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Apr-Jun2001-9(2)
ORIGINAL
ARTICLE
Training for research ethics
committees in the UK
Sue
Eckstein
In Great Britain, as in many other parts of the
world, all medical research involving humans is subject to scrutiny by a local
research ethics committee (LREC). Local research ethics committees provide
independent advice to all bodies belonging to the National Health Service (NHS)
within the geographical area of a health district. They sometimes also
advise on studies not involving NHS patients, records or premises, carried out
by private sector companies, universities, or bodies such as the Medical
Research Council. Research ethics committees normally have between eight and 12
members, drawn from both sexes and from a wide range of age groups. They
should include hospital medical staff, nursing staff, general practitioners and
two or more lay people. Ideally they will also include a statistician and
a pharmacist. If they do not, the chair of the LREC will refer specific
queries to a statistician or pharmacist based at the hospital. Though members
are drawn from groups with particular interests or responsibilities in
connection with health issues, LREC members are not considered to be
representatives of these groups. Members' broad range of experience and
expertise should allow for reconciliation between the scientific and medical
aspects of a research proposal, and the welfare of research subjects and broader
ethical implications (1).In order to facilitate the process of ethical review of
multi-centre research, a system of multi-centre research ethics committees
(MRECs) was established in 1997 to complement the work of existing LRECs.
An MREC is responsible for considering all multi-centre research that is health
related where the research will be conducted within five or more locations
(2). Most pharmaceutical company sponsored research proposals will be
submitted to an MREC. Only a researcher who has received written MREC
approval may go on to seek local REC approval in the areas in which they wish to
work. The LREC will only consider issues that affect local acceptability and is
otherwise bound by the MREC's decision.
The Centre of Medical Law at King's College,
London, is one of the main providers of training for members of research ethics
committees. It has for some time run a three-day introductory course on
the ethics of research on humans. This course involves lectures and
workshops covering ethical tools for reviewing research proposals, different
types of research methods including observational and qualitative research, and
randomised controlled trials. There are also sessions on the development
and licensing of medicines and the regulation of the pharmaceutical industry's
clinical trial activities, and the law relating to consent, confidentiality and
the running of a committee.
It has become apparent that there are aspects of
healthcare research that can be particularly problematical for members of
research ethics committees. One of the most difficult subjects for members of
LRECs is that of research involving vulnerable groups. These include
children, the mentally ill, elderly people and the dying.
In order to begin to address this, the Centre of
Medical Law and Ethics has recently set up a new series of advanced study days,
each concentrating on research involving one of these vulnerable groups.
The first study days was on ethical issues in
paediatric research. Participants were briefed by an ethicist, a medical lawyer
and a key member of the Royal College of Paediatrics and Child Health on the
ethical and legal issues involved in research on children. These
presentations were followed by case study work, in which participants worked
together to consider a number of fictitious ethical dilemmas. They then
had the opportunity to address questions to a panel of experts. The panel
included paediatricians, a parent of children involved in medical research, a
sociologist specialising in children's ability to consent, a child psychiatrist,
a research nurse from a children's hospital and a clinical trials manager from a
pharmaceutical company that produces a number of drugs for
children.
Though a number of the issues raised are particular
to a UK context, many of them are more universally relevant and may be of
interest to readers in India.
The Royal College of Paediatrics and Child Health
(RCPCH) regards research into children's diseases as crucial in securing better
evidence-based care for future children but stresses that it should conform to
the highest ethical standards (3). Children are acknowledged as having a unique
physiological and psychosocial status and are as equally deserving of
evidence-based treatment as adults. The fact that many medicines are not
licensed for children renders them therapeutic orphans (4). A child's
vulnerability and need for protection should not be used to prevent them
benefiting from research which is therapeutically useful. It is particularly
important to establish that the lack of research is not purely driven by
commercial or indemnity-related concerns.
Some parents might feel morally obliged to
contribute to therapeutic research which will benefit their offspring, but this
should be not be motivated by a disproportionate sense of gratitude.
Practitioners involved in the long-term care of children with a chronic or
life-threatening disease should be particularly aware of the impact of the
relationship between the team and the family, and the ways in which this might
influence parents' attitudes.
Putting aside the legal issues relating to consent,
there is a moral requirement to involve a child as much as is possible and/or
appropriate in the consent process. This entails a number of specific duties
when there is the possibility that the child could participate in a meaningful
way. They include testing the individual child's ability to participate in the
consent process and proceed accordingly, ascertaining the extent to which the
child wishes to be involved in the decision making process, discussing with the
parents or guardians the extent to which they are prepared to involve the child
in the process and final decision and providing information which will help the
child to get a realistic sense of what will be involved in participating without
causing undue harm. The key to success in gaining informed consent lies in
effective communication between researchers, families, associated professionals,
professional bodies, LRECs and MRECs, research councils, charities, drug
companies and educational institutions, and possibly parental or patient
involvement in the design of the project (5).
English law relating to medical research on
children is complex and uncertain and it is impossible to state the law relating
to this with complete certainty. There are no statutes or legal cases that deal
with research on children specifically. As a result, it is necessary to identify
the broad legal framework relating to children, and to try to determine the
implications of these principles in the area of medical research. Inevitably,
this involves a degree of speculation about how a judge would deal with the
issues if a case were brought to court.
In England, the legal framework for the care and
upbringing of children (including issues of medical treatment) is mainly derived
from the Children Act 1989. This is a very complex piece of legislation, but
there are at least three key aspects of the law which are relevant to research
involving children - parental responsibility, the powers of the courts and
children's rights. The power of children to consent to treatment is derived from
the famous case of Gillick (6) (which established that children with 'sufficient
understanding' could consent to medical treatment without parental
involvement). It is unclear whether this principle allows children to
consent to involvement in medical research. Even if, in principle, children can
consent to involvement in research, it is also necessary to determine whether an
individual child is competent to do so. The General Medical Council has given
guidance on assessing children's competence to consent to medical treatment (7).
This guidance is consistent with the approach to competence taken by the courts,
but the courts have never considered the level of competence that a child would
need to demonstrate to make a decision about medical research. An assessment
would require consideration of the child's specific circumstances, including
age, maturity and experience, and also the complexity of the research, and the
consequences for the child of involvement or non-involvement. However, in
practice, researchers take a cautious approach, and are likely to seek approval
from both the child and the parents, and not to involve the child in research if
the child or the parents are unwilling.
The RCPCH, in its two recent guidelines (8, 9),
provides a series of questions which research ethics committees should consider
in assessing risks and benefits including the type, nature, magnitude,
probability, timing of risks or benefits; the fairness of research to subjects
and its effect on their future autonomy.
A number of other issues arose out of the
discussions. There were comments and questions on the issue of consent by
adults for children with special needs and on consent by parents who themselves
have a learning disability. There was a broad consensus that there was a
need for research with terminally ill children and discussion on how LREC
members, who would normally be averse to this, could be reassured that such
research can be ethical. There was a discussion on the extent to which
children should have an obligation to take part in research. For example,
parents may refuse to allow their children to participate in research but want
the benefits of gene therapy for their own children.
Members of research ethics committees are clearly
very interested in receiving expert guidance to assist them in their task of
assessing protocols from an ethical perspective. Other planned advanced
study days will focus on ethical issues in psychiatric research, ethical issues
in research into diseases of age, and ethical issues in palliative care.
It is hoped that future days will include ethical issues in research on
neonates, in cancer-related research, and in research on people in a persistent
vegetative state or coma.
The more knowledge and understanding that both
researchers and members of research ethics committees have of the difficult
issues surrounding research involving people in these and other groups, the more
a healthy balance will be established between protecting the interests of
vulnerable participants and valuably expanding the research base in these
complex areas of health care.
References:
1. Local Research Ethics Committees, REC(91)5, Department of Health.
2. Ethics Committee Review of Multi-centre Research, REC(97)23.
3. Guidelines of the ethical conduct on medical research involving children, RCPCH Ethics Advisory Committee, 2000.
4. Sutcliffe Alastair G. Editorial, BMJ 1999; 19:70-71.
5. Eckstein Sue. The advanced study day on ethical research. Dispatches October 2000; 10: 2-4.
6. Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402, [1986] AC 112, House of Lords.
7. General Medical Council. Seeking patients' consent: the ethical considerations, GMC, February 1999.
8. Guidelines of the Ethical Conduct on Medical Research Involving Children, RCPCH Ethics Advisory Committee, 2000.
9. Safe-guarding informed parental involvement in clinical research involving newborn babies and infants. A position statement, RCPCH, December 1999.
1. Local Research Ethics Committees, REC(91)5, Department of Health.
2. Ethics Committee Review of Multi-centre Research, REC(97)23.
3. Guidelines of the ethical conduct on medical research involving children, RCPCH Ethics Advisory Committee, 2000.
4. Sutcliffe Alastair G. Editorial, BMJ 1999; 19:70-71.
5. Eckstein Sue. The advanced study day on ethical research. Dispatches October 2000; 10: 2-4.
6. Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402, [1986] AC 112, House of Lords.
7. General Medical Council. Seeking patients' consent: the ethical considerations, GMC, February 1999.
8. Guidelines of the Ethical Conduct on Medical Research Involving Children, RCPCH Ethics Advisory Committee, 2000.
9. Safe-guarding informed parental involvement in clinical research involving newborn babies and infants. A position statement, RCPCH, December 1999.
Sue Eckstein,Research
associate, Centre of Medical Law and Ethics, King's College, London, Strand,
London WC2R 2LS, UK. Email:sue.eckstein@kcl.ac.uk