History and Ethical Principles – SBE Questions & Answers 100% Correct!!
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History and Ethical Principles – SBE
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History And Ethical Principles – SBE
Introduction - ANSWER-Research with human subjects has a long and often troubled history in the United States (U.S.) and throughout the world. Chances are you already have heard of some of the most egregious and well-known examples of unethical research in the biomedical sciences, such as the exper...
History and Ethical Principles
– SBE Questions & Answers
100% Correct!!
Introduction - ANSWER-Research with human subjects has a long and often troubled history in the
United States (U.S.) and throughout the world. Chances are you already have heard of some of the
most egregious and well-known examples of unethical research in the biomedical sciences, such as
the experiments conducted by Nazi doctors and scientists on concentration camp prisoners during
World War II, and the U.S. Public Health Service (PHS) study titled "Tuskegee Study of Untreated
Syphilis in the Negro Male" (Tuskegee Study). These abuses led to the creation of codes of research
ethics in Europe and the U.S. In the wake of the Second World War, the subsequent Nuremberg Trials
on war crimes produced the Nuremberg Code, which outlined ten points for conducting ethical
research with human subjects. Nearly two decades later, the World Medical Association (WMA)
developed a code of research ethics known as the Declaration of Helsinki, published in 1964 and
subsequently revised. This document is built on both the Nuremberg Code and the physician's code
of ethics known as the Declaration of Geneva.
In the U.S., news that researchers deceived and withheld treatment from subjects who suffered from
syphilis in the Tuskegee Study led to the creation of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research (National Commission or "the Commission").
The Commission was charged with establishing a code of research ethics for U.S. research involving
human subjects. In 1979, the Commission issued the Belmont Report, the foundational document of
the current system of U.S. human subjects protections. The Belmont Report outlines three key
ethical principles for conducting research with human subjects: respect for persons, beneficence,
and justice. The Belmont Report, in turn, informed the U.S. Department of Health and
Respect for Persons - ANSWER-Respect for persons incorporates at least two ethical convictions: first,
that individuals should be treated as autonomous agents, and second, that persons with diminished
autonomy are entitled to protection. The principle of respect for persons thus divides into two
separate moral requirements: the requirement to acknowledge the autonomy and the requirement
to protect those with diminished autonomy (The National Commission 1979).
Autonomy - ANSWER-Autonomy means that people must be empowered to make decisions
concerning their own actions and well-being. According to the principle of respect for persons,
, researchers must acknowledge the "considered opinions and choices" of research subjects. In other
words, individuals must be given the choice whether to participate in research, and they must be
provided sufficient information and possess the mental competence to make that choice.
Respect for persons also recognizes that some individuals may not be capable of making decisions or
choices that are in their best interest. Individuals with "diminished decision-making capacity" may
lack the ability to comprehend study procedures or how participating in a study might adversely
affect them. Special care should be taken to protect those with diminished capacity to the point of
excluding individuals who are not able to give meaningful consent to participate in research.
Children are a class of research subjects with limited autonomy. Typically, a parent or legal guardian
must give permission for a child to participate in a study. Researchers also should ask child subjects
for their assent by explaining the study in terms they can understand.
Voluntariness - ANSWER-Voluntariness is an essential component of respect for persons. Research
subjects must be free to choose to participate in research. They also must be free to end their
participation for any reason, without consequences.
Voluntariness means more than offering people the choice to participate in or withdraw from
research. Researchers should be aware of situations in which prospective subjects may feel
pressured to participate in a study. In situations where a relationship between the researcher and
subjects already exists, such as when a volunteer at a homeless shelter decides to conduct research
with that population, the lines between voluntariness and undue influence may be blurred. People
might be reluctant to decline participation if they have come to know the researcher in another role.
Other examples of situations in which researchers may exert undue influence because they are in
positions of authority include: employers conducting research with their employees and professors
conducting research with their students.
Informed Consent - ANSWER-A prospective research subject's autonomy is honored through the
process of informed consent. The Office for Human Research Protections (OHRP 2014) offers these
guidelines:
The informed consent process involves three key features: (1) disclosing to potential research
subjects information needed to make an informed decision; (2) facilitating the understanding of what
has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to
participate in the research.
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