What Are The Ethical

Issues Surrounding
Human Subject Clinical
Trials?
What will we be going through?

1. What are human subject clinical trials?

2. Consequences to not applying ethics when carrying out human subject
research
3. What are the ethical issues surrounding human subject clinical trials?
- Informed consent
- confidentiality
- beneficence
4. Contemporary perception towards ethics surrounding human subject clinical
trials
5. Conclusion : Methods to create awareness
What are human subject
clinical trials?
Clinical trials are research investigations in
which people volunteer to test new
treatments, interventions or tests as a
means to prevent, detect, treat or manage
various diseases or medical
conditions.(Australian Government Mental Health
Research Council,2015)
Consequences to not applying ethics when
carrying out human subject research

Biotrial, a private company in the city of Rennes

started a clinical trial to test the tolerability of a
candidate drug. Although consent from the subjects
were received, the participants weren’t completely
aware of the risks due to the lack of information
provided. This resulted in one person being brain-
dead and five more being hospitalized after phase 1
of clinical trial went horribly wrong. At least three
of the patients may suffer irreversible brain damage
if they survive. (Enserink, 2016)
1. Informed Consent

Researchers use deceptive ways

- simply masking that they are just a part of the
research (ecancer, 2014)
Example: American researchers pressured soldiers to
volunteer without full knowledge of the risks (Jones,
Grady, Lederer, 2018).
Consent of participants to a research protocol is
crucial
-voluntarily express as a proficient subject and be
sufficiently informed regarding the procedures (ecancer,
2014)
-incorporating the purpose, risks and benefits of the
study beforehand (ecancer, 2014)
Example: William Osler insisted that researchers
experiment on patients only with “full consent.” or the
sacred cord which binds physician and patient snaps
instantly”, as cited in (Jones, Grady, Lederer, 2018).
Conviction of informed consent still casts a
doubt
-Which information is sufficient enough to be
considered valid (ecancer, 2014)
Participants may fall under therapeutic
misconception
-dueto lack of understanding regarding the concept of
medical trials (ecancer, 2014)
Confidentiality
This is the act of safeguarding a person’s
personal information.
Confidentiality in ethics
• Making sure that information is only available to
those who are authorised to have access.
• When conducting a research researchers must try
their best to make it as ethical as they can by
making sure subject’s information is not disclosed
to the public.
• The disclosure of one’s private details can lead to
psychological traumas, embarrassment and loss of
dignity. (Wrigley, 2015)
EXAMPLE OF CONFIDENTIALITY
Humphrey’s study “impersonal sex in public places”
whereby he observed sexual activities done by
homosexuals in public male washrooms.
Beneficence
A principle in clinical trials which
states that the objective of research
should be the wellbeing of the
subject rather than research results.
Equipoise
-The benefits of the research against risks and cost
involved.
- Non maleficence can be defined as avoiding
caution of harm (Nardini,2014)
Degree of harm
-Inevitable
- English physician Edward Jenner’s development of the
smallpox vaccine
in 1796.
-Note that harm that could be caused should not be
disproportionate to the benefits of research.
Conflicts
-occur when doctor’s view and patient’s
request collide
-Doctors must be sure the evidence-based
treatment has been research conducted with
total integrity (Srivastava,2016)
 Consider ideal results as the ultimate
goal when conducting a clinical trial

Believe ethical practice is important

when carrying out research is
important

Unaware of ethics surrounding human

subject clinical trials

Contemporary perception towards ethics surrounding human subject

clinical trials
Conclusion

Practicing ethics surrounding human subject clinical is extremely important

It is an issue that requires a lot more public awareness amongst society
- Handing out brochures
- Talks
- Ethics class in medical school/ Ethics being integrated in syllabus
- Exhibitions
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