Legislating the Ethical Guidelines Indian Model

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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

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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

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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

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1980 ICMR Guidelines

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

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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.

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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

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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)

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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

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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

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ETHICAL REVIEW MECHANISM

• Basic responsibilities of ECs
• Composition
• Review Procedures
• Decision Making
• Record Keeping
• Special Considerations

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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

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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

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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

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

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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.

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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

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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

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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

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Regulation of Ethical Guidelines

• Indirect
• 2002 Amendment to Drugs and Cosmetics
  Act
• 2002 Revised MCI Regulations
• Direct
• Proposed Bill

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The Bill

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

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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

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• 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

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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

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The Twin Pillars of Protection in Biomedical
research
Rights and Welfare of Human Subjects
Informed Consent
Independent Review
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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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• THANK YOU