PHIL 235 Lecture Notes - Lecture 10: Institutional Review Board, National Research Act, Informed Consent
14 May 2018
School
Department
Course
Professor
9.4 Use of Children and Noncompetent Patients in
Research
Ethical and Human-Rights Issues in Research on Mental
Disorders that May Affect Decision-Making Capacity
Alexander M. Capron
• For research with human subjects, the more things change, the more they
remain the same.
• Indeed, the lesson of the past half century is that suffering, death, and
violation of human rights can arise not only when dictators give inhumane
scientists free rein to treat human beings as guinea pigs,2,3 but also when
well-meaning physicians conduct research in a free and enlightened society.
• The inspector general of the Department of Health and Human Services
concluded that reforms were needed in the system of review by
institutional review boards (IRBs) at both the local and the national
level.7 Since the passage of the 1974 National Research Act, universities
and other research centres have been required to use IRBs to protect the
rights and welfare of human subjects.
• Research institutions provide the Department of Health and Human
Services with single- or multiproject assurances that their IRBs will apply
the federal rules to all federally funded research conducted at the institution
or by its employees; many assurances encompass all research with human
subjects regardless of sponsorship.
• The inspector general concluded that the IRB system is in jeopardy because
the local boards are overworked, they fail to oversee approved studies, their
members lack sufficient training, and they face inherent conflicts of interest
• As articulated in the Nuremberg Code and reaffirmed since then, exposing
people to risk in the name of science becomes licit only with their
informed, voluntary consent. Today we add to that requirement the prior
review of research protocols by IRBs to weed out projects whose scientific
merit does not justify their risks and to ensure that accurate and
understandable descriptions of the research will be conveyed to subjects.
• First, it now seems widely accepted that research would be unnecessarily
impeded if such subjects could not be enrolled with the permission of their
guardians when the research presents no more than minimal risk. Second,
guardians may also enroll patients who lack decision-making capacity in
riskier research that can reasonably be predicted to provide the patient with
direct benefits that would otherwise be unattainable. Many of the
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problematic situations regarding research with mentally impaired subjects
are connected to the second exception. It is the first, however, that actually
raises graver issues
The Problems of Therapeutic Research
• As a general rule, as I have written elsewhere, we should “set higher
requirements for consent” and “impose additional safeguards on therapy
combined with experimentation [than on research with normal volunteers],
lest investigators even unwittingly expose ‘consenting’ patientsubjects to
unreasonable risks.
• The risk is not simply that patients who are recruited for research will
become victims of what is called the therapeutic misconception—that is,
construing research interventions as advantageous (especially when no
other proven intervention exists) even when the prospect of benefit is in
truth nonexistent or at best extremely remote.
• Indeed, a collective therapeutic misconception may lie behind the shift in
the paradigm over the past decade: today, many investigators, IRB
members, and commentators alike apparently think the primary ethical
requirement is no longer to protect research subjects from harm (especially
in the case of those least able to protect themselves) but to avoid the
perceived injustice of excluding potential subjects from studies.
• Respect to conditions that radically compromise their victims’ ability to
function successfully in the world, to be themselves, and to enjoy the sense
of safety and stability that most people take for granted.
→ That sense of desperation has led to a willing- ness to permit research in
which the potential for harm would lead any rational person to decline to
participate.
Assessing the Capacity to Consent to
Participate in Research
• The dangers in lowering standards of protection in therapeutic research are
exacerbated for patients whose disorder may impair their capacity to make
decisions
• For this reason, the National Bioethics Advisory Commission, of which I
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am a member, recently recommended that IRBs “should require that an
independent, qualified professional assess the potential subject’s capacity to
consent to any protocol presenting more than a minimal risk, unless the
investigator provides good reasons for using less formal assessment
procedures
• Even if empirical investigation showed that decision-making capacity is
just as likely to be as compromised among patients suffering from other
medical conditions as among those with mental illness, it is not prejudicial
to insist that investigators take reasonable steps to make sure that subjects
whose condition directly affects the brain can actually provide voluntary,
informed consent.
• Ignoring the prima facie need for some evaluation of the ability to consent
makes a mockery of that presumption by rendering it nothing more than a
convenient rationale for ignoring the fact that the consent obtained from
some subjects may not be valid.
The Use of Patients in Research to Benefit Other Patients
• Exception to the requirement of personal consent—namely, allowing
guardians to enroll incapacitated subjects when the research presents no
more than minimal risk of harm to the patient—may seem not to be
problematic.
• Even more important was the idea that parents’ choice to expose their
children to the risks of everyday life encompasses children’s enrolment
in research studies posing minimal risk. The same reasoning was then
applied to other potential subjects who lacked the capacity to make
decisions for themselves, including adults with various illnesses and
injuries.
• The exception for studies posing no more than minimal risk establishes
the principle that it is acceptable to expose unconsenting people to some
risk—not for their own direct good, but for the good of some larger
group.
• Commission for the Protection of Human Subjects recommended in
1977, and he Department of Health and Human Services adopted that
greater risks and burdens may be imposed on sick children than on
healthy ones.
• Ex) In New York → allowing surrogate decision-makers to permit
persons incapacitated with respect to decision-making to participate in
non-beneficial research that presented a minor increase in risk over the
minimal level.
• The reason to assign this task to a national panel is to provide a process
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Document Summary
9. 4 use of children and noncompetent patients in. Ethical and human-rights issues in research on mental. Alexander m. capron: for research with human subjects, the more things change, the more they remain the same. Second, guardians may also enroll patients who lack decision-making capacity in riskier research that can reasonably be predicted to provide the patient with direct benefits that would otherwise be unattainable. It is the first, however, that actually raises graver issues. That sense of desperation has led to a willing- ness to permit research in which the potential for harm would lead any rational person to decline to participate. While it may serve useful societal goals, it fails to serve the child subject"s interests and thus cannot be performed morally: mccormick objected to this argument on the grounds that it presumes an atomistic view of humans. Humans are social beings whose good transcends their individual good.
