Ethical Principles and
Guidelines for Research
Involving Human Subjects
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
Basic Ethical Principles & Applications
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1. Respect for
Persons
2. Beneficence
3. Justice
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1. Informed Consent
2. Assessment of
Risk and Benefits
3. Selection of
Subjects
CITI Program
•
It is the policy of the University that all
personnel involved in the design or
conduct of human subjects research
receive "certification" in human subjects
protections.
Citi course
Citiprogram
How to get Students in research
course
Ana Ruiz
Due Tuesday March 12, 2013
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
Complete The Students In Research
Course for Tuesday
The Basic Course and Informed Consent
modules may be completed for extra credit
but must be completed by Tuesday.
Elements of Consent Form
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28. Standard language for child abuse:
“If information is revealed concerning child abuse,
it is required by law that this be reported to the
appropriate authorities.”
 29. Standard language for other abuse:
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”The only exception is if information is
revealed concerning harm to yourself or
others, child abuse, neglect, or other
forms of abuse that is required by law to
be reported to the appropriate authorities”.
Indicate
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I will submit the results of my research to
my instructor, Daniel Messinger, Ph.D.
and present it to my class (PSY341 or
PSY344). I will not present any identifying
details in my research.
Standard signature line:

“You may ask and will receive answers to any
questions during the course of the study. If
you have any questions about this study,
please contact [your name and phone #] If
you have questions about your rights as a
research participant you may contact Daniel
Messinger, my Professor at 305-284-8443.”
Privacy

Participants being rated rely on the discretion of
the student for their confidentiality in the remote
case they recognize a Participant. Raters will be
asked to communicate their recognition of a
Participant to the Investigators but to no one
else.
No data may be removed from
the lab under any condition
Counseling Center for UM
students
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305-284-5511
Office Hours: M-F 8:30-5pm
Building 21-R
Email: counselingcenter@miami.edu (for
information only)
Research Ethics
Heather Henderson
Research Ethics:
Scientific Fraud
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Plagiarism
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Carelessness
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see
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Holden, C. (2003). Party drug paper pulled.
ScienceNow Daily News, 09/08/03.
History of Unethical Research
with Human Populations
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World War II: Nuremberg Code (1948)
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German physicians and administrators faced criminal
charges for participation in war crimes and crimes
against humanity
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Medical experiments on concentration camp prisoners
without consent resulting in death or permanent disability
Result = Nuremberg Code was first international
document advocating voluntary participation and
informed consent
History of Unethical Research
with Human Populations (cont)
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Late 1950s: Thalidomide
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Approved as sedative in Europe but no FDA approval
in USA
Prescribed in US to control sleep and nausea during
pregnancy…but later found that it caused severe
deformities in fetus
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Many patients didn’t know they were taking an experimental
drug nor did they give informed consent
Result = new regulations from FDA requiring drug
manufacturers to prove effectiveness prior to
marketing
History of Unethical Research
with Human Populations (cont)
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Tuskegee Syphilis Study (1932-1972):
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US Public Health Service research study
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600 low-income African-American males in Alabama
monitored for 40 years
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400 infected with syphilis
Told they were being treated for “bad blood”; free medical
examinations but not told about syphilis diagnosis
In 1950s proven cure (penicillin) discovered but study
continued until 1972 with participants being denied treatment
Ethical Guidelines for Research
with Humans
(APA; 1973, 1982, 1992)
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Planning the Study
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Balance the need to discover the basic laws of
behavior with the need to protect participants
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Defining degree of “risk” for participants
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Are the situations similar to “those ordinarily encountered in
daily life or during the performance of routine physical or
psychological examinations or tests” ???
Especially important consideration with special populations
See
Marshall, E. (2000). Enforcers halt NIH study called less risky
than outdoor play. Science, 290, 1281.
Ethical Guidelines for Research
with Humans

(APA; 1973, 1982, 1992)
Ensuring that participants are volunteers
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Getting informed consent
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must give enough meaningful information for participants to
volunteer
Consent must be documented
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see Fig 2.3 for sample consent form
Read Box 2.2 “Historical Problems with Informed Consent”
Withholding information about the true purpose of a study at the
beginning of the experiment
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Exceptions = anonymous surveys, naturalistic observations
E.g., Milgram’s obedience study
Offering Inducements for Participants
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Targets the vulnerable?
Ethical Guidelines for Research
with Humans
(APA; 1973, 1982, 1992)

Treating participants well
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Full debriefing, “dehoaxing”, desensitizing
Provide appropriate feedback after the study
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Summary of results, follow-up contact, contact info
for them to reach you
Maintaining confidentiality
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Identity of participants not to be revealed
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Exception = when researcher compelled by law to report
certain disclosures e.g., child abuse
Research Ethics:
Scientific Fraud
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Data Falsification
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not collecting any data at all but reporting results
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See Holden, C. (2001). Psychologist made up sex bias
results. Science, 294, 2457.
Altering or omitting collected data to make overall
results look better
Missing data are guessed at and created in order to
have a complete set of information
Suppressing results of a study because results fail to
come out as expected
Research Ethics:
Scientific Fraud
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Other than being dishonest, why is scientific
fraud harmful?
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Ways in which scientific fraud can be detected?
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Research Ethics:
Scientific Fraud
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Current thoughts on the issue of scientific
fraud
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See article posted in Blackboard

Kennedy, D. (2002). More questions about
research misconduct. Science, 297, 12.