Workshop on Ethical Issues in Biomedical Research

[Guest guest]

INDIAN INSTITUTE OF PUBLIC HEALTH - GANDHINAGAR

Sardar Patel Institute Campus, Drive-in Road, Thaltej, Ahmedabad ¡V

380 054

Workshop on Ethical Issues in Biomedical Research

Dates- 23rd to 25th April, 2009

Background

In the field of Clinical Medicine, Public Health/epidemiology,

Biotechnology and Social/Behavioural sciences, a lot of research

activities have been going on involving human being as the subject.

All these research activities involve many ethical issues which have

not been given due attention till recently. Bio-ethics is not taught

elaborately in any conventional graduate/post-graduate curriculum in

our country. Basic principles of ethics concerning medical practice

and research are not discussed with most of the prospective

researchers in their curriculum. Thus in order to create a proper

ethical environment in medico-social field both in

treatment/intervention as well as research, training at all levels is

the need of the hour.

According to ICMR, the apex body in India regulating research in

biomedical field, all research involving human, is to be subjected to

ethical review. All research proposals must be reviewed by a human

research ethics committee and must not be undertaken until approval

has been granted. Moreover, the ethical approval is mandatory for

publishing any research article on human subjects in almost all

journals of repute.

Declaration of Helsinki. Principle 11.............. says

Research that is not conducted in conformity with valid scientific

principles cannot produce relevant results. Indeed, such results may

be misleading and contribute directly, and indirectly, to harmful

clinical practices. Exposure of human participants to the risks and

burdens of such research is unethical.

Consistent with this approach in research, IIPH-Gandhinagar is

organizing this three day workshop with the following objectives¡K¡K

Objectives of the program

1. To make the participants aware of ethical guidelines &

regulations related to research involving human participants

2. To enable the participants to identify the ethical issues

related to any research activity in clinical research,

epidemiological research & social research

3. To develop the skill of the participants to make an ethically

sound research proposal

4. To build the capacity of the participants to function as a

member of institutional ethics committee for processing research

applications

5. To increase awareness among participants about ethical issues

in scientific publications

Content

Day1

Inaugural Registration, Inauguration, Introduction, Pre-test

Session I Introduction, Historical perspective

Session II Guidelines-National/International

Session III Ethics in Clinical Research & GCP

Session IV Informed consent

Day 2

Session V Institutional Ethics Committee- Roles &

responsibilities

Session VI Scientific review vs. Ethical Review, Conflict of

interest

Session VII Risk Benefit analysis

Session VIII Research in Vulnerable & Inducement for participation

Day 3

Session IX Ethics in Public Health & Epidemiological research

Session X Ethics in Social science/Behavioural research

Session XI Ethical issues of New Technologies: Genetics,

Genomics, ART & Organ Transplantation

Session XII Publication ethics

Concluding Conclusion, feedback, post-test and felicitation

Eligibility and Selection

This programme will be useful to research and teaching faculty of

Medical colleges/Pharmacy colleges/Social Science Institutions;

graduates / post graduates of Medicine / Pharmacy/ Social Science;

professionals associated with clinical research, researchers from

pharmaceutical industries, Public Health officials; independent

scholars or NGO members working in the area of public health; social

science and development professionals.

No of Participants : Maximum of 30

Course fee

Course fee inclusive of lunch, refreshments and workshop materials is

Rs. 2000 per participant. Fee for out-station candidates requiring

accommodation is Rs.2500 which additionally includes modest

accommodation and dinner. Fee has to be paid in the form of Demand

Draft drawn in favour of Indian Institute of Public Health -

Gandhinagar payable at Ahmedabad.

Important Dates

Last date for receiving filled application form along with fee: 11th

April, 2009

Dates of Workshop: 23rd to 25th April, 2009

Course material

Participants will be provided with copies of course material

including presentations and selected literature

Resource persons for the workshop:

Dr. Sanjay Zodpey, PHFI, New Delhi

Dr. Nandini Kumar, ICMR, New Delhi

Dr. Vasantha Muthuswamy, Ex-ICMR, New Delhi

Dr. Sridevi Seetharam, SVYM, Mysore

Dr. Barna Ganguly, PSMC, Anand, Gujarat

Dr. N. Nakkeeran, IIPH-Gandhinagar

Dr. P.S.Ganguly, IIPH-Gandhinagar

Dr. Deepak Saxena, IIPH-Gandhinagar

Venue

Indian Institute of Public Health ¡V Gandhinagar, Sardar Patel

Institute Campus, Ahmedabad ¡V 380054

Address for communication:

Dr. P.S.Ganguly; E.mail ¡V psganguly44@..., Mobile: 9825209664

Dr. N. Nakkeeran; E.mail - nnakkeeran@...; Mobile: 9913388528

Dr. Deepak Saxena; E.mail ¡V ddeepak72@...; Mobile: 9327396717

Indian Institute of Public Health, Gandhinagar, Sardar Patel

Institute Campus, Drive-In Road, Thaltej, Ahmedabad ¡V 380054,

Gujarat, Phone No. 079 40240444;

Fax No. 40240445

Indian Institute of Public Health-Gandhinagar (IIPH-G)

IIPHG has been set up to function as one of the nodal Institutions

for public health education, advocacy, research and practice,

providing quality public health training to graduates of diverse

disciplines. IIPHG aims to pursue the mandate of equity in public

health, bringing strategy, resources and networks to the issues and

practice of public health in India. IIPHG is an initiative of Public

Health Foundation of India (PHFI) as one of its responses to the

severeshortfall of public health professionals in the country.

(http://www.phfi.org/iiph/iiphg.html).

Core faculty members in IIPH-G

ľ Dr. Sanjay Zodpey, MD, Ph.D (Director)

ľ Dr. P.S. Ganguly, MD, M.Phil

ľ Dr. N. Nakkeeran, Ph.D

ľ Dr. D. Saxena, MD

ľ Saraswathy Achat, M.Sc

ľ Bhaskar Purohit, PGDHM, MPH

ľ Mayur Trivedi, PGDHM

About Resource persons for Workshop:

Dr. Sanjay P. Zodpey, MD, PhD (Director, Public Health Education,

PHFI, New Delhi & Director, IIPH- Gandhinagar) has training as a

Medical Scientist and Epidemiologist as well as post-graduate

qualification in Sociology, Public Administration and Economics;

academic interests include evidence-based health care, health policy,

health systems research, program evaluation and public health

governance; has experience of teaching public health for more than

sixteen years and has to his credit over 130 publications in reputed

national and international journals. Dr. Zodpey has been faculty for

over 100 workshops dealing with various aspects of research methods,

epidemiology and public health across the country.

Dr. Nandini Kumar, Ex Dy Director-General & presently Consultant,

Division of Basic Medical Sciences, ICMR, New Delhi

Dr. Vasantha Muthuswamy, Ex Sr. Dy Director General & Chief, Basic

Medical Sciences, Traditional Medicine and Bioethics, ICMR, New

Delhi.

Dr. Sridevi Seetharam, MD, DNB, MA-Bioethics (Consultant Pathologist,

Ethicist & Director Research Division- Vivekananda Memorial Hospital

& Swami Vivekananda Youth Movement, Saragur, Mysore) She had her

postgraduate training in Pathology from PGIMER, Chandigarh and has

been associated with SVYM as a core member since last 20 years. She

is a trained ethicist with MA (Bioethics) degree from Europe. She is

also a Member, Editorial Advisory Board, Indian Journal of Medical

Ethics and has been a faculty member in a number of workshop on

research ethics at local, regional and national level

Dr. Barna Ganguly, MD (Professor & Head, Dept of Pharmacology, PS

Medical College, Anand, Gujarat) : Has training in Pharmacology and

has been working in the field of Ethics as a member-secretary of IEC

in PS Medical College and as a member-IEC in other institutions of

repute since last 5 years. She received her formal training in

bioethics as a 1st batch trainee in the only long term training

programme on Bioethics, available in India, conducted by ICMR and

Fogarty-NIH in 2007-08. She has been a resource person in Bioethics

workshops. She has prepared a curriculum on bioethics for MBBS

course, submitted to MCI on behest of ICMR.

Dr. P.S.Ganguly, MD, MPhil (Associate Professor, IIPH-Gandhinagar)

has his training in Public health, epidemiology and health systems

management. He has 15 long years of exposure in teaching, training &

research in Medical colleges & other institutions and has experience

of working in the area of health program management for World Health

Organization for many years. He also brings with him a vast

experience of training of health professionals. He has undergone

formal training in Ethics conducted by ICMR and has a good exposure

on ethical issues in research.

Dr. N. Nakkeeran, M.Phil, PhD (Assistant Professor, IIPH-Gandhinagar)

has training in anthropology, M.Phil & doctoral research in health

social sciences. As a faculty in Tata Institute of Social Sciences,

he has about 10 years of experience in teaching & research in health

for post graduate students, and undertaking health research involving

in-depth ethnographic as well as participatory procedures. He has

been a faculty for a number of workshops on qualitative research

organised for medical & social science teachers and health

professionals. He has attended ICMR regional workshop on Bioethics

and has been nominates as the member-secretary of proposed

Institutional Ethics Committee of IIPH-G.

Dr. Deepak Saxena, MD (Assistant Professor, IIPH-Gandhinagar) has his

training in Public Health & Epidemiology. He has experience of

conducting a number of field level epidemiological studies and has

been a resource person in many workshops/trainings on research

methodology. He also has to his credit a number of research articles

and chapters in books.