This is intended to give participants an overview of the content of each workshop. They may contact the facilitators at the given email id. and register their names for the workshop of their choice.

Workshop 1:
Ethics committees and proposal review: Ethics over Science?

Facilitators:
Dr. S. Swarnalakshmi, Y. R. Gaitonde Center for AIDS Research and Education, Chennai swarna@yrgcare.org
Dr. Anant Bhan, Bioethics and Global Health, Pune
Dr. Prabha Desikan, Institutional Review Board, Bhopal Memorial Hospital and Research Centre, Karond,
Dr. Medha Joshi, Dept. of Library Science, Tata Memorial Hospital, Mumbai

Maximum no. of participants: 40

Proposed methods: Lectures, case studies and group discussions

Due to inadequate resources, many Indian institutions do not have separate institutional ethics and scientific review committees to evaluate research proposals. In this context, a debate often arises whether the proposal review is tilted more in favour of scientific review, as opposed to ethical review. This workshop will strive to analyze the different criteria used by the ICMR and international ethics guidelines in elucidating the process for ethical review of research proposals. The participants will then be engaged in exploring the area of what constitutes a good quality IEC review of a proposal, and formulating, from their own experiences, how ethics committees balance the need for considering ethical and scientific components of proposals in their settings. Best practices will be identified and collated for dissemination through a workshop report.

Workshop 2:
Mainstreaming ethics and gender in Tuberculosis control programmes in urban settings: meeting the challenges of class disparity, gender discrimination and migration and displacement

Facilitators:
Bilkis Vissandjee - University of Montreal (bilkis.vissandjee@umontreal.ca)
Lakshmi Lingam - Tata Institute of Social Sciences
Himanshu Gupte - Inter Aide Development, India
Hemlata Jiwnani - Inter Aide Development, India

Maximum no. of participants: 40

Proposed methodology: Panel discussion and audience participation

The panellists will each discuss the scenario of TB in India, focusing on the profile of affected populations, gender and class differentials, access to treatment and care and health systems response; a review of best practices in mainstreaming gender and ethics in TB programmes worldwide; the social and ethical challenges of implementing TB control programmes in urban settings in India; and some examples of emerging best practices in urban Indian settings.

Workshop 3:
Surreptitious medication for the mentally ill: What are the rules of the game?

Facilitators:
Alok Sarin, Sitaram Bhartia Institute (aloksarin@gmail.com)
Prabha S. Chandra, Nationa Institute of Mental Health and Neuro Sciences, Bangalore.

Maximum no. of participants: 20

Proposed methods: Group work based on case scenarios and brainstorming

The use of medication without consent is clearly violative of all civil and personal liberty and choice of the concerned individual. On the other hand, for the family and care givers of a person suffering from serious mental illness, in the absence of adequate facility or resource, it may constitute the only available method of intervention. This workshop does not seek to approve or disapprove the use of covert medication, but to identify relevant legal and ethical perspectives in this thorny area of psychiatric practice.

Workshop 4:
Healthcare reforms and rationing in India: ethical issues and challenges

Facilitators:
Bijoya Roy, Centre for Women’s Development Studies, New Delhi
(bijoyroy@gmail.com)

Maximum no. of participants: 30

Proposed methodology: Presentation and Discussion

In healthcare provisioning, rationing means the denial or exclusion from accessing care. With changing institutional provisioning arrangements, rationing access to services is becoming a prime issue. In public sector health care institutions like hospitals, reforms since the nineties have been about cost control, management of service provisioning and efficiency. This has led to the exclusion of a large section of the population from public healthcare. the workshop intends to explore how different service delivery processes in the hospitals generate implicit or explicit rationing strategies. What impact it bears on users; particularly women, children and other marginalised groups as they are differently positioned in the health care system.

Workshop 5:
Role of health care providers in tobacco control

Facilitators:
Dr Pankaj Chaturvedi – Tata Memorial Hospital, Mumbai
Devika Chadha- Salaam Bombay Foundation
Dr Jagdish Kaur – Ministry of Health and Family Welfare, Delhi

Tobacco kills almost 900,000 Indians every year. 5,500 adolescents start using tobacco everyday in India, adding to the existing 4 million tobacco users under15 years.
This workshop intends to take the “tobacco control” discussion into the larger social and medical forum and facilitate an informed interaction between all concerned stakeholders. The objectives of the workshop are to make health practitioners understand tobacco use amongst themselves and their patients as an issue, the role health workers should play in tobacco control, the importance of cessation training for health professionals and the role of policy makers in tobacco control and cessation. It would cover three main focus areas i.e. prevalence, counselling and de addiction. It will also address the civil society’s concerns around tobacco control legislation and its lopsided implementation.

Workshop 6 and Workshop 12
The informed consent process in clinical trials

Facilitators:
Nusrat Shafiq, Samir Malhotra, Anjuman Arora, Anita Malhotra, Post Graduate Institute of Medical Education and Research, Chandigarh ((nusrat_shafiq@hotmail.com)

Maximum no. of participants: 40

Proposed methods: During the two sessions, methods would include: group work, role play followed by a video; Demonstration followed by group activity.

In clinical trials, the participants have to bear the burden of proving/disproving the benefit of intervention under investigation. In order to maintain equipoise, the investigators have to adopt procedures such as randomization and blinding. Moreover, at times the inherent risks associated with the administration of a drug or procedure under investigation are unknown or partially known. Besides beneficence and non-maleficence, the principle of autonomy has to be taken care of. To exercise this right in full, it is important that the potential participant is informed of all the aspects of the trials with particular emphasis on his rights and safety. The informed consent process helps in attaining the principle of autonomy. Not following this process is considered a serious violation on the investigator’s part. Getting the informed consent process right, in our view, is the first important step towards achieving GCP standards for conduct of clinical trials.
This workshop will focus on three key aspects: generating informed consent forms for investigation; effective communication of elements of informed consent and the relevant essential documentation; assessing comprehension objectively, using a self generated comprehension tool.

Workshop 7:
Building accountability into the health system - experiences from Tamil Nadu

Facilitators:
Subhasri B., Rakhal Gaitonde, Ameer Khan, Vijayaprasad Gopichandran, Rural Women’s Social Education Centre, Tamil Nadu. ( subhasrib@gmail.com)

Over the last decade or so, a number of attempts have been made to explore various ways of enhancing community involvement in health, especially since the National Rural Health Mission was launched in 2005.
One of the crucial aspects of community involvement has been the capacity building of the community members to engage with accountability spaces at various levels. Over the last two years Rural Women's Social Education Centre (RUWSEC), a grass roots dalit women's organization based in Kancheepuram, Tamil Nadu, and Community Health Cell Extension unit (CEU) based in Chennai, have been exploring various methods / processes and spaces for enhancing community involvement in health. This has occurred at three levels: facilitating the engagement of communities in NRHM accountability spaces at village level; evolving accountability mechanisms at the primary and secondary care facility level; and facilitating engagement of community members in policy level issues.
Through the workshop, we are trying to enlighten the participants on the different methods and the processes of community involvement in health. The focus will be on how the community involvement enhances accountability of the health system.

Workshop 8:
Structuring and running an institutional ethics committee: learning from experience

Facilitators:
Dr Ajit Babu, Member-Secretary, LVPEI Ethics Committee
Dr Subhabrata Chakravarty, Member, LVPEI Ethics Committee and Scientific Review Committee
Justice T Rangarajan, Chair, LVPEI Ethics Committee
Dr Gayatri Ramachandran, Member, LVPEI Ethics Committee (usha.lvpei@gmail.com)

Proposed methods: A 5-minute presentation by each panelist of their perspective of working within the IRB, will be followed by an open ended discussion and group work, leading to preliminary outlines for proposed IRBs.
Many institutions struggle with finding a framework within which to organize and govern research, and institutional review boards and ethics committees are still a relatively new entity. This workshop seeks to draw on two decades of experience to help participants understand the structure and functioning of such a body. The objectives are: to understand how to structure an ethics committee so that it can function as an independent and efficient monitor for institutional research and to understand the work flow of the institutional review board

Workshop 9:
Community Based Monitoring; institutionalizing public accountability

Facilitators:
Rakhal Gaitonde, Community Health Cell, Chennai, Tamil Nadu: (subharakhal@gmail.com)
Nitin Jadhav, SATHI-CEHAT, Pune
Abhijit Das, Centre for Health and Social Justice, Delhi
Narendra Gupta, Prayas, Chittorgarh, Rajasthan.

Maximum no. of participants: 35-40

Proposed methods: Panel discussion, question and answer session and open group discussion.

Community based monitoring (CBM) under the National Rural Health Mission is an effort to institutionalize accountability within the healthcare system. As part of this, several organisations have been involved in developing tools, training materials and standards. This effort has also brought several local organisations into the process. CBM requires state funding and also a readiness on part of the health services to accept CBM as an integral part of their obligation to be accountable to the community.
This workshop will provide an opportunity for participants to become acquainted with the process and tools of CBM, and a forum for sharing their experiences of dealing with conflicts of interest, promoting social justice and preserving the autonomy of the local organisations and the community within this process.

Workshop 10:
Ethics Case Study Writing

Facilitators:
Richard Cash, Department of Global Health and Population, Harvard School of Public Health
Sridevi Seetharaman, Swami Vivekananda Youth Movement,Mysore.
Girish Ingle, Centre for Studies in Ethics and Rights (drgirishingle.tiss@gmail.com)
Maximum no. of participants: 5

Proposed methods: The workshop will apply participatory approaches including participants’ group work on developing case studies, brainstorming and, discussion on case studies. It will involve taking already drafted cases from the participants. These will then be used in the discussion and brainstorming.
Case studies can be a vital instrument in teaching ethics as they present a person with an opportunity to develop the ability to unravel problems using knowledge, concepts, and skills relevant to their future professional work. There is a dearth of case studies in health ethics in India, especially in an Indian context. Existing literature in bioethics mainly comes from western countries and has little relevance to Indian situations. Therefore there is a dire need to develop the skills of professionals in writing effective case studies in an Indian context which will contribute in promoting indigenous knowledge and in solving ethical questions raised by specific Indian situations.

Workshop 11:
The use of advance directives in legislation for mental illness

Facilitators:
Alok Sarin, Sitaram Bhartia Institute, New Delhi
Anirudh Kala, , North India Psychiatry Centre, 95-A, Model Gram, Ludhiana (anirudhkala@gmail.com)

Proposed methods: Group work based on case scenarios and brainstorming

The use of advance directives, or a “living will”, as it is also known, is a declaration by an individual about the way in which he or she would like to be treated or not treated in the eventuality of mental illness. Against the background of amendments to the existing Mental Health Act 1987 in process, and the suggestion of advance directives as one of the amended provisions, this is of topical relevance. While intended to empower the individual, such a provision also has the potential for abuse; a possibility that needs to be adequately addressed. This workshop seeks to look at the international experience with advance directives, and to discuss the possibilities of use and misuse of the same.

Workshop 12:
The informed consent process in clinical trials- (Session -2)

Facilitators:
Nusrat Shafiq, Samir Malhotra, Anjuman Arora, Anita Malhotra, Post Graduate Institution of Medical Education and Research, Chandigarh.

Workshop 13:
Updating guidance for ethics review of research involving human participants- a time to introduce standards?

Facilitators:
Abha Saxena, Research Ethics Review Committee, Research Policy and Cooperation, World Health Organization. (saxenaa@who.int)

In November 2008, Ministers of Health, Science and Technology from 53 developed and developing countries met in Bamako, Mali and launched a call to action, urging governments to allocate at least 2% of Ministry budgets to research .Since then, there have been numerous efforts by the World Health Organisation to persuade member states to establish governance mechanisms for health research, ensure good research standards and protect human subjects involved in research.
There is a need for improving the public accountability of research with the cooperation of national governments and international organisations with other stakeholders like non-governmental organizations, private foundations, civil society, and industry. WHO plays a coordinating role in the articulation and dissemination of standards for REC operations and reviews. These standards would help guide countries, researchers, and committees in terms of what is expected in terms of ethical review of research, and also help provide metrics against which those performing ethics review could be accountable. In 2009, WHO brought out its revised and updated “Standards and Operational Guidance for Ethics Review of Health Related Research With Human Participants” and has received inputs from an international audience at the World Congress of Bioethics held at Singapore this year.
This session will present these draft standards and revised guidelines based on work to date, to obtain inputs from a national perspective.

Workshop 14:
Teaching bioethics through films

Facilitators:
Aamir Jafarey, Centre of Biomedical Ethics and Culture, Karachi, Pakistan Bushra Shirazi, Ziauddin Medical College, Karachi, Pakistan Natasha Anwar, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Karachi, Pakistan Syeda Rubina Naqvi, Sind Institute of Urology and Transplantation, Karachi, Pakistan.

Please register with: aamirjafarey@gmail.com, providing a short 5-line bio-sketch if possible, to gauge the expected audience.
The objective of the session is to introduce the audience to the use of films as bioethics teaching tools. Participants will also be asked to share their ideas and experiences on the subject. The facilitators have been involved in developing and using films in bioethics teaching sessions.
The film “A Matter of Trust” (11 minutes) will be followed by a 30 minute discussion to bring out the ethical issues it highlights as well as to critique the film as a teaching tool. This will be followed by group work, to develop possible themes and plots for films which may be used for teaching bioethics.
Please note that a background in film-making is NOT required to participate in this workshop.