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India - Ethical Guidelines for Biomedical Research on Human ParticipantsETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSINDIAN COUNCIL OF MEDICAL RESEARCH NEW DELHI 2006 Published by: Director-GeneralOctober, 2006 All rights reserved The use of content from this book is permitted for all non-commercial purposes like education, training and dissemination of information, including translation, quotation and reproduction, in any medium, but the content must not be changed and full acknowledgement of the source must be clearly stated. Indian Council of Medical Research (ICMR) shall not be held liable for any damages whatsoever as a result of the use or application of the contents of this document. ICMR, reserves the right to update and change the contents without notice and accepts no liability for any errors or omissions in this regard. Any alteration to the original content brought about by display or access through different media and for any inaccurate advice or information that is provided by sources reached via linkages or references to this document is not the responsibility of ICMR. Design and layout: Neelam Chaudhury and Nandini K. Kumar Production Controller: J.N. Mathur, Press Manager, ICMR, New Delhi Printed at M/s Royal Offset Printers, A-89/1, Naraina Industrial Area, Phase-I, New Delhi-110028 Ph.: 01125797524 TABLE OF CONTENTS Foreword
Preface
Acknowledgement
Introduction
Chapter I. Statement of General Principles on Ethical Considerations
involving Human Participants
Background
General Statement
Statement of General Principles
Chapter II. Ethical Review Procedures
Basic Responsibilities
Composition
Terms of Reference
Training
Regulation
Review procedures
Submission of application
Decision making process
Review Process
Periodic review
Continuing review
Interim review
Monitoring
Record keeping
Administration and management
Special considerations
Chapter III. General Ethical Issues
I. Informed Consent Process
II. Compensation for Participation
III. Conflict Of Interest
IV. Selection of Special Groups as Research Participants
V. Essential Information on Confidentiality for Prospective
Research Participants
VI. Compensation for Accidental Injury
VII. Post-Trial Access
VIII. International Collaboration/Assistance in Bio-Medical/Health
Research
IX. Researcher’s Relations with the Media and Publication Practices
Chapter IV. Statement of Specific Principles for Clinical Evaluation of
Drugs/Devices/Diagnostics/Vaccines/Herbal Remedies
General Principles
Specific Principles
I. Drug Trials
II. Vaccine Trials
III. Clinical Trials with Surgical Procedures/Medical Devices
IV. Diagnostic Agents - Use of Radio - Active Materials and X-Rays
V. Clinical Evaluation of Traditional Ayurveda, Siddha, Unani
Remedies and Medicinal Plants
Chapter V. Statement of Specific Principles for Epidemiological Studies
Introduction
Definitions
General Principles
Specific Principles
Chapter VI. Statement of Specific Principles for Human Genetics and
Genomics Research
Introduction
General Guidelines
I. Pedigree Studies
II. Genetic Screening
III. Therapeutic Trials Including Gene Therapy
IV. Human Genome Project (HGP)
V. DNA and Cell-Line Banking/Repository
VI. DNA Diagnosis
VII. Prenatal Diagnosis
Chapter VII. Statement of Specific Principles for Research in
Transplantation
Introduction
I. Transplants from Live or Cadaver Donors
II. Embryonic and Foetal Tissue
III. Xeno-Transplantation
IV. Transplantation for Cosmetic Purposes
IV. Stem Cell
Chapter VIII. Statement of Specific Principles for Assisted
Reproductive Technologies
Introduction
General Principles
Specific Principles
Bibliography
List of Members of Committee (1996-2006)
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