Presented by: Philomen Prem

WHAT ARE ETHICS, GUIDELINES AND REGULATION /LAW?

ETHICS: Correct behaviour dictated internally by one’s 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.GUIDELINES: Norms for correct behaviour, laid but not forced.

REGULATIONS/LAW: Correct behaviour mandated or enforced by state(what ought to be done)

REGULATIONS/LAW: Correct behaviour mandated or enforced by state(what ought to be done)

FOUNDATION FOR ETHICAL CONDUCT IN MODERN ERA CLINICAL RESEARCH

NAZI MEDICAL EXPERIMENTS

Discovery of the atrocities done by Nazi Physicists(Angels of Death) herald the beginning of human subject protection.

Unethical and Inhuman experiments.

NUREMBERG “HUMAN EXPERIMENTS”

Hypothermia survivability and effectsHypothermia survivability and effects

Bone healing Bone healing

High altitude survivability and effectsHigh altitude survivability and effects

Portability of treated sea water

How to effectively sterilize.

Chemical burn effects

How quickly poison bullets killHow quickly poison bullets kill

Typhus vaccine

Twins studies.

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)

AUTONOMY

TRUTHFULNESS

BENEFICENCE

NON MALFEANCENON MALFEANCE

CONFIDENTIALITY

JUSTICEJUSTICE

FIDELTY

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.

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 GCPINVESTIGATOR

DIFFERENCE BETWEEN INDIAN GCP AND ICH GCPINFORMED CONSENT

DIFFERENCE BETWEEN INDIAN GCP AND ICH GCPDRUG LABEL

DIFFERENCE BETWEEN INDIAN GCP AND ICH GCPRETENTION OF RECORDS

THANK YOU