PHIL 2390H Lecture Notes - Lecture 4: Lumbar Puncture, United States Public Health Service, Arsphenamine
26 Jun 2018
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Module 4 - Is it Ethical to Experiment on Humans?
9.1 Introduction
Medical research is essential to advancing the knowledge necessary for creating effective
treatments to alleviate human suffering
It develops or contributes to generalizable knowledge about human physiology, illness
and injury, and may be combined with medical therapy
Medical research has a greater potential for harm that therapy alone does
Medical research can be divided into clinical and nonclinical research
Clinical research is combined with medical therapy, which includes diagnosis,
treatment, and prevention of illness, in research subjects who are ill or affected
Nonclinical research involves healthy individuals and studies studies their general
susceptibility or their response to various factors
oNot directed toward a specific illness or the susceptibility of particular individuals
to it
The difference between performing research on ill and healthy subjects is morally
significant
Clinical research and therapy are morally justified, by the potential benefit that the
subject gains in participating, as long as harms incurred do not outweigh the benefits to
be gained
Nonclinical research promotes beneficence to the human race in general, not to any one
individual
oThere is little for the participants to immediately gain from the information
collected and their participation may cause them harm
Proponents of nonclinical research state it is no less justified under beneficence and
justice than clinical research is
Because nonclinical research is not essential to the wellbeing or survival of the
participant, participation must be completely voluntary
Ethical question: can we justify using research findings collected under controversial, or
even morally objectionable circumstances?
oSome theorists defend the use of such information if it has potential to save lives
oTheir position is supported by the “ends justify the means” argument - as long as
the information is beneficial, we can overcome any complaints about how it was
obtained
The Nuremberg Code and Declaration of Helsinki are ethical codes that established
requirements of informed consent that researchers are obligated to meet
Since the potential to benefit humanity and the need to gain information that may help
protect national security are compelling reasons to support medical research, it is
important to be aware of the many instances where these motives have superseded the
well-being of individuals
On occasion general well-being should override individual well-being, but only with
proper justification, and definitely not as a default position
Problems Faced in Human Research:
Concerns about inadequate consent, dangerous experiments, and abuse
Role of commercial funding in medical research can create conflicts of interest and moral
dilemmas
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oPharmaceutical companies typically dictate the terms of funding and often insist
that researchers sign a non-disclosure or confidentiality agreement
oIf problems arise (i.e. the researcher turns up evidence that the medication might
cause harm to the subjects) the financial interests of the business can often
override the costs to the human subjects
oThose in positions of authority may turn a blind eye and researchers themselves
may be intimidated to keep quiet
oHowever, as researchers and physicians they have an obligation not to cause
unnecessary and avoidable harm to patients without their consent, particularly
when those patients are very young or non-competent and lack adequate
understanding of what they are participating in and why
Various codes of ethics in research obligate the researcher to disclose information in the
vast majority of cases where the obligations of non-disclosure and nonmaleficence come
into contact
oHave legal backing in “whistleblower” laws that protect those who choose to
make their concerns public
oDangers of speaking out include discrimination, firing, blacklisting, etc.
Sometimes research must be done on children and those who are non-competent, which
necessitates surrogate decision makers to be consulted
Surrogates may find themselves in a conflict of interest when giving consent and it may
be difficult for a HCP to recognize when this occurs
Many individuals that are not legally competent are still able to express their wishes in a
meaningful way, even if such expression does not fulfill the requirements for free and
informed consent
oTCPS: Secondary to the free and informed consent obtained by an authorized
third party, when the legally incompetent individual understand the nature and
consequences of research, the researcher should seek to understand the wishes of
the individual concerning participation. Dissent of the participant will preclude
them from the research.
oBecause failure to recognize individual conflicts of interest could result in harm
being done to the subject, the government is willing to accept the refusal of a non-
competent individual rather than risk going against his wishes
oErring on the side of caution promotes beneficence and non-maleficence
Individual conflict of interest is a situation that occurs when an individual has two or
more distinct interests and/or obligations, both of which make legitimate demands on her
but are in conflict with one another
Guiding principles promoted by the Canadian policy:
oRespect for Human dignity
oRespect for free and informed consent
oRespect for vulnerable persons
oRespect for privacy and confidentiality
oRespect for justice and inclusiveness
oBalance of harms and benefits
oRespect for researchers academic freedom and independence
Research Ethics Boards obligate researchers to:
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oObtain substantially informed consent from the subjects or surrogates by
providing sufficient information on research duration, research aims, expected
risks and benefits, potentially advantageous alternatives to research, subject rights
and researchers obligations, financial charges, etc.
oAllow the subject to voluntarily withdraw from research at any time, and to be
prepared to terminate the research at any time if continuation is likely to result in
the subject’s injury, disability, or death
oConduct research that yields results necessary for the good of society and not
obtainable by other means
oEnsure that the objective of the research is in reasonable proportion to the
inherent risk to the subjects welfare
oConduct research so as to minimize and avoid all unnecessary suffering and
injury, both physical and mental
oArrange subjects so that there is an equal distribution of benefits and burdens
oEnsure that research is conducted by qualified individuals in adequate facilities,
following clearly delineated protocols and in conformity with the laws and
regulations of the province in which it occurs
oObtain substantially informed proxy consent whenever children or non-competent
patients are subjects, and ensure that the information gained is relevant to the
subject group (i.e. research must not be performed on non-competent patients
when it could be done with competent, autonomous subjects)
oMaintain confidentiality
Researchers are morally obligated to use, wherever possible, computer modelling and
alternative methods of obtaining information that are not harmful to human or animal
subjects
9.2 The Tuskegee Study
Questions:
As you read this article about racism and experiments on African American patients, try to think
about relevant comparisons to Canada. In particular, keep in mind the legacy of social
Darwinism and racism in Canadian medicine and experimentation: residential schools, and other
experiments on First Nations people in Canada.
Pence begins his article with a long examination of the history of syphilis and the history of
syphilis treatment.
Why is it important to have this background understanding to the Tuskegee experiment?
What treatments for syphilis were tested in the early twentieth century, and when?
Pence quotes historian Allan Brandt as suggesting that white physicians in the United States
viewed African Americans as "less than human". How did this racism affect medical treatment
and medical experimentation?
List two experiments run on African American patients without their consent.
What was the effect of social Darwinism on the treatment of African American patients
in the United States?
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Document Summary
Medical research is essential to advancing the knowledge necessary for creating effective treatments to alleviate human suffering. It develops or contributes to generalizable knowledge about human physiology, illness and injury, and may be combined with medical therapy. Medical research has a greater potential for harm that therapy alone does. Medical research can be divided into clinical and nonclinical research. Clinical research is combined with medical therapy, which includes diagnosis, treatment, and prevention of illness, in research subjects who are ill or affected. Nonclinical research involves healthy individuals and studies studies their general susceptibility or their response to various factors: not directed toward a specific illness or the susceptibility of particular individuals to it. The difference between performing research on ill and healthy subjects is morally significant. Clinical research and therapy are morally justified, by the potential benefit that the subject gains in participating, as long as harms incurred do not outweigh the benefits to be gained.
