Legislating the Ethical GuidelinesLegislating the Ethical GuidelinesIndian ModelIndian Model

Dr Vasantha MuthuswamyDr Vasantha MuthuswamySenior Deputy Director generalSenior Deputy Director general

Division of BMSDivision of BMS

Indian Council of Medical Indian Council of Medical ResearchResearch

New Delhi - 110029New Delhi - 110029

muthuswamyv@icmr.org.inmuthuswamyv@icmr.org.in

Indian Codes of Ethics, Guidelines & Indian Codes of Ethics, Guidelines &

RegulationsRegulations 1000 BC 1000 BC :: Caraka SamhitaCaraka Samhita to 1-2 ADto 1-2 AD 1947 1947 :: Nuremberg CodeNuremberg Code 1956 1956 :: Code of Medical Ethics, MCICode of Medical Ethics, MCI 1964 1964 :: Helsinki DeclarationHelsinki Declaration 1979 1979 :: Belmont Report (USA)Belmont Report (USA) 19801980 : : Policy Statement on Ethical Considerations Policy Statement on Ethical Considerations

involved in research on Human Subjectsinvolved in research on Human Subjects 1982/19921982/1992 :: Proposed International Guidelines Proposed International Guidelines

(WHO/CIOMS)(WHO/CIOMS) 1986 : 1986 : EPA Act for r-DNA productsEPA Act for r-DNA products 19971997 :: Guidelines for Exchange of Human Biological Guidelines for Exchange of Human Biological

Material for Biomedical Research Purposes Material for Biomedical Research Purposes 20002000 :: Delhi Medical Council RegulationsDelhi Medical Council Regulations 2000 2000 : : Revised ICMR Ethical guidelines Revised ICMR Ethical guidelines 20012001 : : Indian GCP GuidelinesIndian GCP Guidelines 2004 : 2004 : ART GuidelinesART Guidelines

Guidelines in 1980Guidelines 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 Prepared by ethics committee under the the Chairmanship of Honourable Chairmanship of Honourable Justice Shri H.R. KhannaJustice Shri H.R. Khanna

1980 ICMR Guidelines1980 ICMR Guidelines

Ethics CommitteeEthics Committee Informed consentInformed consent Clinical trialsClinical trials Research on children, mentally Research on children, mentally

disadvantaged, those with disadvantaged, those with diminished autonomydiminished autonomy

Traditional MedicineTraditional Medicine PublicationsPublications

PROCEDURE ADOPTEDPROCEDURE 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 1996the year 1996

Ethical , Social, Legal dimensionsEthical , 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 Draft guidelines were prepared by these committees which were considered by CECHER in committees which were considered by CECHER in 19971997

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 remediesremedies

Epidemiological researchEpidemiological research Human Genetic ResearchHuman Genetic Research Transplantation research including fetal Transplantation research including fetal

tissue transplantationtissue transplantation Assisted Reproductive technologiesAssisted Reproductive technologies

Ethical Guidelines for Biomedical Ethical Guidelines for Biomedical Research on Human Subjects, 2000Research on Human Subjects, 2000

All institutions in the country which carry All institutions in the country which carry out any form of biomedical research out any form of biomedical research involving human beings should follow involving human beings should follow these guidelines in letter and spirit to these guidelines in letter and spirit to protect safety and well being of all protect safety and well being of all individuals. individuals.

Guidelines at -Guidelines at - http://www.icmr.nic.inhttp://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 PRINCIPLESGENERAL PRINCIPLES

EssentialityEssentiality Voluntariness, Voluntariness,

informed consent informed consent and community and community agreementagreement

Non-exploitation Non-exploitation Privacy and Privacy and

confidentialityconfidentiality Precaution and risk Precaution and risk

minimisationminimisation Professional Professional

competencecompetence

Accountability and Accountability and transparencytransparency

Maximisation of the Maximisation of the public interestpublic interest

Institutional Institutional arrangementsarrangements

Public domainPublic domain Totality of Totality of

responsibilityresponsibility ComplianceCompliance

General IssuesGeneral Issues

Informed consent of Informed consent of subjectsubject

Obligations of Obligations of investigatorsinvestigators

Essential information Essential information for prospective for prospective research subjectsresearch subjects

Compensation of Compensation of participationparticipation

Selection of special Selection of special group of research group of research subjectssubjects

Essential information Essential information on confidentiality for on confidentiality for prospective research prospective research subjects subjects

Compensation from Compensation from accidental injuryaccidental injury

International International Collaborative ResearchCollaborative Research

Researcher’s relations Researcher’s relations with the media and with the media and publication practicespublication practices

ETHICAL REVIEW MECHANISMETHICAL REVIEW MECHANISM

Basic responsibilities of ECsBasic responsibilities of ECs

CompositionComposition

Review ProceduresReview Procedures

Decision MakingDecision Making

Record KeepingRecord Keeping

Special ConsiderationsSpecial Considerations

Specific PrinciplesSpecific Principles

Clinical Trials of Clinical Trials of Drugs,Devices,Vaccines,Diagnostic agents, Herbal Drugs,Devices,Vaccines,Diagnostic agents, Herbal DrugsDrugs

Epidemiological StudiesEpidemiological Studies Human Genetics ResearchHuman Genetics Research Transplantation Research including Fetal tissue Transplantation Research including Fetal tissue

and Xeno- transplantationand Xeno- transplantation Assisted Reproductive TechnologiesAssisted Reproductive Technologies

Indian Acts/Order related to Indian Acts/Order related to HealthHealth

Epidemic Diseases Act – 1897Epidemic Diseases Act – 1897 Red Cross Society (Allocation of Property Act) – Red Cross Society (Allocation of Property Act) –

19361936 Drugs and Cosmetics Act – 1940Drugs and Cosmetics Act – 1940 Indian Nursing Council Act – 1947Indian Nursing Council Act – 1947 Dentists Act – 1948 Dentists Act – 1948 Pharmacy Act – 1948 Pharmacy Act – 1948 Employees State Insurance Act – 1948Employees State Insurance Act – 1948 Medical Council of India Act – 1956, amended 2002Medical Council of India Act – 1956, amended 2002 Drugs and Magic Remedies Act (Objectionable Drugs and Magic Remedies Act (Objectionable

advertisements), 1954advertisements), 1954 Prevention of Cruelty to Animals Act – 1960Prevention of Cruelty to Animals Act – 1960 Children Act – 1960Children Act – 1960 Maternity Benefit Act – 1961Maternity Benefit Act – 1961 Central Council for Indian Medicine Act – 1970Central 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 – 1971Medical Termination of Pregnancy Act – 1971 Consumer Protection Act – 1986Consumer Protection Act – 1986 Environment Protection Act – 1986Environment Protection Act – 1986 Mental Health Act – 1987 being amendedMental Health Act – 1987 being amended Rehabilitation Council of India Act - 1992Rehabilitation Council of India Act - 1992 Pre-natal Diagnostic Techniques (Regulation and Pre-natal Diagnostic Techniques (Regulation and

Prevention of Misuse) Act -1994, amended 2002Prevention of Misuse) Act -1994, amended 2002 Organ Transplantation Act – 1994Organ Transplantation Act – 1994 Persons with Disabilities (Equal Opportunity, Persons with Disabilities (Equal Opportunity,

Protection of Rights and Full Participation Act, 1995Protection 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 Guidelines for Exchange of Biological Material

(MOH order, 1997)(MOH order, 1997) Right to Information Act - 2005Right to Information Act - 2005

Were these Acts and Were these Acts and Guidelines protective Guidelines protective enough for the participants enough for the participants in medical research?in medical 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 Inadequate regulations to stop violations of ethical norms ethical norms

Availability of naive subjects and ignorant Availability of naive subjects and ignorant researchersresearchers

Inadequate knowledge of ethical review Inadequate knowledge of ethical review procedures when India is emerging as a global procedures when India is emerging as a global hub for clinical trialshub for clinical trials

Participation in research for access to drugs, Participation in research for access to drugs, payment/ compensationpayment/ 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 LegislationRole of Legislation

To decide what is mandatory / recommendatoryTo decide what is mandatory / recommendatory To instill a fear among those violating human To instill a fear among those violating human

rightsrights 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 lawTo 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 aloneethics of morality alone Ethics still relevant since not all ethical guidelines Ethics still relevant since not all ethical guidelines

can be legislatedcan be legislated

Unethical Clinical Trials in IndiaUnethical Clinical Trials in India

Contraceptive trialsContraceptive trials MNCs sponsored drug trialsMNCs sponsored drug trials Use of vulnerable groups - women, Use of vulnerable groups - women,

children, tribals etcchildren, tribals etc Pig Heart TransplantationPig 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

guidelinesguidelines John Hopkins – RCC CollaborationJohn Hopkins – RCC Collaboration

VEGF trial in a private hospital in DelhiVEGF trial in a private hospital in Delhi

Genetics Research on vulnerable population Genetics Research on vulnerable population (tribals) funded by NIH, EU & published in (tribals) funded by NIH, EU & published in American Journal without Indian Collaborator or American Journal without Indian Collaborator or Govt. consentGovt. consent

Anti-cancer drug ‘letrozole’ as fertility agent Anti-cancer drug ‘letrozole’ as fertility agent without DCGI’s clearance – off label usewithout DCGI’s clearance – off label use

Erythromycin trial for contraceptionErythromycin trial for contraception

Regulation of Ethical Guidelines Regulation of Ethical Guidelines

Indirect Indirect 20022002 : : Amendment to Drugs and Amendment to Drugs and

Cosmetics ActCosmetics Act 20022002 : : Revised MCI RegulationsRevised MCI Regulations

DirectDirect Proposed BillProposed Bill

The BillThe Bill

THE BIOMEDICAL RESEARCH ON THE BIOMEDICAL RESEARCH ON HUMAN SUBJECTS (REGULATION, HUMAN SUBJECTS (REGULATION,

CONTROL AND SAFEGUARDS) CONTROL AND SAFEGUARDS) BILL, 2005BILL, 2005

ScopeScope

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 ensure safety and well being of the research subjectsresearch subjects

Necessity to control and monitor the Necessity to control and monitor the application of new technologies application of new technologies eg.eg. stem stem cell research, therapeutic cloning, ART, cell research, therapeutic cloning, ART, Genomics etc.Genomics etc.

To restrict unscrupulous clinical trials on To restrict unscrupulous clinical trials on unsuspecting patientsunsuspecting patients

4.4. Provide legislative power to the ICMR Provide legislative power to the ICMR Ethical Guidelines formulated under Ethical Guidelines formulated under the Chairmanship of Justice Shri M. N. the Chairmanship of Justice Shri M. N. Venkatachaliah, former Chief Justice Venkatachaliah, former Chief Justice and Chairman of National Human and Chairman of National Human Rights Commission of India Rights Commission of India

5.5. Setting up of a National Biomedical Setting up of a National Biomedical Research AuthorityResearch Authority

The Bill envisages oversight The Bill envisages oversight mechanismmechanism

Creation of a National Biomedical Creation of a National Biomedical Research AuthorityResearch Authority

Setting up of a National Ethics Committee Setting up of a National Ethics Committee on Human Researchon Human Research

Registration of Institutional Ethics Registration of Institutional Ethics CommitteesCommittees

Rights and Welfare of Human Subjects

Informed Consent

Independent Review

““The Twin Pillars of The Twin Pillars of Protection” in Biomedical Protection” in Biomedical

researchresearch

Functions of National Biomedical Functions of National Biomedical Research AuthorityResearch Authority

To promote & ensure that research on human To promote & ensure that research on human subjects is in accordance with the four basic ethical subjects is in accordance with the four basic ethical principles in the whole countryprinciples in the whole country

To grant recognition to institutions conducting To grant recognition to institutions conducting biomedical researchbiomedical research

Evaluate & monitor functioning of IECs throughout Evaluate & monitor functioning of IECs throughout the countrythe country

To effect changes in ethical guidelines from time to To effect changes in ethical guidelines from time to timetime

To provide relief in cases of violation and exploitationTo provide relief in cases of violation and exploitation

Authority Members Authority Members

Chairperson – Eminent scientist appointed by Chairperson – Eminent scientist appointed by Central GovernmentCentral Government

Vice-chairperson elected by membersVice-chairperson elected by members Ex –officio members Ex –officio members

Secretaries of Health, Family Welfare, Department of AYUSH, Secretaries of Health, Family Welfare, Department of AYUSH, DST, DBTDST, DBT

Director Generals of ICMR, ICSSR, CSIRDirector Generals of ICMR, ICSSR, CSIR

Financial Advisor, Ministry of HealthFinancial Advisor, Ministry of Health Federal Government nominees Federal Government nominees

6 eminent persons from Basic Sciences, Clinical Sciences, 6 eminent persons from Basic Sciences, Clinical Sciences, Community Health and Behavioral & Social ScienceCommunity Health and Behavioral & Social Science

2 persons representing NGO & social organisations2 persons representing NGO & social organisations 1 eminent person from legal field1 eminent person from legal field

Member Secretary, Chief of Bioethics Cell, ICMRMember Secretary, Chief of Bioethics Cell, ICMR

Functions of the AuthorityFunctions 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-respect for persons, beneficence, non-maleficence and justicemaleficence and justice

The Authority may identify from time to time the The Authority may identify from time to time the basic ethical principlesbasic ethical principles

Evaluate and monitor the performance of Evaluate and monitor the performance of institutional Ethics Review Committeesinstitutional Ethics Review Committees

Recommend to the Central Government the Recommend to the Central Government the specific guidelinesspecific guidelines

Functions of the Authority Functions of the Authority (contd.)(contd.)

Evolve suitable performance appraisal systems, norms Evolve suitable performance appraisal systems, norms and mechanismsand mechanisms

Delineate between biomedical or behavioral researchDelineate between biomedical or behavioral research Integrate medical research with professional careIntegrate medical research with professional care Assess from time to time vulnerability of certain sectorsAssess from time to time vulnerability of certain sectors Determine nature & definition of informed consentDetermine nature & definition of informed consent Determine the potential conflict of interestDetermine the potential conflict of interest Promote disclosure on the ethical, social, legal and Promote disclosure on the ethical, social, legal and

moral implication of advances in biomedical and moral implication of advances in biomedical and behavioral researchbehavioral research

Chapters in the BillChapters in the Bill Chapter I - short title, extent & commencement, and Chapter I - short title, extent & commencement, and

definitionsdefinitions 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

authorityauthority Chapter V – Issue of licenses, fees, cancellation & renewal of Chapter V – Issue of licenses, fees, cancellation & renewal of

licenseslicenses Chapter VI – Ethics review Committees,National ethics Chapter VI – Ethics review Committees,National ethics

committeecommittee Chapter VII – Conditions for Subject participation : special Chapter VII – Conditions for Subject participation : special

groups, women & children, vulnerable groupsgroups, women & children, vulnerable groups Chapter VIII – Clinical ResearchChapter VIII – Clinical Research

Chapters in the Bill (Contd.)Chapters in the Bill (Contd.)

Chapter IX – Research in EpidemiologyChapter IX – Research in Epidemiology Chapters X – Research in Human genetics & Chapters X – Research in Human genetics &

GenomicsGenomics Chapter XI – Research in Assisted Reproductive Chapter XI – Research in Assisted Reproductive

TechnologyTechnology Chapters XII – Reserach in Transplantation of Chapters XII – Reserach in Transplantation of

Human Organs & TissuesHuman Organs & Tissues Chapters XIII – OffencesChapters XIII – Offences Chapters XIV – Control by Central GovernmentChapters XIV – Control by Central Government Chapters XV - MiscellaneousChapters 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 To ensure that research by the recognised institutions is beneficial to the human subjectsinstitutions is beneficial to the human subjects

To identify required changes in various schedulesTo identify required changes in various schedules

To suggest changes in monitoring of the To suggest changes in monitoring of the performance of IECs & the various proceduresperformance of IECs & the various procedures

To suggest procedural changes of biomedical & To suggest procedural changes of biomedical & behavioural researchbehavioural research

To review proposals with far reaching national & To review proposals with far reaching national & international consequencesinternational consequences

Rules & Regulations to be placed Rules & Regulations to be placed before the Parliament: Schedules in before the Parliament: Schedules in

the Billthe 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, evaluation of drugs, vaccines, devices, diagnostic and herbal remedies (includes diagnostic and herbal remedies (includes principles of Drugs & Cosmetics Act & Indian principles of Drugs & Cosmetics Act & Indian GCP guidelines)GCP guidelines)

Schedule C - Guidelines for research on human Schedule C - Guidelines for research on human subjects in epidemiological studiessubjects 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 Schedule E - Guidelines for research in assisted reproductive technologyassisted reproductive technology

Schedule F - Guidelines for research in Schedule F - Guidelines for research in transplantation of human organs and tissuestransplantation of human organs and tissues

OffencesOffences

Powers of Authority to give directionsPowers 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 monthssix 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 misrepresentationPenalty for misrepresentation ….. …..punished with punished with imprisonmentimprisonment for a term which may extend to for a term which may extend to six monthssix months, or with fine which , or with fine which may extend to then may extend to then thousand rupees, or with both.thousand rupees, or with both.

Penalty for breach of confidentiality and privacyPenalty for breach of confidentiality and privacy…………... …………... punished with punished with imprisonment which may extend to six monthsimprisonment 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 Indiaoffence or contravention committed outside India

Current StatusCurrent Status

Draft legislation ready for placing before Draft legislation ready for placing before the Parliament for notification after the Parliament for notification after vetting by the Law departmentvetting by the Law department

Wide Public ConsultationWide Public Consultation Regional and National DebatesRegional and National Debates Will provide legal support to the ethical Will provide legal support to the ethical

guidelines guidelines Implementation Implementation

THANK THANK YOUYOU