Library Catalogue
Legal and Ethical Issues of HIV Vaccine Clinical Trials in India: (Record no. 111231)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 06117nam a2200193Ia 4500 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20251125142807.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 210518s2016 xx 000 0 und d |
| 040 ## - CATALOGING SOURCE | |
| Transcribing agency | nls |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Ms. Saritha T S |
| 245 ## - TITLE STATEMENT | |
| Title | Legal and Ethical Issues of HIV Vaccine Clinical Trials in India: |
| Remainder of title | A Critical Study |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Bangalore |
| Name of publisher, distributor, etc. | NLSIU |
| Date of publication, distribution, etc. | 2016 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 233p |
| 505 ## - FORMATTED CONTENTS NOTE | |
| Formatted contents note | CONTENTS<br/>LEGAL AND ETHICAL ISSUES OF HIV VACCINE CLINICAL TRIALS IN<br/>INDIA- A CRITICAL STUDY;<br/>CERTIFICATE;<br/>DECLARATION;<br/>ACKNOWLEDGEMENT;<br/>ABBREVIATIONS;<br/>LIST OF CASES CITED;<br/>CHAPTER I INTRODUCTION;<br/>1.1 Executive Summary;<br/>CHAPTER II THE RESEARCH STUDY AND METHODOLOGY;<br/>2.1 Need for The Study;<br/>2.2 Statement of Problem;<br/>2.3 Objectives;<br/>2.4 Research Hypothesis;<br/>2.5Limitations of the Study;<br/>2.6 Methodology;<br/>CHAPTER III THE CLINICAL TRIALS;<br/>3.1 History of Clinical Trials;<br/>3.2 Overview of Clinical Trials;<br/>3.3 Definition of Clinical Trials;<br/>3.4 Phases of Clinical Trials;<br/>3.4.1 Phase 0 Trials;<br/>3.4.2 Human Pharmacology Phase I Trials;<br/>3.4.3 Therapeutic Exploratory Phase II Trials;<br/>3.4.4 Therapeutic Confirmatory I Phase III Trials;<br/>3.4.5 Therapeutic Use I Phase IV Trials;<br/>3.5 Vaccine Clinical Trials and Phases of Vaccine Trials;<br/>3.6 Clinical Trial Scenario in India;<br/>3.7 The advantages of Conducting Clinical Trials in India;<br/>3.8 Concerns Expressed against Clinical Trials in India;<br/>3.9 How Prepared is India for Global Clinical Trials;<br/>3.10 Safety of Subjects in Clinical Trials;<br/>3.11 Global Need for Registration;<br/>CHAPTER IV HIVVACCINE CLINICAL TRIALS;<br/>4.1 Introduction;<br/>4.2 Global Epidemic;<br/>4.3 History of HIV/AIDS in India;<br/>4.4 HIV/AIDS Statistics in India;<br/>4.5 Vulnerable Population Affected by HIV IAIDS in India;<br/>4.6 The evolution of AIDS;<br/>4.7 Discovery of Causal Agents of AIDS;<br/>4.8 The Origins of AIDS;<br/>4.9 The Uniqueness of AIDS;<br/>4.10 The AIDS Virus: HIV;<br/>4.11 Replication of HIV;<br/>4.12 HIV and Disease Mechanism 6g;<br/>4.13 Virus Host Interaction in HIV Infection;<br/>4.14 The Transmission of HIV Infection;<br/>4.15 Natural Course and Pathogenesis of HIV Infection;<br/>4.16 Development of Antimicrobial, Antibiotics and Antiviral Agents;<br/>4.17 Therapy of HIV Infection & AIDS;<br/>4.18 Possible Vaccine Effects;<br/>4.19 History of Vaccines;<br/>4.20 Types of Vaccines; <br/>4.21 Spectrum of Possible Strategies for Use of HIV Vaccines;<br/>4.22 HIV Vaccines and Their Implications For Safety; <br/>4.22.1 Inactivated Whole Virus Vaccine I Killed vaccine; <br/>4.22.2 Live Attenuated Vaccine ;<br/>4.22.3 Toxoid Vaccine; <br/>4.22.4 Sub Unit Vaccine; <br/>4.22.5 Mucosal Immunity; <br/>4.22.6 Newer Adjuants;<br/>4.22.7 Cytokines; <br/>4.22.8 Recombinant Vaccinesl Genetically Engineered Vaccines;<br/>4.22.9 DNA Vaccine 4.22.10 Prime Boost vaccination; <br/>4.22.11 Internal or Core Proteins; <br/>4.23 Challenges in the Development of an AIDS Vaccine; <br/>4.23.1 Scientific Obstacles Unique Feature of HIV Potential Adverse Reactions to HIV Vaccines Social Harms! Non-Medical Adverse Events;<br/>4.23.2 Economic Challenges;<br/>4.23.3 Ethical Issues involved In HIV vaccine Trials; <br/>4.23.3.1 How Ethical is Randomisation? ;<br/>4.23.3.2 Is Placebo Control Mandatory ?; <br/>4.23.3.3 Why Should any Healthy Individual Volunteer to Participate in HIV Vaccine Clinical Trials?;<br/>4.23.3.4 Informed Consent Issues in HIV Vaccine Clinical Trials;<br/>4.23.3.5 Confidentiality Issues in HIV Vaccine Clinical Trials;<br/>4.23.3.6 Conflict of Interest;<br/>4.23.3.7 Stigma and Discrimination; <br/>4.23.3.8 Fraud and Abuse Risk in HIV Vaccine Clinical Trials;<br/>4.23.3.9 Coercion and Undue Inducement;<br/>4.23.3.10 Compensation for Disability and Trial Related Injury;<br/>4.23.3.11 Non availability of HIV Insurance as Part of Health Insurance<br/>4.23.3.12 Sharing Benefits of Vaccine Trials with Subjects;<br/>4.23.3.13 Exploitation of Vulnerable Subjects;<br/>4.23.3.14 Standard of Care;<br/>4.23.3.15 Risk of Individual V Benefits of Society;<br/>4.23.3.16 Human Rights Issues and HIV Vaccine Clinical Trials;<br/>CHAPTER V THE LEGAL FRAME WORK TO REGULATE CLINICAL 234-<br/>TRIALS;<br/>5.1 Clinical Trial: International Scenario, Declaration. Guidelines & Conventions;<br/>5.1.1 Nuremberg Code;<br/>5.1.2 Universal Declaration of Human Rights;<br/>5.1.3 Helsinki Declaration;<br/>5.1.4 Belmont Report;<br/>5.1.5 International Guidelines for Biomedical Research involving Human Subjects;<br/>5.1.6 Oviedo Convention;<br/>5.1.7 Universal Declaration on Bioethics and Human Rights;<br/>5.1.8 The Joint United Nations Programme on HIVIAIDS;<br/>5.1.9 ICH GCP Guidelines;<br/>5.1.10 WHO GCP Guidelines;<br/>5.1.11 TRIPS;<br/>5.1.12 Clinical Trial Regulatory System – USA;<br/>5.1.12.1 Informed Consent;<br/>5.1.12.2 Confidentiality and Privacy issues;<br/>5.1.12.3 Clinical Trial Registry;<br/>5.1.12.4 IRBI Ethics Committee;<br/>5.1.12.5 Trial Related Injury and Compensation;<br/>5.1.13 Clinical Trial Regulatory System - European Union;<br/>5.1.13.1 European Medicines Agency;<br/>5.1.13.2 EU Clinical Trial Directive2001120lEC;<br/>5.1.13.3 EU Clinical Trial Register;<br/>5.1.13.4 Data protection and Health Information Privacy;<br/>5.1.13.5 Ethics committee in EU member states <br/>5.1.13.6 Clinical trial insurance <br/>5.1.13.7Informed Consent<br/>5.2 Clinical Trial Regulatory System in India<br/>5.2.1 Statutory frame Work and policies<br/>5.2.2 Regulatory system in India and procedural requirement. <br/>5.2.3 Research ethics committee: Independent, obligations and accountability <br/>5.2.4 Impartial of ethics committee<br/>5.2.5 CTRI- Public Policy and Transparency Issues<br/>5.2.6 Informed Consent and voluntariness<br/>5.2.7 Trial Related Injury and Compensation<br/>5.2.8 State responsibility to protect the participants of HIV vaccine clinical trial<br/>5.2.9 CRO’s Obligation and Responsibilities<br/>5.2.10 Investigator: Responsibilities and Liabilities<br/>5.2.11 Strict Liability or Absolute Liability for Trial Related injuries<br/>Chapter VI Suggestions for policy reforms<br/>Chapter VII CONCLUSIONS & RECOMMENDATIONS<br/>Bibliography<br/>Appendix<br/><br/><br/> |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Acquired Immune Deficiency Syndrome - Virus |
| -- | Clinical Trials - HIV Vaccine - India |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Prof. (Dr.) O V Nandimath - Guide |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://dans.nls.ac.in/handle/123456789/2232">https://dans.nls.ac.in/handle/123456789/2232</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Thesis |
| Withdrawn status | Lost status | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | . | 21.05.2018 | PhD065 | 21.05.2018 | 21.05.2018 | Thesis |