Ethical Guidelines for

Biomedical Research

on Human ParticipantsDr P Paul Kumaran MBBS, BA (Psychology), MPH

Scientist E [Deputy Director Medical]

National Institute for Research in Tuberculosis (ICMR)

Madurai, Tamil Nadu, India

ppaulkumaran@nirt.res.in +91 94432 24962

Ethics: What is it ?

Synonym: Moral Philosophy

Definition: Systematizing, defending, and recommending

concepts of right and wrong behaviour

Moral code of conduct defining the right and

wrong behaviour in a civil society and comes

from within

Different from Law which regulates the external behaviour

Context: Geographic & Cultural

Universal fact: All human beings are vulnerable, can suffer

from harm and cause harm

Humans being fallible – educating is not guaranteed success

Traditional Medical EthicsRules for a good physician

Primary duty of physicians to their patients

Prime concern: safety and best interest of patients

Maintain confidentiality

Avoid institutional entanglements that would compromise

independent judgment

Refrain from unsavory financial deals

Refrain from advertising

Professionalism with patients and colleagues

Caraka Samhita

Indian Codes of Ethics

1-2 BC Caraka Samhita

1956 Code of Medical Ethics, MCI

1980 Policy Statement on Ethical Considerations involved in

research on Human Subjects

2000 Delhi Medical Council Ethics code

2000 Revised ICMR ‘Ethical Guidelines for Biomedical

Research on Human Subjects’

2001 Indian GCP Guidelines

2002 Medical Council of India Act amended

2002 Drugs & Cosmetics Act amended

2005 Revised Schedule Y, ART Guidelines

2006 Revised ethical guidelines, Stem cell guidelines,

Bio-banking guidelines, GM Food safety guidelines

Relationship DefinitionsRef: Oxford English Dictionary 2001

Principles A general truth that is used as a basis for a theory or system of belief for governing one’s personal behaviour

Guidelines A piece of advice or an indication as to how something should be done

RegulationsLaw: A rule/system of rules

made by an authority, recognized by a country / community as governing

actions of its members that controls correct behaviour

Rule: A statement of code

of practice and discipline that must be done or not done for

control of a group, community, or country

India - Guidelines

Guidelines

for

Stem Cell Research And

Therapy

Department of Biotechnology

and

Indian Council of Medical Research

Department of Health Research 2007

Bio-Medical Ethics ?

Clinical Ethics

Service related – provider / patient relationship (social)

Targets service providers – Code of Conduct

Research Ethics

Research with special reference to commercialized

research – vested interest of sponsor / investigator

Targets supervision / monitoring of research conduct

Bioethics

What are the Basic Principles?

Beneficence & Non-maleficence Do GOOD and Do NO HARM

Autonomy Respect for persons

Justice

Fairness, equal distribution of risks & benefits

Ultimate AIM: Human participant protection

Principles: interpreted for research!

Beneficence and Non-malficence Identification of Risks – minor / major

Benefits – direct / indirect / no benefit / society

Appropriate Risk vs Benefit ratio

Respect for individuals Informed Consent / Protection of Vulnerable people

Privacy and Confidentiality

Justice Equitable selection / Equal distribution of burdens and benefits

Post trial benefits / prior agreements

Indian Council of Medical

Research (ICMR) Founded in 1911 - Indian Research Fund Association

Renamed as ICMR in 1949

Apex organization to formulate, conduct, coordinate

and promote biomedical research

Network of Permanent Institutes & Regional Medical

Research Centres

Extramural research and large number of medical

colleges, universities, research institutions as part of

programme beneficiaries

ICMR: Mandate & Role

To undertake and support basic, epidemiological,

applied & operational research in areas of national

public health importance using tools including those

of modern biology

Basic strategy to foster a Research Culture

Improving or developing infrastructure, advocacy and

lobbying, awareness building on research from highest level

to the community, fostering community support, and

promoting an environment conducive to innovative research

Ethical Guidelines for Biomedical

Research on Human Participants ICMR released first ‘Policy Statement on Ethical

considerations involved in research on Human Subjects’

in February 1980

Revised Guidelines Document released in October 2000

Re-revised Guidelines Document released in 2006

Guidelines being converted into legislation to make these

mandatory

Draft Document for Legislation ready

To be placed in the parliament for legislation

1980 ICMR Policy Statement

Institutional Ethics Committees

It must be independent

Should meet at least once every 3 months

Informed consent

Clinical trials – drugs, plants and indigenous systems

Research on Children, Mentally deficient patients,

Prisoners, Medical students, Laboratory personnel

Financial reimbursements to research participants

Publications in IJMR

Major areas identified by Central Ethics

Committee on Human Research (1996) under Justice Venkatachalaiah, Chairman, NHRC

General principles

General Issues

Ethical Review Mechanism

Clinical evaluation of drug / devices / diagnostics / vaccines /

herbal remedies

Epidemiological research

Human Genetic Research

Transplantation research including fetal tissue transplantation

Assisted Reproductive technologies

Guiding Principles for Human

Participant Research

Ethical Guidelines for Biomedical Research on

Human Participants

ICMR (Feb 1980, rev Sept 2000, Nov 2006)

– http://www.icmr.nic.in/ethical.pdf

– One of the foreign guidelines accepted by the US

Federal Government

General Principles: Ethical research

i. Essentiality

ii. Voluntariness, informed consent, community agreement

iii. Non-exploitation

iv. Privacy and confidentiality

v. Precaution and risk minimization

vi. Professional competence

Ref: Ethical Guidelines for biomedical research on human participants, ICMR 2006

vii. Accountability and transparency

viii. Maximisation of public interest and of distributive justice

ix. Institutional arrangements

x. Public domain

xi. Totality of responsibility

xii. Compliance

General Principles…

Ref: Ethical Guidelines for biomedical research on human participants, ICMR 2006

Epidemiological Research:

Principles Individual welfare balanced against Community welfare

Informed Consent:

Individual / Community

Address ‘feel reluctant to disagree / refuse’

Avoid Inducements

Explain all ‘risks’, including loss of privacy

Maintain Confidentiality

Minimize possible harm and Maximize benefits

Disclosure of Conflict Of InterestRef: Ethical Guidelines for biomedical research on human participants, ICMR,

2006: Chapter V; 56-62

Major differences between

2000 & 2006 version of

Ethical Guidelines for Biomedical

Research on Human Participants

Differences: General Principles

Essentiality

Voluntariness, informed consent

and community agreement (ECs

shall decide about waiver)

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

Differences: Review Procedures

Basic responsibilities of ECs – Special situations

Composition – flexibility with specification for drug trial as per Schedule Y of Drugs & Cosmetics Act

Terms of Reference, Training, Regulation

Review Procedures – Exemption from review, expedited, full review

Submission of Application

Decision Making Process

Review Process, Periodic Review, Continuing / Interim Review

Monitoring

Record Keeping, Administration and Management

Special Considerations

Additions: General Issues

Informed consent of subject – Fresh / re-consent

Waiver of consent

Conflict of interest

Post – trial access

International Collaborative Research / Assistance

in Biomedical / Health Research

Researcher’s relations with media & publication

practices

Specific Principles

Clinical Trials of Drugs, Vaccines, Surgical procedures /

Devices, Diagnostic agents, Traditional remedies

Epidemiological Studies

Human Genetics & Genomic Research: Pedigree studies,

Genetic screening, Gene therapy and research, Bio-

banking …

Transplantation Research: Transplant from live or

cadaver, Embryonic & Fetal tissue, Xeno- transplantation,

Stem cell …

Assisted Reproductive Technologies

Compliance: Indirectly mandated

Indian GCP Guidelines – 2001

Indian Medical Council Act – 2002

Drugs and Cosmetics Act – 2005 amendment

Ethical Guidelines for Biomedical

Research on Human Participants

The BillTHE BIOMEDICAL

RESEARCH ON HUMAN SUBJECTS (REGULATION,

CONTROL AND SAFEGUARDS) BILL,

2007

Biomedical Research Ethics Bill

Thank You