Mod 4 Bioethics and Research

Bioethics and Research
Unit V
What is an ‘ ethical issue’?
 When you have to judge what is right or wrong
 Choosing between options
 Deciding whether to do something or do nothing
 Should I or shouldn’t I?
 Weighing up the potential impact of your decisions or actions
 A dilemma – making a difficult choice

Introduction to ethics:
Our care for patients should be based on sound
judgement (or evidence based practice!!)
..some of this judgement is about having a strong sense

of what is right or wrong
..having a strong sense of what we should be doing and

shouldn’t be doing as nurses
..having a strong sense of what our priorities ought to be

 Nurses frequently have to make difficult decisions for
which there is not always a quick, easy or ‘correct’ answer
e.g. Can Mrs X be discharged yet? Can Mr Y manage his
own medications safely?
 Nevertheless, nurses still have to be able to explain and

account for these decisions and actions
 The NMC Code can act as a guide

This can be seen as a ‘code of ethics’ – a set of important
principles to help guide nurses
Ethical issues in health care:
 We Nurses usually think of the ‘big’ issues
e.g. definition of life, what is a person, quality of life, prolonging life,
ending life, human rights.
 But day to day ethical issues can involve:

 Respecting people
 Treating people with dignity
 Treating people fairly
 Supporting patient’s choices
 These ‘principles’ are encompassed in the NMC code
 The code is a useful source of ethical principles in health care

Ethics 2 broad philosophical theories
1) consequentialism – taking the consequences
of our actions into consideration
2) deontology – basing our actions on a set of

principles or duties
Research Ethics:
History 0f Research Ethics:
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.
 This is unethical because subjects were exposed to permanent physical
harm or even death and they could not refuse participation
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.
Others:
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.
Code of Ethics:
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.
Declaration of Helsinki
Adopted in 1964 by the World Medical Association
then later revised in 2000
1995 – American Nurses Association put
forth a document entitled Ethical
Guidelines in the Conduct,
Dissemination, and Implementation of
Nursing Research
Ethical Guidelines:
 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.
 Prevents or minimizes harm and promotes good will
to all research participants, including vulnerable
groups and others affected by the research.
 Respects the personhood of research participants,
their families, and significant others, valuing their
diversity
 Ensures that the benefits or burdens or research are
equitably distributed in the selection of research
participants
 Protects privacy of research participants to the
maximum degree possible
 Ensures the ethical integrity of the research
process by use of appropriate checks and
balances throughout the conduct, dissemination,
and implementation of the research.
 Reports suspected, alleged, or known incidents
of scientific misconduct in research to
appropriate institutional officials for investigation.
 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.
PRINCIPLE OF BENEFICENCE
MAXIM: “Above all, do no harm.”
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
FREEDOM FROM EXPLOITATION

 Involvement in a research study should not place participants at a
disadvantage or expose them to situations for which they have not been
prepared.
 Eg. A participant reporting drug abuse should not fear exposure to criminal
authorities
 Eg. A prostitute study participant telling where she works and gets his/her
customers should not fear exposure to criminal authorities
BENEFITS FROM RESEARCH
 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
 Desire to help others
PRINCIPLE OF RESPECT FOR HUMAN DIGNITY

 Includes right to self-determination and right to full disclosure, Freedom from
Coercion.
 Self-determination
Prospective participants have the right to decide voluntarily whether to
participate in a study, without risking any penalty or prejudicial
treatment.
 Coercion
Involves explicit or implicit threats of penalty from failing to participate in
a study
Excessive rewards from agreeing to participate.
RIGHT TO 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.
 Participants have the right to make informed, voluntary
decisions about study participation
 Full disclosure is normally provided to participants before they
begin the study
INFORMED CONSENT
 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.
RIGHT TO PRIVACY
 Virtually all research with humans involves intruding into
personal lives. Researchers should ensure that participants’
privacy is maintained throughout the study.
THE PRINCIPLE OF JUSTICE

 Includes right to fair treatment
and right to privacy.

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Bioethics and Research

 Choosing between options

 Deciding whether to do something or do nothing

 Weighing up the potential impact of your decisions or actions

 A dilemma – making a difficult choice

..some of this judgement is about having a strong sense

..having a strong sense of what we should be doing and

..having a strong sense of what our priorities ought to be

 Nevertheless, nurses still have to be able to explain and

 The NMC Code can act as a guide

 But day to day ethical issues can involve:

 These ‘principles’ are encompassed in the NMC code

 The code is a useful source of ethical principles in health care

2) deontology – basing our actions on a set of

Revealed in 1993 – US federal agencies had

FREEDOM FROM EXPLOITATION

PRINCIPLE OF RESPECT FOR HUMAN DIGNITY

THE PRINCIPLE OF JUSTICE

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