Page 4 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects
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13. Human Genetic and Genomic Research 54
13.1. Areas of Concern 54
13.2. General Ethical Guideline 56
13.3. Basic Responsibilities of all Researchers 57
13.4. Responsibilities of Directors/Heads of Research Institutions 58
13.5. Duties of Principal Investigator 60
13.6. Matters to be included 62
13.7. Human Genome/Gene analysis, Genetic screening and diagnosis 64
13.7.1. Prenatal Diagnosis 64
13.8. Gene Therapy 67
13.8.1. Basic requirement of a proposal for gene therapy 68
13.8.2 Supervision of gene therapy 69
13.9. Stem Cell Research 70
13.9.1. Guidelines for Human Pluripotent Stem Cell Research 71
13.9.2. Research that restricted with the Guidelines 72
13.10. Bio-Bank 74
13.10.1. Repository Collections 74
13.10.2. Use of research samples 75
13.10.3. Bio-Bank ethical issues 78
14. Bibliography 81
15. Annexure- A 83
Annexure-B 86
16. List of Members for Formulation of Ethical Guidelines Committee 88
