Philomen Power Point Presentation

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


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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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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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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

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