INTERNATIONAL RESEARCH ETHICS WORKSHOPS
dpramanto- Workshop Overview
Currently growing knowledge and technology in the field of health is supported by various number of health research, both interventional and observational, involving one or many research centers (multi-center). Some researchers have also started examining human genetics or genomes or carrying out further research of stored biologic materials. Sensitive ethical issues may arise before, during, or after research. Storage of human biological materials or the use of left-over specimens for future follow-up studies also requires deep ethical considerations, particularly concerning informed consent and confidentiality.
One of the main tasks of health research ethics committee is to ensure that research ethics are conducted in accordance with nationally and internationally accepted standards of health research ethics, ensuring the safety and well-being of humans that are the source of research subjects, considering the privacy and dignity of the study participants. Implementation of these ethical obligations is at the core of health research ethics. To avoid violations, a deep understanding of the ethics of health research is required. Dengvaxia vaccine case can be a lesson learner for us together in re-evaluating the application and use of ethical principles in conducting the study and monitoring a study.
The World Health Organization (WHO) and the Council for International Organizations of Medical Sciences (CIOMS) In line with the guidelines and ethical standards of national health research and development have developed a guide that encourages researchers and members of HREC to obtain both basic and advanced training courses on research ethics guidelines involving human participants. Training in health research for members of the ethics committee is a key element to strengthen the capacity of research institutions. With the support from multi-sector partnerships and national or international networks, capacity building can lead to better ethical review mechanisms. By studying the development of health research ethics in the world from the beginning to the present, we can obtain a comprehensive picture of health research ethics in its effort to protect humans who become the subject of a research.
As a follow up, the National Institute of Health Research and Development (NIHRD / Badan Litbangkes) through the Indonesia Research Partnership on Infectious Diseases (INA-RESPOND) and the United Stated – National Institutes of Health (US-NIH Department of Bioethics) will organize an International Standard of Health Research Ethics Training. This training will be very useful for health research institutions to improve the ability in the study or ethical review of a research protocol. The training will use an international module developed by US-NIH that has been done in several countries to increase multinational capacity Building.
- Training Participants
Participants who can attend this training are:
- Representatives from hospitals involved in the INA-RESPOND network
- Representatives from the Faculty of Medicine involved in the INA-RESPOND network
- Representatives of the Ethics Committee involved in the INA-RESPOND network
- Representatives of the Ethics Committee of National Health Research & Development of Ministry of Health, Indonesia (Komisi Etik Penelitian dan Pengembangan Nasional Kementrian Kesehatan Indonesia/KEPPKN)
- Members of the Health Research Ethics Committee outside the INA-RESPOND Network
- Trainers / Facilitators
Training facilitators from US-NIH:
- David S Wendler, PhD (Senior Investigator, Head Section on Research Ethics) NIH Clinical Center Department of Bioethics)
- Liza Dawson, PhD (Research Ethics Team Leader, Division of AIDS, NIAID / NIH / DHHS)
- Reidar K. Lie, MD, PhD (Head and Professor of Department of Philosophy, University of Bergen, Norway; Bioethicist, Clinical Center Department of Bioethics & Fogarty International Center, NIH.)
- Joseph R. Millum, PhD (Bioethicist, Clinical Center Department of Bioethics & Fogarty International Center, NIH.)
Trainer / facilitators from Indonesia
- R. Sjamsuhidajat Ronokusumo, dr., Sp.B., KBD (Department of Surgery
Faculty of Medicine University of Indonesia) - Dr. M. Sudomo (Chairman of NIHRD Ethics Committee)
- Dr. dr. Suryani As’ad, M.Sc., Sp.GK (K) (Chairman of Medical Research Ethics Committee, Faculty of Medicine, Hasanuddin University of Makassar)
- dr. Moh. Hakimi, Sp.OG (K), Ph.D. (Chairman of Medical Research Ethics Committee, Faculty of Medicine, Gadjah Mada University – Dr. Sardjito Hospital)
- Place, Time and Contact Information
- Training is planned to be held on Tuesday to Thursday, 17 to 19 July 2018, at JS Luwansa Hotel, Jakarta.
- For more information please contact our email at INAMonitoring@ina-respond.net or phone +622142879189.
- Agenda
Day I: 17 July 2018
| Time | Topic | |
| 09.00 – 09.30 | Welcome and introductions | |
| 09.30 – 10.00 | Health care infrastructure and clinical research in Indonesia: current landscape and capacity building | |
| 10.00 – 10.30 | Clinical research ethics: Current challenges in Indonesia | |
| 11.00 – 11.30 | Overview of clinical research contracts and research sponsor policies and regulations in international collaborative research | |
| 11.30 – 12.00 | Ethics lecture: responsibility of care for participants in trials, including ancillary care and post-trial benefits | |
| 12.00 – 12.20 | Case presentation: ancillary care needs in a clinical trial | |
| 12.20 – 12.45 | Discussion of ancillary care case | |
| 12.45 – 13.45 | Break | |
| 13.45 – 14.15 | Ethics lecture: Responsiveness to host country needs and reasonable availability of interventions in clinical trials | |
| 14.15 – 14.30 | Case presentation: reasonable availability concerns surrounding a clinical trial | |
| 14.30 – 14.45 | Discussion of reasonable availability case | |
| 15.15 – 15.45 | Ethics review of multi-national research | |
| 15.45 – 16.00 | Case presentation: challenges of ethics review involving multiple regulatory bodies | |
| 16.00 – 16.30 | Discussion of ethics review case | |
Day II: 18 July 2018
| Time | Topic | |
| 09.00 – 09.30 | Ethics lecture: Standard of care and placebo controlled trials | |
| 09.30 – 09.45 | Case presentation: standard of care and choice of control group in a clinical trial | |
| 09.45 – 10.15 | Discussion of case study | |
| 10.45 – 11.15 | Understanding and interpreting adverse events in a clinical trial | |
| 11.15 – 11.40 | Case study: Dengvaxia clinical trial | |
| 11.40 – 12.00 | Discussion | |
| 12.00 – 13.00 | Break | |
| 13.00 – 13.30 | Data protection, privacy, and data sharing | |
| 13.30 – 14.00 | Discussion | |
| 14.00 – 14.30 | Biobanking, research on stored specimens, custodianship and specimen sharing | |
| 14.30 – 14.45 | Case study: specimen research in an international collaborative study | |
| 14.45 – 15.00 | Discussion of case study | |
| 15.30 – 16.00 | Community engagement in clinical research | |
| 16.00 – 16.30 | Case study on community engagement | |
| 16.30 – 17.00 | Discussion | |
Day III: 19 July 2018
| Time | Topic | |
| 09.00 – 09.30 | Pediatric research | |
| 09.30 – 10.00 | Discussion | |
| 10.00 – 10.30 | Research involving vulnerable groups: HIV research with key populations | |
| 10.30 – 11.00 | Coffee | |
| 11.00 – 11.15 | Case study: key populations in clinical studies | |
| 11.15 – 11.30 | Experience Sharing: Obtaining Ethical Clearance | |
| 11.30 – 12.00 | Discussion | |
PELATIHAN ETIK PENELITIAN KESEHATAN BERSTANDAR INTERNASIONAL
1. Pengantar
Saat ini semakin berkembang ilmu dan teknologi bidang kesehatan yang didukung oleh banyaknya penelitian kesehatan, baik intervensional maupun observasional, yang melibatkan banyak senter penelitian (multi-senter) atau pun di suatu senter penelitian saja. Beberapa peneliti juga sudah mulai melakukan pemeriksaan terhadap genetik atau genomik manusia atau melakukan penelitian lanjutan dari bahan biologik tersimpan. Permasalahan etika yang sensitif dapat timbul sebelum, selama atau setelah penelitian. Penyimpanan bahan biologik manusia atau penggunaan left-over specimens untuk penelitian lanjutan di masa datang juga mumbutuhkan pertimbangan etik mendalam, terutama mengenai informed consent dan kerahasiaan.
World Health Organization (WHO) bersama Council for International Organizations of Medical Sciences (CIOMS), sejalan dengan pedoman dan standar etika dari penelitian dan pengembangan kesehatan nasional telah membuat panduan yang mendorong agar para peneliti dan anggota KEPK untuk mendapatkan program pelatihan baik dasar ataupun tingkat lanjut tentang pedoman etika penelitian yang melibatkan partisipan manusia. Pelatihan dalam penelitian kesehatan untuk anggota komisi etik merupakan elemen kunci untuk memperkuat kapasitas lembaga penelitian.
Sebagai tindak lanjut, Badan Penelitian dan Pengembangan Kesehatan Nasional (Litbangkes) melalui Indonesia Research Partnership on Infectious Disease (INA-RESPOND) dan United Stated – National Institutes of Health (US-NIH Department of Bioethics) akan menyelenggarakan Pelatihan Etik Penelitian Kesehatan berstandar internasional. Pelatihan ini akan sangat bermanfaat bagi institusi penelitian kesehatan untuk meningkatkan kemampuan dalam telaah atau kaji etik suatu protokol penelitian. Pelatihan tersebut akan menggunakan modul internasional yang telah dikembangkan oleh US-NIH yang telah dilakukan dibeberapa negara dalam rangka peningkatan kapasitas multinasional (Multinational Capacity Building).
2. Peserta Pelatihan
Peserta yang dapat mengikuti pelatihan ini adalah :
- Perwakilan dari Rumah Sakit yang terlibat dalam jejaring INA-RESPOND
- Perwakilan dari Fakultas Kedokteran yang terlibat dalam jejaring INA-RESPOND
- Perwakilan dari Komisi Etik yang terlibat dalam jejaring INA-RESPOND
- Perwakilan dari Komisi Etik Penelitian dan Pengembangan Nasional Kementrian Kesehatan Indonesia (KEPPKN)
- Anggota Komite Etik Penelitian Kesehatan diluar Jejaring INA-RESPOND
Peserta diseleksi hanya untuk 75 orang pendaftar pertama. Pendaftaran ditutup pada Jumat, 2 Juli 2018.
3. Trainer / Fasilitator
Trainer /Fasilitator dari US-NIH
- David S Wendler, PhD (Senior Investigator, Head Section on Research Ethics) NIH Clinical Center Department of Bioethics)
- Liza Dawson, PhD (Research Ethics Team Leader, Division of AIDS, NIAID / NIH / DHHS)
- Reidar K. Lie, MD, PhD (Head and Professor of Department of Philosophy, University of Bergen, Norway; Bioethicist, Clinical Center Department of Bioethics & Fogarty International Center, NIH.)
- Joseph R. Millum, PhD (Bioethicist, Clinical Center Department of Bioethics & Fogarty International Center, NIH.)
Trainer /Fasilitator dari Indonesia
- R. Sjamsuhidajat Ronokusumo, dr., Sp.B., KBD (Departemen Ilmu Bedah Fakultas Kedokteran Universitas Indonesia)
- Dr. M. Sudomo (Ketua Komisi Etik Badan Penelitian dan Pengembangan Kesehatan)
- Dr. dr. Suryani As’ad, M.Sc., Sp.GK(K) (Ketua Komisi Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Hasanuddin Makassar)
- dr. Moh. Hakimi, Sp.OG(K), Ph.D. (Ketua Komisi Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Gadjah Mada – RSUP Dr. Sardjito)
4. Tempat, waktu dan Informasi
- Training ini diadakan tanggal 17-19 Juli 2018 di Hotel JS Luwansa, Jakarta
- Untuk informasi lebih lanjut dapat menghubungi email kami di INAMonitoring@ina-respond.net atau telephon di +622142879189.
- Agenda
Hari I : 17 Juli 2018
| Time | Topic | |
| 09.00 – 09.30 | Welcome and introductions | |
| 09.30 – 10.00 | Health care infrastructure and clinical research in Indonesia: current landscape and capacity building | |
| 10.00 – 10.30 | Clinical research ethics: Current challenges in Indonesia | |
| 11.00 – 11.30 | Overview of clinical research contracts and research sponsor policies and regulations in international collaborative research | |
| 11.30 – 12.00 | Ethics lecture: responsibility of care for participants in trials, including ancillary care and post-trial benefits | |
| 12.00 – 12.20 | Case presentation: ancillary care needs in a clinical trial | |
| 12.20 – 12.45 | Discussion of ancillary care case | |
| 12.45 – 13.45 | Break | |
| 13.45 – 14.15 | Ethics lecture: Responsiveness to host country needs and reasonable availability of interventions in clinical trials | |
| 14.15 – 14.30 | Case presentation: reasonable availability concerns surrounding a clinical trial | |
| 14.30 – 14.45 | Discussion of reasonable availability case | |
| 15.15 – 15.45 | Ethics review of multi-national research | |
| 15.45 – 16.00 | Case presentation: challenges of ethics review involving multiple regulatory bodies | |
| 16.00 – 16.30 | Discussion of ethics review case | |
Hari II : 18 Juli 2018
| Time | Topic | |
| 09.00 – 09.30 | Ethics lecture: Standard of care and placebo controlled trials | |
| 09.30 – 09.45 | Case presentation: standard of care and choice of control group in a clinical trial | |
| 09.45 – 10.15 | Discussion of case study | |
| 10.45 – 11.15 | Understanding and interpreting adverse events in a clinical trial | |
| 11.15 – 11.40 | Case study: Dengvaxia clinical trial | |
| 11.40 – 12.00 | Discussion | |
| 12.00 – 13.00 | Break | |
| 13.00 – 13.30 | Data protection, privacy, and data sharing | |
| 13.30 – 14.00 | Discussion | |
| 14.00 – 14.30 | Biobanking, research on stored specimens, custodianship and specimen sharing | |
| 14.30 – 14.45 | Case study: specimen research in an international collaborative study | |
| 14.45 – 15.00 | Discussion of case study | |
| 15.00 – 15.30 | Coffee | |
| 15.30 – 16.00 | Community engagement in clinical research | |
| 16.00 – 16.30 | Case study on community engagement | |
| 16.30 – 17.00 | Discussion | |
Hari III : 19 Juli 2018
| Time | Topic | |
| 09.00 – 09.30 | Pediatric research | |
| 09.30 – 10.00 | Discussion | |
| 10.00 – 10.30 | Research involving vulnerable groups: HIV research with key populations | |
| 10.30 – 11.00 | Coffee | |
| 11.00 – 11.15 | Case study: key populations in clinical studies | |
| 11.15 – 11.30 | Experience Sharing: Obtaining Ethical Clearance | |
| 11.30 – 12.00 | Discussion | |