GUIDELINES : Norms for correct behaviour, laid but not forced. REGULATIONS/LAW : Correct behaviour mandated or enforced by state(what ought to be done) 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)
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.
Hypothermia survivability and effects Bone healing High altitude survivability and effects How quickly poison bullets kill NUREMBERG “HUMAN EXPERIMENTS” Portability of treated sea water How to effectively sterilize. Chemical burn effects 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)
NON MALFEANCE JUSTICE AUTONOMY TRUTHFULNESS BENEFICENCE CONFIDENTIALITY 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 18 th , 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
DIFFERENCE BETWEEN INDIAN GCP AND ICH GCP INFORMED CONSENT
DIFFERENCE BETWEEN INDIAN GCP AND ICH GCP DRUG LABEL
DIFFERENCE BETWEEN INDIAN GCP AND ICH GCP RETENTION OF RECORDS