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Guidelines For Health Research
By Za'im Zaini
Bandar Seri
Begawan - It will become mandatory in Brunei that all
research with human subjects be conducted in line with a research
framework the Ministry of Health has established, marking yet
another milestone in the health field in the country.
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With an approved research in ethic
application to protect the participants and the researcher, the
research will be regulated by the Ministry of Health Medical
Research Committee (MMRC), to be chaired by the permanent
secretary.
This was announced by the
Minister of Health yesterday in his speech as guest of honour at
the launching of the Brunei Darussalam Guidelines for Good
Clinical Practice at the Mutiara Ballroom, Sheraton Utama Hotel,
in the Capital yesterday.
The committee will provide
direction for health research in the Ministry of Health and
identify national health research priorities. Under its umbrella
are two other research committees; the health policy and system
research committee and the medical health research and ethics
committee, the latter to be chaired by |
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Dato Yap Kai San, head of the
clinical services.
"I hope these research
committees will provide guidance to help our researchers
implement good practices and meet legal and ethical
requirements. It will become a mandatory requirement in Brunei
Darussalam that all research with human participants be
conducted in line with an approved research of ethic
application. This is both to protect the participants and the
researchers," the minister said. |
Being aware of the challenges in
starting medical research in Brunei, the minister said, "I believe
that research is the way forward and if we want to see progress in
the fields of science and medicines, we need to invest in research.
I know there have been various forms of research-epidemiological
studies of disease patterns, case reviews and clinical studies -
being carried out already. Today will mark a new milestone in our
efforts to promote and strengthen research in this country," he
added.
"The ultimate benefit of research
lies not only in the generation of new knowledge but in the
translation of this knowledge into technologies, interventions and
strategies which are then effectively and appropriately delivered to
those who would benefit. Ultimately, one hopes that health research
would contribute effectively and efficiently to health system
development, health improvement and health equity. In order to reach
this objective, it is imperative that the entire research process be
pursued within the context of contemporary knowledge, good ethics,
effective policy, adequate resources and international cooperation,"
the minister said.
Up to now there are very few purely
scientific research projects that have been done, although a
clinical research unit is currently being set up at RIPAS Hospital
to coordinate and facilitate research projects in Brunei. This was
remarked by Dato Samuel Yap Kai San Chairperson of Medical and
Health Research and Ethics Committee in his presentation during the
event.
Earlier, those present heard
remarks from Dr Alice Yong, co-chairperson of the event who said, "A
major focus of the Brunei Darussalam Guidelines for GCP (Good
Clinical Practices) is to help initiate and shape the research
culture in Brunei Darussalam."
The event also witnessed the
launching of the Guidebook followed by the guest of honour
sprinkling scented water on the book. Dr Lim Teck Orin, Director of
Clinical Research Centre, Kuala Lumpur Hospital in West Malaysia,
spoke on clinical research -- what it takes to make it happen - in
his presentation.
Dato Yap, Chairperson of Medical
and Health Research and Ethics Committee, spoke on 'Clinical
Research in Brunei Darussalam', where he said that "hopefully
medical research will then be elevated to the next level and we will
begin to see the conduct of medical trials. We are mindful of our
limitations in manpower, infrastructure and funding".
With the implementation of e-health
in the future, data collection, storage and retrieval will be made
that much easier. Reliable information comes from a reliable source.
So a good data bank is important, he said.
Good Clinical Practice is an
international ethical and scientific quality standard for designing,
conducting, recording and reporting trials that involve the
participation of human subjects.
This standard provides assurance
that the data and results are credible and accurate. It also assures
that the rights, integrity and confidentiality of trial subjects are
protected. It is mandatory for investigators to adhere to these
guidelines to conduct trials in Brunei.
The Ministry of Health will be
organising the 2nd GCP workshop from May 10-12, to provide an
overview of clinical research with a comprehensive review of the
Brunei Darussalam guidelines for Good Clinical Practice.
Over 30 doctors and allied health
professionals will participate in the workshop. On hand to
facilitate the workshop are distinguished researchers and speakers
from the Ministry of Health, as well as invited speakers from
clinical research centre, Kuala Lumpur hospital and MOH Malaysia. -- Courtesy
of Borneo Bulletin
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