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Ethical Standards in

Research Writing
RESEARCH ETHICS
Research ethics concerns the responsibility of
researchers to be honest and respectful to
all individuals who are affected by their
research studies or their reports of the
studies’ results.
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HISTORY
When and where does
the implementation of
these research ethics
came from?
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Prior to 1906, when the Pure Food and Drug Act was
passed, there were no regulations regarding the ethical use
of human subjects in research. There were no consumer
regulations, no Food and Drug Administration (FDA), no
Common Rule, and no Institutional Review Board (IRB).
What follows is a brief discussion of why federal rules
and regulations were established and why the IRB became
a necessity.
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1. NUREMBERG CODE
• December 9, 1946 - American military tribunal
opened criminal proceedings against 23 leading
German physicians and administrators for their
willing participation in war crimes and crimes
against humanity
• German physicians conducted a research on
thousands of camp prisoners without their consent
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1. NUREMBERG CODE
• Established 1948
• "The voluntary consent of the human
subject is absolutely essential“
• First international document which
advocated voluntary participation and
informed consent
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Thalidomide
In the late 1950s, thalidomide was approved as a sedative in
Europe; it was not approved in the United States by the FDA.
The drug was prescribed to control sleep and nausea
throughout pregnancy, but it was soon found that taking this
drug during pregnancy caused severe deformities in the fetus.
Many patients did not know they were taking a drug that was
not approved for use by the FDA, nor did they give informed
consent. Some 12,000 babies were born with severe
deformities due to thalidomide. 7
2. Tuskegee Syphilis Study
(1932-1972)
600 low income African- American Males
were given free medical examinations, 400 of
which has syphilis and was monitored for 40
years but the subjects were not told about
their disease
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2. Tuskegee Syphilis Study
(1932-1972)
• Even though a proven cure (penicillin) became available in the 1950s,
the study continued until 1972 with participants being denied
treatment.
• Many subjects died of syphilis during the study
• The study was stopped in 1973 by the U.S. Department of Health,
Education, and Welfare only after its existence was publicized and it
became a political embarrassment. In 1997, under mounting pressure,
President Clinton apologized to the study subjects and their families.
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3. Declaration of Helsinki
• 1964, the World Medical Association established
recommendations guiding medical doctors in
biomedical research involving human subjects.
• "research combined with clinical care" and
"non-therapeutic research“
• revised in 1975, 1983, 1989 and 1996 and is the
basis for Good Clinical Practices used today.
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3. Declaration of Helsinki
Issues addressed in the Declaration of Helsinki include:
1. Research with humans should be based on the results from
laboratory and animal experimentation
2. Research protocols should be reviewed by an independent
committee prior to initiation
3. Informed consent from research participants is necessary
4. Research should be conducted by medically/scientifically
qualified individuals
5. Risks should not exceed benefits
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4. National Research Act
(1974 )
• National Research Act created the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral
Research
• Identify the basic ethical principles that should underlie the
conduct of biomedical and behavioral research involving human
subjects and to develop guidelines which should be followed to
assure that such research is conducted in accordance with those
principles.
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5. The Belmont Report
attempts to summarize the basic ethical
principles identified by the Commission in
the course of its deliberations

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The three basic ethical principles and their
corresponding applications are:
Principle Application
Respect for persons Informed consent
◈ Subjects, to the degree that they are
◈ Individuals should be capable, must be given the
treated as autonomous opportunity to choose what shall or
shall not happen to them
agents
◈ The consent process must include
◈ Persons with diminished three elements:
autonomy are entitled to ◆ information,
◆ comprehension, and
protection. ◆ voluntariness. 14
The three basic ethical principles and their
corresponding applications are:
Principle Application
Beneficence Assessment of risks and
◈ Human subjects benefits
should not be harmed ◈ The nature and scope
◈ Research should of risks and benefits
maximize possible must be assessed in a
benefits and minimize systematic manner
possible harms. 15
The three basic ethical principles and their
corresponding applications are:
Principle Application
Justice Selection of subjects
◈ The benefits and risks ◈ There must be fair
of research must be procedures and
distributed fairly. outcomes in the
selection of research
subjects
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5 PRINCIPLES OF RESEARCH ETHICS

Here are five recommendations APA's


Science Directorate gives to help
researchers steer clear of ethical
quandaries:
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1. Discuss intellectual property frankly
◈ Academe's competitive "publish-or-perish" mindset can be a
recipe for trouble when it comes to who gets credit for
authorship
◈ The APA Ethics Code requires psychologists to release their data
to others who want to verify their conclusions, provided that
participants' confidentiality can be protected and as long as legal
rights concerning proprietary data don't preclude their release.
However, the code also notes that psychologists who request
data in these circumstances can only use the shared data for
reanalysis; for any other use, they must obtain a prior written
agreement. 18
2. Be conscious of multiple roles

◈ APA's Ethics Code says psychologists


should avoid relationships that could
reasonably impair their professional
performance or could exploit or harm others.
But it also notes that many kinds of multiple
relationships aren't unethical--as long as
they're not reasonably expected to have
adverse effects. 19
3. Follow informed-consent rules
◈ When done properly, the consent process
ensures that individuals are voluntarily
participating in the research with full
knowledge of relevant risks and benefits.

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APA's Ethics Code mandates that psychologists who conduct research
should inform participants about:
• The purpose of the research, expected duration and procedures.
• Participants' rights to decline to participate and to withdraw from the
research once it has started, as well as the anticipated consequences of
doing so.
• Reasonably foreseeable factors that may influence their willingness to
participate, such as potential risks, discomfort or adverse effects.
• Any prospective research benefits.
• Limits of confidentiality, such as data coding, disposal, sharing and
archiving, and when confidentiality must be broken.
• Incentives for participation.
• Who participants can contact with questions.
4. Respect confidentiality and privacy
Other steps researchers should take include:
◈ Discuss the limits of confidentiality. Give participants
information about how their data will be used, what will
be done with case materials, photos and audio and video
recordings, and secure their consent.
◈ Know federal and state law. Know the ins and outs of
state and federal law that might apply to your research.
For instance, the Goals 2000: Education Act of 1994
prohibits asking children about religion, sex or family life
without parental permission. 22
◈ Take practical security measures. Be sure confidential records
are stored in a secure area with limited access, and consider
stripping them of identifying information, if feasible.
◈ Think about data sharing before research begins. If
researchers plan to share their data with others, they should note
that in the consent process, specifying how they will be shared
and whether data will be anonymous.
◈ Understand the limits of the Internet. Since Web technology
is constantly evolving, psychologists need to be technologically
savvy to conduct research online and cautious when exchanging
confidential information electronically.
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5. Tap into ethics resources
◈ The Belmont Report
◈ APA's Ethics Code

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