th
12 FERCAP
INTERNATIONAL CONFERENCE & GENERAL ASSEMBLY Development, Ethnicity, Culture and Ethical Health Research
RESOURCE MATERIAL Version 2 Containing all the Presentations Made at the Conference
November 18 to 21, 2012 Waters Edge, Colombo, Sri Lanka
12th FERCAP International Conference Development, Ethnicity, Culture and Ethical Health Research 18 to 21 November 2012 Waters Edge Convention Center, Colombo, Sri Lanka
Forum for Ethical Review Committees in Asia & the Western Pacific
Strategic Initiative for Developing Capacity in Ethical Review HOSTED AND CO-ORGANIZED BY THE
Sri Lanka Medical Association
University of Colombo
National Science Foundation, Sri Lanka WITH SUPPORT FROM
CONTENTS PLENARY SESSION 1 - CONDUCTING ETHICAL HEALTH RESEARCH IN DEVELOPING COUNTRIES FOR BETTER HEALTH OUTCOMES Ethical Research and Diseases of Poverty Ethical Issues in Translational Research and Clinical Investigation International Programs for Capacity Building in Clinical Trials What’s Culture Got to Do with Biomedical Research Ethics?
1 7 9 13
PLENARY SESSION 2 - CULTURE, TRADITION, AND ETHICS IN RESEARCH Contextual Lessons from Surgical Archaeology? Ethics and Thai Buddhist Traditional Medicine Confucianism and Ethics in Research Relevance of Ayurvedic Traditions in Ethics in Modern Research Addressing Multi-Cultural Concerns through Community Research Boards
14 24 26 35 40
PARALLEL SESSION 1.A - ETHICAL, LEGAL, AND SOCIAL ISSUES IN GENETIC RESEARCH Genomic Research: Sharing Data within Large-Scale Research Consortia and with the Wider Scientific Community Ethical Use of Stored Samples of “Ethnic Minorities” Role of Pharmacogenetics in the development of Herbal Medicine
43 46 52
PARALLEL SESSION 1.B - UNDERSTANDING VARIOUS APPROACHES IN TRADITIONAL MEDICINE RESEARCH The Syndrome Method in Traditional Chinese Medicine Research Thai Traditional Approaches in Medical Research Reviewing Traditional Medicine Research in Sri Lanka Case Studies: Reviewing Traditional Medicine Protocols
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55 58 61 64
PARALLEL SESSIONS 2.A - ADDRESSING VULNERABILITY IN RESEARCH A Study on the Effect of Health Education on Hypertension in a Poor Urban Community Perceptions of School Teachers on Ethical Issues Related to Research on Adolescent Risk Behaviour in a Rural Setup in Sri Lanka Ensuring Full Disclosure in the Informed Consent Form for Cancer Patients in Oncology Clinical Trials Tailoring the Consent Process to the Research Context: Should Ethics Committees Look Beyond Consent Form?
67 72 76 81
PARALLEL SESSION 2.B - USE OF IT FOR BETTER ETHICS PROGRAMS Educating Stakeholders through Global Health Trials Website
84
Improving Performance through eIRB Systems The Research for Health and Innovation Organiser (RHInnO) Platform
86 89
PLENARY SESSION 3 - DEVELOPING REGULATIONS, GUIDELINES, MODELS FOR ETHICAL HEALTH RESEARCH Avoiding Ethical Scandals: Improving Compliance with Indian Guidelines Improving the Environment for Clinical Trials in Sri Lanka Guidelines for Ethical Review of Drug Clinical Trials in China Utilization of Clinical Trial Registry for Better Health Research
94 98 103 108
PLENARY SESSION 4 - PROMOTING TRANSPARENCY AND QUALITY STANDARDS FOR ETHICAL RESEARCH Strengthening National Drug Regulations through Ethics Committee Accreditation Research Councils and Ethics Committee Accreditation The IRB/EC Quality Assurance and Improvement System in Taiwan
112 115 121
PARALLEL SESSION 3.A - IMPROVING PERFORMANCE OF RESEARCH ETHICS COMMITTEES Capacity Building of Physicians in Training: Factors Associated with Risk Determination in Ethics Review Monitoring Compliance with Ethical Guidelines by a Research Ethics Committee Retrospective Analysis of Outcomes/Decisions Related to Revision of Proposals Submitted to an Institutional Review Board Administrative Issues of Ethics Committees in the Asian Region based on the SIDCER Recognition Survey Reports
125 129 132 136
PARALLEL SESSION 3.B - ROUND TABLE DISCUSSION: DEVELOPING FERCAP GUIDELINES FOR REVIEW OF SOCIAL SCIENCE RESEARCH Developing FERCAP Guidelines for Social Science Research in the Health Sciences Draft Guidelines on Social Science Research
139 141
PLENARY SESSIONS 5 - COLLABORATION, ETHICS AND RESEARCH CULTURE Biomedical and Health Experimentation in South Asia: An Overview of the Project Situating Evidence in Public Health Interventions: Experiences From India, Nepal and Sri Lanka Collaboration or Brokerage? Local Assemblages in Global Clinical and Public Health Research Themes and Issues in Bioethics, Regulation, and Governance GENERAL ASSEMBLY FERCAP 2012 – Accomplishments and Challenges
142 145 150 153
156
Ethical Research and Diseases of Poverty Hemantha Senanayake Ethics Review Committee, University of Colombo representing the World Health Organization Tropical Disease Research Programme (WHO-TDR)
1
2
3
4
5
6
Ethical Issues in Translational Research and Clinical Investigation Greg Koski Harvard University, USA and Advisory Committee Chair, Strategic Initiative for Developing Capacity in Ethical Research
7
8
International Programs for Capacity Building in Clinical Trials Leslie Ball U.S. Food and Drug Administration
9
10
11
12
What’s Culture Got to Do with Biomedical Research Ethics? Robert Simpson Durham University, UK; Co-Principal Investigator of the BHESA Project
13
Contextual Lessons from Surgical Archaeology? Arjuna Aluwihare University of Peradeniya, Sri Lanka
14
15
16
17
18
19
20
21
22
23
Ethics and Thai Buddhist Traditional Medicine Vichai Chokevivat Institute for Human Research Protection, Bangkok, Thailand
24
25
Confucianism and Ethics in Research Chih-Cheng Chien Sijhih Cathay General Hospital, Taiwan
26
27
28
29
30
31
32
33
34
Relevance of Ayurvedic Traditions in Ethics in Modern Research Subhas Dutta J B Roy State Ayurvedic Medical College & Hospital, India
35
36
37
38
39
Addressing Multi-Cultural Concerns through Community Research Boards Khin Maung Lwin,1 Phaik Yeong Cheah,2,3 Francois Nosten,1,2,3 Michael Parker3 1Shoklo Malaria Research Unit; 2Mahidol Oxford Tropical Medicine Research Unit; 3University of Oxford, UK
40
41
42
Genomic Research: Sharing Data within Large-Scale Research Consortia and with the Wider Scientific Community Susan Bull and Michael Parker, University of Oxford; Jantina de Vries, University of Capetown; and the MalariaGEN Consortium
43
44
45
Ethical Use of Stored Samples of “Ethnic Minorities� Roli Mathur Indian Council for Medical Research, India
46
47
48
49
50
51
Role of Pharmacogenetics in the development of Herbal Medicine Kenji Hiriyama Department of Immunogenetics, Institute of Tropical Medicine (NEKKEN), Nagasaki University, Japan
52
53
54
The Syndrome Method in Traditional Chinese Medicine Research Xiuqin Wang, Jiangsu Provincial Hospital, China
55
56
57
Thai Traditional Approaches in Medical Research Somboon Kietinum Thammasat University, Thailand
58
59
60
Reviewing Traditional Medicine Research in Sri Lanka Chandanie Wanigatunge and the Members of the Ethics Review Committee Faculty of Medical Sciences, University of Sri Jayewardenepura, Sri Lanka
61
62
63
Case Studies: Reviewing Traditional Medicine Protocols Sopit Thamaree National Research Council of Thailand
64
65
66
A Study on the Effect of Health Education on Hypertension in a Poor Urban Community Patricia Agunod-Cheng, Ranulfo Javelosa, Gerald Vilela, Marcelito Durante, Mercedita Parazo, Celia Alino, and Linda Munoz Philippine Heart Cente IEC, Philippines
67
68
69
70
71
Perceptions of School Teachers on Ethical Issues Related to Research on Adolescent Risk Behaviour in a Rural Setup in Sri Lanka Dolamulla SS, Attanayake N, Wickramasinghe PK Provincial Director of Health Office, Hambantota, Sri Lanka
72
73
74
75
Ensuring Full Disclosure in the Informed Consent Form for Cancer Patients in Oncology Clinical Trials Sangeeta Desai Tata Memorial Hospital, Mumbai, India
76
77
78
79
80
Tailoring the Consent Process to the Research Context: Should Ethics Committees Look Beyond Consent Form? Susan Bull University of Oxford, UK
81
82
83
Educating Stakeholders through Global Health Trials Website Susan Bull University of Oxford, UK
84
85
Improving Performance through eIRB Systems Jong Woo Chung Asan Medical Center, Korea
86
87
88
The Research for Health and Innovation Organiser (RHInnO) Platform Boitumelo Mokgatla-Moipolai COHRED
89
90
91
92
93
Avoiding Ethical Scandals: Improving Compliance with Indian Guidelines Vasantha Muthuswamy Forum for Ethical Review Committees in India
94
95
96
97
Improving the Environment for Clinical Trials in Sri Lanka Asita De Silva, National Steering Committee for Clinical Trials in Sri Lanka
98
99
100
101
102
Guidelines for Ethical Review of Drug Clinical Trials in China Jinhong Hu and Jin Huang Changhai Hospital Ethics Committee, Shanghai, China
103
104
105
106
107
Utilization of Clinical Trial Registry for Better Health Research M. Wimalachandra, U.K. Ranawaka, A. de Abrew, C. A. Wanigatunga, L. Rajapakse, C. Goonaratna Sri Lanka Clinical Trials Registry, Sri Lanka Medical Association
108
109
110
111
Strengthening National Drug Regulations through Ethics Committee Accreditation Marita Reyes Philippine Health Research Ethics Board
112
113
114
Research Councils and Ethics Committee Accreditation Sottiporn Chittmitraprap National Research Council of Thailand
115
116
117
118
119
120
The IRB/EC Quality Assurance and Improvement System in Taiwan Shui Ming-Neng Department of Health, Taiwan
121
122
123
124
Capacity Building of Physicians in Training: Factors Associated with Risk Determination in Ethics Review Patricia M Khu MD MS, Ryner Jose Carrillo MD, Eleanor R Mercado, Charie Mae C Cabreros University of the Philippines Manila Research Ethics Board (UPREB), Manila, Philippines
125
126
127
128
Monitoring Compliance with Ethical Guidelines by a Research Ethics Committee Savitree Teanchai Institute for Human Research Protection, Bangkok, Thailand
129
130
131
Retrospective Analysis of Outcomes/Decisions Related to Revision of Proposals Submitted to an Institutional Review Board Dr. Sunil Kuyare, Dr. Padmaja Marathe, Dr. Yashashri Shetty, Dr. Sandhya Kamat,Dr. Urmila Thatte Seth G. S. Medical College & K.E.M. Hospital Ethics Committee, Mumbai, India
132
133
134
135
Administrative Issues of Ethics Committees in the Asian Region based on the SIDCER Recognition Survey Reports Lisa Hamadian Roche, Australia
136
137
138
Developing FERCAP Guidelines for Social Science Research in the Health Sciences Francis P. Crawley Good Clinical Practice Alliance, Europe & Strategic Initiative for Developing Capacity in Ethical Review
139
140
Draft Guidelines on Social Science Research Susan Bull University of Oxford, UK
141
Biomedical and Health Experimentation in South Asia: An Overview of the Project Roger Jeffery Co-Principal Investigator, BHESA Project
142
143
144
Situating Evidence in Public Health Interventions: Experiences From India, Nepal and Sri Lanka Tharindi Udalagama, Rekha Khatri, Deapica Ravindran, Jeevan Raj Sharma, Salla Sariola, Ian Harper and Roger Jeffery BHESA Project
145
146
147
148
149
Collaboration or Brokerage? Local Assemblages in Global Clinical and Public Health Research Anuj Kapilashrami, Rekha Khatri, Robert Simpson, and Deapica Ravindran BHESA Project
150
151
152
Themes and Issues in Bioethics, Regulation, and Governance Bob Simpson, Rekha Khatri, Tharindi Udalagama, and Deapica Ravindran BHESA Project
153
154
155
FERCAP 2012 – Accomplishments and Challenges Cristina Torres FERCAP
156
157
158