Transcript 05. Research ethics

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Nazi Medical
Experiments
(1930s and 1940s)
 Use of prisoners and
racial enemies in
experiments designed
to test the limits of
human endurance,
human reaction to
diseases, and
untested drugs
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This is unethical
because subjects
were exposed to
permanent
physical harm or
even death and
they could not
refuse participation
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Tuskegee Syphilis
Study (1932-1972)
by US public health
service
 Investigated effects of
syphilis among 400
men from a poor
African-American
community
 Medical treatment
was deliberately
withheld to study the
course of the
untreated disease
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Injection of live cancer cells into elderly
patients at the Jewish Chronic Disease
Hospital in Brooklyn
Revealed in 1993 – US federal agencies had
sponsored radiation experiments since the
1940s to prisoner or elderly hospital
patients.
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Nuremberg Code
 One of the first internationally recognized efforts to
establish ethical standards
 Developed after the Nazi atrocities were made public in
the Nuremberg trials.
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Declaration of Helsinki
 Adopted in 1964 by the World Medical Association then
later revised in 2000
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1995 – American Nurses Association put forth a
document entitled Ethical Guidelines in the
Conduct, Dissemination, and Implementation of
Nursing Research
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Respect autonomous research participant’s
capacity to consent to participate in research
and to determine the degree and the duration
of that participation without negative
consequences.
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Prevents or minimizes harm and promotes
good will to all research participants, including
vulnerable groups and others affected by the
research.
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Respects the
personhood of
research
participants, their
families, and
significant others,
valuing their
diversity
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Ensures that the
benefits or burdens
or research are
equitably
distributed in the
selection of
research
participants
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Protects privacy of
research
participants to the
maximum degree
possible
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Ensures the ethical integrity of the research
process by use of appropriate checks and
balances throughout the conduct,
dissemination, and implementation of the
research
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Reports suspected, alleged, or known incidents
of scientific misconduct in research to
appropriate institutional officials for
investigation
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Maintains competency in the subject matter
and methodologies of his or her research, as
well as in other professional and societal
issues that affect nursing research and the
public good.
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Involved in animal
research
maximizes the
benefits of the
research with the
least possible harm
or suffering to the
animals.

MAXIM: “Above all, do no harm.”
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FREEDOM FROM HARM
 Study participants may be harmed physically (injury,
fatigue) psychologically (stress, fear) socially (loss of
friends) and financially (loss of wages)
 Minimize types of harm and discomfort to participants
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Minimal risk is defined as risks anticipated to
be no greater than those ordinarily
encountered in daily life or during routine
physical or psychological tests or
procedures.
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Varda and Behnke (2000) studied the effect of
the timing of an initial bath (1 hr versus 2 hrs
after birth) on newborn temperature. To
minimize risks, the researchers excluded all
infants with conditions (infection, fetal distress,
etc) that could predispose them to temperature
instability.

Involvement in a research study should not
place participants at a disadvantage or
expose them to situations for which they
have not been prepared.

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A participant reporting
drug abuse should not
fear exposure to
criminal authorities
A prostitute study
participant telling
where she works and
gets his/her customers
should not fear
exposure to criminal
authorities

Study participants enter into a special
relationship with researchers. This
relationship should not be exploited.

Exploitation may be overt and malicious
 Examples: sexual exploitation, use of subjects’
identifying information to create a mailing list, use of
donated blood for development of a commercial
product, etc.
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People agree to participate in research
investigations for a number of reasons

Direct personal benefits
 Access to an intervention that might be otherwise
unavailable to them
 Direct money or material gains
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Desire to help others
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Includes right to self-determination and right
to full disclosure

Self-determination
 Prospective participants have the right to decide
voluntarily whether to participate in a study, without
risking any penalty or prejudicial treatment.
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Humans should be treated as autonomous
agents, capable of controlling their own
activities.
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A person’s right to self-determination
includes freedom from coercion.
Coercion
 Involves explicit or implicit threats of penalty from
failing to participate in a study
 Excessive rewards from agreeing to participate
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Full disclosure
 Researcher has fully described the nature of the study,
the person’s right to refuse participation, the
researcher’s responsibilities, and likely risks and
benefits.
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Participants have the right to make
informed, voluntary decisions about
study participation
Full disclosure is normally provided to
participants before they begin the study
Prospective participants who are fully
informed about the nature of research and
its potential risks and benefits are in the
position to make rational decisions about
participating in the study.

Means that participants have adequate
information regarding the research, are capable
of comprehending the information, and have
the power of free choice enabling them to
consent to or decline participation voluntarily.
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Participant status
Study goals
Type of data
Procedures
Nature of the commitment
Sponsorship (if there’s any)
Participant selection
Potential risks and benefits
Confidentiality pledge
Voluntary consent
Right to withdraw/withhold information
Contact information
Voluntary consent
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Includes right to
fair treatment and
right to privacy.

Participants have the right to fair and
equitable treatment before, during, or after
the research study.
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Respect for cultural and other forms of human
diversity
Fair and nondiscriminatory selection of
participants with shared risks and benefits
Honoring of all agreements between
researchers and participants
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Courteous and tactful treatment at all times
Participants access to research personnel at
any point in the study to clarify information
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Virtually all research with humans involves
intruding into personal lives. Researchers
should ensure that participants’ privacy is
maintained throughout the study.
As a member of the health care
team, the nurse aide will frequently
be faced with ethical and legal
decisions that govern his or her
actions.
A knowledge of ethical standards,
resident’s rights and legal issues are
important for the protection of
nurse aides, employers, and
residents.
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5.0 Define ethics.
5.1 List at least six basic rules of ethics
for the nurse aide.
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Discipline concerned with right or
wrong conduct
Guides to moral behavior
Making choices or judgments
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Show respect for each resident as an
individual
Understand the limits of role
 Perform only acts for which
adequately prepared
 Perform acts only within legal
scope of nurse aide
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Carry out assignments to best of
ability
Be loyal:
 Maintain a positive attitude
toward institution that employs
you
 Support co-workers
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Bioethics is a specific discipline that probes the
reasoning behind our moral life within the context of
the life sciences; how we decide what is morally right
or wrong bioscience
Ethics is different from morals. Ethics tries to probe the
reasoning behind our moral life, by examining and
analyzing the thinking used to justify our moral
choices and actions in particular situations
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Bioethics is normative ethics applied to the practice of
science and medicine. It falls under the general group
of applied and professional ethics
It is predicated on an assumption that some solutions
to the ethical problems that arise in science and
medicine are more moral than others and that these
solutions can be arrived at by moral reasoning and
reflections
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It is a branch of knowledge like mathematics, and
thinking in this field is not wholly different from
thinking in those other fields, however it cannot be
reduced to them.
Bioethical conclusions cannot be unambiguously
proved like mathematical theorems
Research ethics or more specifically health research
ethics is the branch of bioethics that deals with issues
relating to the ethical conduct of research
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