Concept of ethics Importance of ethics in health research, Brief overview on history of ethics in public health

1. Ethics in health research
(History)
Course Instructor: Ashok Pandey (MPH/BPH, DGH)
Research Officer - Nepal Health Research Council, Nepal
Research Fellow (Fredskorpset, Norway)
CSF Global, Banani, Dhaka, Bangladesh
11/2/2017University of South Asia, Dhaka, Bangladesh 1

2. 11/2/2017University of South Asia, Dhaka, Bangladesh 2
• Concept of ethics
• Importance of ethics in health
research,
• Brief overview on history of ethics in
public health

3. Ethics
“Ethics” --- “Ethos” --- Character
OR
 Behavior related to customs and moral values of the people.
 A way of characterizing actions with regard to human dignity
 Medical Ethics - Protects the Patient
 Research Ethics - Protects the
Study Participants OR
Community

4. Example
Suppose you are the driver in the trolley car and your trolley car is hurdling down the track at
60 miles per hour at the end of the track you noticed five workers working on the track, You
tried to stop but you can’t. Your break don’t work, You feel desperate because you know
that if you crash into this five workers, they will all die
Lets assume you know that for sure and you fell helpless. Until you notice that there is off to
the right, a side track, at the end of that track, There is one worker working on the track. You
are steering wheel works, So you can, turn the trolley car if you want to onto this side track
killing the one but sparing the five.
What’s is the right thing to do?, What would you do?
Lets take a poll
How many would turn the trolley car onto the side track
How many wouldn’t. How many would go straight ahead
11/2/2017University of South Asia, Dhaka, Bangladesh 4

5. Another trolley car case
This time you are not the driver of the trolley car. You’re an looker. You
are standing on the bridge and looking the trolley car and down the track
come a trolley car, at the end of the track are five workers, the breaks
don’t works, the trolley car about to careen into the five and kill them and
now, you are not the driver.
You really fell helpless until you notice standing next to you leaning over
the bridge is it very fat man and you could give him a shove he would fall
over the bridge onto the track right in the way of the trolley car he would
die, but he would spare the five.
1. How many would push the fat man over the bridge
2. How many wouldn’t?
11/2/2017University of South Asia, Dhaka, Bangladesh 5

6. Lets imagine
you are the doctors in emergency room and six person come to you.
They’ve been in the terrible trolley car wreck. Five of them
sustained moderate injuries one is severely injured you can spend
all day caring for the one severely injured victim, but in that time
five would die, or you could look after the five, restore them to
health, but during that time the one severely injured person would
die
How many would save the five
How many would save the one
11/2/2017University of South Asia, Dhaka, Bangladesh 6

7. Another doctor case
You are the transplant surgeon and you have 5 patient each in
desperate need of an organ transplant in order to survive one need
the heart, one a lung, one a kidney, one a liver and a fifth pancreas
and you have no organ donors. You are about to see them die and
then it occurs to you that in the next room, there is the healthy guy
come for the check up and he is taking the nap. You could go in very
quietly yank out the five organs, that person would die but you can
save the five
How many would do it?
11/2/2017University of South Asia, Dhaka, Bangladesh 7

8. Definitions
 Ethics is the science of morality. It deals with the
right or wrong of any activity.
 Research ethics: analysis of moral worth of all the
actions involved in human or animal research.
 Ethics: “principles of right conduct”
9/15/2016Ashok Pandey 8

9. Activities in research
 Collection of information: primary or secondary
sources of information.
 Using technology for investigation or treatment: draw
blood, collect body fluids or tissues, expose to
radiation, analyze samples, genetic pattern (access
to sensitive information).
 Following up on the participants.
 Using participant data to draw inferences and
disseminate information.
9/15/2016Ashok Pandey 9

10. Importance of ethics in research
 Major expansion in health research, technological
advances, newer vaccines and drugs.
 Newer more intrusive interventions: organ
transplantation, stem cells in therapy, cloning.
 Heavy investment, financial interests.
 Many instances of violation.
 Internationalization of research.
9/15/2016Ashok Pandey 10

11. History of ethics in public health
11/2/2017University of South Asia, Dhaka, Bangladesh 11

12. Ethics in Health Research
 Ethics in Medicine has been practiced since the ancient
times.
Charaka Samhita, Hippocratic oath. (202 codes of
conduct)
 But it also has been recognized as essential in Health
Research in the present day.
9/15/2016Ashok Pandey 12

13. The Basics of Ethics in Research
 Dishonest, fraudulent, or unethical researchers can circumvent
the scientific method
1. Nazi Germany Experimentation
- Charges brought against 23 German physicians in the
Nuremberg War Crime Trials for their medical experiments –
included:
1. Freezing Experiments
(hypothermia experiment)
1. Malaria Experiments
2. High-Altitude Experiments
(test chamber)
- Led to the development of
Nuremberg Code 9/15/2016Ashok Pandey 13

14. 11/2/2017University of South Asia, Dhaka, Bangladesh 14

15. Need more: Go through it
11/2/2017University of South Asia, Dhaka, Bangladesh 15

16. 2. The Tuskegee Syphilis Study
 Was investigation of long-term effects of untreated
syphilis on males
 Decision was made to do long-term prospective study
and follow long-term effects until death
 Participants were never told real nature of study – were
not afforded informed consent
 Treatment for syphilis was withheld (even after
discovery of penicillin to treat syphilis) – study
continued for 40 yrs.
9/15/2016Ashok Pandey 16https://www.cdc.gov/tuskegee/timeline.htm

17. 11/2/2017University of South Asia, Dhaka, Bangladesh 17
Need more: Go through it

18. Thalidomide Tragedy
 In the late 1950s, thalidomide was approved as a sedative in Europe
 The drug was prescribed to control sleep and nausea throughout pregnancy, but it
was soon found that taking this drug during pregnancy caused severe deformities
in the fetus.
 Many patients did not know they were taking a drug that was not approved for
use by the FDA, nor did they give informed consent.
 Some 12,000 babies were born with severe deformities due to thalidomide.
 U.S. Senate hearings followed and in 1962 the so-called "Kefauver Amendments"
to the Food, Drug and Cosmetic Act were passed into law to ensure drug efficacy
and greater drug safety.
 For the first time, drug manufacturers were required to prove to FDA the
effectiveness of their products before marketing them
11/2/2017University of South Asia, Dhaka, Bangladesh 18
http://www.ors.umkc.edu/research-compliance-%28iacuc-ibc-irb-rsc%29/institutional-
review-board-%28irb%29/history-of-research-ethics

19. 11/2/2017University of South Asia, Dhaka, Bangladesh 19
https://images.search.yahoo.com/search/images;_ylt=AwrSbgYjrfpZY2UA2hdXNyoA;_ylu=X3oDMT
EyOWwwdHFiBGNvbG8DZ3ExBHBvcwMxBHZ0aWQDQjQ4MzVfMQRzZWMDc2M-
?p=thalidomide+tragedy&fr=mcafee

20. Declaration of Helsinki.
In 1964, the World Medical Association
established recommendations guiding medical
doctors in biomedical research involving human
subjects.
The Declaration governs international research
ethics and defines rules for "research
combined with clinical care" and "non-
therapeutic research."
The Declaration of Helsinki was revised in 1975,
1983, 1989 and 1996 and is the basis for Good
Clinical Practices used today.
11/2/2017University of South Asia, Dhaka, Bangladesh 20

21. Issues addressed in the Declaration of
Helsinki include:
11/2/2017University of South Asia, Dhaka, Bangladesh 21
• Research with humans should be based on the
results from laboratory and animal experimentation
• Research protocols should be reviewed by an
independent committee prior to initiation
• Informed consent from research participants is
necessary
• Research should be conducted by
medically/scientifically qualified individuals
• Risks should not exceed benefits

22. National Research Act (1974 )
 Due to the publicity from the Tuskegee Syphilis
Study, the National Research Act of 1974 was
passed.
 The National Research Act created the National
Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research,
 The Commission drafted the Belmont Report, a
foundational document in for the ethics of human
subjects research in the United States.
11/2/2017University of South Asia, Dhaka, Bangladesh 22

23. The Belmont Report
The National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research prepared the Belmont Report in 1979.
The Belmont Report attempts to summarize the basic ethical principles identified
by the Commission in the course of its deliberations.
The Report is a statement of basic ethical principles and guidelines that should
assist in resolving the ethical problems that surround the conduct of research with
human subjects.
The three basic ethical principles and their corresponding applications are:
11/2/2017University of South Asia, Dhaka, Bangladesh 23
Principle Application
Respect for persons Informed consent
Beneficence Assessment of risks and benefits
Justice Selection of subjects

24.  Nazi atrocities in World War II drew attention to the lack of international
standards on research with human subjects and led to the formulation of the
Nuremberg Code.
 The thalidomide disaster led to the adoption of the "Kefauver Amendments" to
the Food, Drug and Cosmetic Act, requiring drug manufacturers to prove to the
FDA the effectiveness of their products before marketing them.
 The Declaration of Helsinki is the basis for Good Clinical Practices used today.
 The Tuskegee Syphilis Study is probably the worst case of unethical human
subjects research in the history of the United States.
 The National Research Act codified the requirement that human subjects in
research must be protected and set the stage for the issuance of the Belmont
Report.
11/2/2017University of South Asia, Dhaka, Bangladesh 24
Summary of the history

25. 11/2/2017University of South Asia, Dhaka, Bangladesh 25

26. 11/2/2017University of South Asia, Dhaka, Bangladesh 26

27. Thank you
11/2/2017University of South Asia, Dhaka, Bangladesh 27
Photo credit: https://marisaskitchentalk.files.wordpress.com/2011/10/funny-monkey.jpg