SUMMARY OF FGD

I. FGD at Medical Faculty of Diponegoro University , Semarang Attendance : 10 participants plus 2 facilitators from NIHRD Ethics Committee. The issues that come up and discussed: 1. The existing committee: Medical Ethics Committee of Medical Faculty of

Diponegoro University (UnDip) Dr. Kariadi Hospital (RSDK). Formed with decree on July 1, 1998. Do not have operational guidelineslines yet.

2. Homogeneous membership: doctors from Medical Faculty of Diponegoro University. Some of the members have skills in Law, Religion and other aspect needed to perform Ethical review. Do not have lay person in the committee.

3. The member of Committee realizing the increasing scope of their work, to review health research outside Medical Faculty of Diponegoro University Dr. Kariadi Hospital.

4. There has not been a monitoring process on the research with Ethical Clearance.

5. Private medical faculty such as UniSulA (Sultan Agung University), Research Institute of Diponegoro University, and Nursing Faculty; which present at the meeting, feel that there is a need for Ethics Committee, considering the development of health science as Human Genome and Cloning. They do not have Ethics Committee yet. They are still proposing the protocol To Medical Ethics Committee of Medical Faculty of Diponegoro University Dr. Kariadi Hospital.

6. Research Institute UnDip performs 6 epidemiological researches that are intra-faculty and multi discipline has not asked for Ethical Clearance. Faculty handles the research, which only requires one or two disciplines.

7. UniSuLa performs a lot of researches on traditional medicine and public health. They never propose Ethical Clearance. Therefore, they ask about document on Ethics.

8. With that in mind, the socialization of Ethics in health research is really needed. The National Ethics Committee needs to go to all provinces to perform socialization. The operational ethical guidelineslines for health research needs to be developed and socialized.

9. Protocol review:

The reviewed researchs protocol is generally a thesis / dissertation of postgraduate education (S2, S3, or residens). Some of them are researches, which use intervention. In the mean time, the research, which

is in the form of observation and uses animal subject, has never request for ethical review.

A committee in Dr. Kariadi Hospital reviews the aspect of technical management. The scientific and ethical aspects are discussed by a committee in Medical Faculty of Diponegoro University (UnDip).

Administration fee for protocol review is charged Rp. 100.000 per protocol. II. FGD at Medical Faculty of Gajah Mada University , Yogyakarta

Attendance : 25 people plus 3 facilitators from NIHRD Ethics Committee and

Core Team Ethics. The issues that come up and discussed: 1. The Ethics Committee of Medical Faculty of Gajah Mada University; Other

than that committee, there is also a Bioethics and Humanitarian team, which later becomes The Center of Bioethics Education which is in cooperation with Harvard Medical School, USA.

2. The membership of Ethics Committee is multi discipline in medical field. There has not been Lay Person and other experts outside medical field.

3. Types of reviewed researches are: intervention and multi center study. In the year 2000, 60 research protocols have been reviewed. Some of them are from various clinical trials. Review is based on some standard guidelines (Medical Faculty guidelines, Declaration of Helsinki, CIOMS, GCP-IHC, and WHO guidelines). The decision is usually made without regarding the quorum.

4. The review of Ethics for research protocol is done simultaneously with scientific review.

5. Ethical issues: The incidence of disease can be occurred long after the research finishes

(i.e. radiation effect). Misconduct research is defined as the one with report but never been

performed. A thought on the Ethics for the face change such as facial plastic surgery

is needed. There should be the difference between the Ethics of medical intervention according to standard guidelines with the one, which still looks for standard procedure or material.

Is the informed consent needed for the research that involves vulnerable group (children, pregnant women, homeless, people with low education) or uses placebo? Its very hard to get one. There should be a psychological consideration for vulnerable group.

The Ethics of performing blood sample test of an Indonesian outside the country.

Dr. Sarjito Hospital has Ethical guidelines but the request for Ethical review is directed to Ethics Committee of Medical Faculty of Gajah Mada University. The review of research Ethics in the hospital better if optimizes the existence of Medical Faculty Ethics Committee. The important thing is that the researcher does not have to browse the Ethics Committees, which are lenient in approving an Ethical Clearance.

The understanding regarding Ethics in health research among researchers and Divisions Head (as studys subject) is still low, so socialization is really needed for them.

Ethics on research involving animal subject. As its function; to develop advocacy for researcher, Ethics Committee

feels hard to reject and supervisors a duplicated research. 6. Budget has not been allocated; the attendance of members in the ethics

meetings is still low. Every time they present, they are given transportation fee of Rp. 10,000 (before 2001)

7. The authorities and responsibilities of Ethics Committee.

The scope of Ethical Clearance issued by Ethics Committee (i.e. How far that E.C. covering the research area?)

How far is the responsibility of Ethics Committee in the case of failure in the research or disability or even death?

Is there a need to involve Consumer Foundation or Human Rights Board? Its sufficient if they can be invited to give some feedbacks.

III. FGD at Research Institute of Sebelas Maret University, Solo. The issues that come up and discussed: 1. Medical Faculty of Sebelas Maret University has not formed Ethics

Committee, still in the planning phase. This is based on a course in Bogor (Feb. 2001). The formation of Ethics Committee will be the joint Ethics Committee between Medical Faculty of Sebelas Maret University and Dr Muwardi Hospital, which already has Medical Committee.

2. The Medical Committee consists of 4 divisions and issues a research approval using the Ethics Committee Guidelines of Medical Faculty of Indonesia University.

3. The existing doctoral researches usually request the Ethical Clearance from Ethics Committee of UnAir, UGM or the Medical Committee of Dr. Muwardi Hospital.

4. Research Institute performs a lot of social researches involving human subjects (17) such as the one on participants of Family Planning Program without clinical trial. Community survey gets the approval from the Governor. Research in the Center of Rehabilitation of Children with Disability has not been considering the ethical aspect. They never request an Ethical Clearance.

5. Research of Medical Faculty of Sebelas Maret University is generally in bio molecular field and 2 multi center clinical trial, which are all the procedure in scientific and ethical aspect refers to each center.

6. The form of informed consent follows the guidance from UnAir or UGM. (This is also good because it still refers to its scientific aspect (macro ethics) and ethical basic aspect)

7. There is still a question on the need for Ethical Clearance in biological specimens trial in the hospital (i.e. blood, urine, etc.).

8. Socialization is still needed.

IV. FGD at Medical Faculty of North Sumatra University, Medan Attendance: 16 people plus 2 facilitators from NIHRD Ethics Committee. The issues that come up and discussed: 1. The existing Ethics Committees: Medical Committee of Dr.Pirngadi Hospital

and Ethics Committee of Medical Faculty of North Sumatra University. Ethics Committee is newly formed with Dean decree on August 9, 2001. The members consist of doctors, lawyers, representative from MUI, and lay person from student representatives, chaired by Gynecologist expert. The chairperson of Ethics Committee is not the head of the institution. The performance is not known yet. It is suggested that there is a Ethics Committee for Medical Faculty of North Sumatra University and Adam Malik Hospital (one of educational Hospital in Medan)

2. Investigators also question this performance because they will perform a lot of research protocol reviews. They even ask for the operational guidelines. This request will follow up by Ethics Committee. After FGD, Ethics Committee holds a meeting to discuss that.

3. Before there is a decree, ethical review is done by Dean and some experts, such as former Deans. Dean issues the scientific and Ethical approval. Based on the experience of an investigator who needs Ethical clearance for international journal publication, before Ethics Committee exists, there should be an approval letter signed by Dean.

4. The type of researches done are conducted in the clinic by resident. Research Institute performs socio-medical research.

5. The material on research Ethics has been given to students and has been reinforced in resident level. For the researcher, it should be in the level of understanding of that aspect. However, that is not the case. The understanding on Ethical aspect is still narrowed. Research with medicine intervention is only the one, which requests Ethical review.

6. Research Institute questions the legal status of the informed consent and Ethical clearance. Written consent only reduces criminal law suites, but not the civil one. One of the methods of protecting the subject is insurance (other than the conventional one). What about the protection for the researcher? If there is a mistake in the research then the responsible party would be the researcher, the sponsor and the institution where research is conducted.

7. Investigator understands the important of Ethical aspect review. They also admit that getting the research subject is very difficult. To get informed consent is even more difficult. Right now, the way of getting the consent from the subject is still camouflaged, especially on the subject with direct consequences. In term of the human resource and research, there are no problems because the researchers are usually the resident, the doctor in Masters study (S2) are still mentored. There are also staffs, which perform research, which is sponsored by pharmaceutical industry.

8. The sponsors during this period are faculty and pharmaceutical industry. 9. The review on scientific aspect is done by peer review. 10. Private Medical Faculties (i.e. Methodis University, North Sumatra Islamic

University) do not feel the need for Ethics Committee. They still concentrate on education.

11. Dentistry Faculty of North Sumatra University, does not have Ethics Committee. The research approval is issued by an advisor. The problems related to ethical aspect have come up. Ethical review and ethical clearance are needed more because new program for master and specialist level will open soon.

12. Public Health Faculty of North Sumatra University does not have Ethics Committee. Research, which involves human subject, will increase the future. Public Health Faculty itself has not been performing a lot of researches so that there is not a need to create one.

13. Proposing the idea of changing the Ethics Committee of Medical Faculty of North Sumatra University; to university level so that other faculties can participate. All researches in North Sumatra University request ethical review from Universitys Ethics Committee.

14. Monitoring and supervision on research practice have not been performed.

V. Malang. Place: FK-UniBraw Attendance: 16 people plus 2 facilitators from NIHRD. 1. Ethics Committee of Medical Faculty of Brawijaya University is the same as

Medical Committee of Dr. Syaiful Anwar Hospital. The structure in the hospital gives information that the process of getting the consent has been camouflaged, not as a research subject but as object of an action. There is a big difference between standard medical procedure and research procedures whose results are still sought. A lot of researches are pre-clinic base, even though they are for doctoral dissertation. Research conducted by PPDS is not pure research. It is an observation on medical procedure.

2. The hospital division, which conducts a lot of researches, is Internal Medicine unit such as BIBIR SUMBING (God, please help me!!!!!), meningocele on certain ethnic. The clinical trial performed is usually a phase IV, which is post marketing surveillance. In general, there is a standard protocol; however, scientific and Ethics review are still needed. It is also realized that seeding trial does not constitute enough scientific value.

3. Members consist of some medical discipline, chaired by clinical Pharmacology expert. The head of Ethics Committee is not the head of the institution. One of the members focuses on medical law. There is no lay person.

4. Research Institute has realized the existence and importance of Ethics Committee. Research Institute itself does not have one.

5. Ethical aspects in research involving human subject are clinical information on the subject, drawing and use of blood sample, psychological interview.

6. In performing the review, the scientific aspect is handled by BPP, a board for scientific review on research proposal.

7. Sponsor: World Bank and pharmaceutical industry. 8. Ethical aspect problems:

Substandard research Possibility of claim from subject Difficulty of getting the subject (need to be camouflaged) Problem in giving out incentive such as the subjects withdrawal Ethics Committee is not actively performing review on few protocols. Every

year, they only do 1 or 2 protocols. As we know that a lot of clinical trial conducted in hospital, and some are pre-clinic. Informed consent must fulfill: rules, rights and responsibilities (a researcher is responsible for the continuation of his/her research according to the rule)

Who should issue the Ethical clearance for multi center research?

VI. Makasar. Place: The Center of Food and Nutritional Study of

UnHas Attendance: 8 people plus 2 facilitators from NIHRD Ethics Committee.

1. The existing Ethics Committees: Ethics Committee of FK-UnHas, founded in 1994. Other participating institutions do not know the existence of Ethics Committee. It can be assumed that Ethics Committee activities are not known by other parties, or their performances are still low. The members of Ethics Committee are not present so that there is no description of Ethics Committees performance.

2. The process of proposal review (non protocol) does not follow certain procedures. Sometimes, it is only reviewed by the head of Ethics Committee. The researchers who want to propose the Ethical review have difficulty to access because there is no secretariat. They usually contact the head of the committee, which is usually very busy, directly. There is no budget allocation for the continuation of Ethics Committees jobs. It seems that the organization is not quite good. The Ethics Committee is the head of the committee.

3. The Ethical clearance is assumed to be the formal requirement of a research in FK and hospital. Medical research, which is in the form of clinical trial, only involves informed consent without an Ethical review process. Health research is performed with human subject.

4. Other institutions such as School of Pharmacy, FKM, Research Institute, FKG and Nursing Faculty said that they do not know much about the importance of Ethical clearance in health research involving human subject. School of Pharmacy performs a lot of researches, which are generally pre-clinic using animal subject. The Ethical aspect in animal also becomes the discussions topic. FKM conduct a lot of community surveys, but they do not know if they have to request an Ethical review.

5. With the information regarding the situation of Ethics Committee of LitbangEthics Committees by the facilitator, there appears some topics in the discussion such as the intention, which is proposed by Research Institute which is ready to be a facilitator, to form Ethics Committee in university level, the issues of researchers Ethics, Ethics for animal subject, the intention of hospital such that FK establish the relationship with DikLit of hospital (not only through notice letter, but also through participation and information) to perform monitoring and evaluation of hospital. Similar to the other places, this FGD becomes a forum for exchanging information and even consolidation.

6. FGD also agrees to hold socialization or training regarding Ethics for structural people and member of Ethics Committee, and also for the

researchers. Research Institute is ready to provide financial support; facilitator would be someone from NIHRD Ethics Committee. It is expected that those events will be held at the beginning or middle of 2002.

7. FGD also hopes that the national guidelines will be published soon so that it can be used as reference or modification by the institutions Ethics Committee.

8. The depiction of Ethics Committee in FK-UnHas is not confirmed by the members of Ethics Committee because they are not present in that FGD.

VII. Bandung. Place: FK-Unpad Attendance: 16 people plus 2 facilitators from NIHRD Ethics Committees. 1. The existing Ethics Committees: Ethics Committee of FK-UnPad-RSHS.

Founded in 1990 (joint Ethics Committee). The protocol review is limited to clinical trial or research, which uses patients in RSHS.

2. The member of Ethics Committee has 9 people with one secretary. The members consist of lawyers, medical disciplines, public health, health law, and religion. In term of gender, there is an unbalanced situation where only one woman presents in this Ethics Committee. The member of Ethics Committee has participated in some Ethical meetings in some places such as UI, IDI, UGM, etc.

3. The organization and access of researcher to Ethics Committee are quite good with the support of secretariat. There is not any special budget allocation for Ethics Committee except the meeting fee and the transportation fee for Ethics Committees members attending the seminar. There is not any official fee for assessor (it depends on the one who proposes the protocol).

4. The operational guidelines is being constructed. For the time being, the newly published CUKB and standard material have been used for references. Socialization of CUKB and GCP has been done in September 2001 for FK and hospital in Bandung.

5. The participants of FGD outside FK UnPad and RSHS do not know much about Ethics Committee (because they do not have one). Some researches request the Ethicsal review if the international sponsor requires them. If not, then there is not any Ethical review. Some others feel that the time period of the review is too long; Ethics Committee seems to be bureaucratic and unsupportive. Therefore, the process needs to be simplified a little bit. School of Pharmacy of ITB has not conducted any researches with human subject.

6. The performance of Ethics Committee makes some progress after 11 years. The number of protocols reviewed is about 6-7 per year. Most of them are

clinical trial including the testing of biological sample. The time period for review process could take up to 3 months per protocol. There have not been any reviews on research protocol, which only consist of interview or without intervention.

7. Some things, which are the topics of discussion: the law aspect of hazard for the subject as well as the researcher. There is a difference between the Ethical aspects of medical action with that of health research. The consequences on violation are not clear, except the criminal and civil suite. The other is about the national committee such as when it is going to be formed and what is the relationship with Ethics Committee institution, where is the best place for Ethics Committee (either faculty or university), the independence of Ethics Committees decision even though it is structurally under the institution, the Ethics of promotion of medicine related to the seminar on result of the research.

8. Some problems:

Human resources of Ethics Committee are generally busy. The understanding of the need for Ethical aspect review for research with

intervention only. Others do not need that.

There is not a scientific Committee so that Ethics Committee must also assess that as well. This causes difficulties because friction often occurs among academic advisors.

Some researches have worked but the Ethical clearance has not been out yet.

Some other faculties performing health research, which is not clinical trial involving human subject, have not requested Ethical review. They use the informed consent form instead (this form is just requirement or they might not know).

Socialization is really needed for this kind of research. Ethical problem on animal subject. There is not a guidelines for OTs review. This needs to be addressed since

the master or doctoral students tend to conduct research that way.

Are there any sanctions for violating health research Ethics? 9. The follow up actions proposed in FGD:

The formation of university level Ethics Committee The finishing of local operational guidelines and its socialization in West

Java.

The system/process improvement of Ethical review on protocol. The formation of national Ethics Committee with all of its supports and

partners with institutions Ethics Committee.

The training of Ethics of health research for members of KWE. UnPads researchers are ready to allocate some budget for inviting experts from NIHRD Ethics Committees.

VIII. Surabaya. Place: Research Institute UnAir Attendance: Unknown plus 3 facilitators from NIHRD Ethics Committee. 1. The existing Ethics Committees: the combination of Medical Committee and

Ethics Committee of RSUP Sutomo. In 1995, Committee of Ethical Consideration, which is directly appointed by the director of the hospital, is formed. In 1997, the membership is renewed. In 2001, it is renewed with reference to PP 39/1995. They already have a guidelines for Ethical review.

2. The member is about 16 people (12 men, 4 women) which consists of doctors, specialists, public health, law expert which can be regarded as LAY PERSON.

3. For the last 3 years, they have performed the review of 89 research protocols, 20-30 meetings annually to issue Ethical clearance, receiving Ethical review from outside institutions.

4. The work of Ethics Committee faces some problems because they do not have their own rooms, their own secretariat, and their own budget. Ethics Committee is often blamed as the problem.

5. FKG UnAir has Ethics Committee with SK Dekan 1998. It consists of 10 people, all are from dentistry discipline. The EC request is performed with the presentation from PI in front of Ethics Committees members.

6. FKM UnAir has been proposed. 7. Some problems:

clinical trial on traditional medicine becomes problem if OT is in the form of mixture of several medical plants.

The Ethics of animal subject is really needed because in the future there will be a lot of research using animal. It should be carefully noted that the animal is given the high-dose medicine and human consumes the end result of that animal. Who should issue the EC in the case of distribution of food made of genetically modified material.

Problem in Alternative therapy, the material, whose advantage is not known yet, insecticide, SUTET effect, research involving inter-discipline fields.

Problem in placebo use. The anonymity of the user of secondary data. The clearness of information to the subject with the consequences of

subjects withdrawal. Therefore, the method of getting EC is camouflaged.

The sending of specimen abroad.

Compensation or incentive for subject could sometimes cause problems. IX. BALI : RSUP SANGLAH, DENPASAR Attendance 14 people + 2 facilitators from NIHRD. Issues that come up and discussed:

1. Ethics Committee in Bali: Ethics Committee of FK Unud-RSUP Sanglah; founded in 1996. At the beginning, Ethics Committee is under the Health Research Unit of FK Unud. Since 2000, Ethics Committee has been by itself, supported by FK Unud. Ethics Committee has more activities in 2001.

2. Performance of Ethics Committee:

o 1996-2000: Ethics Committee has not been optimum, it only reviews according to the request only, even the E.C. request from newly performed research. Ethics Committee of FK Unud-RSUPS is only limited to reviewing medical research or health research involving patients of RSUPS.

o 2001: After the Workshop of Health Research Ethic in Bogor on February 2001, Ethics Committee of FK Unud-RSUPS starts the preparations. Some of the important things which are regulated are E.C. is needed not only for medical research but also for all researches with human subject; that is developed into a form of checklist for ethic review convenience. E.C. must be requested before research is conducted.

o Consist of 10 members with 1 chairperson. Membership: multi-discipline/representing every unit in FK; No lay person; There are statisticians (including doctors). There is no special secretariat (room and officer).

o There is no institutions special guide, only in the form of SOP and checklist. Some guides that are referred are Helsinki, CUKB and GCP.

o Protocol review: During the year 2000, Ethics Committee reviews about 50 research protocols. Ethics Committee is specialized in reviewing the ethical side of research. Some scientific aspects are reviewed by some Units in FK. Some others are done by PPI in Litbang Unit of FK.

o The improvement of Ethics Committees performance is inevitable because sometime FKs researchers could not publish their result in international journal and there is a requirement of attaching EC if research is supported by international donor.

o Every result is reviewed in Ethics Committees meeting (meeting depends on the need). There is a presentation of the principle investigator if needed. For certain cases, Ethics Committee also

requests the opinion of the special experts outside of Ethics Committee. In principle, there is no rejected protocol for EC. There is only a revision.

o There is no mechanism for special monitor for research whose EC has been approved.

o The skill improvement of Ethics Committee members: performed by participating in some scientific seminars on health research ethic.

3. Other institutions, which also participate in that meeting, do not know

much about the existence and function of Ethics Committee. 4. Clinical test is usually conducted for education (PPDS). So far, there is no

cooperation with medicine factory in conducting Clinical Test.

5. Other issues: o Does EC need to be discussed in the Unit? Not yet because Ethics

Committee membership must be multidisciplinary. There might be discussion on ethic but Unit does not issue EC.

o Should there be lay person membership? Yes because it is according to the need for research with social impact.

o There should be a special regulation on Ethics Committee formation (the legal aspect of Ethics Committee).

o There should be a study reviewing the performance of Ethics Committee in Indonesia. The result would be an input for Ethics Committees improvement and networking.

o There should be a research ethic standard in the form of national guide, which is, at the same time, followed by socialization for chairpersons and researchers.

o There should be some scientific meetings and ethic workshops for Ethics Committee members and researchers. They should be separated because Ethic Committee focuses more on skill improvement/study case of ethical review. Whereas for researcher, it can focus on the urgency of EC in LitEthics Committees and the ability to create a protocol which fulfills good ethic standard.

o The need for EC is meaningful if all qualifies domestic research journals require an EC for scientific article publication in those journals.

o The EC request must be based on the understanding of the requester on the importance of human right protection on research subject and researcher as well.

X. JAKARTA Attendance 38 people + 5 facilitators from NIHRD Issues that come up and discussed:

1. The existence and performance of Ethic Committee in Jakarta o From several institutions conducting health research and present in

that meeting, there are 8 institutions who already have Ethics Committee: FKUI, Eijkman Institute, NIHRD, BKKBN, RSUP Fatmawati, US NAMRU-2, PuslitEthics Committees UI and Atmajaya University (the last two are Ad Hoc Ethics Committee). RSUP Fatmawati is the only one who does not issue EC.

o The year of Ethics Committee founded varies from 1984 (FK UI) to 1996(Ethic Committee of RSUP Fatmawati).

o In this occasion, the ethic of health research is introduced to the representatives from several health institutions/NGOs/Universities conducting research, which does not know about ethical clearance.

o Operational Guide: 5 institutions who already have one are Eijkman Institute, LitbangEthics Committees, FKUI, BKKBN, and US NAMRU.

o Membership composition: generally multidiscipline. 2 Ethics Committees (FKUI and NIHRD) do not have lay person member. The number of member varies from 7 (RSUP Fatmawati) to 18 (NIHRD). However, there has not been an issue of gender or age balance in the membership.

o In almost all institutions, Ethics Committee reviews their health research ethic. Meanwhile, Scientific Board/PPI reviews the scientific aspect.

o In general, the independence of Ethics Committee has been good. Even in Eijkman, their Ethics Committee has stopped research with human subject, which is conducted before the issuance of EC.

o Most of the protocols reviewed are limited to human subject research. Ethics Committee of Eijkman and US NAMRU are only the one who issues EC for research with animal. The reviewed protocols are not only limited on research with intervention or clinic test, but also on the one with interview.

o It seems that EC for animal subject is more difficult than human subject.

o Clinic test is mostly done by FK and hospital. School of Pharmacy has nevedr done it. Researches conducted are only limited on pre-clinic test, which uses animal as subject or performed in the laboratory.

o NIHRD Ethics Committee has received some EC requests from outside institutions, especially for research with grant from abroad which requires EC from national Ethics Committee. Since national Ethics Committee does not exist yet, NIHRD Ethics Committee can be assumed to be the representative.

o Some Ethics Committees have secretariat (room and special officer). However, not all of them have budget, which is routinely allocated for Ethics Committee. Ethics Committee of FKUI is the only one who charge fee for ethic review request.

o Research monitoring is still passive, only comes from incoming report, and not optimum yet. Researches with high risk are requested to submit progress report to Ethics Committee.

o Ethics Committee Meeting: All Ethics Committees schedule routine meetings (except Ad Hoc Ethics Committee) to discuss the result of ethic review and decision-making. There is mechanism for quorum, especially for high-risk research. Expedited review has also been regulated.

o The EC issuance process in all Ethics Committees usually takes time from 2 weeks to 6 months (depending on risk type). If possible, there is no rejected EC request, however Ethics Committee emphasizes on good research ethic establishment.

2. Other participating institutions:

o Other participating institutions in that meeting do not know much about the existence and function of Ethics Committee (they do not have Ethics Committee in their institution) and the ethic of health research. Some have requested EC if the donor agency requires them for EC. They usually request it from NIHRD Ethics Committee or FKUI. However, in every health research with human subject, with or without intervention, even if there is no EC request, informed consent for subject should be included.

o FKG Trisakti proposes that Ethics Committee of FKG is separated from FK because the scientific field is more specific and hard to be combined with FK. FKG Usakti has had problem with article publication in international journal due to EC unavailability.

o Many question the legal aspect of EC, why they should exist and what are the sanctions if they do not exist, should not IC be enough? If EC is also requested for all health researches, the mechanism should be simplified. Therefore, it will not decrease the research animosity; it even increases the researchers understanding to perform better research.

o YLKI: PP 39/1995 is in agreement with the regulation on consumer protection. Anyone who uses the result of the research has right to get accurate information from research, which meets the scientific requirement and awareness of ethical aspect.

o The problem of research ethic also includes the researchers honesty in using the data (analysis/processing) along with the software, up to its result distribution (not a duplicated work).

o The definition of health research and medical research should be revised. Should health research be comparable to medical research? In this case, which terminology is agreed to be used (if a guide is going

to be made with broad scope). However, WHO/CIOMS uses the term Biomedical research. In UU and PP, the term used is health research.

3. Other issues:

o There should be socialization to Health Minister on that ethic is not a concern of Health Department; it should be up to scientific society, supported and developed by NIHRD. So, the concept of decentralization and autonomy becomes obvious.

o In case of EC for animal subject, why it is not regulated by Department of Agriculture, so that it is not Ministry of Health burden.

o Ethics Committee should work independently. The role of UU/PP/SK is only for legal aspect and does not mean to infringe Ethics Committees independence in improving their performance. Support from structural official involved is needed in upholding Ethics Committees independence.

o Ethic is not related to government because government is usually legalistic. Whereas, health research ethics problem is related to moral. If morality becomes legalistic, then there would be confusion.

o Ethics Committee formation must be considered according to the need. In Jakarta, there are several Ethics Committees who can help in EC issuance for a health research. The Ethics Committee formation must also consider several things, especially the ones related to human resource availability, either the experts who make the review, or the secretariat support; the ones who are qualified to review, the number of research activity conducted by an institution, and budget for Ethics Committee operation.

Some follow-up ideas from the discussion: o The formation of national Ethics Committee, along with the operation

guide book for Ethics Committee and the health research ethics guidelines for researcher, which is followed by the socialization to the institution conducted the research with human subject, facilitated by NIHRD

o For national Ethics Committee, there should be an affirmation on the validity of SK Ministerial Decree Committees, but there is a guarantee to working independently.

o Workshop on Health Research Ethics: for Ethics Committees member and researcher.

o The plan to validity Ministerial Decree on Ethics Committee formation should be re-discussed.

o The cooperation among Ethics Committees in Indonesia: Is possible to form a good network with routine meetings? Ethics Committee of NIHRD is expected to be the focal point.

XI. WEST SUMATRA, RSU Dr. M. JAMIL, PADANG Attendance 10 people + 2 facilitators from LitbangEthics Committees. Issues that come up and discussed: 1. The existence of Ethic Committee in West Sumatra

o From several institutions participating in FGD, FK Unand and RSU Dr. M. Jamil Padang have medical committee, which is also functioning as Ethic Committee (not legally under the organizational structure/ no SK). They are not optimum and do not have guide.

o Does not have EC/Issued, only based on the permit to conduct research from FK/RS.

o Medical Committee of RSU Dr. M. Jamil Padang is only limited for reviewing medical researches (most of them with intervention) or health research using hospitals patient.

o From questioner, it is known that: the existence of hospitals ETHICS COMMITTEE is functionally or structurally legal in RSUD Achmad Muchtar Bukittinggi ( from the questioner), however RSUDAM is not invited in this FGD. ETHICS COMMITTEE of RSUDAM has had SOP for reviewing research proposal, which uses hospitals patient as subject.

2. On the performance of ETHICS COMMITTEE of FK Unand-RSUD:

o Health research: In Padang, the institution, which generally performs research, can be divided into two: clinical test and health research with human subject. The types of research are with and without intervention.

o Proposal review: The scientific review on research proposal is performed by Medical Committee in RSU Dr. M. Jamil Padang. Although EC is not required, the review process also pays attention to the ethical aspect, in research conduct; informed consent from patient is also included.

o Research monitor, which is agreed upon: researcher must report the progress achieved to the advisor periodically. The advisor also controls the research continuity.

o Research budget usually comes from institution (faculty/hospital/university), sponsor (in small percentage) or private fund.

3. General discussion:

o There are participants who inquire the definition and legal limit of Ethic Committee. Also on the legal position of that Committee, does it need to exist and what is the base?

o There is a researcher who had problems in publishing his research in international journal because his research does not get review by Ethics Committee.

o The validity of IC itself is not according to procedure, so that doctor can treat his/her patient freely.

o The discussions participants also question the type of research, which must have EC. Does this request has to be proposed to Ethics Committee in the institution or could be in the outside?

o National Ethical Guidelines for health research, if exists, should be socialized to all people.

The problems discussed in FGD vary with the sophistication of Ethics Committee. The experience, age, the total and type of Ethics Committee are good additions. The experience of performing review is also an on going formation, which does not have to be through formal education.