1114237 - Wiley US © 3434 Chapter Chapter 2 2 Ethics Ethics and and ResearchResearch researchers researchers developed developed the the Nuremberg Nuremberg Code Code (Resnik, (Resnik, 1998). 1998). The The Nuremberg Nuremberg Code, Code, summarized summarized in in Box Box 2.1, 2.1, consists consists of of nine nine fundamental fundamental principles principles that that researchers researchers must must use use when when conducting conducting research research with with humans.humans. As As you you should should see, see, the the Nuremberg Nuremberg Code Code is is a a reaction reaction to to horrible horrible treatment treatment of of people people who who could could not not defend defend themselves. themselves. As As you you read read the the components components of of the the Nuremberg Nuremberg Code, Code, can can you you recognize recognize the the components components that that represent represent a a utilitarian utilitarian ethical ethical perspective? perspective? How How about about the the principle principle of of rights? rights? For For example, example, how how would would you you describe describe the the “no “no malfeasance” malfeasance” requirement requirement or or the the “social “social value” value” criterion? criterion? Why Why do do you you think think principles principles 6–9 6–9 were were added added to to the the list?list? UnfortunatelyUnfortunately, , horrible horrible and and immoral immoral experiments experiments on on humans humans did did not not only only occur occur at at the the hands hands of of Nazi Nazi scientists. scientists. Recently Recently released released documents documents from from the the U.S. U.S. Department Department of of Energy Energy reveal reveal that that during during the the 1940s 1940s and and 1950s, 1950s, U.S. U.S. government government researchers researchers conducted conducted experiments experiments on on unsuspecting unsuspecting American American citizens citizens to to deter-deter- mine mine the the effects effects of of nuclear nuclear rradiation adiation (W(Welsome, elsome, 1999). 1999). None None of of the the people people knew knew that that they they had had been been exposed exposed to to these these deadly deadly conditions. conditions. In In another another case, case, physicians physicians at at the the TTuskegee uskegee Institute Institute purposefully purposefully withheld withheld treatment treatment from from 399 399 people people who who had had contracted contracted syphilis, syphilis, for for the the sole sole purpose purpose of of studying studying the the long-term long-term effects effects of of this this dreadful dreadful disease disease (Jones, (Jones, 1982). 1982). UnfortunatelyUnfortunately, , these these examples examples are are not not isolated isolated cases cases (Resnik, (Resnik, 1998).1998). This This bleak bleak history history ...

1. 1114237 - Wiley US ©
3434 Chapter Chapter 2 2 Ethics Ethics and and
ResearchResearch
researchers researchers developed developed the the Nuremberg
Nuremberg Code Code (Resnik, (Resnik, 1998). 1998). The The
Nuremberg Nuremberg Code, Code,
summarized summarized in in Box Box 2.1, 2.1, consists
consists of of nine nine fundamental fundamental principles
principles that that researchers researchers
must must use use when when conducting conducting research
research with with humans.humans.
As As you you should should see, see, the the Nuremberg
Nuremberg Code Code is is a a reaction reaction to to horrible
horrible treatment treatment of of
people people who who could could not not
defend defend themselves. themselves. As As you you read read
the the components components of of the the
Nuremberg Nuremberg Code, Code, can can you you
recognize recognize the the components components that that
represent represent a a utilitarian utilitarian
ethical ethical perspective? perspective? How How about about
the the principle principle of of rights? rights? For For example,
example, how how would would

2. you you describe describe the the “no “no malfeasance”
malfeasance” requirement requirement or or the the “social
“social value” value” criterion? criterion? Why Why
do do you you think think principles principles 6–9 6–9 were
were added added to to the the list?list?
UnfortunatelyUnfortunately, , horrible horrible and
and immoral immoral experiments experiments on on humans
humans did did not not only only
occur occur at at the the hands hands of of Nazi Nazi scientists.
scientists. Recently Recently released released documents
documents from from the the U.S. U.S.
Department Department of of Energy Energy reveal reveal that
that during during the the 1940s 1940s and and 1950s, 1950s,
U.S. U.S. government government
researchers researchers conducted conducted
experiments experiments on on unsuspecting unsuspecting
American American citizens citizens to to deter-deter-
mine mine the the effects effects of of nuclear nuclear
rradiation adiation (W(Welsome, elsome, 1999). 1999). None
None of of the the people people knew knew
that that they they had had been been exposed exposed to to
these these deadly deadly conditions. conditions. In In another
another case, case, physicians physicians
at at the the TTuskegee uskegee Institute Institute
purposefully purposefully withheld withheld treatment
treatment from from 399 399 people people who who
had had contracted contracted syphilis, syphilis, for for the the

3. sole sole purpose purpose of of studying studying the the long-
term long-term effects effects of of
this this dreadful dreadful disease disease (Jones, (Jones, 1982).
1982). UnfortunatelyUnfortunately, , these these examples
examples are are not not isolated isolated
cases cases (Resnik, (Resnik, 1998).1998).
This This bleak bleak history history of of ethical ethical abuses
abuses in in research research with with human human
participants participants illus-illus-
trates trates the the need need to to create create and and
enforce enforce clear clear ethical ethical guidelines guidelines
for for social social and and behav-behav-
ioral ioral research. research. The The , , which
which became became law law in in 1974 1974 (PL(PL
National National Research Research ActAct
93-348), 93-348), established established the the
IRB IRB that that we we described described earlierearlier. .
The The law law requires requires that that
researchers researchers receiving receiving federal federal
money money to to conduct conduct research research with with
humans humans and and animals animals
must must demonstrate demonstrate that that their their research
research methods methods meet meet minimal minimal ethical
ethical standards standards and and
BOX BOX 2.1 2.1 The The Nuremberg Nuremberg Code Code
of of Principles Principles Governing Governing Research
Research Using Using HumansHumans

4. 1. 1. Informed Informed Consent Consent The The
participant participant must must
understand understand what what will will happen
happen to to him him or or her her in in
the the research research and and then then volunteer volunteer
to to participate.participate.
2. 2. Social Social VValue alue The The results
results of of a a study study should should
benefit benefit societysociety..
3. 3. Scientific Scientific VValidity alidity Only Only
trained trained scientists scientists
who who employ employ careful careful and and well-designed
well-designed studies studies
should should conduct conduct research.research.
4. 4. No No Malfeasance Malfeasance Researchers
Researchers must must conduct conduct
studies studies that that are are safe safe and and minimize
minimize risk risk of of harm harm
to to the the participants.participants.
5. 5. TTermination ermination The The participant
participant may may withdraw withdraw
from from the the study study for for any any reason, reason,
and and the the researcher researcher

5. must must stop stop the the study study if if the the participant
participant is is at at risk risk
of of injury injury or or death.death.
6. 6. Privacy Privacy The The researcher researcher
must must preserve preserve the the
privacy/confidentiality privacy/confidentiality of of the the
participant.participant.
7. 7. VVulnerable ulnerable Populations Populations
Researchers Researchers need need to to
use use special special caution caution to to protect protect the
the rights rights of of those those
who who cannot cannot act act for for themselves, themselves,
including including chil-chil-
dren, dren, the the developmentally developmentally delayed,
delayed, or or the the men-men-
tally tally disabled.disabled.
8. 8. Fairness Fairness Selection Selection of of the the
participants participants for for the the
research research and and assignment assignment to to treatment
treatment conditions conditions
must must be be fairfair, , consistent, consistent, and and
equitable.equitable.
9. 9. Monitoring Monitoring The The reseresearcher

6. archer must must continu continu --
ally ally monitor monitor the the study study to to
ensure ensure the the safety safety of of
participants.participants.
NoteNote: : The The original original Nuremberg
Nuremberg Code Code included included
principles principles 1–5. 1–5. Principles Principles 6–9
6–9 are are more more recent recent
additions additions to to the the code code (Resnik, (Resnik,
1998).1998).
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The U.S. Public Health Service Syphilis Study at Tuskegee
Tuskegee Home " # $ %
Research Implications
After
the
U.S
Public
Health

7. Service’s (USPHS) Syphilis Study at Tuskegee, the government
changed its research
practices.
In 1974, the National Research Act was signed into law,
creating the National
Commission for the Protection of Human Subjects of
Biomedical and Behavioral
Research . The group identi!ed basic principles of research
conduct and
suggested ways to ensure those principles were followed.
In addition to the Commission’s recommendations, regulations
were passed in 1974
that required researchers to get voluntary informed consent
from all persons taking
part in studies done or funded by the Department of Health,
Education, and Welfare
(DHEW). They also required that all DHEW-supported studies
using human subjects
be reviewed by Institutional Review Boards, which decide
whether research
protocols meet ethical standards.
The rules and policies for human subjects research have been
reviewed and revised
many times since they were !rst approved and e"orts to promote
the highest
ethical standards in research are ongoing.
An Ethics Advisory Board was formed in the late-1970s to
review ethical issues of
biomedical research. As a result of their work, the 1979
publication commonly
known as The Belmont Report summarized the three ethical
principles that

8. should guide human research: respect for persons; bene!cence;
justice. From 1980-
1983, the President’s Commission for the Study of Ethical
Problems in Medicine and
Biomedical and Behavioral Research reported “every two years
on the adequacy
and uniformity of the Federal rules and policies, and their
implementation, for the
protection of human subjects in biomedical and behavioral
research.” In 1991,
federal departments and agencies (16 total) adopted the Federal
Policy for the
Protection of Human Subjects .
In October 1995, President Bill Clinton created a National
Bioethics Advisory
Commission , funded and led by the Department of Health and
Human Services.
The commission’s task was to review current regulations,
policies, and procedures to
ensure all possible safeguards are in place to protect research
volunteers. It was
succeeded by the President’s Council on Bioethics , which was
established in
2001, and then the Presidential Commission for the Study of
Bioethical Issues
established in 2009.
&
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9. &
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Page last reviewed: April 22, 2021
Content source: National Center for HIV, Viral Hepatitis, STD,
and TB Prevention, Centers for Disease
Control and Prevention
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