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V M India modein Biomedical Research l.ppt

Brief presentation on ICMR Guidelines on Biomedical Research

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Legislating the Ethical Guidelines Legislating the Ethical Guidelines Indian Model Indian Model Dr Vasantha Muthuswamy Dr Vasantha Muthuswamy Senior Deputy Director general Senior Deputy Director general Division of BMS Division of BMS Indian Council of Medical Research Indian Council of Medical Research New Delhi - 110029 New Delhi - 110029 muthuswamyv@icmr.org.in muthuswamyv@icmr.org.in
Indian Codes of Ethics, Guidelines & Indian Codes of Ethics, Guidelines & Regulations Regulations  1000 BC 1000 BC : : Caraka Samhita Caraka Samhita to 1-2 AD to 1-2 AD  1947 1947 : : Nuremberg Code Nuremberg Code  1956 1956 : : Code of Medical Ethics, MCI Code of Medical Ethics, MCI  1964 1964 : : Helsinki Declaration Helsinki Declaration  1979 1979 : : Belmont Report (USA) Belmont Report (USA)  1980 1980 : : Policy Statement on Ethical Considerations Policy Statement on Ethical Considerations involved in involved in research on Human Subjects research on Human Subjects  1982/1992 1982/1992 : : Proposed International Guidelines Proposed International Guidelines (WHO/CIOMS) (WHO/CIOMS)  1986 : 1986 : EPA Act for r-DNA products EPA Act for r-DNA products  1997 1997 : : Guidelines for Exchange of Human Biological Guidelines for Exchange of Human Biological Material for Material for Biomedical Research Purposes Biomedical Research Purposes  2000 2000 : : Delhi Medical Council Regulations Delhi Medical Council Regulations  2000 2000 : : Revised ICMR Ethical guidelines Revised ICMR Ethical guidelines  2001 2001 : : Indian GCP Guidelines Indian GCP Guidelines  2004 : 2004 : ART Guidelines ART Guidelines
Guidelines in 1980 Guidelines in 1980 “ “Policy statement on ethical Policy statement on ethical considerations involvement in considerations involvement in research on human subjects” research on human subjects” Prepared by ethics committee under the Prepared by ethics committee under the Chairmanship of Honourable Justice Shri Chairmanship of Honourable Justice Shri H.R. Khanna H.R. Khanna
1980 ICMR Guidelines 1980 ICMR Guidelines  Ethics Committee Ethics Committee  Informed consent Informed consent  Clinical trials Clinical trials  Research on children, mentally Research on children, mentally disadvantaged, those with disadvantaged, those with diminished autonomy diminished autonomy  Traditional Medicine Traditional Medicine  Publications Publications
PROCEDURE ADOPTED PROCEDURE ADOPTED A central ethics committee was constituted under A central ethics committee was constituted under chairmanship of justice Sh.M.N. Venkatachalia in chairmanship of justice Sh.M.N. Venkatachalia in the year 1996 the year 1996  Ethical , Social, Legal dimensions Ethical , Social, Legal dimensions  27 members and Five Sub-committees of experts 27 members and Five Sub-committees of experts were set up for drawing up the guidelines in were set up for drawing up the guidelines in respective area . respective area .  Draft guidelines were prepared by these committees Draft guidelines were prepared by these committees which were considered by CECHER in 1997 which were considered by CECHER in 1997  A draft consultative document was prepared. A draft consultative document was prepared.
Major Areas Identified by the Major Areas Identified by the committee (1996) committee (1996)  Clinical evaluation of Clinical evaluation of drug/devices/diagnostics/vaccines/herbal drug/devices/diagnostics/vaccines/herbal remedies remedies  Epidemiological research Epidemiological research  Human Genetic Research Human Genetic Research  Transplantation research including fetal Transplantation research including fetal tissue transplantation tissue transplantation  Assisted Reproductive technologies Assisted Reproductive technologies
Ethical Guidelines for Biomedical Ethical Guidelines for Biomedical Research on Human Subjects, 2000 Research on Human Subjects, 2000 All institutions in the country which carry out All institutions in the country which carry out any form of biomedical research involving any form of biomedical research involving human beings should follow these human beings should follow these guidelines in letter and spirit to protect guidelines in letter and spirit to protect safety and well being of all individuals. safety and well being of all individuals. Guidelines at - Guidelines at - http://www.icmr.nic.in http://www.icmr.nic.in It is mandatory that all proposals on It is mandatory that all proposals on biomedical research involving human biomedical research involving human subjects should be cleared by an subjects should be cleared by an appropriately constituted Institutional appropriately constituted Institutional Ethics Committee (IEC) Ethics Committee (IEC)
GENERAL PRINCIPLES GENERAL PRINCIPLES  Essentiality Essentiality  Voluntariness, Voluntariness, informed consent and informed consent and community community agreement agreement  Non-exploitation Non-exploitation  Privacy and Privacy and confidentiality confidentiality  Precaution and risk Precaution and risk minimisation minimisation  Professional Professional competence competence  Accountability and Accountability and transparency transparency  Maximisation of the Maximisation of the public interest public interest  Institutional Institutional arrangements arrangements  Public domain Public domain  Totality of Totality of responsibility responsibility  Compliance Compliance
General Issues General Issues  Informed consent of Informed consent of subject subject  Obligations of Obligations of investigators investigators  Essential information Essential information for prospective for prospective research subjects research subjects  Compensation of Compensation of participation participation  Selection of special Selection of special group of research group of research subjects subjects  Essential information on Essential information on confidentiality for confidentiality for prospective research prospective research subjects subjects  Compensation from Compensation from accidental injury accidental injury  International International Collaborative Research Collaborative Research  Researcher’s relations Researcher’s relations with the media and with the media and publication practices publication practices
ETHICAL REVIEW MECHANISM ETHICAL REVIEW MECHANISM Basic responsibilities of ECs Basic responsibilities of ECs Composition Composition Review Procedures Review Procedures Decision Making Decision Making Record Keeping Record Keeping Special Considerations Special Considerations
Specific Principles Specific Principles  Clinical Trials of Drugs,Devices,Vaccines,Diagnostic Clinical Trials of Drugs,Devices,Vaccines,Diagnostic agents, Herbal Drugs agents, Herbal Drugs  Epidemiological Studies Epidemiological Studies  Human Genetics Research Human Genetics Research  Transplantation Research including Fetal tissue and Transplantation Research including Fetal tissue and Xeno- transplantation Xeno- transplantation  Assisted Reproductive Technologies Assisted Reproductive Technologies
Indian Acts/Order related to Indian Acts/Order related to Health Health  Epidemic Diseases Act – 1897 Epidemic Diseases Act – 1897  Red Cross Society (Allocation of Property Act) – 1936 Red Cross Society (Allocation of Property Act) – 1936  Drugs and Cosmetics Act – 1940 Drugs and Cosmetics Act – 1940  Indian Nursing Council Act – 1947 Indian Nursing Council Act – 1947  Dentists Act – 1948 Dentists Act – 1948  Pharmacy Act – 1948 Pharmacy Act – 1948  Employees State Insurance Act – 1948 Employees State Insurance Act – 1948  Medical Council of India Act – 1956, amended 2002 Medical Council of India Act – 1956, amended 2002  Drugs and Magic Remedies Act (Objectionable Drugs and Magic Remedies Act (Objectionable advertisements), 1954 advertisements), 1954  Prevention of Cruelty to Animals Act – 1960 Prevention of Cruelty to Animals Act – 1960  Children Act – 1960 Children Act – 1960  Maternity Benefit Act – 1961 Maternity Benefit Act – 1961  Central Council for Indian Medicine Act – 1970 Central Council for Indian Medicine Act – 1970
Indian Acts/Order related to Indian Acts/Order related to Health Health (Contd.) (Contd.)  Medical Termination of Pregnancy Act – 1971 Medical Termination of Pregnancy Act – 1971  Consumer Protection Act – 1986 Consumer Protection Act – 1986  Environment Protection Act – 1986 Environment Protection Act – 1986  Mental Health Act – 1987 being amended Mental Health Act – 1987 being amended  Rehabilitation Council of India Act - 1992 Rehabilitation Council of India Act - 1992  Pre-natal Diagnostic Techniques (Regulation and Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act -1994, amended 2002 Prevention of Misuse) Act -1994, amended 2002  Organ Transplantation Act – 1994 Organ Transplantation Act – 1994  Persons with Disabilities (Equal Opportunity, Persons with Disabilities (Equal Opportunity, Protection of Rights and Full Participation Act, 1995 Protection of Rights and Full Participation Act, 1995  Pre-conception and Prenatal Diagnostic Techniques Pre-conception and Prenatal Diagnostic Techniques (Prohibition of sex selection) Act - 2003 (Prohibition of sex selection) Act - 2003  Guidelines for Exchange of Biological Material (MOH Guidelines for Exchange of Biological Material (MOH order, 1997) order, 1997)  Right to Information Act - 2005 Right to Information Act - 2005
 Were these Acts and Guidelines Were these Acts and Guidelines protective enough for the protective enough for the participants in medical participants in medical research? research?
Need for Laws Related to Biomedical Need for Laws Related to Biomedical and Behavioral Research and Behavioral Research  Inadequate regulations to stop violations of ethical Inadequate regulations to stop violations of ethical norms norms  Availability of naive subjects and ignorant Availability of naive subjects and ignorant researchers researchers  Inadequate knowledge of ethical review procedures Inadequate knowledge of ethical review procedures when India is emerging as a global hub for clinical when India is emerging as a global hub for clinical trials trials  Participation in research for access to drugs, Participation in research for access to drugs, payment/ compensation payment/ compensation  Legislation in place for animal welfare in Legislation in place for animal welfare in experimentation but not so for human research. experimentation but not so for human research.
Role of Legislation Role of Legislation  To decide what is mandatory / recommendatory To decide what is mandatory / recommendatory  To instill a fear among those violating human rights To instill a fear among those violating human rights  To provide access to justice To provide access to justice  To upgrade norms of ethical research To upgrade norms of ethical research  To honour human rights obligations and rule of law To honour human rights obligations and rule of law  Justice ultimately is the function of law and not Justice ultimately is the function of law and not ethics of morality alone ethics of morality alone  Ethics still relevant since not all ethical guidelines Ethics still relevant since not all ethical guidelines can be legislated can be legislated
Unethical Clinical Trials in India Unethical Clinical Trials in India  Contraceptive trials Contraceptive trials  MNCs sponsored drug trials MNCs sponsored drug trials  Use of vulnerable groups - women, Use of vulnerable groups - women, children, tribals etc children, tribals etc  Pig Heart Transplantation Pig Heart Transplantation  Fetal tissue transplantation Fetal tissue transplantation
Recent Violation of Ethical Norms Recent Violation of Ethical Norms after release of revised ethical after release of revised ethical guidelines guidelines  John Hopkins – RCC Collaboration John Hopkins – RCC Collaboration  VEGF trial in a private hospital in Delhi VEGF trial in a private hospital in Delhi  Genetics Research on vulnerable population (tribals) Genetics Research on vulnerable population (tribals) funded by NIH, EU & published in American Journal funded by NIH, EU & published in American Journal without Indian Collaborator or Govt. consent without Indian Collaborator or Govt. consent  Anti-cancer drug ‘letrozole’ as fertility agent without Anti-cancer drug ‘letrozole’ as fertility agent without DCGI’s clearance – off label use DCGI’s clearance – off label use  Erythromycin trial for contraception Erythromycin trial for contraception
Regulation of Ethical Guidelines Regulation of Ethical Guidelines  Indirect Indirect  2002 2002 : : Amendment to Drugs and Amendment to Drugs and Cosmetics Act Cosmetics Act  2002 2002 : : Revised MCI Regulations Revised MCI Regulations  Direct Direct  Proposed Bill Proposed Bill
The Bill The Bill THE BIOMEDICAL RESEARCH ON THE BIOMEDICAL RESEARCH ON HUMAN SUBJECTS (REGULATION, HUMAN SUBJECTS (REGULATION, CONTROL AND SAFEGUARDS) BILL, CONTROL AND SAFEGUARDS) BILL, 2005 2005
Scope Scope  Promote and regulate biomedical and Promote and regulate biomedical and behavioural research on human subjects to behavioural research on human subjects to ensure safety and well being of the research ensure safety and well being of the research subjects subjects  Necessity to control and monitor the application Necessity to control and monitor the application of new technologies of new technologies eg. eg. stem cell research, stem cell research, therapeutic cloning, ART, Genomics etc. therapeutic cloning, ART, Genomics etc.  To restrict unscrupulous clinical trials on To restrict unscrupulous clinical trials on unsuspecting patients unsuspecting patients
4. 4. Provide legislative power to the ICMR Provide legislative power to the ICMR Ethical Guidelines formulated under the Ethical Guidelines formulated under the Chairmanship of Justice Shri M. N. Chairmanship of Justice Shri M. N. Venkatachaliah, former Chief Justice and Venkatachaliah, former Chief Justice and Chairman of National Human Rights Chairman of National Human Rights Commission of India Commission of India 5. 5. Setting up of a National Biomedical Setting up of a National Biomedical Research Authority Research Authority
The Bill envisages oversight The Bill envisages oversight mechanism mechanism  Creation of a National Biomedical Research Creation of a National Biomedical Research Authority Authority  Setting up of a National Ethics Committee on Setting up of a National Ethics Committee on Human Research Human Research  Registration of Institutional Ethics Registration of Institutional Ethics Committees Committees
Rights and Welfare of Human Subjects Informed Consent Independent Review “ “The Twin Pillars of The Twin Pillars of Protection” in Biomedical Protection” in Biomedical research research
Functions of National Biomedical Functions of National Biomedical Research Authority Research Authority  To promote & ensure that research on human subjects To promote & ensure that research on human subjects is in accordance with the four basic ethical principles in is in accordance with the four basic ethical principles in the whole country the whole country  To grant recognition to institutions conducting To grant recognition to institutions conducting biomedical research biomedical research  Evaluate & monitor functioning of IECs throughout the Evaluate & monitor functioning of IECs throughout the country country  To effect changes in ethical guidelines from time to time To effect changes in ethical guidelines from time to time  To provide relief in cases of violation and exploitation To provide relief in cases of violation and exploitation
Authority Members Authority Members  Chairperson – Eminent scientist appointed by Central Chairperson – Eminent scientist appointed by Central Government Government  Vice-chairperson elected by members Vice-chairperson elected by members  Ex –officio members Ex –officio members  Secretaries of Health, Family Welfare, Department of AYUSH, DST, DBT Secretaries of Health, Family Welfare, Department of AYUSH, DST, DBT  Director Generals of ICMR, ICSSR, CSIR Director Generals of ICMR, ICSSR, CSIR  Financial Advisor, Ministry of Health Financial Advisor, Ministry of Health  Federal Government nominees Federal Government nominees  6 eminent persons from Basic Sciences, Clinical Sciences, Community 6 eminent persons from Basic Sciences, Clinical Sciences, Community Health and Behavioral & Social Science Health and Behavioral & Social Science  2 persons representing NGO & social organisations 2 persons representing NGO & social organisations  1 eminent person from legal field 1 eminent person from legal field  Member Secretary, Chief of Bioethics Cell, ICMR Member Secretary, Chief of Bioethics Cell, ICMR
Functions of the Authority Functions of the Authority  take steps ensuring biomedical research in take steps ensuring biomedical research in accordance with four basic principles, namely accordance with four basic principles, namely respect for persons, beneficence, non-maleficence respect for persons, beneficence, non-maleficence and justice and justice  The Authority may identify from time to time the The Authority may identify from time to time the basic ethical principles basic ethical principles  Evaluate and monitor the performance of Evaluate and monitor the performance of institutional Ethics Review Committees institutional Ethics Review Committees  Recommend to the Central Government the specific Recommend to the Central Government the specific guidelines guidelines
Functions of the Authority Functions of the Authority (contd.) (contd.)  Evolve suitable performance appraisal systems, norms and Evolve suitable performance appraisal systems, norms and mechanisms mechanisms  Delineate between biomedical or behavioral research Delineate between biomedical or behavioral research  Integrate medical research with professional care Integrate medical research with professional care  Assess from time to time vulnerability of certain sectors Assess from time to time vulnerability of certain sectors  Determine nature & definition of informed consent Determine nature & definition of informed consent  Determine the potential conflict of interest Determine the potential conflict of interest  Promote disclosure on the ethical, social, legal and moral Promote disclosure on the ethical, social, legal and moral implication of advances in biomedical and behavioral implication of advances in biomedical and behavioral research research
Chapters in the Bill Chapters in the Bill  Chapter I - short title, extent & commencement, and definitions Chapter I - short title, extent & commencement, and definitions  Chapter II - Provision for the establishment of the Biomedical Chapter II - Provision for the establishment of the Biomedical Research on Human Subjects Regulatory Authority Research on Human Subjects Regulatory Authority  Chapter III - functions of Authority Chapter III - functions of Authority  Chapter IV – provisions for finance, accounts & audit of the Chapter IV – provisions for finance, accounts & audit of the authority authority  Chapter V – Issue of licenses, fees, cancellation & renewal of Chapter V – Issue of licenses, fees, cancellation & renewal of licenses licenses  Chapter VI – Ethics review Committees,National ethics Chapter VI – Ethics review Committees,National ethics committee committee  Chapter VII – Conditions for Subject participation : special Chapter VII – Conditions for Subject participation : special groups, women & children, vulnerable groups groups, women & children, vulnerable groups  Chapter VIII – Clinical Research Chapter VIII – Clinical Research
Chapters in the Bill (Contd.) Chapters in the Bill (Contd.)  Chapter IX – Research in Epidemiology Chapter IX – Research in Epidemiology  Chapters X – Research in Human genetics & Chapters X – Research in Human genetics & Genomics Genomics  Chapter XI – Research in Assisted Reproductive Chapter XI – Research in Assisted Reproductive Technology Technology  Chapters XII – Reserach in Transplantation of Human Chapters XII – Reserach in Transplantation of Human Organs & Tissues Organs & Tissues  Chapters XIII – Offences Chapters XIII – Offences  Chapters XIV – Control by Central Government Chapters XIV – Control by Central Government  Chapters XV - Miscellaneous Chapters XV - Miscellaneous
NECHR will recommend the following to NECHR will recommend the following to the authority the authority  To ensure that research by the recognised institutions To ensure that research by the recognised institutions is beneficial to the human subjects is beneficial to the human subjects  To identify required changes in various schedules To identify required changes in various schedules  To suggest changes in monitoring of the performance To suggest changes in monitoring of the performance of IECs & the various procedures of IECs & the various procedures  To suggest procedural changes of biomedical & To suggest procedural changes of biomedical & behavioural research behavioural research  To review proposals with far reaching national & To review proposals with far reaching national & international consequences international consequences
Rules & Regulations to be placed Rules & Regulations to be placed before the Parliament: Schedules in before the Parliament: Schedules in the Bill the Bill  Schedule A - General Principles for conducting Schedule A - General Principles for conducting biomedical research on human subjects biomedical research on human subjects  Schedule B - Guidelines for research in clinical Schedule B - Guidelines for research in clinical evaluation of drugs, vaccines, devices, diagnostic evaluation of drugs, vaccines, devices, diagnostic and herbal remedies (includes principles of Drugs & and herbal remedies (includes principles of Drugs & Cosmetics Act & Indian GCP guidelines) Cosmetics Act & Indian GCP guidelines)  Schedule C - Guidelines for research on human Schedule C - Guidelines for research on human subjects in epidemiological studies subjects in epidemiological studies
Schedules in the Bill (Contd.) Schedules in the Bill (Contd.)  Schedule D - Guidelines for research in human Schedule D - Guidelines for research in human genetics and genomics (includes genetics and genetics and genomics (includes genetics and genomics guidelines of DBT as one common genomics guidelines of DBT as one common code) code)  Schedule E - Guidelines for research in assisted Schedule E - Guidelines for research in assisted reproductive technology reproductive technology  Schedule F - Guidelines for research in Schedule F - Guidelines for research in transplantation of human organs and tissues transplantation of human organs and tissues
Offences Offences  Powers of Authority to give directions Powers of Authority to give directions………...shall be liable on ………...shall be liable on conviction to conviction to imprisonment imprisonment which may extend to which may extend to six months six months or to or to a fine which may extend to a fine which may extend to ten thousand rupees or with both. ten thousand rupees or with both.  Penalty for misrepresentation Penalty for misrepresentation ….. …..punished with punished with imprisonment imprisonment for a term which may extend to for a term which may extend to six months six months, or with fine which may , or with fine which may extend to then extend to then thousand rupees, or with both. thousand rupees, or with both.  Penalty for breach of confidentiality and privacy Penalty for breach of confidentiality and privacy…………... …………... punished with punished with imprisonment which may extend to six months imprisonment which may extend to six months or or a fine which extend to a fine which extend to ten thousand rupees or with both. ten thousand rupees or with both.  offence or contravention committed outside India offence or contravention committed outside India
Current Status Current Status  Draft legislation ready for placing before the Draft legislation ready for placing before the Parliament for notification after vetting by Parliament for notification after vetting by the Law department the Law department  Wide Public Consultation Wide Public Consultation  Regional and National Debates Regional and National Debates  Will provide legal support to the ethical Will provide legal support to the ethical guidelines guidelines  Implementation Implementation
THANK YOU THANK YOU

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V M India modein Biomedical Research l.ppt

  • 1.
    Legislating the EthicalGuidelines Legislating the Ethical Guidelines Indian Model Indian Model Dr Vasantha Muthuswamy Dr Vasantha Muthuswamy Senior Deputy Director general Senior Deputy Director general Division of BMS Division of BMS Indian Council of Medical Research Indian Council of Medical Research New Delhi - 110029 New Delhi - 110029 muthuswamyv@icmr.org.in muthuswamyv@icmr.org.in
  • 2.
    Indian Codes ofEthics, Guidelines & Indian Codes of Ethics, Guidelines & Regulations Regulations  1000 BC 1000 BC : : Caraka Samhita Caraka Samhita to 1-2 AD to 1-2 AD  1947 1947 : : Nuremberg Code Nuremberg Code  1956 1956 : : Code of Medical Ethics, MCI Code of Medical Ethics, MCI  1964 1964 : : Helsinki Declaration Helsinki Declaration  1979 1979 : : Belmont Report (USA) Belmont Report (USA)  1980 1980 : : Policy Statement on Ethical Considerations Policy Statement on Ethical Considerations involved in involved in research on Human Subjects research on Human Subjects  1982/1992 1982/1992 : : Proposed International Guidelines Proposed International Guidelines (WHO/CIOMS) (WHO/CIOMS)  1986 : 1986 : EPA Act for r-DNA products EPA Act for r-DNA products  1997 1997 : : Guidelines for Exchange of Human Biological Guidelines for Exchange of Human Biological Material for Material for Biomedical Research Purposes Biomedical Research Purposes  2000 2000 : : Delhi Medical Council Regulations Delhi Medical Council Regulations  2000 2000 : : Revised ICMR Ethical guidelines Revised ICMR Ethical guidelines  2001 2001 : : Indian GCP Guidelines Indian GCP Guidelines  2004 : 2004 : ART Guidelines ART Guidelines
  • 3.
    Guidelines in 1980 Guidelinesin 1980 “ “Policy statement on ethical Policy statement on ethical considerations involvement in considerations involvement in research on human subjects” research on human subjects” Prepared by ethics committee under the Prepared by ethics committee under the Chairmanship of Honourable Justice Shri Chairmanship of Honourable Justice Shri H.R. Khanna H.R. Khanna
  • 4.
    1980 ICMR Guidelines 1980ICMR Guidelines  Ethics Committee Ethics Committee  Informed consent Informed consent  Clinical trials Clinical trials  Research on children, mentally Research on children, mentally disadvantaged, those with disadvantaged, those with diminished autonomy diminished autonomy  Traditional Medicine Traditional Medicine  Publications Publications
  • 5.
    PROCEDURE ADOPTED PROCEDURE ADOPTED Acentral ethics committee was constituted under A central ethics committee was constituted under chairmanship of justice Sh.M.N. Venkatachalia in chairmanship of justice Sh.M.N. Venkatachalia in the year 1996 the year 1996  Ethical , Social, Legal dimensions Ethical , Social, Legal dimensions  27 members and Five Sub-committees of experts 27 members and Five Sub-committees of experts were set up for drawing up the guidelines in were set up for drawing up the guidelines in respective area . respective area .  Draft guidelines were prepared by these committees Draft guidelines were prepared by these committees which were considered by CECHER in 1997 which were considered by CECHER in 1997  A draft consultative document was prepared. A draft consultative document was prepared.
  • 6.
    Major Areas Identifiedby the Major Areas Identified by the committee (1996) committee (1996)  Clinical evaluation of Clinical evaluation of drug/devices/diagnostics/vaccines/herbal drug/devices/diagnostics/vaccines/herbal remedies remedies  Epidemiological research Epidemiological research  Human Genetic Research Human Genetic Research  Transplantation research including fetal Transplantation research including fetal tissue transplantation tissue transplantation  Assisted Reproductive technologies Assisted Reproductive technologies
  • 7.
    Ethical Guidelines forBiomedical Ethical Guidelines for Biomedical Research on Human Subjects, 2000 Research on Human Subjects, 2000 All institutions in the country which carry out All institutions in the country which carry out any form of biomedical research involving any form of biomedical research involving human beings should follow these human beings should follow these guidelines in letter and spirit to protect guidelines in letter and spirit to protect safety and well being of all individuals. safety and well being of all individuals. Guidelines at - Guidelines at - http://www.icmr.nic.in http://www.icmr.nic.in It is mandatory that all proposals on It is mandatory that all proposals on biomedical research involving human biomedical research involving human subjects should be cleared by an subjects should be cleared by an appropriately constituted Institutional appropriately constituted Institutional Ethics Committee (IEC) Ethics Committee (IEC)
  • 8.
    GENERAL PRINCIPLES GENERAL PRINCIPLES Essentiality Essentiality  Voluntariness, Voluntariness, informed consent and informed consent and community community agreement agreement  Non-exploitation Non-exploitation  Privacy and Privacy and confidentiality confidentiality  Precaution and risk Precaution and risk minimisation minimisation  Professional Professional competence competence  Accountability and Accountability and transparency transparency  Maximisation of the Maximisation of the public interest public interest  Institutional Institutional arrangements arrangements  Public domain Public domain  Totality of Totality of responsibility responsibility  Compliance Compliance
  • 9.
    General Issues General Issues Informed consent of Informed consent of subject subject  Obligations of Obligations of investigators investigators  Essential information Essential information for prospective for prospective research subjects research subjects  Compensation of Compensation of participation participation  Selection of special Selection of special group of research group of research subjects subjects  Essential information on Essential information on confidentiality for confidentiality for prospective research prospective research subjects subjects  Compensation from Compensation from accidental injury accidental injury  International International Collaborative Research Collaborative Research  Researcher’s relations Researcher’s relations with the media and with the media and publication practices publication practices
  • 10.
    ETHICAL REVIEW MECHANISM ETHICALREVIEW MECHANISM Basic responsibilities of ECs Basic responsibilities of ECs Composition Composition Review Procedures Review Procedures Decision Making Decision Making Record Keeping Record Keeping Special Considerations Special Considerations
  • 11.
    Specific Principles Specific Principles Clinical Trials of Drugs,Devices,Vaccines,Diagnostic Clinical Trials of Drugs,Devices,Vaccines,Diagnostic agents, Herbal Drugs agents, Herbal Drugs  Epidemiological Studies Epidemiological Studies  Human Genetics Research Human Genetics Research  Transplantation Research including Fetal tissue and Transplantation Research including Fetal tissue and Xeno- transplantation Xeno- transplantation  Assisted Reproductive Technologies Assisted Reproductive Technologies
  • 12.
    Indian Acts/Order relatedto Indian Acts/Order related to Health Health  Epidemic Diseases Act – 1897 Epidemic Diseases Act – 1897  Red Cross Society (Allocation of Property Act) – 1936 Red Cross Society (Allocation of Property Act) – 1936  Drugs and Cosmetics Act – 1940 Drugs and Cosmetics Act – 1940  Indian Nursing Council Act – 1947 Indian Nursing Council Act – 1947  Dentists Act – 1948 Dentists Act – 1948  Pharmacy Act – 1948 Pharmacy Act – 1948  Employees State Insurance Act – 1948 Employees State Insurance Act – 1948  Medical Council of India Act – 1956, amended 2002 Medical Council of India Act – 1956, amended 2002  Drugs and Magic Remedies Act (Objectionable Drugs and Magic Remedies Act (Objectionable advertisements), 1954 advertisements), 1954  Prevention of Cruelty to Animals Act – 1960 Prevention of Cruelty to Animals Act – 1960  Children Act – 1960 Children Act – 1960  Maternity Benefit Act – 1961 Maternity Benefit Act – 1961  Central Council for Indian Medicine Act – 1970 Central Council for Indian Medicine Act – 1970
  • 13.
    Indian Acts/Order relatedto Indian Acts/Order related to Health Health (Contd.) (Contd.)  Medical Termination of Pregnancy Act – 1971 Medical Termination of Pregnancy Act – 1971  Consumer Protection Act – 1986 Consumer Protection Act – 1986  Environment Protection Act – 1986 Environment Protection Act – 1986  Mental Health Act – 1987 being amended Mental Health Act – 1987 being amended  Rehabilitation Council of India Act - 1992 Rehabilitation Council of India Act - 1992  Pre-natal Diagnostic Techniques (Regulation and Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act -1994, amended 2002 Prevention of Misuse) Act -1994, amended 2002  Organ Transplantation Act – 1994 Organ Transplantation Act – 1994  Persons with Disabilities (Equal Opportunity, Persons with Disabilities (Equal Opportunity, Protection of Rights and Full Participation Act, 1995 Protection of Rights and Full Participation Act, 1995  Pre-conception and Prenatal Diagnostic Techniques Pre-conception and Prenatal Diagnostic Techniques (Prohibition of sex selection) Act - 2003 (Prohibition of sex selection) Act - 2003  Guidelines for Exchange of Biological Material (MOH Guidelines for Exchange of Biological Material (MOH order, 1997) order, 1997)  Right to Information Act - 2005 Right to Information Act - 2005
  • 14.
     Were theseActs and Guidelines Were these Acts and Guidelines protective enough for the protective enough for the participants in medical participants in medical research? research?
  • 15.
    Need for LawsRelated to Biomedical Need for Laws Related to Biomedical and Behavioral Research and Behavioral Research  Inadequate regulations to stop violations of ethical Inadequate regulations to stop violations of ethical norms norms  Availability of naive subjects and ignorant Availability of naive subjects and ignorant researchers researchers  Inadequate knowledge of ethical review procedures Inadequate knowledge of ethical review procedures when India is emerging as a global hub for clinical when India is emerging as a global hub for clinical trials trials  Participation in research for access to drugs, Participation in research for access to drugs, payment/ compensation payment/ compensation  Legislation in place for animal welfare in Legislation in place for animal welfare in experimentation but not so for human research. experimentation but not so for human research.
  • 16.
    Role of Legislation Roleof Legislation  To decide what is mandatory / recommendatory To decide what is mandatory / recommendatory  To instill a fear among those violating human rights To instill a fear among those violating human rights  To provide access to justice To provide access to justice  To upgrade norms of ethical research To upgrade norms of ethical research  To honour human rights obligations and rule of law To honour human rights obligations and rule of law  Justice ultimately is the function of law and not Justice ultimately is the function of law and not ethics of morality alone ethics of morality alone  Ethics still relevant since not all ethical guidelines Ethics still relevant since not all ethical guidelines can be legislated can be legislated
  • 17.
    Unethical Clinical Trialsin India Unethical Clinical Trials in India  Contraceptive trials Contraceptive trials  MNCs sponsored drug trials MNCs sponsored drug trials  Use of vulnerable groups - women, Use of vulnerable groups - women, children, tribals etc children, tribals etc  Pig Heart Transplantation Pig Heart Transplantation  Fetal tissue transplantation Fetal tissue transplantation
  • 18.
    Recent Violation ofEthical Norms Recent Violation of Ethical Norms after release of revised ethical after release of revised ethical guidelines guidelines  John Hopkins – RCC Collaboration John Hopkins – RCC Collaboration  VEGF trial in a private hospital in Delhi VEGF trial in a private hospital in Delhi  Genetics Research on vulnerable population (tribals) Genetics Research on vulnerable population (tribals) funded by NIH, EU & published in American Journal funded by NIH, EU & published in American Journal without Indian Collaborator or Govt. consent without Indian Collaborator or Govt. consent  Anti-cancer drug ‘letrozole’ as fertility agent without Anti-cancer drug ‘letrozole’ as fertility agent without DCGI’s clearance – off label use DCGI’s clearance – off label use  Erythromycin trial for contraception Erythromycin trial for contraception
  • 19.
    Regulation of EthicalGuidelines Regulation of Ethical Guidelines  Indirect Indirect  2002 2002 : : Amendment to Drugs and Amendment to Drugs and Cosmetics Act Cosmetics Act  2002 2002 : : Revised MCI Regulations Revised MCI Regulations  Direct Direct  Proposed Bill Proposed Bill
  • 20.
    The Bill The Bill THEBIOMEDICAL RESEARCH ON THE BIOMEDICAL RESEARCH ON HUMAN SUBJECTS (REGULATION, HUMAN SUBJECTS (REGULATION, CONTROL AND SAFEGUARDS) BILL, CONTROL AND SAFEGUARDS) BILL, 2005 2005
  • 21.
    Scope Scope  Promote andregulate biomedical and Promote and regulate biomedical and behavioural research on human subjects to behavioural research on human subjects to ensure safety and well being of the research ensure safety and well being of the research subjects subjects  Necessity to control and monitor the application Necessity to control and monitor the application of new technologies of new technologies eg. eg. stem cell research, stem cell research, therapeutic cloning, ART, Genomics etc. therapeutic cloning, ART, Genomics etc.  To restrict unscrupulous clinical trials on To restrict unscrupulous clinical trials on unsuspecting patients unsuspecting patients
  • 22.
    4. 4. Provide legislativepower to the ICMR Provide legislative power to the ICMR Ethical Guidelines formulated under the Ethical Guidelines formulated under the Chairmanship of Justice Shri M. N. Chairmanship of Justice Shri M. N. Venkatachaliah, former Chief Justice and Venkatachaliah, former Chief Justice and Chairman of National Human Rights Chairman of National Human Rights Commission of India Commission of India 5. 5. Setting up of a National Biomedical Setting up of a National Biomedical Research Authority Research Authority
  • 23.
    The Bill envisagesoversight The Bill envisages oversight mechanism mechanism  Creation of a National Biomedical Research Creation of a National Biomedical Research Authority Authority  Setting up of a National Ethics Committee on Setting up of a National Ethics Committee on Human Research Human Research  Registration of Institutional Ethics Registration of Institutional Ethics Committees Committees
  • 24.
    Rights and Welfareof Human Subjects Informed Consent Independent Review “ “The Twin Pillars of The Twin Pillars of Protection” in Biomedical Protection” in Biomedical research research
  • 25.
    Functions of NationalBiomedical Functions of National Biomedical Research Authority Research Authority  To promote & ensure that research on human subjects To promote & ensure that research on human subjects is in accordance with the four basic ethical principles in is in accordance with the four basic ethical principles in the whole country the whole country  To grant recognition to institutions conducting To grant recognition to institutions conducting biomedical research biomedical research  Evaluate & monitor functioning of IECs throughout the Evaluate & monitor functioning of IECs throughout the country country  To effect changes in ethical guidelines from time to time To effect changes in ethical guidelines from time to time  To provide relief in cases of violation and exploitation To provide relief in cases of violation and exploitation
  • 26.
    Authority Members Authority Members Chairperson – Eminent scientist appointed by Central Chairperson – Eminent scientist appointed by Central Government Government  Vice-chairperson elected by members Vice-chairperson elected by members  Ex –officio members Ex –officio members  Secretaries of Health, Family Welfare, Department of AYUSH, DST, DBT Secretaries of Health, Family Welfare, Department of AYUSH, DST, DBT  Director Generals of ICMR, ICSSR, CSIR Director Generals of ICMR, ICSSR, CSIR  Financial Advisor, Ministry of Health Financial Advisor, Ministry of Health  Federal Government nominees Federal Government nominees  6 eminent persons from Basic Sciences, Clinical Sciences, Community 6 eminent persons from Basic Sciences, Clinical Sciences, Community Health and Behavioral & Social Science Health and Behavioral & Social Science  2 persons representing NGO & social organisations 2 persons representing NGO & social organisations  1 eminent person from legal field 1 eminent person from legal field  Member Secretary, Chief of Bioethics Cell, ICMR Member Secretary, Chief of Bioethics Cell, ICMR
  • 27.
    Functions of theAuthority Functions of the Authority  take steps ensuring biomedical research in take steps ensuring biomedical research in accordance with four basic principles, namely accordance with four basic principles, namely respect for persons, beneficence, non-maleficence respect for persons, beneficence, non-maleficence and justice and justice  The Authority may identify from time to time the The Authority may identify from time to time the basic ethical principles basic ethical principles  Evaluate and monitor the performance of Evaluate and monitor the performance of institutional Ethics Review Committees institutional Ethics Review Committees  Recommend to the Central Government the specific Recommend to the Central Government the specific guidelines guidelines
  • 28.
    Functions of theAuthority Functions of the Authority (contd.) (contd.)  Evolve suitable performance appraisal systems, norms and Evolve suitable performance appraisal systems, norms and mechanisms mechanisms  Delineate between biomedical or behavioral research Delineate between biomedical or behavioral research  Integrate medical research with professional care Integrate medical research with professional care  Assess from time to time vulnerability of certain sectors Assess from time to time vulnerability of certain sectors  Determine nature & definition of informed consent Determine nature & definition of informed consent  Determine the potential conflict of interest Determine the potential conflict of interest  Promote disclosure on the ethical, social, legal and moral Promote disclosure on the ethical, social, legal and moral implication of advances in biomedical and behavioral implication of advances in biomedical and behavioral research research
  • 29.
    Chapters in theBill Chapters in the Bill  Chapter I - short title, extent & commencement, and definitions Chapter I - short title, extent & commencement, and definitions  Chapter II - Provision for the establishment of the Biomedical Chapter II - Provision for the establishment of the Biomedical Research on Human Subjects Regulatory Authority Research on Human Subjects Regulatory Authority  Chapter III - functions of Authority Chapter III - functions of Authority  Chapter IV – provisions for finance, accounts & audit of the Chapter IV – provisions for finance, accounts & audit of the authority authority  Chapter V – Issue of licenses, fees, cancellation & renewal of Chapter V – Issue of licenses, fees, cancellation & renewal of licenses licenses  Chapter VI – Ethics review Committees,National ethics Chapter VI – Ethics review Committees,National ethics committee committee  Chapter VII – Conditions for Subject participation : special Chapter VII – Conditions for Subject participation : special groups, women & children, vulnerable groups groups, women & children, vulnerable groups  Chapter VIII – Clinical Research Chapter VIII – Clinical Research
  • 30.
    Chapters in theBill (Contd.) Chapters in the Bill (Contd.)  Chapter IX – Research in Epidemiology Chapter IX – Research in Epidemiology  Chapters X – Research in Human genetics & Chapters X – Research in Human genetics & Genomics Genomics  Chapter XI – Research in Assisted Reproductive Chapter XI – Research in Assisted Reproductive Technology Technology  Chapters XII – Reserach in Transplantation of Human Chapters XII – Reserach in Transplantation of Human Organs & Tissues Organs & Tissues  Chapters XIII – Offences Chapters XIII – Offences  Chapters XIV – Control by Central Government Chapters XIV – Control by Central Government  Chapters XV - Miscellaneous Chapters XV - Miscellaneous
  • 31.
    NECHR will recommendthe following to NECHR will recommend the following to the authority the authority  To ensure that research by the recognised institutions To ensure that research by the recognised institutions is beneficial to the human subjects is beneficial to the human subjects  To identify required changes in various schedules To identify required changes in various schedules  To suggest changes in monitoring of the performance To suggest changes in monitoring of the performance of IECs & the various procedures of IECs & the various procedures  To suggest procedural changes of biomedical & To suggest procedural changes of biomedical & behavioural research behavioural research  To review proposals with far reaching national & To review proposals with far reaching national & international consequences international consequences
  • 32.
    Rules & Regulationsto be placed Rules & Regulations to be placed before the Parliament: Schedules in before the Parliament: Schedules in the Bill the Bill  Schedule A - General Principles for conducting Schedule A - General Principles for conducting biomedical research on human subjects biomedical research on human subjects  Schedule B - Guidelines for research in clinical Schedule B - Guidelines for research in clinical evaluation of drugs, vaccines, devices, diagnostic evaluation of drugs, vaccines, devices, diagnostic and herbal remedies (includes principles of Drugs & and herbal remedies (includes principles of Drugs & Cosmetics Act & Indian GCP guidelines) Cosmetics Act & Indian GCP guidelines)  Schedule C - Guidelines for research on human Schedule C - Guidelines for research on human subjects in epidemiological studies subjects in epidemiological studies
  • 33.
    Schedules in theBill (Contd.) Schedules in the Bill (Contd.)  Schedule D - Guidelines for research in human Schedule D - Guidelines for research in human genetics and genomics (includes genetics and genetics and genomics (includes genetics and genomics guidelines of DBT as one common genomics guidelines of DBT as one common code) code)  Schedule E - Guidelines for research in assisted Schedule E - Guidelines for research in assisted reproductive technology reproductive technology  Schedule F - Guidelines for research in Schedule F - Guidelines for research in transplantation of human organs and tissues transplantation of human organs and tissues
  • 34.
    Offences Offences  Powers ofAuthority to give directions Powers of Authority to give directions………...shall be liable on ………...shall be liable on conviction to conviction to imprisonment imprisonment which may extend to which may extend to six months six months or to or to a fine which may extend to a fine which may extend to ten thousand rupees or with both. ten thousand rupees or with both.  Penalty for misrepresentation Penalty for misrepresentation ….. …..punished with punished with imprisonment imprisonment for a term which may extend to for a term which may extend to six months six months, or with fine which may , or with fine which may extend to then extend to then thousand rupees, or with both. thousand rupees, or with both.  Penalty for breach of confidentiality and privacy Penalty for breach of confidentiality and privacy…………... …………... punished with punished with imprisonment which may extend to six months imprisonment which may extend to six months or or a fine which extend to a fine which extend to ten thousand rupees or with both. ten thousand rupees or with both.  offence or contravention committed outside India offence or contravention committed outside India
  • 35.
    Current Status Current Status Draft legislation ready for placing before the Draft legislation ready for placing before the Parliament for notification after vetting by Parliament for notification after vetting by the Law department the Law department  Wide Public Consultation Wide Public Consultation  Regional and National Debates Regional and National Debates  Will provide legal support to the ethical Will provide legal support to the ethical guidelines guidelines  Implementation Implementation
  • 36.

Editor's Notes

  • #7 The ethical guidelines for biomedical research on human subjects were released in Oct 2000 and it is expected that all Instt involved in biomedical research on human subjects must follow the same. The guidelines clearly specify that all research before initiation must be reviewed by Institutional Ethics Committees. This document is among the few guidelines that have been recognised by some of the best Institutes in the world and in India it has been widely circulated including to all the ICMR Institutes and I would like to request all members of Ethics Committees to please go through this carefully.