Research Bioethics Training in Bangladesh

Special Article Research Bioethics Training in Bangladesh HA Rashid Bangladesh Med. Res. Counc. Bull. 2003; 29(3); 78-85 Summary The Bangladesh Medical Research Council is implementing a training program on research bioethics under International Bioethics Education and Career Development Award of Fogarty International Center of National Institutes ofheaith (NIB), USA. The ultimate goal ofthe program is to improve ethical practice in implementation of health research through capacity strengthening of the professionals involved in health research in Bangladesh. The duration of the program is 4 years and it has started from the year 2002. The first year (2002-2003) was assigned for curriculum development. Several workshops, focus group discussions and consultative meetings were organized during 2002-2003and curriculum was developed. Under-this training program every year 2 Certificate Courses on Research Bioethics (CCRB) with a duration of 10 weeks will be conducted for 40 participants (20 participants in each batch). Each year one Advance Course on Research Bioethics (ACRB) will be organized for 10 participants with a duration of 6 days. The courses are to be conducted during 2nd, 3rd and 4th year. The Certificate Course on Research Bioethics is intended for multidisciplinary participants having previous experience in research methodology while the Advance Course on Research Bioethics will target for training the members of Ethics Review Committees of the country. Through this program one hundred fifty Bangladeshi professionals will get adequate training on research bioethics. The training program will be implemented by national experts with technical assistance from distinguished international scientists in the field. Introduction Bangladesh is a developing country of South Asia with enormous health problems. Demand for health research in this country is constantly increasing. The international collaboration is growing rapidly.bangladesh is getting attention of international researchers because of high prevalence of emerging and reemerging infections, nutrition deficiencies, family planning & reproductive health problems etc. In addition Bangladesh is facing widespread arsenic contamination of drinking water with substantial public health impact'. It is assumed that about 50 million peoples are Director, Bangladesh Medical Research Council (BMRC), Mohakhali, Dhaka, Bangladesh and Program Director. Training on Research Bioethics (TORB)- Program supported by a Research Grant of NtH. USA. 78

Bangladesh Med. Res. Counc. Bull December 2003 vulnerable and have already been exposed to the risk of developing arsenic toxiciti. Several international institutions/ scientists are engaged and interested to be engaged in research on arsenic related health problems. The research on genetics has opened another probability for more research in this area due to genetic diversity3. Health research is an essential tool for achieving equity in health and developmen~. It is important to mention that inequity in health and development are more prominent in developing c"0untries with huge health related problems asking for solutions. However, less than 10% of global spending on health research by both the public and private sectors is devoted to 90% of the world's health problems5 and 87% of the $2 trillion spent on health care globally is spent on 16% of the world's populationr.. The International Conference on Health Research, held at Bangkok in October, 2000 recommended major strategic directions and action plans for promoting health research in the developing countries? The Asian Forum for Health Research convened in Manila in 2000, suggested that Asians must be c'ommitted to research towards better equity in health. There was consensus that new thinking, tools and ethics for research are needed to drive the concept of equity in healthx. To correct the existing inequities, research activities and initiatives that address health problems of developing countries be increased. But many countries of the developing world lack the capacity to assess or ensure the scientific quality or ethical acceptability of biomedical research proposed or carried out in their jurisdictions'l. So, there is an urgent need for further education and training to ensure that those in developing countries are able to discuss ethical issues effectively with external sponsors & others and to have mechanisms in place to deal with issues that arisejii. A truly cooperative research partnership should be based on development of national research capacityii. Strengthened capacity in research ethics is needed in both developed and developing countries, though the need is particularly acute in developing countries.' The crucial step, yet to be taken, is to strengthen ethics centers and training programs in developing countriesl2. Bangladesh needs a core group of highly trained professionals to provide guidance to the research community on ethical questions during conduct of research, considering current and future research situation. Despite this urgent need there is no program available for comprehensive training of the relevant health professionals. Bangladesh wi II experience huge number of research studies in coming years. Collaboration with researchers of developed world will cel1ainly increase. To cope with the future situation Bangladeshi scientists should be trained through suitable training in research bioethics, so that the local researchers can provide leadership in bioethics and contribute to the ethical conduct of research studies and protection of research participants. The objective of this paper is to give an overview of a training program on research bioethics and to create awareness about training opportunities on research bioethics 79

Vol. 29, No.3 Research Bioethics Training HA Rashill in B~ngladesh funded by the Fogarty International Center of National Institutes of Health (NIH), USA under the International Bioethics Education and Career Development Award. The ultimate goal of the training program is to improve ethical practice in conducting health research through capacity strengthening of health professionals and members of Ethics Review Committees by organizing Certificate Courses on Research Bioethics for multidisciplinary participants having previous exposure in research methodology and Advance Courses on Research Bioethics for the members of the presently fun.ctioning Ethics Review Committees of the country. It may be mentioned here that the stated training program include an international component under which Intensive Workshop on Research Bioethics will be conducted in Almaty, Kazakhstan through the Kazakhstan School of Public Health (KSPH). The international component however wi II not be discussed here. Table-I: Courses with duration, number of batches and participants Course Title Duration Objectives to Nu"!ber of Participants Total be achieved in each batch batches Certificate Course on 10 weeks Objective # 2 20 6 Research Bioethics Advance Course on 06 Days Objective # 3 10 3 Research Bioethics Objectives afthe Training Program The research bioethics training program has following major objectives: I. To make available a standard curriculum for training on research bioethics. 2. To improve the ethical practice through capacity strengthening of the health professionals/researchers of Bangladesh in research bioethics. 3. To prepare a cohort of experts in Bangladesh in ethical review of research proposals and capable of serving as a member of the Ethics Review Committees. Activities to be undertaken to attain the objectives of the program include development of comprehensive curriculum for Certificate & Advance Courses on Research Bioethics, training manpower in fundamental areas of research bioethics and provide training to the members of the Ethics Review Committees of Bangladesh. Courses with duration, number of batches and participants are presented in Table-I. The training program will be conducted by national experts from different institutions of the country. Four international scientists from Johns Hopkins University, Joint Centre for Bioethics of University of Toronto. Indian Council for Medical Research and Aga Khan University will provide technical assistance in implementation of the program... 80

Bangladesh Med. Res. Counc. Bull Decem Curriculum Development Five workshops, 3 focus group discussions and 6 faculty meetings were conducted ensuring multidisciplinary and multisectorial participation for curriculum development. Total 175 participants from different medical colleges, post-graduate medical institutes, universities & health related organizations of the country attended the workshops and focus group discussions. The aim of the workshops, focus group discussions and faculty n was to develop curriculum for Ce Course on Research Bioethics. Part were divided into groups and grot utilizing guidelines which were de prior to workshops was used a~ strategy for development of the cun Curriculum development workshop group discussions/faculty meetin~ conducted separately for Basic EI Applied Ethics. Fig.-!: A schematic presentation of major training activities under the Program (National CO Training on Research Bioethics (TORB) National Component (Bangladesh) CERTIFICATECOURSE ON RESEARCH BIOETHICS Duration of Each Course: 10 Weeks Number of Courses: 2 per year x 3 =6 Participants in each Course: 20 Total Manpower Development: 20 x 6 = 120 Compilation of group opinions on curriculum was done with technical assistance from experts in medical education. A draft curriculum for Certificate Course on Research Bioethics (Basic Ethics & Applied Ethics) was formulated. Members of Ethics Review Committees were involved to develop the draft curriculum for the Advance Course on Research Bioethics. The drafts then were reviewed by different committees, experts and international national scientists attached to the program for their due inputs, comments ADVANCE COURSE ON RESEARCH BIOETHICS Duration of Each Course: 6 Working Days Number of Courses: I per year x 3 = 3 Participants in Each Cours 10 Total Manpower Developme lox 3 =30 & suggestions. Finally compre curriculum for the Certificate and i Courses on Research Bioethic developed. A schematic present: major training activities under the] is demonstrated in Fig.-l. Certificate Course on Research Sir; conducted with following major ob. research bioethics, to equip particip~ critical skills for leadership develo} Non-degree certificate course to provide fundamental knowlt 81

Vol. 29. No.3 Research Bioethics Training HA.Rashid research ethics and to acquaint trainees with research ethics review process. Total duration of the certificate cours\.. will be 10 weeks. The course will be implemented in two (2) phases with an inter-workshop period and an internship scheme at the end (Fig.2). Phase-I wi II deal with basic knowledge, while Phase-II with applied knowledge on research bioethics. During the inter-workshop period the participants should complete an assignment on health research ethics. In internship period the participants will be attached to the Bangladesh Medical Research Council's Ethics Review Committee (ERC). Trainees should prepare all necessary documents to be presented in the ERC meeting and should observe the activities of the ERC of the Council during evaluation & approval of research proposals. Fig-2: Flow Diagram of Different Phases of Certificate Course on Research Bioethics 2 Weeks.. 4Weeks I.. 2 Weeks.. 2 Weeks I Phase-I (Basic Ethics).. Inter-workshop Phase (Assignment).. Phase-II.. Internship Phase (Applied Ethics) (Practicum) Phase-I-Basic Ethics: The first Phase will have 2 weeks duration- 12 working days. Thus 5 hours in a day i.e. total 60. hours will be allotted for Basic Ethics. This Phase will deal with foundations of research ethics. Course contents of Phase-I are given in Table-II. Inter-workshop Phase (Assignment): During this period the participants should complete an assignment on one of the topics assigned to them individualiy. The assignment is due at the start of Phase-II of the Course. Each participant should prepare a plan for the assignment during Phase-I and present the same at the last day of phase-i. As assignment each ofthe participants should write a scientific article or review paper or develop teaching material on research ethics following prescribed guidelines. Table-II: Course Contents of Phase-I (Basic Ethics). Philosophical Foundations. Ethical Theories & Models. Basic Principles of Ethics. Legal Aspects & Legislations. Legal & Regulatory Codes. Religious Views. Cultural Pluralism. Genetics Research & Ethics. Transplantation & Ethical Issues. International Bioethics. Reproductive Health & Rights. Ethical Declarations & Guidelines. Project Development on Research Ethics.Prioritiesin ResearchEthics. Intellectual Property Rights 82

Bangladesh Med. Res. Counc. Bull December 2003 Phase-II-Applied Ethics: The Phase-II will be of 2 weeks duration, which will also have an allocation of 12 working days-60 hours at the rate of 5 hours per day. This phase will primarily be devoted to discussions on applied research ethics. Course contents are provided in Table-III. Table-III: Course Content.~ ofphase-li: Applied Ethics. InformedConsent. Inducement. Confidentiality. Compensation. EthicalReviewBoards. Ethical Review of Research Proposal. Serving as Member of Ethics Review Committee. Presentation of Research Proposals in Ethics Review Committee. Teaching Research Bioethics. Ethical Conduct of Clinical Trial. Animal Experiment & Ethics. Ethics in Public Health Research. Research Ethics in Developing Countries.. Collaborative Studies and Research Ethics. ConflictofInterest. ScientificMisconduct Internship Phase (Practicum on Research Ethics): The duration of this period will be of two (2) weeks for a course. During this period participants will be attached to the Ethics Review Committee of the Bangladesh Medical Research Council. The purpose of this Internship is to provide practical/ technical knowledge and skill required to provide leadership in guiding research community on ethical issues. Trainees of a course will be divided into 4 groups - each group will consists of maximum 5 participants. The group has to critique at least 5 research protocols (minimum I by each individual), write summary for the Ethics Review Committee under supervision of the technical persons (who usually perform this job in the Council), c,heck documents necessary for the ethical review, present the research protocol, participate in the discussions of the committee, and observe the procedures followed in the Ethics Review Committee meeting for revie~ and evaluation of research proposals. The participants should also prepare official letters (approval or/and clarification) directed to the principal investigator of the research proposal. Advance Course 011Research Bioethics The Advance Course on Research Bioethics will be targeted for the members of Ethics Review Committees of the country. Preliminary analysis of a survey on Ethics Review Boards in the country showed that in Bangladesh most of the institujions do not have Ethics Review Committee. It was found that around 8 institutions have functioning Ethics Review Committees with 8-13 members in each of the committees. Members in the committees are taken from different professions: lawyers, journalists, religious leaders, lay persons, paediatric ian, obst. & gynae. experts, epidemiologists etc. In many of the cases these members do not have any formal training on bioethics. The course will be conducted mainly: to train the members of the Ethics Review Committees in technical expertise on research bioethics. to familiarize trainees with ethical guidelines 83

Vol. 29. No.3 Research BioethiGS Training HA Rashid & declarations and to provide knowledge on ethical review of research proposals. The duration of the Advance Course on Research Bioethics will be 6 (six) working days, and total 30 hours will be available for this course. Based on the objective to train the Ethics Review Committee members in review & evaluation of research proposals, following topics will be included for discussions during the Advance Course (Table-IV). Table-IV: Course Contents of Advance Course on Research Bioethics. Basic Principles of Ethics. International Declarations & Guidelines. Cultural Dimension of Research Ethics. Ethical Guidelines of Countries of South Asia. National Ethical Guidelines. Ethical Review Boards. Ethical Review of Research Proposals. Research on Bioethics. Informed Consent. Confidentiality,Inducement& Compensation. Ethics in Research Involving Pregnant Women & Children. Clinical Trial & Ethical Issues. Pharmaceutical Industry Supported Research. Research Supported by Development Partners. CollaborativeStudies. ResearchInvolvingVulnerableGroups. PostApprovalMonitoringof EthicalIssues. InvestigatorsResponsibility. Contlictof Interest. ScientificMisconduct Discussion Considering the present practice of research ethics and its importance due to increase of research studies including multicenter collaborative research specially supported by the developed countries, we think the attempt for this research bioethics training in Bangladesh is highly important. The training program is targeted for professionals of a developing country- Bangladesh and will provide int~nsive training to individuals to enable them to provide leadership in research bioethics. The training will be implemented by the Bangladesh Medical Research Councilfocal point for promotion and coordination of health research in the country, having considerable reputation and experience in conducting trainings with multi-disciplinary participants.. The Certificate Course on Research Bioethics with Phase-I: Basic Ethics, Phase-II: Applied Ethics, Interworkshop Phase: Assignmen~ and Internship Phase: Practicum on Research Ethics is an innovative approach in bioethics training which combines theoretical & practical approaches. Time distribution for the courses is unique and highly suitable for a developing country like Bangladesh. Conclusion The program will help in capacity building of 150 professionals from Bangladesh which will contribute towards practice of ethical standards in conducting health research involving human subjects. Acknowledgement The Training on Research Bioethics-Program is supported by NIB Research Grant funded by the Fogarty International Center, the National Institute of Environmental Health Sciences, the National Institute of General 84

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