PHIL 235 Lecture Notes - Lecture 9: Academic Freedom, Advantageous, Penicillin
14 May 2018
School
Department
Course
Professor
Lesson 9
Chapter 9
Research with Humans
Fisher
Introduction
• Medical research is essential to advancing the knowledge necessary for
creating effective treatments to alleviate human suffering
• However, medical research has a greater potential for harm than therapy
alone does, and at least one type of research requires strong moral
justification.
• Medical research can be divided into two categories:
1. Clinical: combined with medical therapy, which includes diagnosis,
treatment, and prevention of illness, in research subjects who are ill
or affected.
2. Nonclinical: nonclinical research is not directed toward a specific
illness or the susceptibility of particular individuals to it. It involves
healthy individuals and studies their general susceptibility or
response to various factors
• Clinical research and therapy are morally justified, under obligations of
beneficence toward the patient, by the potential to benefit that the subjects
gain by participating.
• Nonclinical research, however, promotes beneficence to the human race in
general, not to any one individual → but may cause them harm but is
voluntary
• The Nazis are notorious for having carried out ruthless medical research on
human subjects, but they are by no means the only ones to have conducted
unsafe research with subjects who did not give their consent and who were
harmed in the process.
• 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these motives have superseded the well-being of individuals.
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• Medical researchers and the institutions they represent are largely
dependent on external funding from pharmaceutical companies and other
commercial interests. These businesses typically dictate the terms of the
funding, and often insist that researchers sign a non-disclosure or
confidentiality agreement.
• If or when problems arise in the research—for example, when the
researcher turns up evidence that the medication being tested might cause
harm to the subjects—the financial interests of the business can often
override the costs to the human subjects. Those in positions of authority
may turn a blind eye to researchers’ concerns, and researchers themselves
may be intimidated into keeping silent
• Yet 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 noncompetent and
lack adequate understanding of what they are participating in and
why.
• The use of children and noncompetent patients as research subjects raises
another set of moral problems
• However, as we saw in Chapter 2 surrogates may find themselves in a
conflict of interest when giving consent, and it may be difficult for an HCP
to recognize when that conflict exists
The Canadian Tri-Council policy on human research sets out the
following guideline:
Where free and informed consent has been obtained from an authorized
third party, and in those circumstances where the legally incompetent
individual understands the nature and consequences of the research, the
researcher shall seek to ascertain the wishes of the individual concerning
participation. The potential subject’s dissent will preclude his or her
participation
• Because 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.
• Promoted by the Canadian policy are the same as those throughout health
care and discussed at length throughout this text:
• Respect for human dignity
• Respect for free and informed consent
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• Respect for vulnerable persons
• Respect for privacy and confidentiality
• Respect for justice and inclusiveness
• Balance of harms and benefits (i.e., minimizing harm and maximizing
benefit)
• Respect for researchers’ academic freedom and independence, including
freedom of inquiry and the right to disseminate the results of that inquiry,
and the freedom to challenge conventional thought.
But knowing the principles to promote does not always provide insight
into how to promote them in practice. Thus, government-mandated
research ethics boards (REBs) all across Canada oversee human research
and obligate researchers to
1. Obtain substantially informed consent from the subjects or
surrogates by providing sufficient information on, for example,
research duration, research aims, expected risks and benefits,
potentially advantageous alternatives to the research, subject rights
and researcher’s obligations, financial charges and compensations,
and what information will be made public;
2. Allow 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;
3. Conduct research that yields results necessary for the good of society
and not obtainable by other means;
4. Ensure that the objective of the research is in reasonable proportion
to the inherent risk to the subject’s welfare;
5. Conduct research so as to minimize and avoid all unnecessary
suffering and injury, both physical and mental;
6. Arrange subjects so that there is an equitable distribution of benefits
and burdens;
7. Ensure that research is conducted by qualified individuals in
adequate facilities, following clearly delineated protocols and in
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Document Summary
These businesses typically dictate the terms of the funding, and often insist that researchers sign a non disclosure or confidentiality agreement. The canadian tri council policy on human research sets out the following guideline: But knowing the principles to promote does not always provide insight into how to promote them in practice. The nuremburg code: the voluntary consent of the human subject is absolutely essential. Declaration of helsinki: the world medical association has developed the declaration of helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. International code of medical ethics declares that, a physician shall act only in the patient"s interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized.
