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

`

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


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