Bioethics and Research / Ethical Issues
Related to Technology in the delivery of
Healthcare
NCM 67
BS Nursing 2A | MIDYEAR 2024
Introduction
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Bioethics
○ Field
of
study
that
examines the ethical issues
arising from advances in
biology and medicine.
Research
○ Research within the realm
of bioethics specifically
focuses on investigating
and addressing ethical
dilemmas and questions
that arise in biomedical and
life sciences research.
Research may explore issues
such as:
○ Informed consent
○ Vulnerability
○ Privacy and Confidentiality
○ Research Integrity
○ Justice and Fairness
○ Emerging Technologies
The Nuremberg Code
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Set of ethical principles for human
experimentation that resulted from
the Nuremberg trials held after
World War 2.
Most important document in the
history of the ethics of medical
research.
Formulated 50 years ago in August
1947, in Nuremberg, Germany.
Purpose
○ Blueprint
for
today’s
principles that ensure the
rights of subjects in medical
research.
Key Principles of the Nuremberg Code
● Voluntary consent
● Beneficence
● Avoidance
of
unnecessary
suffering
● No anticipation of results
● Qualified experts
Declaration of Helsinki
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Statement outlining the ethical
principles for medical research.
Adopted in June 1964 and
underent 6 revisions and 2
clarifications.
First significant effort by the
Medical community to regulate
research.
Before the Nuremberg Code, only
specific countries had National
Policies.
Forms
the
basis
of
most
subsequent documents.
Developed by the World Medical
Association
for
medical
community-human
experimentation.
Followed the Nuremberg Code
Cornerstone of document of
human research ethics.
Included Within Clinical trial
protocols.
After the thalidomide scandal,
which left 2,000 children dead and
10,000 children disabled, they
decided to take action and make
regulatory
arrangements
to
oversee the testing of new
medicines.
Guiding Principles of the Declaration of
Helsinki
● Protecting Patient Health
○ Emphasizes “the health of
my patient will be my first
consideration”.
○ Medical research should
prioritize promoting the
health and well-being of
patients involved.
● Knowledge
Cannot
Trample
Rights
○ The
goal
of
gaining
knowledge can never take
precedence over the rights
and interests of individual
research subjects.
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Bioethics and Research / Ethical Issues
Related to Technology in the delivery of
Healthcare
NCM 67
BS Nursing 2A | MIDYEAR 2024
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Must protect: life, health,
dignity, integrity, autonomy,
privacy, and confidentiality
of personal information
Consideration
of
Risks,
Burdens, and Benefits
○ Medical research must only
be
conducted
if
the
importance of the findings
outweighs the risks and
burdens to the research
subjects.
Protection of Vulnerable Groups
and Individuals
○ Special protections must be
implemented to protect
vulnerable individuals and
groups.
○ These groups include:
■ Children
■ People who are
incarcerated
■ People
with
intellectual
or
physical disabilities
■ Racial or ethnic
minorities who may
face
systemic
injustice
Focus on Ethics
○ The basis for medical
research must rest in sound
scientific inquiry.
○ Study design must be
clearly
described
and
justified in the research
protocol.
○ Researchers
need
to
disclose:
■ Funding sources
■ Sponsors
institutional
affiliations
■ Potential conflicts of
interest
■ Incentives
for
subjects
■ Compensation for
harm
Protection
of Privacy and
Confidentiality
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Personal information must
be kept confidential and the
privacy
of participating
research subjects must be
protected.
Allowance of informed consent
○ Always obtain informed
consent
and
that
participation in medical
research
should
be
voluntary.
○ Information
should
be
disclosed
to
the
participants.
○ Research subjects have the
right to withdraw consent at
any time without reprisal.
Use of Placebo
○ The use of placebo should
happen when there are no
proven interventions that
exist or if there is a
compelling
reason
to
determine the efficacy or
safety of the intervention
and it’s determined that
there is no additional risk to
not receiving treatment.
Post-Trial Provisions
○ If
an
intervention
is
identified
as
beneficial
within a trial, provision for
post-trial access for all
participants
should
be
offered.
Dissemination of Research
○ All studies involving human
subjects
should
be
registered in a publicly
accessible database.
Guidelines
for
Unproven
Interventions
○ When a proven intervention
does not exist, a physician
may use an unproven
intervention
after
appropriate considerations.
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Bioethics and Research / Ethical Issues
Related to Technology in the delivery of
Healthcare
NCM 67
BS Nursing 2A | MIDYEAR 2024
Belmont Report
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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.
Result of an intensive 4-day
discussion period that was held in
February 1976 at the Smithsonian
Institution’s Belmont Conference
Center.
According
to
the
National
Commission,
it
provides an
analytical framework to guide the
resolution of the ethical problems
arising from research with human
subjects.
Framework of the Belmont Report
Boundaries between Practice
and Research
○ Practice: accepted medical
and behavioral practice.
This aims to solely to
improve individual patient
well-being with established
therapies that have a
reasonable expectation of
success.
■ Outcome:
reasonable
expectation
of
success
○ Research: involves testing
hypotheses,
drawing
conclusions,
and
contributing
to
generalizable knowledge.
■ Outcome: permits
conclusion to be
drawn.
● Basic Ethical Principles
○ Respect for persons:
autonomy.
○ Beneficence: do no harm;
maximize benefits/minimize
risks; not an act of kindness
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or charity, but a concrete
obligation.
Justice: treat people fairly;
do not exploit those who
are readily available or
malleable; fair distributiom
of risks and the benefits of
research based upon the
problem.
Application: apply the
concept of ‘respect for
persons’, ‘beneficence’ and
‘justice’.
National Research Act (1974)
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Passed because of the publicity of
the Tuskegee syphilis study.
This act created the National
Commission for the Protection of
Human Subjects of Biomedical and
Behavioral Research.
National Commission
○ To identify the basic ethical
principles
that
should
underlie the conduct of
biomedical and behavioral
research involving human
participants and to develop
guidelines which should be
followed to assure that
such research is conducted
in accordance with those
principles.
Ethical Issues relate to Technology in
the Delivery of Healthcare
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Republic Act No. 10173
○ “Data Privacy Act of 2012”
○ A law that seeks to protect
all forms of information, be
it private, personal, or
sensitive.
○ Protect the fundamental
right
to
privacy
of
communication
while
ensuring free flow to
promote innovation and
growth.
National Privacy Commission
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Bioethics and Research / Ethical Issues
Related to Technology in the delivery of
Healthcare
NCM 67
BS Nursing 2A | MIDYEAR 2024
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The ones in charge to
make sure each person’s
privacy will be protected.
Personal Information
○ Set of information that
identifies the person.
○ Personal information may
be processed, provided that
the requirements of the
Data Privacy Act are
complied with.
Sensitive Personal Information
○ Person’s race, ethnic origin,
marital status, age, color,
religious, philosophical, and
political affiliations.
Section 3 of RA 10173
○ “Personal
Information
refers to any information
whether recorded in a
material form or not, from
which the identity of an
individual is apparent or
can be reasonably and
directly ascertained by the
entity
holding
the
information, of when put
together
with
other
information would directly
and certainly identify an
individual”.
Exceptions to the Application of
DPA
○ Person who is or was an
officer or an employee of a
government institution.
○ Information
about
an
individual who is or was
performing service under
contract for a government
institution.
○ Information related to any
discretionary benefit of a
financial nature such as the
granting of a license or
permit
given
by
the
government
to
an
individual.
○ Personal
information
processed for journalistic,
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artistic, literary, or research
purposes
○ Information necessary for
banks and other financial
institutions.
○ Personal
information
originally collected from
residents
of
foreign
jurisdictions.
RA 10173 applies to:
○ If the person or institution
involved in the processing
of personal data is located
in the Philippines.
○ The act or practice involves
personal
data
of
a
Philippine
citizen
or
Philippine resident.
○ The processing of personal
data is done in the
Philippines.
○ The
act,
practice
or
processing of personal data
is done by an entity with
links to the Philippines,
subject to international law
and comity.
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