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This year’s FERCAP Annual International Conference will be held at Hotel Equatorial Shanghai, Shanghai, China on November 23-24, 2010 (Pre-Conference is on November 22 and FERCAP General Assembly and NAREC Meeting are set on November 25, 2010). This conference will provide a forum for various stakeholders to discuss leading concepts, initiatives, and models of partnerships and alliance building in the conduct of ethical health research. The goal is to create an international network of national ethical research systems, consisting of ethically motivated, adequately informed, and responsible stakeholders who communicate and interact with one another to assure the public about the protection of the rights and safety of human participants in the conduct of research. The conference will have the following sessions: 1) concepts and practices in networking and alliance building in ethical health research; 2) regulatory compliance for ethical health research; 3) strategic partnership and capacity building of research ethics committees; 4) investigator networking for ethical health research; 5) sponsor alliance building for ethical health research; and 6) alliance building with community groups for ethical health research.

The advanced registration conference fee (by September 30) is US$ 150 for FERCAP members or US$ 200 for non-FERCAP members. Registration conference fee (after September 30) is US$ 200 for FERCAP members or US$ 250 for non-FERCAP members.

FERCAP welcomes the submission of abstracts for oral

presentation for any of the conference sessions. Limited scholarships are available to speakers from Asia. Abstracts should be submitted to atoynavarro@yahoo.com before August 31, 2010. Abstract submission should have the following format:

Abstract title: Author: About the author (3 sentences): Session number and session title: Abstract (300 words): Together with the Graduate Program in Biomedical Sciences of Thammasat University (TU) - Rangsit Campus and the Forum for Ethical Review Committees in Thailand (FERCIT), FERCAP will be holding an International Course on Research Ethics at the WHO-TDR Clinical Coordination and Training Center (CCTC), TU - Rangsit Campus on September 27-30, 2010. This international course is an overview of research ethics, focusing on the ethics of biomedical research. This course will cover the following topics: a) historical background, principles, and guidelines of research ethics; b) structure, roles, and functions of research ethics committees; c) ethical considerations in biomedical research such as those related to informed consent, privacy and confidentiality, conflict of interest, vulnerability, risk and benefit evaluation, research integrity and scientific misconduct, and authorship and publication; and d) ethical issues and methodologies in different biomedical research fields (animal research, genetics research, and epidemiological and social research) in the context of national, regional, and international collaborative research. The course fee for this course is US$ 300 (includes course materials, coffee/tea breaks, lunch, and accommodations during the training period) for foreign participants and THB 1,000 for Thai participants (includes course materials, coffee/tea breaks, and lunch during the training period). For those interested to attend this course, please submit the following: a) letter of interest; b) curriculum vitae; c) photo. E-mail these application requirements to the following email: atoynavarro@yahoo.com, on or before August 15, 2010. For more information about the conference and the research ethics course, visit the FERCAP Website: http://www.fercap-sidcer.org/index.php

Forum for Ethical Review

C o m m i t t e e s i n A s i a

and the Western Pacific

FERCAP NEWSLETTER July 30, 2010

International Course on International Course on International Course on International Course on

Research EthicsResearch EthicsResearch EthicsResearch Ethics

Call for Abstract for 10th

FERCAP Annual Conference

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Dr. Roli Mathur, Ph.D., Scientist ‘C’ Division of Basic Medical Sciences Indian Council of Medical Research Department of Health Research

Ministry of Health and Family Welfare Ansari Nagar, New Delhi- 110029, India

E-mail: mathurr@icmr.org.in

In recent years, India witnessed an exponential increase in health research as in a number of other countries that are fast becoming major contributors to the globalised research process. India was not isolated from cases of exploitation and the need to tackle ethical challenges in conducting biomedical research. Before 1980 there was no formal national structure for ethical review, but with the rapid developments in biomedical sciences, there is a need to create one.

The very first comprehensive document was prepared in 1980 by the Central Ethics Committee of the Indian Council of Medical Research (ICMR): “Policy Statement on Ethical Considerations Involved in Research on Human Subjects” (1). This Policy document urged all research organizations in the country to form multidisciplinary ethics committees to review research proposals and described the ethical issues related to research on medicines, plants and indigenous systems of medicine, as well as specific considerations for research on children, mentally deficient patients, prisoners, students, lab personnel, and other vulnerable groups. It also discussed issues of financial reimbursements, publication ethics, and informed consent. However, the guidelines faced several challenges related to its proper interpretation and use due to lack of general understanding of its need.

With the rapid scientific advancements, newer ethical issues continued to emerge. This led to an updated revised document released in 2000 (2). These guidelines were widely circulated throughout the country, and it was expected that all institutions in the country that carry out research on human subjects should follow them. However with the continuous advancement and explosion in scientific knowledge during the last decade, the guidelines were again revised and released in 2006 to address some of the newer emerging ethical concerns and are well known as ICMR “Ethical Guidelines for Biomedical Research on Human Participants” (3).

In India the concept and value of research ethics is still developing and even with well defined guidelines in place, challenges remain regarding compliance and oversight. Furthermore, there is a need for developing regulatory structures so that better review processes and standards can be put in place. The Guidelines have yet to be transposed into regulation and law for enforcement.

It has also been realized that for some of the newly emerging areas of research there is need to widen up and prepare detailed guidelines. In view of this specific guidelines on many topics have been developed in such areas as stem cell research (4), genetically modified

food, assisted reproductive technology (5), traditional medicine research, animal experimentation and many others like Guidelines on biobanking are in the pipeline. There are also a number of existing laws in India related to health research that provide regulatory coverage for research in these newer areas, such as the Organ Transplantation Act, the Drugs and Cosmetics Act, the Medical Council of India Act, and the Preconception and Prenatal Diagnostic Techniques Act. In spite of these laws being in place, however, ethical principles are often not fully implemented in research.

India is recently becoming a global hub for health research and clinical trials since it is both easier and cheaper to do clinical trials on unaware participants in view of the not so vigilant regulatory and monitoring framework. In a country with a large number of medical colleges, research institutions, NGO’s, and private practitioners involved in research, alongside cultural, religious, linguistic, and socio-economic diversity, it is a huge challenge to generate awareness and put efficient ethical review mechanisms into place. The widening gap and the increasing disparities in the availability of resources, together with the huge potential for the exploitation of vulnerable groups or populations, calls for improved local, regional, national, and international efforts to strengthen capacity building.

The ethical review system in India is mainly institutional, with the actual functioning of committees being uncertain. There has also been a rise in the number of private practitioners lured by pharma rewards to become researchers and enroll unsuspecting patients in clinical trials without appropriate ethics committee approval or informed consent. The concept of an independent ethics committee has also come into existence with the establishment of several private ethics committees in different cities of the country. However, information about their quality of review is not available.

Overall, the existing structural framework for human subject protections is weak as demonstrated in a survey of institutional ethics committees carried out by ICMR with WHO support. The actual problem arises from the fact that bioethics or research ethics is not yet an integral part of research-oriented training or

Developing an Ethical Framework for Health Research in India

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medical education. Many researchers are unaware of even the basic issues in research ethics. Real ethical dilemmas and fear of the exploitation of vulnerable patient populations are serious issues now. There is also a real concern that unethical practices may still go unnoticed. The Council has organised the Human Subject Protection Course and SOP Workshop in six institutions in Mumbai out of which two IEC’s received the SIDCER recognition in the last FERCAP Conference in Nov. 2009 in Chiang Mai. Some other institutions have also shown interest to participate in the SIDCER Recognition Program, however there is a need for extensive work in order to take this program to several hundreds of ethics committees of research institutions/medical colleges in India.

To a large extent, the developing world has learned from mistakes made in the past by other countries. India stands at a clear advantage in trying not to repeat these same mistakes. However, a lack of awareness as well as at times commercial or academic conflicts creates situations where ethics gets a backseat. There is a need to create a demand for better quality research in the Indian scientific community, especially in the face of scientific developments that are rapidly crossing international boundaries. Sound health research that genuinely meets Indian and international standards would be able to ethically and effectively benefit public health in India. There is a growing need for manpower training in clinical trials and a number of institutes in the private sector are offering special courses.

The ICMR is currently in the process of carrying out country-wide workshops for the training of all stakeholders, including ethics committee members, researchers, and policy makers. Ethics committee surveys have been initiated for assessing capacity for ethical review along with the use of ethical guidelines. An important landmark achievement has been the establishment of a Clinical Trial Registry of India (CTRI) in 2007 which is funded by the Department of Science and Technology (DST) and managed at the National Institute of Research in Medical Statistics under the Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare, Government of India. Since 15th June, 2009 it is mandatory to register any clinical trial with CTRI. The objective of CTRI is to encourage all clinical trials conducted in India to be prospectively registered before the enrollment of the first participant.

Loopholes have also been identified in the existing regulatory machinery related to areas such as medical devices, surgical interventions, animal feed, genetically modified food. There is a felt need, as well as scope, for debate and improvements in the country’s research systems. It is high time for action in the country alongside the need to urgently enforce the existing ethical guidelines by putting into place an integrated system of protections, including efficient ethics committees, aware and sensitive researchers, and appropriate monitoring and oversight mechanisms.

The current proposed legislation on ethical guidelines has evoked hope for improvement in the regulatory infrastructure within the country; however, making a law and implementing it are not the same. The implementation of the law when it comes will also need to be carefully and thoughtfully approached. A systematic approach to build the capacity of ethical review will go a long way in guarding the rights of patients and protecting them from exploitation.

References:

1. Policy Statement for Research on Human Subjects, ICMR, 1980

2. Ethical Guidelines for Biomedical Research on Human Participants, ICMR, 2000.

3. Ethical guidelines for biomedical research on human participants, ICMR, 2006.

4. ICMR-DBT Guidelines for Stem cell Research and Therapy, 2006

5. National Guidelines for accreditation, supervision and regulation of ART clinics in India, ICMR, 2006

6. Clinical Trials Registry of India (CTRI). Accessed online on 12 July 2010 at http://www.ctri.in/Clinicaltrials/index.jsp

FERCAP Main Activities 17-19 February 2010 □ Human Participant Protection Course, National Institutes

of Health, University of the Philippines, Manila, Philippines

1-3 March 2010 □ Training/Re-Survey of EC/IRB, National Cheng Kung University Hospital Human Experiment and EC, Tainan, Taiwan

4-6 March 2010 □ Training/Re-Survey of EC/IRB, Chi-Mei Medical Center Human Study Committee IRB, Tainan, Taiwan

8-10 March 2010 □ Human Participant Protection Course, Chong Hua Hospital, Cebu, Philippines

15-16 March 2010 □ Human Participant Protection Course, Chulalongkorn University, Bangkok, Thailand

24-25 March 2010 □ Standard Operating Procedures Training, Thammasat University - Rangsit Campus, Pathumthani, Thailand

7-10 April 2010 □ Training/Re-Survey of EC/IRB, University of the Philippines Manila (UPM)-National Institute of Health (NIH) ERC, Manila, Philippines

11-13 April 2010 □ Training/Re-Survey of EC/IRB, University of the Philippines Manila (UPM)-Research Implementation and Development Office (RIDO) ERC, Manila, Philippines

14-16 April 2010 □ Human Participant Protection Course, National Institutes of Health, University of the Philippines, Manila, Philippines

21-24 April 2010 □ Training/Re-Survey of EC/IRB, Affiliated Hospital of Nanjing Traditional Chinese Medicine University IRB, Nanjing, China

FERCAP at a GLANCE

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25 April 2010 □ Regular Steering Committee Meeting [hosted by Shanghai Changhai Hospital EC, Second Military Medical University (SMMU)], Jin Xue Yuan Hotel, Shanghai, China

25-28 April 2010 □ Training/Re-Survey of EC/IRB, Shanghai Changhai Hospital EC, Second Military Medical University (SMMU), Shanghai, China

17-20 May 2010 □ Training/Survey of EC/IRB, Southwest IRB, Chongqing, China

22 May 2010 □ Special Steering Committee Meeting for the 2011 FERCAP Annual International Conference [hosted by Daegu Catholic University Medical Center (DCUMC)], Hotel Inter-Burgo, Daegu, South Korea

23-26 May 2010 □ Training/Survey of EC/IRB, Keimyung University Dongsan Hospital IRB, Daegu, South Korea □ Training/Survey of EC/IRB, Kyungpook National University Hospital (KNUH) IRB, Daegu, South Korea

27-29 May 2010 □ Training/Survey of EC/IRB, Yeungnam University Hospital IRB, Daegu, South Korea □ Training/Survey of EC/IRB, Kangdong Sacred Heart Hospital IRB, Seoul, South Korea

30 May-2 June 2010 □ Training/Re-Survey of EC/IRB, Inje University Busan Paik Hospital (IJUBPH) IRB, Busan, South Korea

3-5 June 2010 □ Training/Re-Survey of EC/IRB, Chonnam National University Hospital IRB, Gwangju, South Korea

13-16 June 2010 □ Training/Survey of EC/IRB, Xi Yuan Hospital EC, China Academy of Chinese Medical Sciences, Beijing, China

18-19 June 2010 □ EC/IRB Trainer’s Training, Huashan Hospital IRB, Fudan Univeristy (HIRB), Shanghai, China

21-24 June 2010 □ Training/Survey of EC/IRB, Guangzhou Provincial Traditional Medicine Hospital IRB, Guangzhou, China

27-30 June 2010 □ Training/Survey of EC/IRB, Renji Hospital IRB, Shanghai, China

7 July 2010 □ Standard Operating Procedures Training, Kyungpook National University Hospital (KNUH), Daegu, South Korea

7-9 July 2010 □ Standard Operating Procedures Training, National Institutes of Health, University of the Philippines, Manila, Philippines

12-15 July 2010 □ Training/Re-Survey of EC/IRB, Research Institute for Tropical Medicine (RITM) IRB, Department of Health (DOH) Philippines, Manila, Philippines

20-23 July 2010 □ Training/Re-Survey of EC/IRB, Taipei Medical University-Joint Institutional Review Board (TMU-JIRB), Taipei, Taiwan

FERCAP Collaborative and Network Activities 8-12 February 2010 □ WHO-TDR and WHO-TDR CCTC Strategic Project

Management Training Workshop [Organized by WHO-TDR and WHO-TDR CCTC], WHO-TDR CCTC, Thammasat University - Rangsit Campus, Pathumthani, Thailand

5-6 March 2010 □ WHO-TDR and WHO-TDR CCTC Short Course Development Meeting on Ethical, Legal, and Social Issues of Product Research and Development [Organized by WHO-TDR and WHO-TDR CCTC], WHO-TDR CCTC, Thammasat University - Rangsit Campus, Pathumthani, Thailand

18-19 March 2010 □ WHO-TDR GCP Workshop [Organized by WHO-TDR], WHO-TDR Office, Geneva, Switzerland

18-20 April 2010 □ IRB Management and SOP Training [Organized by Shanghai Changhai Hospital EC, Second Military Medical University (SMMU)], Shanghai Changhai Hospital, Shanghai, China

21-22 May 2010 □ SIDCER-FERCAP IRB Training [Organized by Daegu Catholic University Medical Center (DCUMC)], Hotel Inter-Burgo, Daegu, South Korea

28-30 June 2010 □ 9th Nagasaki International Course on Research Ethics [Organized by Nagasaki Forum on Medical Research Ethics], Institute of Tropical Medicine, Nagasaki University - Sakamoto Campus, Nagasaki, Japan

FERCAP Annual Conference

Networking and Alliance Building for Ethical Health Research Hotel Equatorial Shanghai, Shanghai, China

November 23-24, 2010

For more information about 10th conference, please click:

http://www.fercap-sidcer.org/index.php

FERCAP Newsletter Prepared by: Xiuqin Wang, Cristina Torres

Arthur Navarro, Roli Mathur

FERCAP Office WHO-TDR Clinical Coordination and Training Center (CCTC),

1st Floor, Academic Affairs Building,

Thammasat University - Rangsit Campus,

99 Mu 18, Phaholyothin Road, Klongluang,

Pathumthani 12120, Thailand

Phone: +6625644440 ext 1800 | Fax: +6625165379

E-mail: fercap.sidcer@yahoo.com | Website: www.fercap-sidcer.org