GTU304 RESEARCH ETHICS

DR. VINA TAN PHEI SEAN WITH ADAPTED SLIDES FROM DR. REENA K.
VIJAYAKUMARAN
WHY IS ETHICS RELEVANT OR IMPORTANT TO US?
When research involves humans and animals

 In humans  In animals

 Data collected – private,  Welfare, care

personal  Experimentations
 Rights, consent,  Humane end-of-life practices
confidentiality
 Consequences & effects
HOW RESEARCH ETHICS START
NUREMBERG TRIAL, HTTPS://YOUTU.BE/IYUEXRM6ESO
HTTPS://YOUTU.BE/4HRN2XW5QY4
 Nuremberg Trial, https://youtu.be/iyuEXrM6Eso
 What was it for?
 Who was tried?
 Is it for revenge?

 Holocost survivor, https://youtu.be/4hrN2xW5qY4

 What is the Holocost?
 What did they do in the camps?
 Why is it important to know about Holocost?
1906 – FDA ESTABLISHED https://youtu.be/Alv90bASoRI
1948 – THE NUREMBERG CODE (2 KEY POINTS)
1932-1973 – TUSKEGEE SYPHILIS STUDY (2 KEY POINTS)
1964 – THE DECLARATION OF HELSINKI (5 KEY POINTS)
1972 – THE BELMONT REPORT (3 KEY POINTS)
 DECLARATION OF HELSINKI

Briefly 1964, ’75, ‘83, ‘89, ‘96

- International research ethics
- Involving human subjects
- Rules of research and clinical care
- Basis for good clinical practice
HOW SHOULD WE
CONDUCT HEALTH • Based on labs and animals
AND CLINICAL • Protocols reviewed by independent committee
RESEARCH
• Informed consent
ETHICALLY?
• Medically/scientifically qualified individuals
• Risks should not exceed benefits
Belmont Report
https://youtu.be/86zW
BjDaXPk

ALSO INCLUDES
EXPLANATION OF
INSTITUTIONAL
REVIEW BOARD
• Individual • Fair distribute burden
(IRB) autonomy & benefits
• Limited • Study benefits • Equal share, indv
autonomy more than risks needs, indv effort,
contribution, merit
INSTITUTIONAL REVIEW
BOARD

Human Research Ethics

Committee of USM,
http://www.jepem.kk.usm.my/i
ndex.php/forms
• Informed consent
• Risk versus benefits
• Selection of human
participants

USM Institutional Animal

Care and Use Committee,
http://www.kk.usm.my/usmiac
uc/index.php/en/
 1. POPULATION
CONDUCTING
ETHICAL RESEARCH Ensure participant (subject) fully aware and understands the
research
1. POPULATION
- Their rights as participants. Question researchers, stop

2. anytime they chose to without any repercussions

EXPERIMENTATION - Clear on their contribution & returns (benefits, harms)
- Right to know what & how their data is used
3. DATA
• Children/minors
4. REPORTING • Pregnant women (benefits/risks)
• People with disabilities
• Individuals tied by legal relations
• Older adults
CONDUCTING 2. EXPERIMENTATION
ETHICAL RESEARCH

1. POPULATION Intervention or experimentation is sound

- Not harming the participant
2. - Based on previously validated, reliable scientific
EXPERIMENTATION
methods
3. DATA
• Test protocols
4. REPORTING • Medicine/drug
• Supplementation
• Intervention protocol
CONDUCTING 3. DATA (SINGULAR – DATAE)
ETHICAL RESEARCH

1. POPULATION Data collected, stored, used

- Getting relevant data
2. - Security & responsibility of data storage
EXPERIMENTATION - Use data as informed to participants
3. DATA
• Private information required?
4. REPORTING • Hardcopy, softcopy, who has access
• Data not for sale or other colleagues
 4. REPORTING
CONDUCTING
ETHICAL RESEARCH
Analysis and publication of data
1. POPULATION - No data manipulation
- Report as found, not significant data is also info
2.
EXPERIMENTATION - No removal or hiding of data

3. DATA • Images

4. REPORTING • Statistical output

• Clear explanation of analyses
• Interpretation of data
• Responsible publication
https://www.science.org/doi/10.1126/science.361.6403.636
SCIENCE – ON SHOULDERS OF
OTHERS

Yoshihiro Sato’s 12 papers published in high-

impact journals

Ripple effect of the published work

DOING THE RIGHT
THING
https://www.bbc.com/news/world-
us-canada-50989423
INTENTION TO DECEIVE
https://www.the-scientist.com/news-opinion/nobel-prize-winner-faces-investigation-into-paper-integrity-70669
IT’S TOUGH TO STAY
TRUE?

Please use good

mental judgement in
everything… Easy to
hurt, less easy to
unhurt.

THANK YOU