Page 3 - ICMR Ethical Guidelines for Biomedical Research
P. 3
TABLE OF CONTENTS
Foreword vi
Preface vii
Acknowledgement viii
Introduction 1
Chapter I. Statement of General Principles on Ethical Considerations 2
involving Human Participants
Background 2
General Statement 3
Statement of General Principles 4
Chapter II. Ethical Review Procedures 8
Basic Responsibilities 8
Composition 9
Terms of Reference 10
Training 10
Regulation 10
Review procedures 11
Submission of application 14
Decision making process 17
Review Process 18
Periodic review 18
Continuing review 18
Interim review 18
Monitoring 18
Record keeping 19
Administration and management 19
Special considerations 19
Chapter III.General Ethical Issues 21
I. Informed Consent Process 21
II. Compensation for Participation 21
III. Conflict Of Interest 26
