Vulnerability in Research:

Basic Ethical Concepts and

General Approach to Review
Pembimbing
Drg. Nevy Yanti, Sp.KG.,Subsp KE (K)., M.Kes.
Oleh:
NUR’AINI BADRIAH
237160023
PPDGS FKG USU 2023
INTRODUCTION

The concept of vulnerability

is a cornerstone of the
theoretical basis and
practical application of
ethics in human subjects
research.

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 ETHICAL AND CONCEPTUAL BASIS OF
VULNERABILITY

In the 2001 report Ethical and Policy Issues in Research

Involving Human Participants, the National Bioethics
Advisory Commission (NBAC) suggested that
“vulnerability, in the context of research, should be
understood to be a condition, either intrinsic or
situational, of some individuals that puts them at greater
risk of being used in ethically inappropriate ways in
research

Reflecting the principle of

respect for persons, the National
Commission for the Protection
of Human Subjects of
Biomedical and Behavioral
Research wrote that “persons
with diminished autonomy are
entitled to protection
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 Declaration of
VULNERABILITY Helsinki,WMA “may
have an increased
The NBAC noted two general likelihood of being
themes defining wronged or of incurring
vulnerability: “In general,
persons are vulnerable in additional harm
research either because they
have difficulty providing
voluntary, informed consent
arising from limitations in
decisionmaking capacity

… or situational
circumstances …, or
because they are
especially at risk for
exploitation

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 VULNERABILITY
CATEGORICA
L COGNITIVE or
COMMUNICATIVE
CONTEXTUAL

INSTITUTIONALL ECONOMICAL
MEDICAL
DEFERENTIAL
SOCIAL 5
 CATEGORICAL
VULNERABILITY

Considers certain groups or populations as

vulnerable. More specifically, vulnerable
populations are those groups in society whose
members share features that might make them
vulnerable children, prisoners, pregnant
women, fetuses, mentally disabled persons,
and economically and educationally
disadvantaged person

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 CONTEXTUAL
VULNERABILIT
Y

01 Cognitive or Communicative Vulnerability

02 Institutional Vulnerability
 CONTEXTUAL
VULNERABILIT
Y

03 Deferential Vulnerability

04 Medical Vulnerability
 CONTEXTUAL
VULNERABILIT
Y

05 Economic Vulnerability

06 Social Vulnerability
INSTITUTIONAL REVIEW BOARD
REVIEW

(1) Is inclusion necessary? and

(2) If so, are safeguards adequate?

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0
Minimization of
Risk

Henry Beecher: “the more reliable safeguard is provided

by the presence of an intelligent, informed,
conscientious, compassionate, responsible
investigator.”

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1
CONCLUSIONS

CONCLUSIONS
Investigators and IRBs are advised to
take a stepwise approach to
determining if the study meets the
regulatory and ethical admonition to
ensure that safeguards protect the
rights and welfare of vulnerable
subjects.

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GRACIAS
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FINDINGS

EVOLUTION PREVALENCE

10% 30% 40% 20%

If you want to modify these graphs, click on them, follow the

link, change the data and replace them 200,000,000
BIG NUMBER

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4
COMPARISON

MERCUR
JUPITER VENUS MARS
Y

1
5
DIAGNOSIS
Despite being red, Mars is a cold
place, not hot

Mercury is the closest Jupiter is the biggest planet in our

planet to the Sun Solar System

Venus has a beautiful name, but Neptune is the farthest planet

it’s terribly hot from the Sun

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6
TREATMENT

VENUS
Venus has a beautiful name
and is the second planet
from the Sun. It’s hotter
than Mercury and its
atmosphere is poisonous

MERCUR
Y
Mercury is the closest
planet to the Sun and the
smallest one in the Solar
System—it’s only a bit
larger than our Moon

1
7
 PATIENT
MONITORIN
G
Mercury is the closest planet to the WEEK 1 WEEK 2 Despite being red, Mars is a cold
Sun and the smallest one place, not hot

MERCU MERCU
RY RY
MARS MARS

SATURN SATURN

MERCU MERCU
RY RY
MARS MARS

SATURN SATURN

Jupiter is the biggest planet in our Saturn is a gas giant, composed

Solar System WEEK 3 WEEK 4 mostly of hydrogen and helium

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 POST-
PREVENTION

Despite being red, Mars is a cold

place, not hot
Mercury is the closest planet to
the Sun

Venus has a beautiful name, but Neptune is the farthest planet

it’s terribly hot from the Sun

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CASE TIMELINE

Jupiter is the biggest The Sun is the star at the

planet in our Solar center of the Solar
System System

1 2 3 4

Mercury is the smallest Despite being red, Mars

planet in our Solar is a cold place, not hot
System

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0
REFERENCES

● AUTHOR (YEAR). Title of the publication. Publisher

● AUTHOR (YEAR). Title of the publication. Publisher

● AUTHOR (YEAR). Title of the publication. Publisher

● AUTHOR (YEAR). Title of the publication. Publisher

● AUTHOR (YEAR). Title of the publication. Publisher

● AUTHOR (YEAR). Title of the publication. Publisher

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