HISTORY OF ICHGCP AND COMPARISON BETWEEN

INDIAN GCP AND ICHGCP

Presented by: Philomen Prem

 WHAT ARE ETHICS, GUIDELINES AND
REGULATION /LAW?

GUIDELINES: Norms for correct

behaviour, laid but not forced.

ETHICS: Correct behaviour dictated

internally by one’s own moral
integrity(what ought to be done and
what is the right thing to do)

REGULATIONS/LAW: Correct behaviour

mandated or enforced by state(what
ought to be done)
FOUNDATION FOR ETHICAL CONDUCT IN MODERN ERA CLINICAL
RESEARCH

THE • 1947
NUREMBERG
CODE

THE • 1964
DECLARATION
OF HELSINKI

THE BELMONT • 1979

REPORT
NUREMBERG CODE
NAZI MEDICAL EXPERIMENTS

Unethical and
Inhuman
experiments.

Discovery of the atrocities

done by Nazi
Physicists(Angels of Death)
herald the beginning of
human subject protection.
NUREMBERG “HUMAN EXPERIMENTS”

Hypothermia survivability and effects

Chemical burn effects

Bone healing

How quickly poison bullets kill

High altitude survivability and effects

Typhus vaccine

Portability of treated sea water

How to effectively sterilize.

Twins studies.
NUREMBERG’S DOCTORS TRIAL

Defense Arguments: 1:Legal

2:Medically necessary
3:Morally right
 DECLARATION OF HELSINKI-THALIDOMIDE TRAGEDY

*1957 TO 1962 in U.K., CANADA, GERMANY, JAPAN-not

approved by FDA
*Prevented morning sickness
*12000 babies who survived, with phocomelia (flipper-like arms
or legs)
 SEVEN CORE PRINCIPLES OF ETHICS IN CLINICAL
RESEARCH

AUTONOMY JUSTICE
NON MALFEANCE

TRUTHFULNESS

FIDELTY
CONFIDENTIALITY

BENEFICENCE
ANOTHER RESEARCH ABUSE

*Tuskegee Syphilis Study(1932-1972)

*The US government’s 40 year experiment on black
men with syphilis
*The longest non Therapeutic experiment on
human beings in medical history.
AN APOLOGY

The United States government did something

that was wrong-deeply, profoundly, morally
wrong. It was an outrage to our commitment
to integrity and equality for all our
citizens.......clearly racist.
President Bill Clinton apologizes to study
survivors, May 16, 1997
THE BELMONT REPORT, April 18th, 1979

Respect For Persons –That individual autonomy

be respected and that persons with diminished
autonomy be protected.

Beneficence-the obligation to protect

persons from harm.1. Do not harm..And
(2) protect from harm by maximising
possible benefits and minimizing
possible risks of harm.

Justice-requires fairness in distribution of

burdens and benefits: often expressed in
terms of treating persons of similar
circumstances or characteristics similarly.
DIFFERENCE BETWEEN INDIAN GCP AND ICH GCP
INVESTIGATOR

INDIAN GCP ICH-GCP

In this, the investigator must
be qualified as per
requirement of
medical council of India.
Investigator should be
qualified by Education,
training and experience and
should meet all qualification
specified by applicable
regulatory requirements.

It is mandatory that the It is impossible for the sponsor

sponsor and investigator
should sign a copy of the SOPs
to obtain the signature in each
copy of the SOPs .ICHGCP
expects the investigator to
comply with the protocol and
leaves task of
monitoring compliance to
SOPs to monitors and
auditors.
DIFFERENCE BETWEEN INDIAN GCP AND ICH GCP
INFORMED CONSENT

INDIAN GCP ICH-GCP

Apart from the essential As per the ICHGCP informed
elements of consent should include all the
informed consent following essential elements.
should be included.

Right to prevent use of his/her

biological
Samples at any time during
the conduct of research
for other purposes.

Risk of discovery of
biologically sensitive
information.
DIFFERENCE BETWEEN INDIAN GCP AND ICH GCP
DRUG LABEL

INDIAN GCP ICH-GCP

It is mentioned that the drug Not required. Globally not in
label should include name, practice.
contact no. of investigator and
name of institution
DIFFERENCE BETWEEN INDIAN GCP AND ICH GCP
RETENTION OF RECORDS

INDIAN GCP ICH-GCP

Mandates that the sponsor Essential documents should be
should make retained until at least 2 year
arrangements for safe and after the last approval of a
secure custody marketing application.
of all study related documents
and materials
for a period of three years
after the completion
of the study or submission of
data to the
regulatory authorities
THANK YOU