CONTENTS
LEGAL AND ETHICAL ISSUES OF HIV VACCINE CLINICAL TRIALS IN
INDIA- A CRITICAL STUDY;
CERTIFICATE;
DECLARATION;
ACKNOWLEDGEMENT;
ABBREVIATIONS;
LIST OF CASES CITED;
CHAPTER I INTRODUCTION;
1.1 Executive Summary;
CHAPTER II THE RESEARCH STUDY AND METHODOLOGY;
2.1 Need for The Study;
2.2 Statement of Problem;
2.3 Objectives;
2.4 Research Hypothesis;
2.5Limitations of the Study;
2.6 Methodology;
CHAPTER III THE CLINICAL TRIALS;
3.1 History of Clinical Trials;
3.2 Overview of Clinical Trials;
3.3 Definition of Clinical Trials;
3.4 Phases of Clinical Trials;
3.4.1 Phase 0 Trials;
3.4.2 Human Pharmacology Phase I Trials;
3.4.3 Therapeutic Exploratory Phase II Trials;
3.4.4 Therapeutic Confirmatory I Phase III Trials;
3.4.5 Therapeutic Use I Phase IV Trials;
3.5 Vaccine Clinical Trials and Phases of Vaccine Trials;
3.6 Clinical Trial Scenario in India;
3.7 The advantages of Conducting Clinical Trials in India;
3.8 Concerns Expressed against Clinical Trials in India;
3.9 How Prepared is India for Global Clinical Trials;
3.10 Safety of Subjects in Clinical Trials;
3.11 Global Need for Registration;
CHAPTER IV HIVVACCINE CLINICAL TRIALS;
4.1 Introduction;
4.2 Global Epidemic;
4.3 History of HIV/AIDS in India;
4.4 HIV/AIDS Statistics in India;
4.5 Vulnerable Population Affected by HIV IAIDS in India;
4.6 The evolution of AIDS;
4.7 Discovery of Causal Agents of AIDS;
4.8 The Origins of AIDS;
4.9 The Uniqueness of AIDS;
4.10 The AIDS Virus: HIV;
4.11 Replication of HIV;
4.12 HIV and Disease Mechanism 6g;
4.13 Virus Host Interaction in HIV Infection;
4.14 The Transmission of HIV Infection;
4.15 Natural Course and Pathogenesis of HIV Infection;
4.16 Development of Antimicrobial, Antibiotics and Antiviral Agents;
4.17 Therapy of HIV Infection & AIDS;
4.18 Possible Vaccine Effects;
4.19 History of Vaccines;
4.20 Types of Vaccines;
4.21 Spectrum of Possible Strategies for Use of HIV Vaccines;
4.22 HIV Vaccines and Their Implications For Safety;
4.22.1 Inactivated Whole Virus Vaccine I Killed vaccine;
4.22.2 Live Attenuated Vaccine ;
4.22.3 Toxoid Vaccine;
4.22.4 Sub Unit Vaccine;
4.22.5 Mucosal Immunity;
4.22.6 Newer Adjuants;
4.22.7 Cytokines;
4.22.8 Recombinant Vaccinesl Genetically Engineered Vaccines;
4.22.9 DNA Vaccine 4.22.10 Prime Boost vaccination;
4.22.11 Internal or Core Proteins;
4.23 Challenges in the Development of an AIDS Vaccine;
4.23.1 Scientific Obstacles Unique Feature of HIV Potential Adverse Reactions to HIV Vaccines Social Harms! Non-Medical Adverse Events;
4.23.2 Economic Challenges;
4.23.3 Ethical Issues involved In HIV vaccine Trials;
4.23.3.1 How Ethical is Randomisation? ;
4.23.3.2 Is Placebo Control Mandatory ?;
4.23.3.3 Why Should any Healthy Individual Volunteer to Participate in HIV Vaccine Clinical Trials?;
4.23.3.4 Informed Consent Issues in HIV Vaccine Clinical Trials;
4.23.3.5 Confidentiality Issues in HIV Vaccine Clinical Trials;
4.23.3.6 Conflict of Interest;
4.23.3.7 Stigma and Discrimination;
4.23.3.8 Fraud and Abuse Risk in HIV Vaccine Clinical Trials;
4.23.3.9 Coercion and Undue Inducement;
4.23.3.10 Compensation for Disability and Trial Related Injury;
4.23.3.11 Non availability of HIV Insurance as Part of Health Insurance
4.23.3.12 Sharing Benefits of Vaccine Trials with Subjects;
4.23.3.13 Exploitation of Vulnerable Subjects;
4.23.3.14 Standard of Care;
4.23.3.15 Risk of Individual V Benefits of Society;
4.23.3.16 Human Rights Issues and HIV Vaccine Clinical Trials;
CHAPTER V THE LEGAL FRAME WORK TO REGULATE CLINICAL 234-
TRIALS;
5.1 Clinical Trial: International Scenario, Declaration. Guidelines & Conventions;
5.1.1 Nuremberg Code;
5.1.2 Universal Declaration of Human Rights;
5.1.3 Helsinki Declaration;
5.1.4 Belmont Report;
5.1.5 International Guidelines for Biomedical Research involving Human Subjects;
5.1.6 Oviedo Convention;
5.1.7 Universal Declaration on Bioethics and Human Rights;
5.1.8 The Joint United Nations Programme on HIVIAIDS;
5.1.9 ICH GCP Guidelines;
5.1.10 WHO GCP Guidelines;
5.1.11 TRIPS;
5.1.12 Clinical Trial Regulatory System – USA;
5.1.12.1 Informed Consent;
5.1.12.2 Confidentiality and Privacy issues;
5.1.12.3 Clinical Trial Registry;
5.1.12.4 IRBI Ethics Committee;
5.1.12.5 Trial Related Injury and Compensation;
5.1.13 Clinical Trial Regulatory System - European Union;
5.1.13.1 European Medicines Agency;
5.1.13.2 EU Clinical Trial Directive2001120lEC;
5.1.13.3 EU Clinical Trial Register;
5.1.13.4 Data protection and Health Information Privacy;
5.1.13.5 Ethics committee in EU member states
5.1.13.6 Clinical trial insurance
5.1.13.7Informed Consent
5.2 Clinical Trial Regulatory System in India
5.2.1 Statutory frame Work and policies
5.2.2 Regulatory system in India and procedural requirement.
5.2.3 Research ethics committee: Independent, obligations and accountability
5.2.4 Impartial of ethics committee
5.2.5 CTRI- Public Policy and Transparency Issues
5.2.6 Informed Consent and voluntariness
5.2.7 Trial Related Injury and Compensation
5.2.8 State responsibility to protect the participants of HIV vaccine clinical trial
5.2.9 CRO’s Obligation and Responsibilities
5.2.10 Investigator: Responsibilities and Liabilities
5.2.11 Strict Liability or Absolute Liability for Trial Related injuries
Chapter VI Suggestions for policy reforms
Chapter VII CONCLUSIONS & RECOMMENDATIONS
Bibliography
Appendix

Acquired Immune Deficiency Syndrome - Virus Clinical Trials - HIV Vaccine - India