BIOMEDICAL HUMAN RESEARCH

AND EXPERIMENTATION
WHAT IS RESEARCH?
TYPES OF RESEARCH
ETHICS ON RESEARCH AND EXPERIMENTATION
MEDICAL RESEARCH IN THE U.K.
WHAT IS RESEARCH?
MEDICAL RESEARCH IN MALAYSIA

Dr. Noraiza Abdul Rahman 2

WHAT IS RESEARCH?
It is not easy to define what medical research
is.
The key distinction is whether the treatment is
given in order to derive knowledge, in which
case it is research, or whether it is provided
for the benefit of the patient.
Medical research covers a broad range of TYPES OF RESEARCH
activities aimed at improving or maintaining
human health.

Dr. Noraiza Abdul Rahman 3 Dr. Noraiza Abdul Rahman 4

TYPES OF RESEARCH
Research could involve one of the following:
Human participants
Human gametes (sperm or ova)
Human embryos
Animals
Data relating to individuals
ETHICS ON RESEARCH AND
EXPERIMENTATION

Dr. Noraiza Abdul Rahman 5 Dr. Noraiza Abdul Rahman 6

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 ETHICS ON RESEARCH AND
EXPERIMENTATION
International codes of research ethics such as
Nuremberg Code and the Helsinki Declaration
have established universally applicable
principles of good research practice.
All research protocols must first be approved
by an ethics committee.
Consent to participation in research must be
both informed and voluntary.
ETHICS ON RESEARCH AND
EXPERIMENTATION
For incompetent subject, consent must be
sought from their representative and a
number of protections exists to ensure that
researchers only use people who lack capacity
when the research could not be done on
competent adults.

Dr. Noraiza Abdul Rahman 7 Dr. Noraiza Abdul Rahman 8

ETHICS ON RESEARCH AND ETHICS ON RESEARCH AND

EXPERIMENTATION EXPERIMENTATION
Certain principles could be summarised as Before the research starts:
follows: It must be established that the research is
During the
scientifically valid.
research The risks must be proportionate to the benefits
Before the After the
research research The research protocols should have been
starts has finished approved by an ethics committee.
PRINCIPLES If competent, the subject must give informed
OF
RESEARCH consent.
If incompetent, other protections must be in
place.

Dr. Noraiza Abdul Rahman 9 Dr. Noraiza Abdul Rahman 10

ETHICS ON RESEARCH AND ETHICS ON RESEARCH AND

EXPERIMENTATION EXPERIMENTATION
During the research: After the research has finished:
The experiment must be stopped if there is a risk The subject should have access to information
of injury or death. about the trial, and to treatment which has been
The experiment must be stopped once equipose proved to be effective as a result of the trial.
has been lost. Research findings should be disseminated.
The subject must be free to withdraw from the Subjects who have been injured as a result of the
trial at any time. trial should be appropriately compensated.

Dr. Noraiza Abdul Rahman 11 Dr. Noraiza Abdul Rahman 12

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RESEARCH INVOLVING CHILDREN
Dr. Noraiza Abdul Rahman 13
RESEARCH INVOLVING CHILDREN
Malaysia has no specific law that regulates the
participation of mentally incapacitated
subjects in clinical research, but some
guidance may be obtained from the laws that
regulate decision-making for those who are
considered unable to provide consent because
of immaturity or infirmity.
Dr. Noraiza Abdul Rahman 15
RESEARCH INVOLVING
INCOMPETENT ADULTS
Dr. Noraiza Abdul Rahman 17
RESEARCH INVOLVING CHILDREN
The general principle is that a doctor could
carry out medical research involving a child if
the research was otherwise lawful and she or
he had the consent of someone with parental
responsibility for the child.
Paragraph 28 to the Declaration of Helsinki.
Dr. Noraiza Abdul Rahman 14
RESEARCH INVOLVING CHILDREN
In the case of children, the parents or
guardians of infants are given powers to make
health decisions for them under Section 3 of
the Guardianship of Infants Act 1961, which
stipulates that the guardian of an infant shall
be responsible for his support, health and
education.
Dr. Noraiza Abdul Rahman 16
RESEARCH INVOLVING
INCOMPETENT ADULTS
The answer as to who should be allowed to
make health care decisions for mentally
incapacitated adults is much less clear.
In addition to the consent of their personal or
legal representative, a number of additional
conditions and principles must be complied
with.
Dr. Noraiza Abdul Rahman 18
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 RESEARCH INVOLVING
INCOMPETENT ADULTS
Research into conditions that are not linked to
incapacity should never be undertaken with
adults with incapacity if it could equally well
be done with other adults.
It should be limited to areas of research
related to participants incapacity or to
physical illnesses that are linked to their
incapacity.
Dr. Noraiza Abdul Rahman 19
MEDICAL RESEARCH IN THE U.K.
Dr. Noraiza Abdul Rahman 21
MEDICAL RESEARCH IN THE U.K.
In addition, various legislations can impact the
performance of medical research including the
following: the Human Fertilisation and
Embryology Act 1990, Data Protection Act
1998, Human Tissue Act 2004, Mental
Capacity Act 2005.
Dr. Noraiza Abdul Rahman 23
RESEARCH INVOLVING
INCOMPETENT ADULTS
It must be demonstrated that:
The research could be of the direct benefit to their
health.
It is of special benefit to the health of people in
the same age group with the same incapacity.
The research is ethical and will not cause the
participants emotional, physical or psychological
harm; and
The person does not express objections physically
or verbally.
Dr. Noraiza Abdul Rahman 20
MEDICAL RESEARCH IN THE U.K.
In the UK, a variety of bodies have issued
guidance on good practice in research.
The first was the Medical Research Council
(MRC) which issued a statement in 1963
entitled Responsibility in Investigations on
Human Subjects.
Its latest general set of Guidelines for Good
Clinical Practice in Clinical Research was
published in 1998.
Dr. Noraiza Abdul Rahman 22
MEDICAL RESEARCH IN MALAYSIA
Dr. Noraiza Abdul Rahman 24
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 MEDICAL RESEARCH IN MALAYSIA
The Institute of Medical Research (IMR), Kuala
Lumpur, established in 1900 by the British as a
Pathological Institute to study tropical
diseases is the oldest medical research centre
in Malaysia.
Dr. Noraiza Abdul Rahman
MEDICAL RESEARCH IN MALAYSIA
The CRC is the main clinical research organisation
in the country, with a network of 14 centres
around the country, providing a single point of
contact to access all Ministry of Health (MOH)
hospitals and clinics nationwide.
Apart from the Ministry of Health facilities,
clinical trials are also run by the university
hospitals. Private health care facilities as a rule do
not carry out clinical trials.
Dr. Noraiza Abdul Rahman
MEDICAL RESEARCH IN MALAYSIA
The act and the regulation fall under the purview
of the National Pharmaceutical Board (NPB) of
the Ministry of Health.
The body entrusted with developing government
policies for the clinical trial industry is the
National Committee for Clinical Research (NCCR).
There appears to be some interest in the NCCR
for bringing the clinical trial industry under some
sort of regulation, but specific information as to
how this would be accomplished could not be
obtained because of the Official Secrets Act 1972.
Dr. Noraiza Abdul Rahman
MEDICAL RESEARCH IN MALAYSIA
In relation to health care matters, the Malaysian
Biotech Corporation (MBC) works together with
the National Institutes of Health (NIH), which was
set up in 1996 to set research priorities and
allocate research funding.
There are seven institutes under the NIH and
each institute has its own major research thrust,
with the Network for Clinical Research Centres
(CRC) as the clinical research arm of the NIH.
25 Dr. Noraiza Abdul Rahman 26
MEDICAL RESEARCH IN MALAYSIA
There is no law in Malaysia that specifically
regulates the running of clinical trials.
The only relevant legislation is the Sale of
Drugs Act 1952 and its corresponding Control
of Drugs and Cosmetics Regulations 1984,
which regulate the importation and licensing
of drugs for clinical trials.
27 Dr. Noraiza Abdul Rahman 28
MEDICAL RESEARCH IN MALAYSIA
It is however quite clear that the
government does not have any
immediate plans to create a
comprehensive piece of legislation to
regulate clinical trials.
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