Transcript Document

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
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Caraka Samhita
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Nuremberg Code
Code of Medical Ethics, MCI
Helsinki Declaration
Belmont Report (USA)
Policy Statement on Ethical Considerations
involved in research on Human Subjects
Proposed International Guidelines
(WHO/CIOMS)
EPA Act for r-DNA products
Guidelines for Exchange of Human Biological
Material for Biomedical Research Purposes
Delhi Medical Council Regulations
Revised ICMR Ethical guidelines
Indian GCP Guidelines
ART Guidelines
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1000 BC
to 1-2 AD
1947
1956
1964
1979
1980
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1982/1992 :
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1986
1997
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2000
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2001
2004
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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
1980 ICMR Guidelines
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Ethics Committee
Informed consent
Clinical trials
Research on children, mentally
disadvantaged, those with diminished
autonomy
Traditional Medicine
Publications
PROCEDURE ADOPTED
A central ethics committee was constituted under
chairmanship of justice Sh.M.N. Venkatachalia in
the year 1996
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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)
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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
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
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Essentiality
Voluntariness,
informed consent and
community
agreement
Non-exploitation
Privacy and
confidentiality
Precaution and risk
minimisation
Professional
competence
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Accountability and
transparency
Maximisation of the
public interest
Institutional
arrangements
Public domain
Totality of
responsibility
Compliance
General Issues
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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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Essential information on
confidentiality for
prospective research
subjects
Compensation from
accidental injury
International
Collaborative Research
Researcher’s relations
with the media and
publication practices
ETHICAL REVIEW MECHANISM
Basic responsibilities of ECs
Composition
Review Procedures
Decision Making
Record Keeping
Special Considerations
Specific Principles
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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
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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.)
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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?
Need for Laws Related to Biomedical
and Behavioral Research
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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
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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
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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
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John Hopkins – RCC Collaboration
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VEGF trial in a private hospital in Delhi
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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
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Indirect
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2002 :
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2002 :
Direct
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Proposed Bill
Amendment to Drugs and
Cosmetics Act
Revised MCI Regulations
The Bill
THE BIOMEDICAL RESEARCH ON
HUMAN SUBJECTS (REGULATION,
CONTROL AND SAFEGUARDS) BILL,
2005
Scope
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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
Research Authority
National
Biomedical
The Bill envisages oversight
mechanism
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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
Rights and Welfare of Human Subjects
Independent
Review
Informed
Consent
Functions of National Biomedical
Research Authority
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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
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To effect changes in ethical guidelines from time to time
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To provide relief in cases of violation and exploitation
Authority Members
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Chairperson – Eminent scientist appointed by Central
Government
Vice-chairperson elected by members
Ex –officio members
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Financial Advisor, Ministry of Health
Federal Government nominees
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Secretaries of Health, Family Welfare, Department of AYUSH, DST, DBT
Director Generals of ICMR, ICSSR, CSIR
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
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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.)
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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
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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.)
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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
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To ensure that research by the recognised institutions is
beneficial to the human subjects
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To identify required changes in various schedules
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To suggest changes in monitoring of the performance of
IECs & the various procedures
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To suggest procedural changes of biomedical & behavioural
research
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To review proposals with
international consequences
far
reaching
national
&
Rules & Regulations to be placed
before the Parliament: Schedules in
the Bill
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Schedule A - General Principles for
biomedical research on human subjects
conducting
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.)
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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
Offences
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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.
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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
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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
THANK
YOU