Orientation on health ethics

Ethics in health research
Course Instructor: Ashok Pandey (MPH/BPH, DGH)
4/1/2019Nepal Health Research Council (NHRC) 1

Table of content
• Concept of ethics
• Forms of ethics
• Few events on history of ethics in public
health
• Historical development of health research
ethics in Nepal

Ethics
“Ethics” --- “Ethos” --- Character
OR
 Behavior related to customs and moral values of the people.
 Medical Ethics - Protects the Patient
 Research Ethics - Protects the
Study Participants OR
Community

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

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?

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

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?

Forms of ethics
1. Metaethics (what is good? )
2. Normative ethics (what should we do?)
3. Applied ethics (how do we apply ethics to work and lives?)
4. Descriptive ethics (what morals people follow)

Types of Professional Ethics
Business ethics
Journalism ethics
Medical ethics (Hippocrates)
Nursing ethics
Legal
Accounting (Luca Pacioli)

Interesting example
?

Few events on history of ethics in
public health

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

NUREMBERG CODE 1947
• Voluntary informed consent
• Usefulness of Research
• Prior knowledge
• Avoid physical and mental suffering
• Protection against risk
• Qualified researcher
• Freedom to withdraw
• Legal status
• Termination of study

The Tuskegee Syphilis Study
 Was investigation of long-term effects of untreated
syphilis on males
 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.
4/1/2019Nepal Health Research Council (NHRC) 20https://www.cdc.gov/tuskegee/timeline.htm

"Tuskegee Study of Untreated Syphilis in the
Negro Male”
When?
1932 – 1972
Where?
Macon County, Alabama
Who?
The US Public Health Service along with the Tuskegee Institute
600 African American men
399 with syphilis (Experimental Group)
201 without syphilis (Control Group)
2. "About the USPHS Syphilis Study." Tuskegee University. Tuskegee University, n.d. Web. 20 June 2012.
<http://www.tuskegee.edu/about_us/centers_of_excellence/bioethics_center/about_the_usphs_syphilis_study.aspx>.

Need more: Go through it

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
http://www.ors.umkc.edu/research-compliance-%28iacuc-ibc-irb-rsc%29/institutional-
review-board-%28irb%29/history-of-research-ethics

https://images.search.yahoo.com/search/images;_ylt=AwrSbgYjrfpZY2UA2hdXNyoA;_ylu=X3oDMT
EyOWwwdHFiBGNvbG8DZ3ExBHBvcwMxBHZ0aWQDQjQ4MzVfMQRzZWMDc2M-
?p=thalidomide+tragedy&fr=mcafee

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:
Principle Application
Respect for persons Informed consent
Beneficence Assessment of risks and benefits
Justice Selection of subjects

ERB/IRBs aim to enhance justice and protection
of subjects in health research
Message

Historical Development of Health Research Ethics in Nepal
Early developments of research ethics in Nepal (1952-1991)
1952: United States Operations Mission conducted a survey on malaria.
1963 : Journal of Nepal Medical Association
April 15, 1982: Nepal Medical Research Committee (NMRC), the first regulatory body of health research (established on under Ministry of
Health)
June 27, 1982: NMRC established a three member Ethical review body, the first ethical review structure in Nepal, comprising of Dr. Mrigendra
Raj Pandey, Dr. Hemang Dixit and Dr. Santosh Man Shrestha
(First research approved by NMRC was a study on hypertension by WHO)
September 1983: Important decisions made by NMRC were the requirement of Nepalese investigator in the foreign led
research project.
January 1989: formation of Monitoring and Evaluation Sub-committee to monitor the progress of research projects

Conti…
Developments after establishment of NHRC (1991-2002)
NMRC was developed into NHRC through the NHRC Act no 129 of the year
1991 and Ethical sub-committee led by Dr. Dibya Shree Malla.
July 29, 1992 in consultation with then Chief justice Bishwanath Upadhyaya
appointed him as the chairperson of the Ethical sub-committee.
June 29, 1995 decided to allow transportation of medical herbs and human bio-
samples outside Nepal for research only after approval from NHRC.
2001: Development of national ethical guidelines (Lead by Prof. Dr. Ramesh
Kanta Adhikari)

Conti…
Developments after the formation of Ethical Revie Board (ERB) in NHRC (2002-till date)
March 2002 to October 2014: Prof. Adhikari led the ERB as a Coordinator and developed
Institutional Review Committees (IRCs), clinical trials, use of animals in health research and
standard operating procedures of ERB
2014: Prof. Dr. Jeevan Bahadur Sherchand led the ERB and revised IRC guidelines and draft of
biomedical guidelines, online research proposal submission system.
2018: Prof. Dr. Prakash Ghimire led the ERB as a chairperson and revising guidelines, SoP,
Taking initiation on Clinical Trail Registry establishment, etc.

Thank you
Photo credit: https://marisaskitchentalk.files.wordpress.com/2011/10/funny-monkey.jpg

Orientation on health ethics

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