction between “therapeutic” and “non-therapeutic” research,
has said in relation to non-therapeutic research:
"If, however, the participant lacks capacity to consent to his
or her participation, and the procedure cannot be justified
under the doctrine of necessity, then any person who
touches or restrains that participant is committing an
unlawful battery. The simple fact is that the researcher is
making no claim to be acting in the best interests of that ..
individual person and does not therefore come within the
rule so set out in Re F [1990]. In some cases relatives are
asked to “consent” to what is proposed, and do so. It
appears that some funding bodies and ethics committee
stipulate for consent by a relative where the research
participant cannot consent. As a matter of law, such
“consent” is meaningless. It appears that the question of the
legality of non-therapeutic research procedures is regularly
misunderstood or ignored by those who design, fund and
approve the projects.”
It is to be noted that, in relation to research involving pharmaceutical products,
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the European Commission Guidelines on Good Clinical Practice for Tals of
Medicinal Products effectively restrict research on subjects incapable of giving
personal consent to that which “promotes the welfare and interests of the subject”
Such as considered by the House of Lords in In re F. (a mental patient - sterilisation) [1990] 2 AC 1.
Apart from Kennedy & Grubb, Medical Law (2nd Ed.), Chapter 14; see also, by way of examples only,
Powers & Harris, Medical Negligence (2nd Ed.), paragraphs 12.66 to 12.68, and McHale “Guidelines for
Medical Research - Some Ethical and Legal Problems” ((1993) Med. L.Rev. 160.
Sez Law Commission ReporNto . 231 on Mental Incapacity at paragraphs 6.28 and 6.29. Sez also
Assessment of Mental Capacity - Guidance for Doctors and Lawyers, a report of the Law Society and the
British Medical Association (December 1995) - paragraphs 11:3.2.2 and 11:4.2.
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(ie. therapeutic research).° .
a} A detained patient occupies a different position and is admitted to hospital so
that he/she can be treated; an important criterion for the compulsory admission
of a patient to hospital is that such admission is necessary for his/her health -
seevic esis (2) (co) m Part IV of the 1983 Act makes no provision for consent to,
or involvement in, research on a detained patient. The starting point for the
interpretation of the 1983 Act must be that, as with all statutory restrictions on
liberty, the presumption prevails that all freedoms or rights not taken away
(either expressly, or by necessary implication) are preserved’. Therefore,
although the 1983 Act does not deal with research, it is to be assumed that a
detained patient is not prevented from taking part in research if:
e he/she has the capacity to consent and does consent,
e such involvement does not conflict with any provision of the~1983 Act,
or any prohibition or restriction imposed by law, and
C2) such involvement is not otherwise inconsistent with the patient’s status as
a detained patient.
TH ERAPEGIIC RESTAKCH
4.] In relation to therapeutic research (but not involving ECT or the administration
of medicine), the position under the 1983 Act for a detained patient (or more
correctly, a patient “liable to be detained”), is that consent by the patient to such
research is not necessary if: 2 ee :
6 the research falls within the definition of “medical treatment given to him
for the mental disorder from which he is suffering”, and
° the treatment is “given by or under the direction of the responsible
medical officer”
(see s.63 of the 1983 Act).
,
It is acknowledged that this reference to an international obligation is selective and incomplete. A complete
_study of the subject of research, whether or not involving detained patients, would require reference to
international and national obligations imposed or suggested by, for example, the Helsinki Declaration.
7 See, for example, Raymond v. Honey [1983]1 AC 1, and R. v. Halstrom, ex parte W. [1986}2 Ail ER 306.
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hoe We have excluded ECT and the administration of medicine from the previous
paragraph because of the effect of s.58 of the 1983 Act. S.58(1)(a), with
regulation 16 of the Mental Health (Hospital,-Guardianship and Consent to - |
Treatment) Regulations 1983, and s.58(3) ensures that-a patient will not receive
ECT unless the patient has consented or the SOAD has approved the treatment,
. in the absence of consent, on the basis that the treatment will alleviate or prevent
a deterioration of the patient’s condition. - §.58(1)(b) makes it clear that
non-consensual involvement in research, which involves the administration of
medicine, cannot extend beyond 3 months - after that period.o f time, the
certified consent of the patient is required, or if consent is refused (or is not
possible because of deficiencies of understanding), the approval of the SOAD.
(Further, the subject matter of s.57, namely any surgical operations for
destroying brain tissue, and surgical implantation of hormones for the purposes
of reducing male sex drive, requires actual consent, together with SOAD
approval - save where s.62 emergency treatment applies.)
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4.3 The possible problems in relation to research involving detained patients were
raised by the Commission in its 6th Biennial Report, at paragraph 5.17 as
follows:
“The Commission has, as yet, made no formal statement on
this matter. However, it does seem clear that even if, for
example, a detained patient consents to take part in a
randomised drug trial, the consent to treatment provisions
still apply, which may cause some difficulty. For example,
during the initial three months period of treatment whilst
detained, the Code of Practice states (Para. 16.11) ‘The -
patient’s RMO must ensure that the patient's valid consent
is sought prior to the administration of any medication, and
(para. 16.13), Although the patient can be treated in the
absence of consent in this period no such treatment should
be given in the absence of an attempt to gain valid
consent. e393
4.4
The problems arising from involvement in randomised drug trials can be
illustrated by considering the position of two detained patients in the same
hospital, who have been detained for treatment (for these purposes it is assumed
that they would receive the same treatment) - one is given medication, the other _
The above is of course subject to the exception of emergency treatment unde rs.62 - not relevant when
considering research.
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