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Health Research Ethics Committe in

Indonesia
by Ronny Isnuwardana
This essay will examine the health research ethics
committe in Indonesia and whether the concept of health
research ethics committees are well accepted in Indonesia and
what are the barriers for health research ethics committee as a
consultative body for ethics in health research in Indonesia.
Research ethics committees was set up because researcher
usually have an agenda to work on their research, therefore they
have a shift in moral from right-based point of view to a more
emphasis on goal-based, duty-based moral (arkness,
!""#$ .Therefore, to balance this view, I agree that we need an
external view so the right-based moral is balanced between the
other two moralities. This is where a health research ethics
committee comes in place.
%ccording to &oster, some researcher thinks the health
research ethics committee are a counterpart body for 'nding
mistakes done by the researchers. %ctually, the health research
ethics committee are more as a consultative body where
researchers can have a better ethical (udgement on what they
have done in the research. )ith the committee consists of
professional and layperson, they can give a balanced view on
ethical matters found in a research. *onse+uently, researcher
can have an ethically sound research, which is re+uired in many
publications and by many stakeholders nowadays.
%lthough the committee gives an insight for the researcher,
this does not mean that morality is the only concern for the
committee and researchers have no concern over morality.
,ecause the health research ethics committee is only as a
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consultative body for researcher to get an ethical clearance,
researcher still have the duty to implement ethical measures in
their research. The responsibility is still on the shoulder of the
researcher, nevertheless the health research ethics committee
also have the responsibility to any ethical conse+uences of the
research.
1 Framework for ethical review
There are three approaches, as mentioned above, to make
moral decisions for ethical review- they are goal-based morality,
duty-based morality, and right-based morality. These three
approaches can be explained into a list of +uestions to help the
analysis of ethics when an ethical committee decides whether it
is reasonable or not.
These +uestions are
1.1 Goal-based questions
)hat +uestion is the research pro(ect deal with.
Is the purpose of the research good and desirable.
ow will the research complete that purpose therefore the
results are trustworthy.
ow will the results of the research be disseminated.
1. !ut"-based questions
%re the procedures for the research participants risky.
Is there a balance between risks.
%re the risks greater than minimum risk.
1.# Ri$ht-based questions
Is there a consent sought from potential research
participant.
)hat are the procedures to obtain that consent.
ow will con'dentiality be appreciated.
/
%he develo&ment of research ethics committee
The development of research ethics committee is only
recently started in the twentieth century. The 0uremberg *ode
was drawn after the trials in 0uremberg, 123#, of 0a4i doctors
who had conducted experiments on concentration camp. These
codes consist of principles, but notably is the re+uirement of
informed consent taken from human participant before the
research started
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. )ithout the consent of the participant, a
research is not considered ethical. %lthough this consent is
needed, some people interpreted it that the consent does not
have to be in written form. Therefore, they claim that they can
have consent by simply an oral agreement, based on
conversation or interview.
The next step is when )orld 5edical %ssociation chart up
the 6eclaration of elsinki in 12#3. This started the revolution in
medical research, where in the developed country, research
conducted have to be under the supervision of ethical board. This
was implemented in a law constituted in 7uropean countries, 89
and %ustralia. &ollowing that, many district health research ethics
committees were set up in those countries
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. This model then was
also set up in the developing world, since there is no other model
for health research ethics committee available. %lthough I agree
that there are no a given set of model for the right health
research ethics committee, for now this is the accepted model for
a health research ethics committee.
The donors of research and research (ournal soon realised
the importance of research ethics committee. It becomes a rule
that a (ournal should not publish research without research ethics
committee approval. This also leads the re+uirement of
committee-approved research from pharmaceutical companies
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.
)e shall see that the need of a good health research ethics
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committee is a re+uirement for researcher to get their works
published. Therefore, in relation to the following, to promote
researches done by developing country, we also need health
research ethics committee in place.
# 'arriers and &roblem known in the &resent
health research ethics committee
:ne of the problems here is monitoring on the work of
these committees. 9everal countries have a set of regulation that
monitor the work of health ethics committee from a government
agency. :thers only based on multi-centred review on research.
owever, the most important is these committees have to give
reasons on their (udgement
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. &or me this is the best way a health
research ethics committee could work in developing countries,
where there are still limited law and regulation to conduct ethical
review on health research.
9ome of the problem relates to the committee is the
balance between those who understand on scienti'c research but
also with those who understand to be independent of the
research in +uestion. Therefore it is important to make sure that
professional and non professional has voices in the health
research ethics committee.
There is also a need of the health research ethics
committee to present their annual report as part of their
monitoring and evaluation. This is needed so they can improve
their function in the health research.
There is also the need of public interest and
pharmaceutical interest. The public is the reason why the ethical
committee comes in the 'rst place. The research committee
have the responsibility to the public on their (udgement. If they
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approve unethical research, the public will +uestion the
(udgement of the ethics committee. owever, the accountability
of the ethics committee to the public must not forgo the
con'dentiality of research. These also apply when dealing with
the interest from pharmaceutical companies.
( Health Research Ethics Committee in
!evelo&in$ Countries
6eveloping countries in this essay are those countries who
have (ust recently adopted the ethics model from developed
country. %lthough the model from the developed country is not
known to be the best model, nevertheless the scienti'c
community have to follow that for the re+uirement for publishing
(ournal and pharmaceutical industries.
)hile health research ethics committee was only recently
has a strong position in developed countries, their counterparts
in developing countries are only beginning to build up. These
ethics committees usually started in universities where research
done primarily and the need to address the ethical raised from
this research come from this community too. These university-
based ethical committees usually formed after researcher
needed an ethical approval so they can implement their research
in their own country. 9ince there are limited understanding on
ethical framework on a research (although not on morality$, their
work have been not as satisfying as their counterparts. %lso since
there is only limited to almost no power of the health research
ethical committee, made developing countries a good place for
research without much concern for ethical barriers
/
. 7ven though
there are laws regulating these, sometimes laws and regulation
still have no (urisdiction over some ethical problem.
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) Health Research Ethics Committee in Indonesia
Indonesia is only recently starting their framework on
bioethical research. 5any research centres in Indonesia doing
research based on researcher ethics, which is goal-based and
duty-base morality. owever, the need of a health research
ethics committee comes eventually. The author<s institutions in
Indonesia once faced with the re+uirement of an ethical approval
for a community development research. 9ince we are the only
academic medical institutions in the region, they re+uested an
ethical review for their research. This is the condition where
eventually health research ethics committee were needed in
developing countries.
The regulation on health research ethics in Indonesia was
drawn up since 122;. This government regulation deals with all
matters related to health research and development. To
implement this, the 5inistry of ealth set up a 5inisterial 6ecree
on 0ational ealth Research 7thics *ommittee in !""!. This set
of regulations is the starting point for setting up the health
research ethics committee in Indonesia. %lthough research in
Indonesia is still mostly at the early stage, at least we can be
sure that a good practice in research is starting to take place in
Indonesia. )e (ust have to make sure that the implementation of
this regulation is going to take place.
0evertheless, there are still some problems regarding
setting up health research ethics committees in Indonesia. &rom
the report of ealth Research %gency from 6epartment of ealth,
Republic of Indonesia, there are at least !# health research ethics
committees in Indonesia, mostly from &aculty of 5edicine or part
of 5edical 7thics *ommittee in a hospital
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. 9ince research were
mostly conducted in universities in Indonesia, it is not surprising
that health research ethics committees were founded in these
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institutions. The earliest records in the health research ethics
committee was in 12>3 where it was founded in 8niversity of
Indonesia. The problems regarding health research ethics
committee are described in the following.
* + burden to research communit",
There are ethical problems come up with the health
research ethics committee in Indonesia. 9ome of the barriers for
an ethical committee to work in Indonesia are recognised. &irstly
is the concept of bioethics or their implementation in research is
still di?ers from one committee to the other. Research by
Indonesian science community is still developing. They came
from di?erent background or even di?erent specialty. @et this is
still the professional-only committee, without any layperson
involved. 5ostly is about limited knowledge about ethics in
research. 9ome of the human resources needed is only
concentrated in several cities in Indonesia, while regional ethics
committee have to use the only available resources they have.
Research is done mainly in these areas, mostly in Aava Island,
while their counterparts in another region in Indonesia have no
better access to knowledge in bioethics.
9econdly, ethical problem found by the health research
ethics committees are in the use of informed consent. )hile
informed consent is already widely used in medical procedure in
hospitals in Indonesia, their use in health research still have to be
recogni4ed. 5ost of researches conducted in these institutions in
Indonesia are still taking consent based on oral agreement only,
without any printed form. This will give a drawback, especially for
research in vulnerable populations.
Thirdly, almost all university health research ethics
committee are working for medical faculty, limiting their work
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only for research in medicine. :nly some works with other health
institutions, such as faculty of health sciences, pharmacy and
others.
%nother problem is that it is still hard to work on research
without insuBcient support and funding, which is mostly comes
from the government. 5ost still agree that lack support and
funding from the government are essential in the recent
condition in ethics committee in Indonesia. %lthough the
government of Indonesia regulate an ethical clearance for
research, the realisation for this is still not monitored. 9ome only
see the ethical clearance as an unnecessary part of research.
owever, few centres have maintained proper consultative action
of the health research committee. This lack of resources also
includes no standard framework for health research ethics
committee in Indonesia. )hile it is recogni4ed to have good
morality in research (which in this case duty-based and goal-
based morality$, there is no concept of what are the steps
needed to be taken to have an ethical approval for research.
&inally, even though there are still no visible legal charges
regarding ethics in research in Indonesia, taking the lesson from
the awareness of people in Indonesia regarding ethics in clinical
medicine, health research ethics committee should prepare the
research community on dealing with ethical matters.
:ther recognised problems within health research ethics
committees in Indonesia are the lack participation of layperson in
the committee and the gender proportion of in the committee.
The concept of medical and health research is somewhat
only limited to certain community, in this case the medical
clinician and academician. Involving layperson in research of
medical and health is still hard to implement in Indonesia. The
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committee usually re+uired those who understand the goal of
research. %ccording to 9iegler it is unethical to delegate this
responsibility to people who did not understand (although his
article focuses primarily in the ethics for doctor-patient
relationship$. owever, a layperson should give an insight on the
right-based morality without the bias of research goal.
%nother problem is the ine+uity of gender proportion in
health research ethics committee. )hile there is an increase of
the number of women in health research ethics in Indonesia,
their participation in health research ethics committee is still
limited. 7ven though in Indonesia, women are becoming closer in
gender e+uity in health profession, their places in the health
research ethics committee is still limited. In a research by yder
et al., they found that in developing countries, most researchers
were middle aged male with part time basis as a researcher.
I think in Indonesia we have to put more women in the
health research ethics committee, since some health research
actually focused in child and women health in Indonesia. % more
balanced committee will give a balanced view and can give more
insights into the ethics of health research.
- +dvanta$es for research communit"
%lthough to have a health research ethics committee is
considered a burden for developing country such as Indonesia,
there are several advantages to have a working system of health
research ethics.
%s mentioned before, with the health research ethics
committee working with the research community in Indonesia
can give a credible predicate for research done in Indonesia.
9ince an ethical approval is needed for research, the health
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research ethics committee should also have accountability for
their given approval to the research. In turns, this will increase
the credibility of the health research ethics committee, a win-win
solution for both researcher and ethicist.
%nother advantage is increasing publication in
internationally recognised scholarly (ournal from Indonesia. This
will also recognised by other stakeholder, eventually such as
pharmaceutical or biotechnology company.
&inally, the advantages to have a good health research
ethics committee is to increase the partnership between
developed and developing countries, as mentioned by Carmus
and 9atcher. )ith a good health research ethics committee,
Indonesia can have better access to knowledge and information
for their research.
. /te&s to be taken for Indonesian health
research ethics committee
There are recognised steps needed to be taken by ethicist
in Indonesia for the implementation of the health research ethics
committee. :ne of them is setting a common understanding on
health research ethics for all research community in Indonesia.
%nother step is to set up common guidelines for health research
ethics committee for Indonesia so we can have common
procedures when dealing with ethical matters and also promoting
new health research ethics committee in regional provinces. I
think these guidelines are the most important part. )hen
comparing to other national health research ethics committee
such as %ustralia<s 0ational 9tatement on 7thical *onduct in
Research Involving umans, these show what we have to achieve
in Indonesia for a better research.
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0 Conclusion
In conclusion, Indonesia is still at the development stage
for ethical consideration in health research. There are still many
problems for health research ethics committee to work in
Indonesia, from lack of resources and support, gender e+uity,
lack participation from layperson, to the unsupportive condition
of research in Indonesia itself. I think, before a set of standard
guidelines were put up by the national committee, many regional
health research ethics committee have di?erent concept to rely
on the ethical of health research. %fter this task is completed, we
can expect that several barriers, such as gender e+uity,
involvement of both professional and laypersons, and others
regarding health research ethics committee in Indonesia will be
solved.
11References
DAFTAR ISI
1 &ramework for ethical review...........................................................!
1.1 Doal-based +uestions................................................................!
1.! 6uty-based +uestions................................................................!
1./ Right-based +uestions...............................................................!
! The development of research ethics committee..............................!
/ ,arriers and problem known in the present health research ethics
committee.............................................................................................. 3
3 ealth Research 7thics *ommittee in 6eveloping *ountries...........3
; ealth Research 7thics *ommittee in Indonesia..............................;
# % burden to research community....................................................#
= %dvantages for research community...............................................>
> 9teps to be taken for Indonesian health research ethics committee2
2 *onclusion...................................................................................... 1"
1" References..................................................................................... 1"
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