S2-2 Palazzani DoH Vatican

Medical research today: the
geographics of vulnerable
populations
Laura Palazzani
palazzani@lumsa.it
1. who is vulnerable? what is vulnerability
everyone/all: ‘natural condition’ – ‘special/particular vulnerabilities’
• a particular condition or state of high exposure to certain risks and
uncertainties (dignity, autonomy, justice)
• reduced ability to protect/defend oneself against those risks and
uncertainties and cope with their negative consequences
kinds of vulnerabilities
• existential: age; sex; ethnical belonging; severe illness/disability
• positional/situational: cognitive/communicative ability; illiteracy/low
literacy; inferiority condition; illness (not permanent); economic-
social-cultural position; personal limitations; environmental condition
this list may not be exhaustive
‘tailored vulnerability’
2. who is vulnerable in resource poor settings?
amplification of every kind of vulnerabilities
economic vulnerability: being disadvantaged in the distribution of
social goods and services
social vulnerability: being a member of a marginalized social group, in
precarous conditions
‘social determinants of health’
resource poor settings/medical research
settings: location, not countries (geography)
(CIOMS, Guideline 2: Research conducted in low-resource settings: «setting
can change over time» and space)
medical research: pharmacological and non pharmacological (clinical, psycho-
social environmental)
specific vulnerabilities: exploitation/abuse, deception,
dependence, inferiority, disadvantage
3. How can we protect vulnerabilities in medical
research? General ethical requirements
all participants in medical research are vulnerable (uncertainties)
ethical requirements:
– scientific relevance of research
– equity in the enrolling/selection of participants
– proportionality
– informed consent
– compensation
– distribution of equal burdens and benefits
socio-economic vulnerabilites: additional
ethics requirements
• need of additional ethical requirements :
– normative documents
– opinions of bioethics committees
WMA, The Helsinki Declaration (2013)
– responsiveness to the health needs or priorities of the communities (art.
20);
– non possibility to carry out research on non-vulnerable groups (art. 20)
– family members/community leaders consultation (art. 25);
– post-trial access (art. 34)
– justification of placebo (the best proven intervention, wherever, must be
given)
ù
Belmont report (1979)
• Voluntariness: undue inducement
• Risk benefit assessment: demonstration of appropriateness of
involving
• Selection of subjects: the economically disadvantaged (given their
dependent status and their frequently compromised capacity for free
of consent:
risks of convenience and manipulation
CIOMS, International ethical Guidelines for Health
related research involving humans (2016)
Guideline 2: Research conducted in low-resource settings – The ethical
standards applied should be no less stringent than they would be for
research carried out in high-resource settings
Guideline 3: Equitable distribution of benefits and burdens in the
selection – scientific selection not easiness to recruit
Guideline 15: Research involving vulnerable persons and
groups – From ‘traditional approach’ to the
contextual approach’
Council of Europe, The Additional Protocol
Biomedical Research Oviedo Convention (2005)
• Article 29
Affirming that particular protection shall be given to human beings who
may be vulnerable in the context of research;
• Article 12 – Undue influence
The ethics committee must be satisfied that no undue influence,
including that of a financial nature, will be exerted on persons to
participate in research. In this respect, particular attention must be
given to vulnerable or dependent persons.
Regulation (EU) No 536/2014 on clinical trials on
medicinal products for human use
• The EU Clinical Trials Regulationof 2014
Article 10 (“Specific considerations for vulnerable populations”)
certain groups and categories (minors, incapacitated persons, pregnant
or breastfeeding women, or other groups or subgroups) specific
precautions and procedures are required, due both to a reduced
capacity to make decisions and to an increased risk of harm or injury
-direct benefit/minimum risks and burden
UNESCO Declaration of Bioethics and Human
Rights (2005)
Respect for human vulnerability and personal integrity (art. 8): Social
responsibility and health (art. 14); Sharing of benefits (art. 15)
• Solidarity and cooperation: global health challenges (2023)
• The principle of the sharing of benefits (2015)
• The principle of non-discrimination and non-stigmatization (2014)
• Respect for human vulnerability and personal integrity (2013)
• Social responsibility and health (2010)
EGE, Opinion on the ethical aspects of clinical
research in developing countries (2003)
Ethical aspects related to economic differences
The strict transposition of a system of protection to developing
countries, without considering their socioeconomic specificities, will
not ensure the same level of protection of the participants.
The protocol cannot ignore the context where the clinical trial will take
place and in a context of poverty and absence of healthcare, the fact of
participating in a clinical trial may constitute for the patient the only
opportunity to have access to healthcare.
EGE, Opinion on the ethical aspects of clinical
research in developing countries (2003)
• there is continuity from very poor countries to countries with a
standard of living close to developed ones.
• (…) may also be applicable to research involving cultural minorities or
vulnerable groups within industrialised countries.
EGE, Opinion on the ethical aspects of clinical
research in developing countries (2003)
• a weakening of the standards would be in contradiction to the
fundamental principles of human rights and dignity and their
universal guarantee and protection.
• But a legal framework does not exist in every country – the lack of
means and capacities or appropriate governance systems.
Italian Committee for Bioethics, Pharmacological
trials in developing countries (2011)
• populations whatever their social-economic-cultural condition should
be considered “always as an end” and never “just as a means” for
experimentation (I. Kant)
• the right to health care as protection of the objective good of a
person must be considered a fundamental international right
Italian Committee for Bioethics, Pharmacological
trials in developing countries (2011)
• the aspect of solidarity must prevail over every other consideration,
in order to prevent that economic and social inferiority may justify
exploitation, creating irreversible situations of vulnerability
• the immediate utility in terms of cost saving and rapid results is often
only apparent when one considers the elements of uncertainty that in
the long run, could emerge. Only a balanced social relationship can
provide optimum conditions for the correct assessment of the
possible advantages of a trial.
Italian Committee for Bioethics, Pharmacological
trials in developing countries (2011)
• The particular difficulty at this level that can be detected in
populations living in economic poverty and / or lack of culture and
scientific knowledge should not be a reason to exclude them from
the trial and the benefits that it can bring: it would be a kind of
acceptance and amplification of a disadvantaged condition.
• The objective difficulties regarding information must be a stimulus to
support the activity of experimentation with a contemporaneous
intensification of the activities of information and formation
Italian BC, Biomedical research for novel
treatments within the Covid-19 pandemic, 2020
• Trials aimed at therapeutic treatments for Covid-19 must include all
subjects – according to the most appropriate phases and timing –
without excluding anyone, unless there is an unfavorable risk/benefit
ratio.
• The exclusion of particularly vulnerable subjects from the trial is
contrary to the principle of justice, as it deprives them of the same
possibility of treatment, as no safe and effective treatment is
currently available.
summarizing…what could be important today
• education of reserchers/physicians, members of ethics committees to
identify vulnerabilities: raise awareness of context vulnerability (need
of population, priorities: justice for all)
• not (necessarily) exclusion, but (possibile) inclusion with specific
protection: not weaken standards but additional requirements
appropriate selection-recruitment (exclusion: high risks and minimum
benefits) – equity benefits/burdens and sharing benefits – no undue
inducement – tailored information
• negative duty (not to exploit); positive duty (responsibility)
• global regulation (Henk ten Haven, Global Bioethics, 2016)