Using vulnerable populations in clinical research raises ethical concerns and requires special considerations to ensure that their rights, welfare, and well-being are protected. Vulnerable populations may include children, pregnant women, elderly individuals, individuals with cognitive impairments or mental illness, and individuals from low socioeconomic backgrounds or marginalized communities. Here are some key considerations for using vulnerable populations in clinical research: Informed Consent: Informed consent must be obtained from vulnerable populations in a manner that is clear and understandable. The consent process may require additional safeguards, such as using plain language, using a third-party advocate or interpreter, or providing additional time for decision-making. Risk-Benefit Ratio: The risks and benefits of participation in the study must be carefully evaluated for vulnerable populations, taking into account their specific health and social circumstances. The potential risks must be minimized, and the potential benefits must be significant and direct. Ethical Review: The study must undergo a rigorous ethical review by an independent ethics committee or institutional review board (IRB) that has expertise in working with vulnerable populations. Privacy and Confidentiality: The privacy and confidentiality of vulnerable populations must be protected to the fullest extent possible. Any identifiable information must be kept confidential, and access to the information must be restricted. Respect for Autonomy: Researchers must respect the autonomy and decision-making capacity of vulnerable populations. This requires providing information in a manner that is culturally and linguistically appropriate, taking into account the individual's values, beliefs, and preferences. Oversight and Monitoring: Vulnerable populations require additional oversight and monitoring throughout the study to ensure that their rights and welfare are protected. This may include additional safety monitoring, data monitoring, and regular follow-up care.

1. Welcome
USING VULNERABLE POPULATION IN CLINICAL
RESEARCH
Name: Chandana. N
Qualification: B. Tech Biotechnology
Student Id: 049/0323
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2. Index
Introduction
• What is Vulnerability?
• Vulnerable Population
Approaches to define vulnerable populations
• Categorical approach
• Contextual approach
Purpose to include vulnerable population
Role of IRB
Strategies to support vulnerable population
Conclusion
References
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3. Introduction
What is Vulnerability?
 The word “vulnerability” stems from the Latin vulnerare, “to wound.” (Oxford Encyclopedic English Dictionary
1995).
 In clinical research, the term vulnerable generally is applied to individuals who are unable to give informed consent
or who are susceptible to coercion.
 Following up on the Declaration of Helsinki characterization of vulnerability, the Council for International
Organizations of Medical Sciences (CIOMS) noted, “persons are vulnerable because they are relatively (or
absolutely) incapable of protecting their own interests” or “because some feature of the circumstances (temporary or
permanent) in which they live makes it less likely that others will be vigilant about, or sensitive to, their interests.”
Vulnerable Population
 The Common Rule (45 CFR 46, Subpart A) lists specific vulnerable research subjects: children, prisoners, pregnant
women, and persons who are handicapped, mentally disabled, economically disadvantaged, or educationally
disadvantaged.
 Although the Common Rule specifies certain vulnerable categories, the guidelines were not intended to be
exclusive, leaving the interpretation of vulnerability open.
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4. Approaches to define vulnerable populations
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1.1.Categorical approach
Considers vulnerable populations are
those groups whose members share same
reason for being vulnerable
For example, all children are vulnerable
because they lack the fully developed
capacity for autonomous decision making
that comes with developmental maturity
However, it is not optimal approach as it
doesn’t consider, persons with multiple
vulnerabilities, variation in the degree of
vulnerability, doesn’t identifying
situations of an individuals causing
vulnerability
1.2.Contextual approach
An alternate approach of vulnerability is
the contextual approach. The NBAC
defined vulnerability in terms of
“situations in which individuals might be
considered vulnerable.”
This approach provides more distinct
understanding of the nature of the
vulnerability than the categorical
approach
Therefore, it can be considered as more
focused approach to safeguards.

5. Conti…
• NBAC described six types of vulnerability that could apply to research participants in different circumstances:
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Cognitive &
Communicativ
e Vulnerability
• Includes
people
incapable of
comprehendin
g information
and decision
making about
participation
• Children,
fetuses,
decisional
impaired,
seriously ill
Institutional
Vulnerability
• Includes
people under
the formal
authority of
others who
might have
different
values, goals,
and priorities
• Prisoners or
military
personnel
Deferential
Vulnerability
• Includes
people being
under the
informal
authority of
others
• Children or
military
personnel
Medical
Vulnerability
• Includes
people having
serious health
conditions for
which no
satisfactory
standard
treatment are
available
• Medical
Terminally or
incurably ill
patients
Economical
Vulnerability
• Includes
people
disadvantaged
in the
distribution of
social goods
and services
such as
income,
housing, or
healthcare
• Impoverished
populations
Social
Vulnerability
• Includes
people who
belong to
undervalued
social groups
• Ethnic,
sexuality
minorities

6. Purpose to include vulnerable population
During drug development, inclusion of broad patient populations in clinical trials helps,
minimizing negative impact on the value of clinical trials and the interests of vulnerable groups
Heterogeneity in subjects to observe variability in a study population
Providing evidence that the investigational medical products will be safe and effective in the full range of
patients likely to use the product if the product is approved
Broad inclusion criteria can increase the understanding of the risk benefit of the study treatment relevant
to the patient population likely to take the drug if the drug is approved.
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7. Role of IRB
The IRB should ensure and review,
That additional safeguards to protect the rights and welfare of subjects who are likely to be vulnerable are
included in the study under review.
Whether conditions for informed consent are satisfied, information presented is understandable, details of
research and rights as research subject are comprehended by the participants.
The investigator has provided adequate safeguards to minimize risk of undue inducement.
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8. Strategies to support vulnerable population
SOPs addressing Vulnerability for each of the stakeholders in the “chain of protection,” which can
include specific measures of protection for the categories of vulnerability.
Development of learning and education for those dealing with issues of vulnerability.
Development of subject Vulnerability assessment tool(s).
Systematic addition of an inclusion criteria about Vulnerability management in research protocols.
A collaborative Informed Consent process involving legally authorized representative with subject.
That risk must be minimized to the greatest extent possible consistent with the scientific goals of the
research.
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9. Conclusion
Vulnerability should be approached as occurring along a spectrum of seriousness and as a consequence of
situations and context. Stigmatization and default exclusion of vulnerable groups should be avoided as, it
can undermine the value of clinical trials, also has potential to undermine the interests of vulnerable groups.
Investigators and IRBs should take a stepwise approach to determine if the study meets the regulatory and
ethical standards to ensure that additional safeguards protect the rights and welfare of vulnerable subjects.
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10. References
 Gordon, B. G. (2020). Vulnerability in research: basic ethical concepts and general approach to review.
Ochsner Journal, 20(1), 34–38, doi: 10.31486/toj.19.0079.
 Yelgar, S. K., Kasarla, L. S., & Mujeebuddin, C. S. (2020). Vulnerability in Clinical Trials. International
Journal of Pharmaceutical Sciences Review and Research, 64(1), doi: 10.47583/ijpsrr.2020.v64i01.001.
 Wendler, D. (2020). When and how to include vulnerable subjects in clinical trials. Clinical Trials, 17(6), 696-
702, doi:10.1177/1740774520945601.
 Shivayogi, P. (2013). Vulnerable population and methods for their safeguard. Perspectives in clinical
research, 4(1), 53, doi: 10.4103/2229-3485.106389.
 DuBois, J. M., Beskow, L., Campbell, J., Dugosh, K., Festinger, D., Hartz, S., ... & Lidz, C. (2012). Restoring
balance: A consensus statement on the protection of vulnerable research participants. American journal of
public health, 102(12), 2220-2225, https://doi.org/10.2105/AJPH.2012.300757.
 Mermet-Bouvier, P., & Whalen, M. D. (2020). Vulnerability and clinical research: Mapping the challenges for
stakeholders. Therapeutic innovation & regulatory science, 54(5), 1037-1046, https://doi.org/10.1007/s43441-
020-00121-7.
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11. Thank You!
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