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

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.

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

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.

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.”

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

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.

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.

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.

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 Desire to help others

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.

Humans should be treated as autonomous agents, capable of controlling their own activities.

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

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

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.

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

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.

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

Courteous and tactful treatment at all times Participants access to research personnel at

any point in the study to clarify information

Virtually all research with humans involves intruding into personal lives. Researchers should ensure that participants’ privacy is maintained throughout the study.

DHSR Approved Curriculum-Unit 5 50

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.

DHSR Approved Curriculum-Unit 5 51

DHSR Approved Curriculum-Unit 5 52

5.0 Define ethics.5.1 List at least six basic rules of

ethics for the nurse aide.

DHSR Approved Curriculum-Unit 5 53

Discipline concerned with right or wrong conduct

Guides to moral behavior Making choices or judgments

DHSR Approved Curriculum-Unit 5 54

Show respect for each resident as an individual

Understand the limits of rolePerform only acts for which adequately prepared

Perform acts only within legal scope of nurse aide

DHSR Approved Curriculum-Unit 5 55

Carry out assignments to best of ability

Be loyal:Maintain a positive attitude toward institution that employs you

Support co-workers

DHSR Approved Curriculum-Unit 5 56

Bioethics is a specific discipline that probes the Bioethics is a specific discipline that probes the reasoning behind our moral life within the reasoning behind our moral life within the context of the life sciences; how we decide what context of the life sciences; how we decide what is morally right or wrong bioscienceis morally right or wrong bioscience

Ethics is different from morals. Ethics tries to Ethics is different from morals. Ethics tries to probe the reasoning behind our moral life, by probe the reasoning behind our moral life, by examining and analyzing the thinking used to examining and analyzing the thinking used to justify our moral choices and actions in justify our moral choices and actions in particular situationsparticular situations

DHSR Approved Curriculum-Unit 5 57

Bioethics is normative ethics applied to the Bioethics is normative ethics applied to the practice of science and medicine. It falls under practice of science and medicine. It falls under the general group of applied and professional the general group of applied and professional ethicsethics

It is predicated on an assumption that some It is predicated on an assumption that some solutions to the ethical problems that arise in solutions to the ethical problems that arise in science and medicine are more moral than science and medicine are more moral than others and that these solutions can be arrived at others and that these solutions can be arrived at by moral reasoning and reflectionsby moral reasoning and reflections

DHSR Approved Curriculum-Unit 5 58

It is a branch of knowledge like mathematics, It is a branch of knowledge like mathematics, and thinking in this field is not wholly different and thinking in this field is not wholly different from thinking in those other fields, however it from thinking in those other fields, however it cannot be reduced to them. cannot be reduced to them.

Bioethical conclusions cannot be unambiguously Bioethical conclusions cannot be unambiguously proved like mathematical theoremsproved like mathematical theorems

Research ethics or more specifically health Research ethics or more specifically health research ethics is the branch of bioethics that research ethics is the branch of bioethics that deals with issues relating to the ethical conduct deals with issues relating to the ethical conduct of researchof research