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8/8/2019 Philomen Power Point Presentation
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HISTORY OF ICHGCP AND COMPARISON BETWEEN
INDIAN GCP AND ICHGCP
Presented by: Philomen Prem
8/8/2019 Philomen Power Point Presentation
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WHAT ARE ETHICS, GUIDELINES AND
REGULATION /LAW?
ETHICS: Correct behaviour dictated
internally by ones own moral
integrity(what ought to be done and
what is the right thing to do)
GUIDELINES: Norms for correct
behaviour, laid but not forced.
REGULATIONS/LAW: Correct behaviour
mandated or enforced by state(what
ought to be done)
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FOUNDATION FOR ETHICAL CONDUCT IN MODERN ERA CLINICAL
RESEARCH
1947
1947THE
NUREMBERGCODE
1964
1964THE
DECLARATIONOF HELSINKI
1979
1979THE BELMONTREPORT
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NUREMBERG CODENAZI MEDICAL EXPERIMENTS
Discovery of the atrocitiesdone by Nazi
Physicists(Angels of Death)
herald the beginning of
human subject protection.
Unethical and
Inhuman
experiments.
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NURE ERG UMAN E ERIMENTS
ypothermia survivability and effects
one healing
igh altitude survivability and effects
ortability of treated sea water
ow to effectively sterilize.
Chemical burn effects
ow quickly poison bullets kill
Typhus vaccine
Twins studies.
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NUREMBERGS DOCTORS TRIAL
Defense Arguments: 1:Legal
2:Medically necessary
3:Morally right
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DE LARATI N F ELSINKI-T ALIDOMIDE TRAGEDY
*1957TO 1962 in U.K., CANADA, GERMANY, JAPAN-not
approved by FDA
*Prevented morning sickness*12000babies who survived, with phocomelia (flipper-like arms
or legs)
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SEVEN CORE PRINCIPLES OF ETHICS IN CLINICAL
RESEARCH
AUTONOMY
TRUTHFULNESS
BENEFICENCE
NON MALFEANCE
CONFIDENTIALITY
JUSTICE
FIDELTY
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ANOTHER RESEARCH ABUSE
*Tuskegee Syphilis Study(1932-1972)
*The US governments 40year experiment on
black men with syphilis
*The longest non Therapeutic experiment on
human beings in medical history.
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AN APOLOGY
The United States government did something
that as rong-deeply, profoundly, morally
rong. It as an outrage to our commitment
to integrity and equality for all ourcitizens.......clearly racist.
President Bill Clinton apologizes to study
survivors, May 16, 1997
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T E ELMONT RE ORT, April 18t , 1979
Respect For ersons T at individual autonomy
be respected and t at persons it diminis ed
autonomy be protected.
eneficence-t e obligation to protectpersons from arm.1. Do not arm..And
(2) protect from arm by maximising
possible benefits and minimizing
possible risks of arm.
Justice-re uires fairness in distribution of
burdens and benefits: often expressed in
terms of treating persons of similar
circumstances or c aracteristics similarly.
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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 applicableregulatory requirements.
It is mandatory that the
sponsor and investigator
should sign a copy of the SOPs
It is impossible for the sponsor
to obtain the signature in each
copy of the SOPs .ICHGCP
expects the investigator tocomply ith the protocol and
leaves task of
monitoring compliance to
SOPs to monitors and
auditors.
DIFFERENCE ET EEN INDIAN GCP AND ICH GCP
INVESTIGATOR
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DIFFERENCE ET EEN INDIANGCPAND ICHGCP
INFORMED CONSENT
INDIAN GCP ICH-GCP
Apart from the essential
elements of
informed consent follo ing
should be included.
As per the ICHGCP informed
consent should include all the
essential elements.
Right to prevent use of his/herbiological
Samples at any time during
the conduct of research
for other purposes.
Risk of discovery ofbiologically sensitive
information.
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DIFFERENCE ET EEN INDIANGCPAND ICHGCP
DRUG LABEL
INDIAN GCP ICH-GCP
It is mentioned that the drug
label should include name,
contact no. of investigator and
name of institution
Not required. Globally not in
practice.
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DIFFERENCE ET EEN INDIANGCPAND ICHGCP
RETENTION OF RECORDS
INDIAN GCP ICH-GCP
Mandates that the sponsor
should make
arrangements for safe and
secure custody
of all study related documentsand materials
for a period of three years
after the completion
of the study or submission of
data to the
regulatory authorities
Essential documents should
be retained until at least 2
year after the last approval of
a marketing application.
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THANK YOU