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Books > Ayurveda > Ayurveda > Ethical Guidelines for Biomedical Research on Human Participants
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Ethical Guidelines for Biomedical Research on Human Participants
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Ethical Guidelines for Biomedical Research on Human Participants
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Foreword

The release of revised Ethical guidelines for Biomedical Research on Human subjects by the Council in 2000 was followed by a number of developments in science and technology. These have led to further widening of healthcare between the developed and developing countries. Due to globalization rapid techniques of diagnosis and therapy are now available through R & D. The advances in the area of genetics, genomics and molecular biology have grown by leaps and bounds with the resultant need to rein in these advances with sufficient safeguards to protect the rights and welfare of human participants subjected to biomedical research. Globally international agencies have been bringing out guidelines for researchers in their countries with relevance to developing countries. Who and Unesco are striving to bring a universal consensus to these guidelines in an attempt to reduce disparity across the world.

Considering the recent advances in the field of Assisted Reproductive Technologies, separate guidelines have been brought out by the Indian Council of Medical Research as "National Guidelines for Accreditation, Supervision and Regulation of Art Clinics in India"(2005). Since India is being projected as a global hub for clinical trials and the number of corporate hospitals with state-of-the-art facilities is growing, visits by foreign specialists using newer techniques or devices is increasing. Some Indian institutions are also involved in making indigenous devices, which have to be tried in Indian patients for safety and efficacy. Although a separate document has been made for regulating the medical devices under Indian Medical Devices Regulatory Authority (IMDRA) relevant portions have been included in this document. The guidelines for the important biotechnology areas like stern cell research and stored tissue including DNA banking have also been added in this revision. Taking into consideration the changing dimensions of ethical issues in the context of new technologies and evolving universal guidelines, the existing chapters on Clinical trials, Organ Transplantation, Human Genetics, Epidemiology and Assisted Reproductive Technologies have also been revised.

I hope the scientific community, the regulatory agencies and the public at large will be immensely benefited by this revised guidelines.

 

Preface

It was proposed in the earlier revised "Ethical Guidelines for Biomedical Research on Human Subjects" of 2000, that the guidelines to each of the areas described would be updated periodically pari passu with the developments in the area of Biomedical Science. Hence revision has been undertaken in view of the recent development in the area of Science and technology. Further the points raised in several international and national meetings or workshops on bioethics have been taken into account for making the changes with relevance to Indian ethos in this third version of ethical guidelines now being released. The Bioethics Cell of the Division of Basic Medical Sciences has over the years acquired considerable expertise in addressing ethical queries in relation to advances made in biological sciences and biotechnology. This revision will address most of these in this version. The Statement of General principles remains almost the same as they continue to have relevance for future and are template for universal application for developing ethical guidelines in any area relevant to the Indian scenario. All the seven major Chapters, namely, Ethical Review Procedures, General Ethical issues, Clinical evaluation of drugs/vaccines/devices/diagnostics/ herbal remedies, Epidemiological studies, Human genetics and Genomics research, Transplantation research and Assisted reproductive technologies required updating as per the prevalent ethical debates around the globe. Care is taken to include new areas like stem cell research and therapy and biobanking while elaborating many existing topics to make it more user friendly.

As promised during the release of the ethical guidelines of 2000 about periodic update, the present version is being released. I hope this effort will continue to bring out future revisions to keep pace with the global developments in the area of Bioethics.

 

Introduction

The Indian Council of Medical research brought out the 'Policy Statement on Ethical Considerations involved in Research on Human Subjects' in 1980 which revised these guidelines in 2000 as the 'Ethical guidelines for Biomedical Research on Human Subjects'. Due to further rapid developments in science and technology in India after the release of the second version, it became necessary to update these guidelines to make adequate specific provision to meet ethical challenges posed by these advances. Necessitated by the globalization leading to increasing research in the developing world, the international guidelines released in 2002 by the developed countries including the revised CIOMS guidelines focused on observance of ethical norms relevant to different pluralistic cultural environment in these countries for the protection of the research participants in these regions. In India the challenge faced is to apply universal ethical principles to biomedical research in the multicultural Indian society with a multiplicity of health-care systems of considerably varying standards. The scope of this third version of the Council's guidelines takes note of these changes, and in keeping with the national policies and the demands of Indian culture, addresses ethical issues in specific situations to the extent possible. While on one hand, research involving human participants must not violate any universally applicable ethical standards, on the other hand, a researcher needs to consider local cultural values when it comes to the application of the ethical principles to individual autonomy and informed consent. In India, one will have to consider autonomy versus harmony of the environment of the research participant. In research on sensitive issues, this will have to be properly addressed in the research protocol to safeguard the human rights of the dependent or vulnerable persons and populations.

Some of the points in the international guidelines for biomedical research on human participants, which have relevance to international collaborative research initiatives, have been included in this version. Detailed description of vaccine trials, herbal products, biobanking, stem cell research etc. has been provided to make the document reflect current ethical requirements, which can be applied to Indian circumstances from ethical, legal and social angle. The intention is to update this document at frequent intervals to keep the scientific community knowledgeable about the current concepts in bioethics, which is a dynamic process. Such an exercise is in keeping with similar trends seen in many countries and worked out by international agencies.

 

Contents

 

  Foreword vi
  Preface vii
  Acknowledgement viii
  Introduction 1
Chapter I. Statement of General Principles on Ethical Considerations involving Human Participants 2
  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
  Review procedures 11
  Submission of application 14
  Decision making process 17
  Review in special settings 18
  Periodic review 20
  Continuing review 20
  Interim review 21
  Record keeping 21
  Monitoring 22
  Administration and management 22
  Special considerations 22
Chapter III. General Ethical Issues 23
I Informed Consent Process 23
II Compensation for Participation 25
II Conflict Of Interest 26
IV Selection of Special Groups as Research Participants 27
V Essential Information on Confidentiality for Prospective Research Participants 29
VI Compensation for Accidental Injury 29
VII Post-Trial Access 30
VIII International Collaboration/ Assistance in Bio-Medical/ Health Research 30
IX Researcher's Relations with the Media and Publication Practices 32
Chapter IV Statement of Specific Principles for Clinical Evaluation of Drugs/Devices/Diagnostics/Vaccines/Herbal Remedies 34
  General Principles 34
  Specific Principles 35
I Drug Trials 35
II Vaccine Trials 43
III Clinical Trials with Surgical Procedures/Medical Devices 46
IV Diagnostic Agents - Use of Radio - Active Materials and X-Rays 49
V Clinical Evaluation of Traditional Ayurveda, Siddha, Unani Remedies and Medicinal Plants 50
Chapter V Statement of Specific Principles for Epidemiological Studies 56
  Introduction 56
  Definitions 57
  General Principles 58
  Specific Principles 59
Chapter VI Statement of Specific Principles for Human Genetics and Genomics Research 62
  Introduction 62
  General Guidelines 64
I Pedigree Studies 65
II Genetic Screening 67
III Therapeutic Trials Including Gene Therapy 69
IV Human Genome Project (HGP) 70
V DNA and Cell-Line Banking/Repository 71
VI DNA Diagnosis 74
VII Prenatal Diagnosis 75
Chapter VII Statement of Specific Principles for Research in Transplantation 77
  Introduction 77
I Transplants from Live or Cadaver Donors 77
II Embryonic and Foetal Tissue 81
III Xeno- Transplantation 86
IV Transplantation for Cosmetic Purposes 88
V Stem Cell 89
Chapter VIII Statement of Specific Principles for Assisted Reproductive Technologies 97
  Introduction 97
  General Principles 98
  Specific Principles 102
  Bibliography 105
  List of Members of Committee (1996-2006) 108

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Ethical Guidelines for Biomedical Research on Human Participants

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Foreword

The release of revised Ethical guidelines for Biomedical Research on Human subjects by the Council in 2000 was followed by a number of developments in science and technology. These have led to further widening of healthcare between the developed and developing countries. Due to globalization rapid techniques of diagnosis and therapy are now available through R & D. The advances in the area of genetics, genomics and molecular biology have grown by leaps and bounds with the resultant need to rein in these advances with sufficient safeguards to protect the rights and welfare of human participants subjected to biomedical research. Globally international agencies have been bringing out guidelines for researchers in their countries with relevance to developing countries. Who and Unesco are striving to bring a universal consensus to these guidelines in an attempt to reduce disparity across the world.

Considering the recent advances in the field of Assisted Reproductive Technologies, separate guidelines have been brought out by the Indian Council of Medical Research as "National Guidelines for Accreditation, Supervision and Regulation of Art Clinics in India"(2005). Since India is being projected as a global hub for clinical trials and the number of corporate hospitals with state-of-the-art facilities is growing, visits by foreign specialists using newer techniques or devices is increasing. Some Indian institutions are also involved in making indigenous devices, which have to be tried in Indian patients for safety and efficacy. Although a separate document has been made for regulating the medical devices under Indian Medical Devices Regulatory Authority (IMDRA) relevant portions have been included in this document. The guidelines for the important biotechnology areas like stern cell research and stored tissue including DNA banking have also been added in this revision. Taking into consideration the changing dimensions of ethical issues in the context of new technologies and evolving universal guidelines, the existing chapters on Clinical trials, Organ Transplantation, Human Genetics, Epidemiology and Assisted Reproductive Technologies have also been revised.

I hope the scientific community, the regulatory agencies and the public at large will be immensely benefited by this revised guidelines.

 

Preface

It was proposed in the earlier revised "Ethical Guidelines for Biomedical Research on Human Subjects" of 2000, that the guidelines to each of the areas described would be updated periodically pari passu with the developments in the area of Biomedical Science. Hence revision has been undertaken in view of the recent development in the area of Science and technology. Further the points raised in several international and national meetings or workshops on bioethics have been taken into account for making the changes with relevance to Indian ethos in this third version of ethical guidelines now being released. The Bioethics Cell of the Division of Basic Medical Sciences has over the years acquired considerable expertise in addressing ethical queries in relation to advances made in biological sciences and biotechnology. This revision will address most of these in this version. The Statement of General principles remains almost the same as they continue to have relevance for future and are template for universal application for developing ethical guidelines in any area relevant to the Indian scenario. All the seven major Chapters, namely, Ethical Review Procedures, General Ethical issues, Clinical evaluation of drugs/vaccines/devices/diagnostics/ herbal remedies, Epidemiological studies, Human genetics and Genomics research, Transplantation research and Assisted reproductive technologies required updating as per the prevalent ethical debates around the globe. Care is taken to include new areas like stem cell research and therapy and biobanking while elaborating many existing topics to make it more user friendly.

As promised during the release of the ethical guidelines of 2000 about periodic update, the present version is being released. I hope this effort will continue to bring out future revisions to keep pace with the global developments in the area of Bioethics.

 

Introduction

The Indian Council of Medical research brought out the 'Policy Statement on Ethical Considerations involved in Research on Human Subjects' in 1980 which revised these guidelines in 2000 as the 'Ethical guidelines for Biomedical Research on Human Subjects'. Due to further rapid developments in science and technology in India after the release of the second version, it became necessary to update these guidelines to make adequate specific provision to meet ethical challenges posed by these advances. Necessitated by the globalization leading to increasing research in the developing world, the international guidelines released in 2002 by the developed countries including the revised CIOMS guidelines focused on observance of ethical norms relevant to different pluralistic cultural environment in these countries for the protection of the research participants in these regions. In India the challenge faced is to apply universal ethical principles to biomedical research in the multicultural Indian society with a multiplicity of health-care systems of considerably varying standards. The scope of this third version of the Council's guidelines takes note of these changes, and in keeping with the national policies and the demands of Indian culture, addresses ethical issues in specific situations to the extent possible. While on one hand, research involving human participants must not violate any universally applicable ethical standards, on the other hand, a researcher needs to consider local cultural values when it comes to the application of the ethical principles to individual autonomy and informed consent. In India, one will have to consider autonomy versus harmony of the environment of the research participant. In research on sensitive issues, this will have to be properly addressed in the research protocol to safeguard the human rights of the dependent or vulnerable persons and populations.

Some of the points in the international guidelines for biomedical research on human participants, which have relevance to international collaborative research initiatives, have been included in this version. Detailed description of vaccine trials, herbal products, biobanking, stem cell research etc. has been provided to make the document reflect current ethical requirements, which can be applied to Indian circumstances from ethical, legal and social angle. The intention is to update this document at frequent intervals to keep the scientific community knowledgeable about the current concepts in bioethics, which is a dynamic process. Such an exercise is in keeping with similar trends seen in many countries and worked out by international agencies.

 

Contents

 

  Foreword vi
  Preface vii
  Acknowledgement viii
  Introduction 1
Chapter I. Statement of General Principles on Ethical Considerations involving Human Participants 2
  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
  Review procedures 11
  Submission of application 14
  Decision making process 17
  Review in special settings 18
  Periodic review 20
  Continuing review 20
  Interim review 21
  Record keeping 21
  Monitoring 22
  Administration and management 22
  Special considerations 22
Chapter III. General Ethical Issues 23
I Informed Consent Process 23
II Compensation for Participation 25
II Conflict Of Interest 26
IV Selection of Special Groups as Research Participants 27
V Essential Information on Confidentiality for Prospective Research Participants 29
VI Compensation for Accidental Injury 29
VII Post-Trial Access 30
VIII International Collaboration/ Assistance in Bio-Medical/ Health Research 30
IX Researcher's Relations with the Media and Publication Practices 32
Chapter IV Statement of Specific Principles for Clinical Evaluation of Drugs/Devices/Diagnostics/Vaccines/Herbal Remedies 34
  General Principles 34
  Specific Principles 35
I Drug Trials 35
II Vaccine Trials 43
III Clinical Trials with Surgical Procedures/Medical Devices 46
IV Diagnostic Agents - Use of Radio - Active Materials and X-Rays 49
V Clinical Evaluation of Traditional Ayurveda, Siddha, Unani Remedies and Medicinal Plants 50
Chapter V Statement of Specific Principles for Epidemiological Studies 56
  Introduction 56
  Definitions 57
  General Principles 58
  Specific Principles 59
Chapter VI Statement of Specific Principles for Human Genetics and Genomics Research 62
  Introduction 62
  General Guidelines 64
I Pedigree Studies 65
II Genetic Screening 67
III Therapeutic Trials Including Gene Therapy 69
IV Human Genome Project (HGP) 70
V DNA and Cell-Line Banking/Repository 71
VI DNA Diagnosis 74
VII Prenatal Diagnosis 75
Chapter VII Statement of Specific Principles for Research in Transplantation 77
  Introduction 77
I Transplants from Live or Cadaver Donors 77
II Embryonic and Foetal Tissue 81
III Xeno- Transplantation 86
IV Transplantation for Cosmetic Purposes 88
V Stem Cell 89
Chapter VIII Statement of Specific Principles for Assisted Reproductive Technologies 97
  Introduction 97
  General Principles 98
  Specific Principles 102
  Bibliography 105
  List of Members of Committee (1996-2006) 108

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