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Legislating the Ethical Guidelines Indian Model

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Title: Legislating the Ethical Guidelines Indian Model


1
Legislating the Ethical GuidelinesIndian Model
  • Dr Vasantha Muthuswamy
  • Senior Deputy Director general
  • Division of BMS
  • Indian Council of Medical Research
  • New Delhi - 110029
  • muthuswamyv_at_icmr.org.in

2
Indian Codes of Ethics, Guidelines Regulations
  • 1000 BC Caraka Samhita
  • to 1-2 AD
  • 1947 Nuremberg Code
  • 1956 Code of Medical Ethics, MCI
  • 1964 Helsinki Declaration
  • 1979 Belmont Report (USA)
  • 1980 Policy Statement on Ethical
    Considerations involved in research on Human
    Subjects
  • 1982/1992 Proposed International Guidelines
    (WHO/CIOMS)
  • 1986 EPA Act for r-DNA
    products
  • 1997 Guidelines for Exchange of Human
    Biological Material for Biomedical Research
    Purposes
  • 2000 Delhi Medical Council Regulations
  • 2000 Revised ICMR Ethical guidelines
  • 2001 Indian GCP Guidelines
  • 2004 ART Guidelines

3
Guidelines in 1980
  • Policy statement on ethical considerations
    involvement in research on human subjects
  • Prepared by ethics committee under the
    Chairmanship of Honourable Justice Shri H.R.
    Khanna

4
1980 ICMR Guidelines
  • Ethics Committee
  • Informed consent
  • Clinical trials
  • Research on children, mentally disadvantaged,
    those with diminished autonomy
  • Traditional Medicine
  • Publications

5
PROCEDURE ADOPTED A central ethics committee
was constituted under chairmanship of justice
Sh.M.N. Venkatachalia in the year 1996
  • Ethical , Social, Legal dimensions
  • 27 members and Five Sub-committees of experts
    were set up for drawing up the guidelines in
    respective area .
  • Draft guidelines were prepared by these
    committees which were considered by CECHER in
    1997
  • A draft consultative document was prepared.

6
Major Areas Identified by the committee (1996)
  • Clinical evaluation of drug/devices/diagnostics/va
    ccines/herbal remedies
  • Epidemiological research
  • Human Genetic Research
  • Transplantation research including fetal tissue
    transplantation
  • Assisted Reproductive technologies

7
Ethical Guidelines for Biomedical Research on
Human Subjects, 2000
  • All institutions in the country which carry out
    any form of biomedical research involving human
    beings should follow these guidelines in letter
    and spirit to protect safety and well being of
    all individuals.
  • Guidelines at - http//www.icmr.nic.in
  • It is mandatory that all proposals on biomedical
    research involving human subjects should be
    cleared by an appropriately constituted
    Institutional Ethics Committee (IEC)

8
GENERAL PRINCIPLES
  • Essentiality
  • Voluntariness, informed consent and community
    agreement
  • Non-exploitation
  • Privacy and confidentiality
  • Precaution and risk minimisation
  • Professional competence
  • Accountability and transparency
  • Maximisation of the public interest
  • Institutional arrangements
  • Public domain
  • Totality of responsibility
  • Compliance

9
General Issues
  • Essential information on confidentiality for
    prospective research subjects
  • Compensation from accidental injury
  • International Collaborative Research
  • Researchers relations with the media and
    publication practices
  • Informed consent of subject
  • Obligations of investigators
  • Essential information for prospective research
    subjects
  • Compensation of participation
  • Selection of special group of research subjects

10
ETHICAL REVIEW MECHANISM
  • Basic responsibilities of ECs
  • Composition
  • Review Procedures
  • Decision Making
  • Record Keeping
  • Special Considerations

11
Specific Principles
  • Clinical Trials of Drugs,Devices,Vaccines,Diagnost
    ic agents, Herbal Drugs
  • Epidemiological Studies
  • Human Genetics Research
  • Transplantation Research including Fetal tissue
    and Xeno- transplantation
  • Assisted Reproductive Technologies

12
Indian Acts/Order related to Health
  • Epidemic Diseases Act 1897
  • Red Cross Society (Allocation of Property Act)
    1936
  • Drugs and Cosmetics Act 1940
  • Indian Nursing Council Act 1947
  • Dentists Act 1948
  • Pharmacy Act 1948
  • Employees State Insurance Act 1948
  • Medical Council of India Act 1956, amended 2002
  • Drugs and Magic Remedies Act (Objectionable
    advertisements), 1954
  • Prevention of Cruelty to Animals Act 1960
  • Children Act 1960
  • Maternity Benefit Act 1961
  • Central Council for Indian Medicine Act 1970

13
Indian Acts/Order related to Health (Contd.)
  • Medical Termination of Pregnancy Act 1971
  • Consumer Protection Act 1986
  • Environment Protection Act 1986
  • Mental Health Act 1987 being amended
  • Rehabilitation Council of India Act - 1992
  • Pre-natal Diagnostic Techniques (Regulation and
    Prevention of Misuse) Act -1994, amended 2002
  • Organ Transplantation Act 1994
  • Persons with Disabilities (Equal Opportunity,
    Protection of Rights and Full Participation Act,
    1995
  • Pre-conception and Prenatal Diagnostic Techniques
    (Prohibition of sex selection) Act - 2003
  • Guidelines for Exchange of Biological Material
    (MOH order, 1997)
  • Right to Information Act - 2005

14
  • Were these Acts and Guidelines protective enough
    for the participants in medical research?

15
Need for Laws Related to Biomedical and
Behavioral Research
  • Inadequate regulations to stop violations of
    ethical norms
  • Availability of naive subjects and ignorant
    researchers
  • Inadequate knowledge of ethical review procedures
    when India is emerging as a global hub for
    clinical trials
  • Participation in research for access to drugs,
    payment/ compensation
  • Legislation in place for animal welfare in
    experimentation but not so for human research.

16
Role of Legislation
  • To decide what is mandatory / recommendatory
  • To instill a fear among those violating human
    rights
  • To provide access to justice
  • To upgrade norms of ethical research
  • To honour human rights obligations and rule of
    law
  • Justice ultimately is the function of law and not
    ethics of morality alone
  • Ethics still relevant since not all ethical
    guidelines can be legislated

17
Unethical Clinical Trials in India
  • Contraceptive trials
  • MNCs sponsored drug trials
  • Use of vulnerable groups - women, children,
    tribals etc
  • Pig Heart Transplantation
  • Fetal tissue transplantation

18
Recent Violation of Ethical Norms after release
of revised ethical guidelines
  • John Hopkins RCC Collaboration
  • VEGF trial in a private hospital in Delhi
  • Genetics Research on vulnerable population
    (tribals) funded by NIH, EU published in
    American Journal without Indian Collaborator or
    Govt. consent
  • Anti-cancer drug letrozole as fertility agent
    without DCGIs clearance off label use
  • Erythromycin trial for contraception

19
Regulation of Ethical Guidelines
  • Indirect
  • 2002 Amendment to Drugs and Cosmetics
    Act
  • 2002 Revised MCI Regulations
  • Direct
  • Proposed Bill

20
The Bill
  • THE BIOMEDICAL RESEARCH ON HUMAN SUBJECTS
    (REGULATION, CONTROL AND SAFEGUARDS) BILL, 2005

21
Scope
  • Promote and regulate biomedical and behavioural
    research on human subjects to ensure safety and
    well being of the research subjects
  • Necessity to control and monitor the application
    of new technologies eg. stem cell research,
    therapeutic cloning, ART, Genomics etc.
  • To restrict unscrupulous clinical trials on
    unsuspecting patients

22
  • 4. Provide legislative power to the ICMR Ethical
    Guidelines formulated under the Chairmanship of
    Justice Shri M. N. Venkatachaliah, former Chief
    Justice and Chairman of National Human Rights
    Commission of India
  • 5. Setting up of a National Biomedical Research
    Authority

23
The Bill envisages oversight mechanism
  • Creation of a National Biomedical Research
    Authority
  • Setting up of a National Ethics Committee on
    Human Research
  • Registration of Institutional Ethics Committees

24
The Twin Pillars of Protection in Biomedical
research
Rights and Welfare of Human Subjects
Informed Consent
Independent Review
25
Functions of National Biomedical Research
Authority
  • To promote ensure that research on human
    subjects is in accordance with the four basic
    ethical principles in the whole country
  • To grant recognition to institutions conducting
    biomedical research
  • Evaluate monitor functioning of IECs throughout
    the country
  • To effect changes in ethical guidelines from time
    to time
  • To provide relief in cases of violation and
    exploitation

26
Authority Members
  • Chairperson Eminent scientist appointed by
    Central Government
  • Vice-chairperson elected by members
  • Ex officio members
  • Secretaries of Health, Family Welfare, Department
    of AYUSH, DST, DBT
  • Director Generals of ICMR, ICSSR, CSIR
  • Financial Advisor, Ministry of Health
  • Federal Government nominees
  • 6 eminent persons from Basic Sciences, Clinical
    Sciences, Community Health and Behavioral
    Social Science
  • 2 persons representing NGO social organisations
  • 1 eminent person from legal field
  • Member Secretary, Chief of Bioethics Cell, ICMR

27
Functions of the Authority
  • take steps ensuring biomedical research in
    accordance with four basic principles, namely
    respect for persons, beneficence, non-maleficence
    and justice
  • The Authority may identify from time to time the
    basic ethical principles
  • Evaluate and monitor the performance of
    institutional Ethics Review Committees
  • Recommend to the Central Government the specific
    guidelines

28
Functions of the Authority (contd.)
  • Evolve suitable performance appraisal systems,
    norms and mechanisms
  • Delineate between biomedical or behavioral
    research
  • Integrate medical research with professional care
  • Assess from time to time vulnerability of certain
    sectors
  • Determine nature definition of informed consent
  • Determine the potential conflict of interest
  • Promote disclosure on the ethical, social, legal
    and moral implication of advances in biomedical
    and behavioral research

29
Chapters in the Bill
  • Chapter I - short title, extent commencement,
    and definitions
  • Chapter II - Provision for the establishment of
    the Biomedical Research on Human Subjects
    Regulatory Authority
  • Chapter III - functions of Authority
  • Chapter IV provisions for finance, accounts
    audit of the authority
  • Chapter V Issue of licenses, fees, cancellation
    renewal of licenses
  • Chapter VI Ethics review Committees,National
    ethics committee
  • Chapter VII Conditions for Subject
    participation special groups, women children,
    vulnerable groups
  • Chapter VIII Clinical Research

30
Chapters in the Bill (Contd.)
  • Chapter IX Research in Epidemiology
  • Chapters X Research in Human genetics
    Genomics
  • Chapter XI Research in Assisted Reproductive
    Technology
  • Chapters XII Reserach in Transplantation of
    Human Organs Tissues
  • Chapters XIII Offences
  • Chapters XIV Control by Central Government
  • Chapters XV - Miscellaneous

31
NECHR will recommend the following to the
authority
  • To ensure that research by the recognised
    institutions is beneficial to the human subjects
  • To identify required changes in various schedules
  • To suggest changes in monitoring of the
    performance of IECs the various procedures
  • To suggest procedural changes of biomedical
    behavioural research
  • To review proposals with far reaching national
    international consequences

32
Rules Regulations to be placed before the
Parliament Schedules in the Bill
  • Schedule A - General Principles for conducting
    biomedical research on human subjects
  • Schedule B - Guidelines for research in clinical
    evaluation of drugs, vaccines, devices,
    diagnostic and herbal remedies (includes
    principles of Drugs Cosmetics Act Indian GCP
    guidelines)
  • Schedule C - Guidelines for research on human
    subjects in epidemiological studies

33
Schedules in the Bill (Contd.)
  • Schedule D - Guidelines for research in human
    genetics and genomics (includes genetics and
    genomics guidelines of DBT as one common code)
  • Schedule E - Guidelines for research in assisted
    reproductive technology
  • Schedule F - Guidelines for research in
    transplantation of human organs and tissues

34
Offences
  • Powers of Authority to give directions...shall
    be liable on conviction to imprisonment which may
    extend to six months or to a fine which may
    extend to ten thousand rupees or with both.
  • Penalty for misrepresentation ..punished with
    imprisonment for a term which may extend to six
    months, or with fine which may extend to then
    thousand rupees, or with both.
  • Penalty for breach of confidentiality and
    privacy... punished with imprisonment which
    may extend to six months or a fine which extend
    to ten thousand rupees or with both.
  • offence or contravention committed outside India

35
Current Status
  • Draft legislation ready for placing before the
    Parliament for notification after vetting by the
    Law department
  • Wide Public Consultation
  • Regional and National Debates
  • Will provide legal support to the ethical
    guidelines
  • Implementation

36
  • THANK YOU
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