Page 3 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects
P. 3
SECTION – B
10. Interventional Studies 21
10.1. Drug Trial 22
10.1.1 Special Considerations 22
10.1.2. Phases of Clinical Trials 24
10.1.3. Special studies 26
10.1.4. Dissolution Studies 26
10.1.5. Special Concerns 27
10.1.5.1. Multicenter Trials 27
10.1.5.2. Contraceptives 28
10.1.5.3. Randomized Controlled Trial (RCT) 28
10.2. Vaccine Trials 30
10.2.1. Combination Vaccines 31
10.2.2. Special Concerns 32
10.3. Trials with Surgical Procedures/Medical Devices 33
10.3.1. Definition of Device 34
10.4. Diagnostic Agents- Use of Radio-Active Materials and X-Ray 35
10.5. Traditional Ayurveda, Unani (AU) Remedies and Medicinal Plants 36
10.5.1. Special Concerns 38
10.5.2. Classification of Herbal medicines 39
10.5.3. Quality Control 43
11. Principles of Epidemiological Studies 44
11.1 Introduction 44
11.2. Definitions 44
11.3. General Principles 45
11.4. Specific Principles 46
11.5. Community Participation 48
12. Tissue Transplantation and Related Subjects 49
12.1. Ethical Guidelines of Transplantation Research 51
12.1.1. Organ and tissue Transplantation 49
12.2. Guideline for Steam Cell Research 51
12.3. Human fetal tissue transplantation 52
12.4. Xeno Transplantation 53
