This document discusses the definitions and foundations of ethics, guidelines, and regulations/laws as they relate to clinical research. It defines ethics as correct behavior dictated internally, guidelines as norms for behavior that are suggested but not enforced, and regulations/laws as behavior that is mandated or enforced by the state. It then discusses some of the key events that shaped modern ethical standards, including the unethical Nazi experiments, Nuremberg Code, Declaration of Helsinki, Thalidomide tragedy, and Tuskegee Syphilis study. The document concludes by outlining the three principles of the 1979 Belmont Report - respect for persons, beneficence, and justice.

1. Presented by: Philomen Prem

2. WHAT ARE ETHICS, GUIDELINES AND
REGULATION /LAW?
GUIDELINES: Norms for correct
GUIDELINES: Norms for correct
behaviour, laid but not forced.
behaviour, laid but not forced.
ETHICS: Correct behaviour dictated
internally by one’s own moral
integrity(what ought to be done and
what is the right thing to do)
REGULATIONS/LAW: Correct behaviour
REGULATIONS/LAW: Correct behaviour
mandated or enforced by state(what
mandated or enforced by state(what
ought to be done)
ought to be done)

3. FOUNDATION FOR ETHICAL CONDUCT IN MODERN ERA
CLINICAL RESEARCH

4. 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.

5. 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.

6. Defense Arguments: 1:Legal
2:Medically necessary
3:Morally right

7. 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)

8. AUTONOMY JUSTICE
JUSTICE
NON MALFEANCE
NON MALFEANCE
TRUTHFULNESS
FIDELTY
CONFIDENTIALITY
BENEFICENCE

9. 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.

10. 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

11. 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.

12. DIFFERENCE BETWEEN INDIAN GCP AND ICH GCP
INVESTIGATOR

13. DIFFERENCE BETWEEN INDIAN GCP AND ICH GCP
INFORMED CONSENT

14. DIFFERENCE BETWEEN INDIAN GCP AND ICH GCP
DRUG LABEL

15. DIFFERENCE BETWEEN INDIAN GCP AND ICH GCP
RETENTION OF RECORDS

16. THANK YOU