Kenny

1. Dr. Boniphace Idindili MD, MPH, PhD
[Public Health and Clinical Epidemiology]

2.  Introduction
 Origin of Ethics & Morality
 History of research ethics
 Origin of human subject in research ethics
 Post war response
 Codes and guidelines that govern health
research

3.  Ethics and Morality of the individual have
been philosophically studied for over 2000
years
 The idea of ethics being principles that are
set and applied to a group (not necessarily
focused on the individual) is relatively new,
though, primarily dating back to the 1600s.
 The distinction between ethics and morals
is particularly important for philosophical
ethicist.

4. What is Ethics:
 Is the study of principles relating to right and
wrong conduct.
 It is dealing with values relating to human
conduct, with respect to the rightness and
wrongness of actions and the goodness and
badness of motives.

5.  Ethics can also be considered a social system
or a framework for acceptable behavior.

6. What is Morality
 Is about right and wrong in human behavior.
 It is relating to human behavior, especially
the distinction between good and bad or right
and wrong behavior.

7.  The word "ethic" comes from Old French
(etique), Late Latin (ethica), and Greek (ethos)
and referred to customs or moral
philosophies.
 The word "Morals" comes from Late Latin's
moralis, which referred to appropriate
behavior and manners in society.
 Originally - the two have very similar, if not
synonymous, meanings.

8. Why History
 History places ethics in perspective
 History help to explain what historical
problem people were trying to solve.

9.  Biomedical research has made tremendous
contributions to improvement of human
health and welfare.
 HRE as discipline born in scandals and
tragedies of biomedical research.
 Codes ,regulation and guidelines developed
from public debates or in response or
anticipation of human abuses.

10. The 1900 Prussian Directive
 Response to “case of Neisser”
 Dr. Neisser studied immunization of healthy
persons against syphillis by inoculating
them with serum from syphillitc patients.
 3 prostitute inoculated; all contracted
syphiils.
 No consent obtained

11. THE 1900 PRUSSIAN DIRECTIVE
Response to Public debate on Human Subject
Experiment
 Prohibited experiments on minors and those not
fully competent.
 Informed consent is an essential requirement
after explanation of the experiment and possible
adverse consequences.
 Only certain people were allowed to do research
and must keep written records
 Did not apply to medical treatment, diagnosis,
therapy or immunization.

12. Nazi Germany
 Dr. Mengele’s Experiments
 Infected one twin with a “germ”. When s/he
died, the other twin was killed and their organs
compared at autopsy.
 Sewed twins together to create a Siamese twin.
 Studied subjects with genetic traits so as to
better “purify the Aryan super race”.
 Performed cross transfusions to “make boys
into girls and girls into boys”.

13. Involved 200 Jews, 50 gypsies, 500 Poles, and 1,000
Russians, war prisoners:
 High-altitude (low-pressure) experiments: put
prisoners in low-pressure tanks, how long could they
survive with little oxygen?, autopsies followed;
 Freezing exp.: force prisoners to remain outdoors,
naked, freezing, 9-14 hrs; or put in freezing water
3hrs; try rewarming bodies;
 Malaria exp.: infect prisoners, give drugs, many died;
 Typhus exp. Inject prisoners with antityphus “vaccine”.
Then infect with typhus; controls: infect with typhus
no treatment;

14.  Mustard Gas Expt: inhale mg; try various
treatments;
 Sulfanilamide expt: inflict wounds, apply
bacteria,etc to wound; control group: wound
then infect, no sulfanilamide;
 Poison expt: feed patients various poisons,
many died; kill survivors for autopsy;
 Incendiary bomb expt: burn with phosphorus;
study wounds;
 Sterilization expt: use chemicals or x-rays
instead of surgery.

15. Nuremberg Doctors’ Trial – 1946 –47
23 defendants; 3 non-physicians
15 found guilty
7 were hanged (4 physicians)
5 sentenced to life in prison
4 sentenced to 10-20 years in prison
7 were acquitted and freed.
*Separate Trial:
31 “underlings” were also found guilty; 22 of
them were hanged.

16. Nuremberg Code of Medical Ethics (1947
It laid down 10 standards to which physicians
must conform when carrying out
experiments on human subjects:
 True voluntary consent; freely given; prior to
experimental procedures
 Truly necessary, well thought out
experiments in which the expected benefits
justify the risks and there is no unnecessary
psychical or mental suffering or injury.

17.  The person performing the task is qualified
 No experiment shall be undertaken where
death or disabling injury will likely to occur.
 Proper preparation & adequate facilities to
protect subjects must be present to prevent
further injuries.
 Subjects should be allowed to discontinue
participation at anytime.
 Upon observing the likely risk of injury,
disability or death, the researcher should
terminate the experiment.

18.  Nuremberg Code of Medical Ethics adopted
by World Medical Association 1964 as
Declaration of Helsinki, which:
 Set ethical principles regarding human
experimentation.
 It is widely regarded as the cornerstone
document on human research ethics.

19. Dr. HENRY BEECHER – NEJM (1966)
 Criticized lack of sincerity in implementing
basic concepts of informed consent,
 Cited 50 episodes of potential “Code”
violations which were published in peer-
reviewed scientific journals in the US.
 Suggested that journal editors reject articles
based on violation of patient rights.
 1966 – NIH required establishment of IRBs
for institutions receiving funding for
medical research.

20. “No one shall be subjected to torture or to
cruel, inhuman or degrading treatment or
punishment.
In particular, no one shall be subjected
without his free consent to medical or
scientific experimentation”

21.  Prompted by Tuskegee syphilis study (1932-
1972)
Published 1979
The National Commission on Biomedical and
Behavioral Research (1974-1978)
• Identify the ethical principles and guidelines
for research involving human subjects.
• Develop guidelines to assure that human
research is conducted in accordance with
those principles

22. • Respect for Persons
• Beneficence
• Justice

23.  CIOMS (2002) International Ethical
Guidelines for Biomedical Research
Involving Human Subjects
(www.codex.uu.se/texts/international.html)
 CIOMS (2008) International Ethical
Guidelines for Epidemiological Studies.
Provisional Text
<http:www.cioms.ch/080221Feb
2008.pdf>
 ICH GCP Guidelines 1996 (www.ifpma.org)

24.  National Bioethics Advisory Commission
(www.bioethics.georgetown.edu/nbac/huma
n/overvol1/html).
 Nuffield Council on Bioethics
(www.nuffieldbioethics.org/filelibrary/pdf/er
rhdc-fullreport.pdf).

25.  African countries use DoH as global ethical
standard
 Tanzanian (1997) gazetted DoH and CIOMS
 Most African documents refer to DoH in their
national ethical/legal frameworks

26. WHO/TDR Operational Guidelines for Ethics
Committees that Review Biomedical Research
(2000).
 All biomedical research involving human
subjects has to comply with established
international guidelines that require ethical
and scientific review of the research,
alongside informed consent.

27.  Ahsanteni sana