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Legislating the Ethical Guidelines Indian Model. Dr Vasantha Muthuswamy Senior Deputy Director general Division of BMS Indian Council of Medical Research New Delhi - 110029 [email protected] Indian Codes of Ethics, Guidelines & Regulations. 1000 BC : Caraka Samhita

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legislating the ethical guidelines indian model

Legislating the Ethical GuidelinesIndian Model

Dr Vasantha Muthuswamy

Senior Deputy Director general

Division of BMS

Indian Council of Medical Research

New Delhi - 110029

[email protected]

indian codes of ethics guidelines regulations
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
guidelines in 1980
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

1980 icmr guidelines
1980 ICMR Guidelines
  • Ethics Committee
  • Informed consent
  • Clinical trials
  • Research on children, mentally disadvantaged, those with diminished autonomy
  • Traditional Medicine
  • Publications
PROCEDURE ADOPTEDA 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.
major areas identified by the committee 1996
Major Areas Identified by the committee (1996)
  • Clinical evaluation of drug/devices/diagnostics/vaccines/herbal remedies
  • Epidemiological research
  • Human Genetic Research
  • Transplantation research including fetal tissue transplantation
  • Assisted Reproductive technologies
ethical guidelines for biomedical research on human subjects 2000
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)

general principles

Voluntariness, informed consent and community agreement


Privacy and confidentiality

Precaution and risk minimisation

Professional competence

Accountability and transparency

Maximisation of the public interest

Institutional arrangements

Public domain

Totality of responsibility


general issues
Informed consent of subject

Obligations of investigators

Essential information for prospective research subjects

Compensation of participation

Selection of special group of research subjects

Essential information on confidentiality for prospective research subjects

Compensation from accidental injury

International Collaborative Research

Researcher’s relations with the media and publication practices

General Issues
ethical review mechanism

Basic responsibilities of ECs


Review Procedures

Decision Making

Record Keeping

Special Considerations

specific principles
Specific Principles
  • Clinical Trials of Drugs,Devices,Vaccines,Diagnostic agents, Herbal Drugs
  • Epidemiological Studies
  • Human Genetics Research
  • Transplantation Research including Fetal tissue and Xeno- transplantation
  • Assisted Reproductive Technologies
indian acts order related to health
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
indian acts order related to health contd
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
need for laws related to biomedical and behavioral research
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.
role of legislation
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
unethical clinical trials in india
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
recent violation of ethical norms after release of revised ethical guidelines
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 DCGI’s clearance – off label use
  • Erythromycin trial for contraception
regulation of ethical guidelines
Regulation of Ethical Guidelines
  • Indirect
    • 2002 : Amendment to Drugs and Cosmetics Act
    • 2002 : Revised MCI Regulations
  • Direct
    • Proposed Bill
the bill
The Bill


  • 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
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

the bill envisages oversight mechanism
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
the twin pillars of protection in biomedical research
“The Twin Pillars of Protection” in Biomedical research

Rights and Welfare of Human Subjects

Independent Review

Informed Consent

functions of national biomedical research authority
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
authority members
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
functions of the authority
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
functions of the authority contd
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
chapters in the bill
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
chapters in the bill contd
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
nechr will recommend the following to the authority
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
rules regulations to be placed before the parliament schedules in the bill
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
schedules in the bill contd
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
  • 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
current status
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