Gives basic idea on research ethics

1. Ethics in Health Research
Achyut Raj Pandey
Research Officer
Nepal Health Research Council

2.  Ethics originated before Greece 2000 years
ago with Socrates

3. “A man without ethics is a wild beast ”.
Albert Camus

4.  Ethics determined by reason rather than
custom
 Ethics is concerned with prescribing action
rather than describing action so is a
normative discipline
 How one ought to act?

5. Teleological: Telos= Greek word for end or purpose
 Morality and immorality is function of
consequences of an act. Also called
consequentialist theory
 Proponents: Plato, Aristotle
Deontologocal: Deon= Greek word for duty
 Morality is grounded by some form of authority.
People must some action prescribed. Christian
conception thought as basis

6. Huge gulf between theoretical speculation and
practical implementation

7. Ethics in research
1. How useful is research?
Whom it is useful for ? Or
whose interest does it serve?
All research works - big or small -
consumes resource, which could be used
otherwise.
Every research has opportunity cost

8. Ethics in research
2. Research may cause harms
For example, in interventional study,
medicine under trial may have some
adverse consequences

9. Research and Ethics
Research and Fraudism
On 28 February 1998, a paper written by Wakefield and
twelve other authors about children with autism was
published in The Lancet.
In it, the authors claimed to have identified a
new syndrome they called autistic enterocolitis, raising
the possibility of a link between a novel form of bowel
disease, autism, and the MMR vaccine
Remember ethics at ALL TIMES when you plan
conduct, or
use research

10. Nazi Medical Experiments in
WWII Concentration Camps
Experiments on twins
Freezing experiments
Different poisons

11. Unit 731
Estimated Up to 250,000men, women, and children died
in human experimentation during the Second Sino-
Japanese War (1937–1945)
Germ warfare attacks
Syphilis: Forced to have sex, vivisected at different
stages of infection, so that internal and external organs
could be observed as the disease progressed
Rape and forced pregnancy: To test vertical
transmission of disease
Weapon testing

12. Nevada Experimentation
 Nuclear race between Russia and USA pushed human
experimentation to new dimension soon after WWII
 Between 1952 and 1963, USA performed 925 test of
atomic and hydrogen bomb and underground test in
Nevada desert.
 2,00,000 military personal participated in test, 3000 served
at test site as subject of research to assess how soldiers
perform in nuclear battlefield following the order of seniors
and very few volunteered
 1963 test ended

13. Research Ethics, Jan. 2011

14. WILLOWBROOK STUDY, NEW YORK
1956-1972,
• 800 Children -
Willowbrook State
School for the
Mentally Retarded
• Researchers injected
students with mild
form of hepatitis
Research Ethics, Jan. 2011

15. International efforts
 1946-49 Nuremberg Trial and formulation of the
Nuremberg Code.
 The trials began on December 9, 1946 in Nuremberg,
Germany and were led exclusively by the United States
 Nuremberg Code - basic principles must be observed in
order to satisfy moral, ethical and legal concepts.
 The first and longest principle is “The voluntary consent of
the human subject is absolutely essential.”
 1964 - World Medical Assembly issues the Declaration
of Helsinki with recommendations “as a guide to every
physician in biomedical research involving human subjects.”

16. THE BELMONT REPORT (1979)
• In 1972, the public became aware of the Tuskegee study, which
took place in the southern United States from 1932 to 1972.
• In 1974 the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research was established.
• In 1978, the commission submitted its report titled, The Belmont
Report: Ethical Principles and Guidelines for the Protection of
Human Subjects of Research.
• Those principles—respect for persons, beneficence and justice—
are accepted as the 3 fundamental principles for the ethical
conduct of research involving human participants.

17. IS IT OVER?... TORVAN TRIAL IN KANO,
NIGERIA
Kano Trovan (Trovafloxacin) clinical trials in
1996 in Nigeria, on pediatric age group,
during the worst ever meningococcal
meningitis.
 Pfizer never obtained ethical clearance
 Pfizer did not obtain informed consent
 Pfizer left the town after conducting the
study despite the fact that the epidemic
was still ongoing
 Pfizer later agreed to a $75 million out of
court settlement

18. Ethical principles
Autonomy
Beneficence/Non-maleficence
Justice
Respect for environment

19. Autonomy
Sovereignty of research participants
 Respect for the dignity of person
 Right to know about the research
 Information to the research participants
 Freedom to refuse participation/withdraw at any
time
 No threat or undue inducement
 Informed consent from the participants/legal
guardian
 Privacy and confidentiality

20. Beneficence and Non-Malficence
 Risks and benefits
 Foreseeable discomforts
 Adverse events
 Compensation for injury
 Insurance
 Possible use of biological samples

21. Justice
Adequate ethical review
Compensation for injury/harm
Publication /confidentiality of research results
Post research benefits
Non participation will not affect treatment

22. Respect for environment
Proper disposal of hazardous substance
Respect to animals
Example : Nevado Experiment

23. Elements of informed consent
Language
Study purpose/Aims
Procedures
Risks and discomforts
Benefits
Payment for participation
Voluntary participation/withdrawal
Compensation for injury
Confidentiality
Alternatives
Sample storage
Contact information
Signed Consent

24. Vulnerable population
Those who cannot protect sovereignty
Disease/condition mentally ill
Age Children and old age
Socially vulnerable uneducated
poor
women
tribal
Otherwise vulnerable employee
military
prisoners

25. National ethical Guidelines for Health
Research in Nepal
Ethical Review Board within the NHRC
Authorized body in Nepal

26. Thank you