Vulnerability in Research Populations
Research on Populations Prone to
Being Vulnerable
Henry Silverman, MD, MA
How to Define Vulnerability?
Two senses of vulnerability
vul·ner·a·ble
•
“to be exposed to the possibility of being attacked
or harmed, either physically or emotionally.”
–
Synonyms: defenseless, unprepared, frail, weak,
helpless, in danger, at risk.
•
‘liable to succumb to temptation or manipulation’.
–
Undue inducement, coercion, exploitation
International Guidelines
CIOMS Guideline #13
•
Vulnerable persons are those who are
relatively (or absolutely) incapable of
protecting their own interests. More
formally, they may have insufficient
power, intelligence, education,
resources, strength, or other needed
attributes to protect their own
interests.
•
Special Justification is required for
inviting vulnerable subjects…the
means of protecting their rights and
welfare must be strictly applied.
Helsinki (2013)
•
Some research populations are
particularly vulnerable and have an
increased likelihood of incurring
additional and greater harm.
•
These include those who cannot
give or refuse consent for
themselves and those who may be
vulnerable to coercion or undue
influence.
•
All vulnerable groups need
specifically considered protection.
Exploitation
Two Part Definition
•
First, to be vulnerable, one has to be exposed to the
possibility of harm. EXTERNAL
•
Second, to be vulnerable one has to be substantially
unable to protect oneself. INTERNAL
•
Both elements are necessary
Definition: To be vulnerable means to be exposed to the
possibility of harm while substantially lacking ability and/or
means to protect oneself.
Reasons for vulnerability in the
context of research
•
Intrinsic and situational reasons account for
subjects unable to protect themselves.
•
Intrinsic: lack decision making capacity
•
Situational: political, social, or economic
circumstances that make subjects easily
victimized or vulnerable to undue inducement,
coercion, and exploitation.
Types of Vulnerability
•
Decision making incapacity
–
Cognitive vulnerability
–
Communicative vulnerability
•
Economic (poverty)
–
?
Types of Vulnerability
•
Dependent Relationships
–
Informal socially constructed power imbalances
•
Patients and physicians
•
Parents and children
•
Students, employees
•
Citizens and Government
•
Lack of Freedom (Institutional)
–
Prisoners, military, communities in developing
and developed countries
Too Broad a Concept?
How Broad a Concept?
•
All human beings are exposed (vulnerable)
to the possibility of “harm”
•
But, not to the same degree
Definition:
To be vulnerable means to be exposed to a
significant probability
of incurring an identifiable harm
while
substantially
lacking ability/means to protect oneself
.
How to approach vulnerability
•
“Rather than checking a list of predefined
vulnerable groups, the IRB should identify
who was vulnerable based on the wrongs
likely to occur in the case of each protocol
they reviewed.”
•
Hurst, SA. Vulnerability in Research and Health Care. 2008
Vulnerability as a Claim to Special Protection
Against Several Types of Harms
•
Breach of confidentiality or privacy
•
Unfavorable risk/benefit ratio
•
Lack of a valid consent
–
Poor decision making
–
Lack of voluntariness
•
Lack of access to the benefits of research
14
SPECIAL
PROTECTIONS
FOR
VULNERABLE
POPULATIONS
US Regulations: 45 CFR 46
Criteria for Approval:
•
When some or all of the subjects are likely to
be vulnerable to coercion or undue influence,
such as children, prisoners, pregnant women,
mentally disabled persons, or economically or
educationally disadvantaged persons,
additional safeguards have been included in
the study to protect the rights and welfare of
these subjects.
Special Protections
•
Claim to special protection
•
an identifiably increased likelihood of incurring
additional or greater wrong.
•
“To be vulnerable means to face a significant
probability of incurring an identifiable harm while
substantially
lacking ability and/or means to
protect oneself”.
Special Protections
•
Necessity Requirement
–
The physical/mental/social condition that causes the vulnerability
is a necessary characteristic of the research population.
–
Research cannot be performed by enrolling adults who can
consent or who are less vulnerable.
•
Responsiveness
–
The research is intended to obtain knowledge that will lead to
improved diagnosis/treatment
unique
to the vulnerable group.
•
Access
–
Research subjects and other members of the vulnerable group will have
reasonable access to products that becomes available as a consequence of the
research
Special Protections
•
Consent
–
Surrogate Consent
–
Additional consent mechanisms
•
Limitations on risk
–
Minimal risk for research only
procedures
Vulnerable Countries
•
Commentators have suggested that
communities in developing and developed
countries should be considered vulnerable,
because the populations lack basic rights and
freedoms that make them particularly open to
exploitation.
CIOMS guideline 10
•
Before undertaking research in a population or
community with limited resources, the sponsor
and the investigator must make every effort to
ensure that:
–
the research is responsive to the health needs and the
priorities of the population or community in which it
is to be carried out; and
–
any intervention or product developed, or
knowledge generated, will be made reasonably
available for the benefit of that population or
community.
Helsinki Declaration
•
Medical research involving a disadvantaged or vulnerable
population or community is only justified if the research
•
is responsive to the health needs and priorities of this population
or community and the research cannot be carried out in a non-
vulnerable population.
•
there is a reasonable likelihood that this population or
community should stands to benefit from the knowledge,
practices or interventions that result from the results of the
research.
•
Consideration should also be given to ensuring that the
community receives a fair level of additional benefits.
Thank you!
Vulnerability in research populations refers to being exposed to harm without the ability to protect oneself adequately. Factors contributing to vulnerability include intrinsic limitations like decision-making capacity and situational influences such as political or economic circumstances. Different types of vulnerability include cognitive, communicative, economic (poverty), and dependent relationships. International guidelines emphasize the protection of vulnerable individuals in research settings to prevent exploitation and undue influence.
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Presentation Transcript
Research on Populations Prone to Being Vulnerable Henry Silverman, MD, MA
How to Define Vulnerability? Two senses of vulnerability vul ner a ble to be exposed to the possibility of being attacked or harmed, either physically or emotionally. Synonyms: defenseless, unprepared, frail, weak, helpless, in danger, at risk. liable to succumb to temptation or manipulation . Undue inducement, coercion, exploitation
International Guidelines Helsinki (2013) CIOMS Guideline #13 Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests. Some research populations are particularly vulnerable and have an increased likelihood of incurring additional and greater harm. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence. Special Justification is required for inviting vulnerable subjects the means of protecting their rights and welfare must be strictly applied. Exploitation All vulnerable groups need specifically considered protection.
Two Part Definition First, to be vulnerable, one has to be exposed to the possibility of harm. EXTERNAL Second, to be vulnerable one has to be substantially unable to protect oneself. INTERNAL Both elements are necessary Definition: To be vulnerable means to be exposed to the possibility of harm while substantially lacking ability and/or means to protect oneself.
Reasons for vulnerability in the context of research Intrinsic and situational reasons account for subjects unable to protect themselves. Intrinsic: lack decision making capacity Situational: political, social, or economic circumstances that make subjects easily victimized or vulnerable to undue inducement, coercion, and exploitation.
Types of Vulnerability Decision making incapacity Cognitive vulnerability Communicative vulnerability Economic (poverty) ?
Types of Vulnerability Dependent Relationships Informal socially constructed power imbalances Patients and physicians Parents and children Students, employees Citizens and Government Lack of Freedom (Institutional) Prisoners, military, communities in developing and developed countries
How Broad a Concept? All human beings are exposed (vulnerable) to the possibility of harm But, not to the same degree Definition: To be vulnerable means to be exposed to a significant probability of incurring an identifiable harm while substantially lacking ability/means to protect oneself.
How to approach vulnerability Rather than checking a list of predefined vulnerable groups, the IRB should identify who was vulnerable based on the wrongs likely to occur in the case of each protocol they reviewed. Hurst, SA. Vulnerability in Research and Health Care. 2008
Vulnerability as a Claim to Special Protection Against Several Types of Harms Breach of confidentiality or privacy Unfavorable risk/benefit ratio Lack of a valid consent Poor decision making Lack of voluntariness Lack of access to the benefits of research
SPECIAL PROTECTIONS FOR VULNERABLE POPULATIONS 14
US Regulations: 45 CFR 46 Criteria for Approval: When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Special Protections Claim to special protection an identifiably increased likelihood of incurring additional or greater wrong. To be vulnerable means to face a significant probability of incurring an identifiable harm while substantially lacking ability and/or means to protect oneself .
Special Protections Necessity Requirement The physical/mental/social condition that causes the vulnerability is a necessary characteristic of the research population. Research cannot be performed by enrolling adults who can consent or who are less vulnerable. Responsiveness The research is intended to obtain knowledge that will lead to improved diagnosis/treatment unique to the vulnerable group. Access Research subjects and other members of the vulnerable group will have reasonable access to products that becomes available as a consequence of the research
Special Protections Consent Surrogate Consent Additional consent mechanisms Limitations on risk Minimal risk for research only procedures
Vulnerable Countries Commentators have suggested that communities in developing and developed countries should be considered vulnerable, because the populations lack basic rights and freedoms that make them particularly open to exploitation.
CIOMS guideline 10 Before undertaking research in a population or community with limited resources, the sponsor and the investigator must make every effort to ensure that: the research is responsive to the health needs and the priorities of the population or community in which it is to be carried out; and any intervention or product developed, or knowledge generated, will be made reasonably available for the benefit of that population or community.
Helsinki Declaration Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and the research cannot be carried out in a non- vulnerable population. there is a reasonable likelihood that this population or community should stands to benefit from the knowledge, practices or interventions that result from the results of the research. Consideration should also be given to ensuring that the community receives a fair level of additional benefits.
