12th FERCAP Conference - Resource Material

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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