Symposium on Bioethics

Indian Council of Medical

Research
Ansari Nagar, New Delhi
 Ethics, Guidelines & Law
> Ethics – correct behaviour dictated internally
by one’s own moral integrity

> Guidelines – Norms for correct behaviour

laid but not forced

> Law – Correct behaviour governed

externally or enforced by State
 Philosophy
> Greatest good for the greatest number –
consequencial ; means to an end

> Do right – non consequential; means not

ends
“Primum non nocere”
(first do no harm)
 Ethics in Traditional Medicine
• Prime concern- safety and best interest of patients
• Liberal outlook
• Cost effective Rx to the poor
• No drastic/costly measure for the incurable
• 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
 Code of conduct / Ethical Guidelines for
physicians and / Researchers
> 1000 B.C. - Caraka Samhita
to 1-2 C. AD
> 1-2 C. AD - Hammurabi Code
> 600 AD - Hippocratic oath
> 1846 - AMA code of ethics, first national
> 1865 - Claude Bernard ‘Introduction to
Experimental Medicine’
> 1897 - Code of medical Ethics, AMA
> 1898 - German Ethics of Science & Medicine
> 1933 - Guidelines by Reich Government
> 1947 - Nuremberg Code
> 1948 - Universal Declaration of Human
Rights, Geneva
> 1956 - Code of Medical Ethics, MCI
> 1964, 2004 last - WHA, Helsinki Declaration
> 1970 - Central Council of Indian
Medicine Act
 Codes of Medical Ethics / Guidelines

> 1979 : Belmont Report, USA

> 1980 : ICMR’s Policy Statement, India

> 1993 -95 : Genetics, Human tissue, Xeno -

transplantation (Nuffield Council, UK)

> 1982, 1991, : The WHO / CIOMS guidelines

1993, 2002
> 1996 : ICH GCP Guidelines

> 2000 : Revised ICMR guidelines

> 2004 : Revised Helsinki Declaration (last version)

 Guidelines
> 2000 : Revised ICMR guidelines ‘Ethical Guidelines for
Biomedical
Research on Human Subjects’- India

> 2000 : Delhi Medical Council Regulations

> 2001 : NBAC Report – Developing countries

> 2001 : Indian GCP Guidelines

> 2002 : Nuffield Council – Developing Countries

> 2002 : CIOMS - Developing Countries

> 2003 : Draft Amendment of Schedule Y of Drugs &

Cosmetics
Act, 1940
Nazi Medical Experiments in WWII
Concentration Camps

High Altitude Test Chamber

Hypothermia Experiments
 Nuremberg Trial

15 of 23 guilty, 7 hanged, 5 life sentences

 Historical Justification
> 1946-49 Nuremberg Trial and formulation of the
Nuremberg Code.

§ Basic principles must be observed in order to satisfy moral,

ethical and legal concepts.

§ The first and longest principle is “The voluntary consent of

the human subject is absolutely essential.”

> 1964 - World Medical Assembly issues the

Declaration of Helsinki with recommendations “as
a guide to every physician in biomedical research
involving human subjects.”
Landmark Article on U.S. Abuses

Henry Beecher, NEJM, 1966

“Bad Blood” Tuskegee Syphilis trial
Ethical Principles in Modern Medicine

Autonomy

Beneficence

Non-maleficence

Justice
 1980 ICMR Guidelines
Policy Statement on Ethical Considerations involved in
research on Human Subjects

> Ethics Committee

> Informed consent
> Clinical trials
> Research on children, mentally disadvantaged, those
with diminished autonomy
> Traditional Medicine
> Publications
Ethical issues in New
Biology & Technology
 Revised ICMR Ethics Guidelines

> Released in 2000

> All institutions involved in biomedical

research involving human beings should
follow these guidelines to protect safety
and well being of all individuals.

> Guidelines on website -

http://www.icmr.nic.in

> To be legislated - The Biomedical

Research on Human Subjects
(Promotion and Regulation) Bill, 2005
 Globalisation

Indian scenario
> Global health – 10/90
gap •Drug development
•Traditional medicine

> International § Outsourcing

collaborative studies –
§ Brain gain
developed vs
developing countries § Indian diaspora
 NIH Planning Grant
> Bioethics curriculum
> Subjects

§ Yoga § Clinical ethics

§ Philosophy § Internet use
§ Law § Art of writing
§ Research § Teaching skills
methodology § Resource allocation
§ Research ethics § Public Health
 NIH Training Grant
> Symposium / Seminar for sensitisation – UGs &
PGs

> Workshops – researchers, faculty, ethics

committee members

> Short term – 8 weeks for researchers, faculty,

trainers

> Long term – 6 months for trainers

> Distance education