WHO Collaborating Centre for District Health System based on Primary Health Care

Institute of Health Management ResearchJaipur

Management Development Programme

on

September 1-6, 2014

Ethics in Health Research

Rule ofConduct

Rules andRegulations

Values

ResearchEthical

Practices

MoralPrinciples

Ethics

Background

The Objectives

Contents

Research is not a privilege. An ethical practice in health research is extremely important. Health research involving human participants is invaluable in advancing knowledge and practice in the biomedical, social, and behavioral sciences. It is increasingly conducted in developing countries. Working with human participants can also pose ethical dilemmas and regulatory challenges prior to, during and post research. The effects of ethical and unethical health research practice on the public at large can be a matter of damages, development and life and death. As the emphasis on research in the field of health gains momentum, it is important to conduct scientifically sound research, which does not harm people using human beings just as a means to achieving the research goals. To safeguard the ethical norms Institutional Ethics Committees (IEC) has also increased in recent years. It is important for the stakeholders, i.e. the investigators, institution, IEC, and funding agency or sponsors, to answer that how we can ensure that the work we do is both relevant and transformative, and, how can we be certain that the work we produce does not only satisfy our own research agendas but takes into account the needs of the communities we research.

The Institute of Health Management Research (IIHMR), Jaipur recognizes vital role of ethics in research in general and health research specifically. It is an intensive training programme, especially designed for researchers and programme managers, in which participants will gain knowledge and develop insight into ethics and practices, thereby enhancing their personal skill base while increasing their ability to impact the quality of research.

The overall objective of this course is to increase participants’ awareness of and ability to reason through ethical issues that arise in the conduct of human subject research. The program is designed to address specific challenges, and obtain tools to increase participants’ efficiency and effectiveness in reviewing, conducting, and monitoring health research. After participating in the course, participants will be able to:

A. Define various concepts of ethical issues in health research;

B. Explain the existing guidelines for ethics in health research;

C. Understand the role and mandate of research ethics committees; and

D. Identify and use the ethical principles for decision making

The topics explored in this program include ethical issues in research design, and specific guidance on challenges facing vulnerable populations. These are:

• Defining Human rights, bioethics and ethics in research

• Biomedical and social research in India: An Overview

• Current guidelines of the Indian Council of Medical Research, Schedule Y of the Drugs and Cosmetics Act, the ICH-GCP and other relevant national and international bodies

• Principles of Healthcare ethics

• Ethical Challenges in Study Design

• Ethical Issues in Informed Consent

• Privacy and confidentiality

• Researchers’ Responsibilities

• Integrity and Conflict of interest in Research

• Ethics Review Committee and its Processes

This dynamic program is designed for individuals working in a field of research involving human participants. The participants will include:

• Members of Institutional Ethics Committees / Ethics Review Boards

• Researchers involved in reviewing and conducting biomedical, social, behavioral, and public health research in public and private sector

• Executives with policy-making responsibility in government agencies that are seeking to redefine or expand their research work

• Senior Programme Managers of NGOs who are in implementation and translational research

• Faculty of research and training institutions involved in pre-service and in-service training of researchers and managers

The course will also be of interest to individuals who currently serve as researchers, research ethics consultants or committee members, and to those who anticipate serving as consultants or committee members in the future.

The programme adopts a range of participatory and experiential approaches to facilitate hands-on training in equivalent protection of research participants to apply within their organizations. The participants will get ample opportunity to translate the concepts in to practice. The methods such as lecture-cum-discussion, Small group discussions of case studies on topics such as the informed consent process in different cultural settings, informal round table exchanges of real-world examples, participation in mock-ethics committees, and group work will be used to make learning enjoyable and sustainable.

Dr S D Gupta, MD; PhD (Johns Hopkins University, USA); FAMS, Director

Dr. Nutan P. Jain, PhD, MPH (University of North Carolina, USA), Professor

Dr Shivam Gupta, MD, PhD, MPH (Johns Hopkins University, USA), Resource Person

Dr Suresh Joshi, MD Preventive and Social Medicine, Professor

The programme is of six-day duration. The programme will start at 10.00 am on Monday, September 1, 2014 and conclude at 5.00 pm on Friday, September 6, 2014. The programme will be held at Institute of Health Management Research, Jaipur.

A certificate of participation on completion of the programme will be issued by the Institute of Health Management Research, Jaipur.

Who Should Attend?

Approach

Resource Persons

Duration and Venue

Certification

Programme Fee

Discount

Nominations

About the Institute

For Residential Participants• Indian Participants: Rs. 35,000 per participant plus 12.36% service tax

• Foreign Participants: USD 600 per participant plus 12.36% service tax

• The fee covers tuition fee, training material, stay in air-conditioning room (twin-sharing basis), breakfast, lunch, dinner, tea/coffee during the programme and pick-up and drop from Jaipur airport/railway station/bus stand.

For Non-Residential Participants• Indian Participants: Rs. 25,000 per participant plus 12.36% service tax

• Foreign Participants: USD 450 per participant plus 12.36% service tax

• The fee covers tuition fee, training material, lunch, and tea/coffee during the programme.

Early Bird Discount: Nominations received with payments on or before 2-weeks will be entitled to an early bird discount of 10%.

Group Discount: Any organization sponsoring five or more participants to the programme will be entitled to a discount of 15% on total fee payable provided that at least five participants actually attend the programme.

Maximum Discount: Organization can avail themselves of both the discounts subject to a maximum discount of 20%.

Women participants who have small children need to inform in advance so that special arrangements can be made for them.

Nomination form duly filled-in along with the Demand Draft made out in favour of “Institute of Health Management Research, Jaipur” payable at Jaipur should reach latest by August 25, 2014 at the following address:

Dr. Nutan P. Jain, Programme CoordinatorInstitute of Health Management Research1, Prabhu Dayal Marg, Sanganer Airport, Jaipur - 302 029Phone: 0141-3924700 (30 Lines) Fax: 0141-3924738Email: nutan@iihmr.org

The Institute of Health Management Research, Jaipur is an institution dedicated to improvement in standards of health through better management of health care and related programmes. It seeks to accomplish this through management education, training, research, consultation and institutional networking in a national and global perspective. The institute has been designated as WHO Collaborating Center for District Health Systems based on Primary Health Care. The Ministry of Health and Family Welfare, Government of India has identified the institute as an Institute of Excellence for training and capacity building. The Institute has Gender Health Resource Center. For more information please visit our website www.iihmr.org

Name & Address of Sponsoring Authority

Prof. Nutan P. Jain, Programme Coordinator

Institute of Health Management Research

1, Prabhu Dayal Marg, Sanganer Airport, Jaipur-302 029 (India)

Phone : 0141-3924700 (30 Lines), Fax : 0141-3924738

E-mail : nutan@iihmr.org

We are happy to nominate the following candadate(s) from our organination for the

above mentioned programme.

Enclosed please find a cheque/draft No. ...................... dated .................................. for

Rupees/US $ ........................... in words Rs./$ ..............................................................

towards participation fee, drawn in favour of “Institute of Health Management

Date :

Place :

Signature

Research, Jaipur”.

Nomination Form for MDP

Institute of Health Management Research, Jaipur

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Programme Title

Duration

Venue

September 1-6, 2014

Jaipur

Ethics in Health Research