WHAT ARE ETHICS, GUIDELINES AND REGULATION /LAW?GUIDELINES: Norms for correct GUIDELINES: Norms for correctbehaviour, laid but not forced. behaviour, laid but not forced.ETHICS: Correct behaviour dictatedinternally by one’s own moralintegrity(what ought to be done andwhat is the right thing to do)REGULATIONS/LAW: Correct behaviour REGULATIONS/LAW: Correct behaviourmandated or enforced by state(what mandated or enforced by state(whatought to be done) ought to be done)
FOUNDATION FOR ETHICAL CONDUCT IN MODERN ERA CLINICAL RESEARCH
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 Hypothermia survivability and effects Chemical burn effects Bone healing Bone healing How quickly poison bullets kill How quickly poison bullets kill High altitude survivability and effects High altitude survivability and effects Typhus vaccine Portability of treated sea water How to effectively sterilize. 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-notapproved by FDA*Prevented morning sickness*12000 babies who survived, with phocomelia (flipper-like armsor legs)
AUTONOMY JUSTICE JUSTICE NON MALFEANCE NON MALFEANCE TRUTHFULNESS FIDELTY CONFIDENTIALITY BENEFICENCE
ANOTHER RESEARCH ABUSE*Tuskegee Syphilis Study(1932-1972)*The US government’s 40 year experiment onblack men with syphilis*The longest non Therapeutic experiment onhuman beings in medical history.
The United States government did somethingthat was wrong-deeply, profoundly, morallywrong. It was an outrage to our commitmentto integrity and equality for all ourcitizens.......clearly racist.President Bill Clinton apologizes to studysurvivors, 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
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