LITA NOVIA ANGGRAINI (0910015024).doc

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Health Research Ethics Committe inIndonesia

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 onethical 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


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%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 1 . )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 canhave 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 1 . 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 1 .

)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 &resenthealth 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 1 . &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 theirmonitoring 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 IndonesiaIndonesia 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


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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 onlysee 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 stilllimited. 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 researchactually 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 healthresearch 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 promotingnew 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


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0 ConclusionIn 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.

1 References

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 ethicscommittee.............................................................................................. 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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