Hurst_-__Vulnerability

WMA expert conference on the Revision of the Declaration of Helsinki
Cape Town, 5-7.12.2012
Pr Samia Hurst, MD
Institute for Biomedical Ethics
Geneva University Medical School
samia.hurst@unige.ch
Vulnerability
Some forms of vulnerability seem obvious
Others are clearly not obvious
Vulnerability
• Definitions and lists
• Problems
• Possible solutions
Definitions
Declaration of Helsinki (DoH), Paragraph 9
‘Some research populations are particularly vulnerable and need
special protection. These include…’
CIOMS, Commentary on 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 interest’
ICH-GCP (1.61) Vulnerable Subjects
‘Individuals whose willingness to volunteer in a clinical trial may be
unduly influenced by the expectation, whether justified or not, of
benefits associated with participation, or of a retaliatory response from
senior members of a hierarchy in case of refusal to participate’
Lists
Declaration of Helsinki:
…These include those who cannot give or refuse consent for
themselves and those who may be vulnerable to coercion or undue
influence.
US (Common Rule) 45 CFR 46:
– children, prisoners, pregnant women and foetuses
ICH-GCP:
-members of a group with hierarchical structure (medical students,
hospital and laboratory personnel, employees in the pharmaceutical
industry), unemployed or impoverished persons, ethnic minority group,
homeless persons, nomads, refugees, minors
Problems
Definitions:
Incomplete: incapacity to protect one’s interests, susceptibility to coercion
Lists:
Absence of an explicit organizing principle leads to confusion (pregnancy
does not remove the capacity to consent for example)
Incompleteness, obsolescence, absurdity, labeling
General:
Lack of clarity as to what protection of vulnerable persons mean,
potentially counterproductive effects.
Declaration of Helsinki
Paragraph 9
‘Some research populations are particularly vulnerable and need
special protection. These include those who cannot give or refuse
consent for themselves and those who may be vulnerable to coercion
or undue influence.’
Paragraph 16
The responsibility for the protection of research subjects must always
rest with the physician or other health care professional and never the
research subjects, even though they have given consent.
Inconsistent
Implicitly states – without justification- that vulnerability is
inherently based on a deficit on the part of the vulnerable person.
Options
Dissolve: Vulnerability is a matter of degree. The same protections
should apply. Although they will require greater effort, this does not
require any additional principles.
Problem: invisibility, inappropriate uniformity in protocol design and
REC review.
List: Attempt to devise a list of vulnerable groups or persons which
adheres to an appropriate –and explicit- organizing principle.
Problem: … incompleteness, obsolescence, absurdity, labeling
Instruct: provide clarification of vulnerability and the required
protections.
Vulnerability
Hurst S.: Vulnerability in Research and Health Care; Describing the Elephant in the
Room? Bioethics. 2008; 22(4):191-202
A greater likelihood of incurring a wrong in the context of research.
Any wrong. For any reason.
9. Medical research is subject to ethical standards that promote
respect for all human subjects and protect their health and rights.
Some research populations are particularly vulnerable and need
special protection. These include those who cannot give or
refuse consent for themselves and those who may be vulnerable
to coercion or undue influence.
9. Medical research is subject to ethical standards that promote
respect for all human subjects and protect their health and rights.
Some research populations are particularly vulnerable and need
special protection. These include those who cannot give or
refuse consent for themselves and those who may be vulnerable
to coercion or undue influence.
9. Medical research is subject to ethical standards that promote
respect for all human subjects and protect their health and rights.
Some research populations are particularly vulnerable and need
special protection. These include those who cannot give or
refuse consent for themselves and those who may be vulnerable
to coercion or undue influence. The responsibility for the
protection of research subjects must always rest with the
physician or other health care professional and never the
research subjects, even though they have given consent.
9. Medical research is subject to ethical standards that promote
respect for all human subjects and protect their health and rights.
Some research populations are particularly vulnerable and need
special protection. These include those who cannot give or
refuse consent for themselves and those who may be vulnerable
to coercion or undue influence. The responsibility for the
protection of research subjects must always rest with the
physician or other health care professional investigators and
never the research subjects, even though they have given
consent.
9. Medical research is subject to ethical standards that promote
respect for all human subjects and protect their health and rights.
Some research populations are particularly vulnerable and need
special protection. These include those who cannot give or
refuse consent for themselves and those who may be vulnerable
to coercion or undue influence. The responsibility for the
protection of research subjects must always rest with the
physician or other health care professional investigators and
never the research subjects, even though they have given
consent. This implies a duty to guarantee equal protection for
vulnerable participants, whose health and rights are more
difficult to protect.
9. Medical research is subject to ethical standards that promote
respect for all human subjects and protect their health and rights.
The responsibility for the protection of research subjects must
always rest with the investigators and never the research
subjects. This implies a duty to guarantee equal protection for
vulnerable participants, whose health and rights are more
difficult to protect.
9. Medical research is subject to ethical standards that promote
respect for all human subjects and protect their health and rights.
The responsibility for the protection of research subjects must
always rest with the investigators and never the research
subjects. This implies a duty to guarantee equal protection for
vulnerable participants, whose health and rights are more
difficult to protect.
16. Researchers’ Ethical Obligations:
16.0: Researchers have an obligation to implement the principles
contained in the present declaration at all stages of research.
This implies a duty to guarantee equal protection for vulnerable
participants, whose health and rights are more difficult to protect.
Possible concerns
Virtually all studies will recruit vulnerable persons
We lose subsidiarity
We lose protections associated with REC structure
This is not per se a problem, if the protections extended to them are appropriate.
Protection against being recruited in exploitative research is required for all
As is protection against non-existence of research targeting one’s needs
Protection against conflicts of interests in RECs should also apply to everyone.
Protection against sloppy protections is easier with clearer standards
Conclusion
• Don’t list the vulnerable
• Provide a clear guidance: vulnerability is a matter of degree.
– Protecting vulnerability implies a duty to guarantee equal
protection for vulnerable participants, whose health and rights
are more difficult to protect
• Stick to the general guidance: require a case by case
specification but don’t do it within the DoH.
• As far as vulnerabiliy is concerned, scrap the rest: all other
so-called protections of vulnerability should really apply to
everyone.