CITI Social/Behavioral Research Course Exam
Questions and Answers
Belmont Report - -provides the ethical framework for the federal regulations
designed to protect human research subjects.
-Belmont Report and Its Principles - -
-The Belmont Report's principle of 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 Belmont Report's principle of 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. Persons with diminished autonomy should not be
excluded from participating in research, because then they would be
excluded from receiving the benefits of research. The Belmont Report does
not limit persons with diminished autonomy with participating in greater than
minimal risk research. The Belmont Report also does not limit persons
involved in research from benefitting financially.
-Which of the following is an example of how the principle of beneficence
can be applied to a study employing human subjects? - -Determining that
the study has a maximization of benefits and a minimization of risks.
-The principle of beneficence - -The principle of beneficence includes the
obligation of researchers to strive to do no harm and to maximize benefits
and minimize harms. "Persons are treated in an ethical manner not only by
respecting their decisions and protecting them from harm, but also by
making efforts to secure their well-being" (The National Commission 1979).
The principle of beneficence can be applied to a study employing human
subjects by determining that the study has a maximization of benefits and a
minimization of risks. Providing detailed information during consent and
ensuring persons with diminished autonomy are protected would be
examples of applying the principle of respect for persons. Ensuring the
selection of subjects is equitable is an example of applying the principle of
justice.
-Which of the following are the three principles discussed in the Belmont
Report? - -Respect for Persons, Beneficence, Justice
-The three principles discussed in the Belmont Report are - -Respect for
Persons, Beneficence, Justice.
, -Students in Research - -
-A master's degree candidate needs to conduct a research project for her
master's thesis. She is interested in the types of junk food available to the
public. She plans on going to the local convenience stores and asking the
owners what types of junk food the store normally stocks and which are the
biggest sellers. Identifiers will not be collected. This study would fall under
which of the following? - -Not Human Subjects
-This study would qualify as not human subjects because - -the data that
the student is collecting does not meet the definition of human subjects
research as stated by federal regulations. She is not collecting any
information about the store owners, but her study mainly seeks to find
information about the items in the store.
-The history of ethical regulations in human subjects research began with
the - -Nuremberg Code
-Nuremberg Code - -Prior to the Nuremberg Code in 1949, the U.S. did not
have a set of ethical regulations in human subjects research. The Nuremberg
Code paved the way in creating the human subjects research guidelines and
regulations we follow today.
-How can faculty researchers avoid undue influence of student subjects? - -
Avoid using their own students in their research
-Avoid using their own students in their research - -By recruiting students
from other classes, faculty researchers can minimize the potential of undue
influence. Students from the faculty's own classroom may feel coerced to
participate so to protect them, students who do not have any courses with
the faculty should be recruited when possible.
-Per federal regulations, which of the following elements must be included in
an informed consent document? - -All foreseeable risks and discomforts.
-The federal regulations require - -all foreseeable risks and discomforts
must be included in an informed consent.
-Which type of IRB review does not require an IRB approval but does require
a determination by the IRB or an IRB designee? - -Exempt
-Exempt research is - -research with human subjects. However, it is
"exempt" from the provisions stated in Title 45, Part 46, Subpart A (the
Common Rule). Federal guidance recommends that investigators not be
allowed to self-determine whether a study qualifies for exemption. Therefore,
Questions and Answers
Belmont Report - -provides the ethical framework for the federal regulations
designed to protect human research subjects.
-Belmont Report and Its Principles - -
-The Belmont Report's principle of 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 Belmont Report's principle of 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. Persons with diminished autonomy should not be
excluded from participating in research, because then they would be
excluded from receiving the benefits of research. The Belmont Report does
not limit persons with diminished autonomy with participating in greater than
minimal risk research. The Belmont Report also does not limit persons
involved in research from benefitting financially.
-Which of the following is an example of how the principle of beneficence
can be applied to a study employing human subjects? - -Determining that
the study has a maximization of benefits and a minimization of risks.
-The principle of beneficence - -The principle of beneficence includes the
obligation of researchers to strive to do no harm and to maximize benefits
and minimize harms. "Persons are treated in an ethical manner not only by
respecting their decisions and protecting them from harm, but also by
making efforts to secure their well-being" (The National Commission 1979).
The principle of beneficence can be applied to a study employing human
subjects by determining that the study has a maximization of benefits and a
minimization of risks. Providing detailed information during consent and
ensuring persons with diminished autonomy are protected would be
examples of applying the principle of respect for persons. Ensuring the
selection of subjects is equitable is an example of applying the principle of
justice.
-Which of the following are the three principles discussed in the Belmont
Report? - -Respect for Persons, Beneficence, Justice
-The three principles discussed in the Belmont Report are - -Respect for
Persons, Beneficence, Justice.
, -Students in Research - -
-A master's degree candidate needs to conduct a research project for her
master's thesis. She is interested in the types of junk food available to the
public. She plans on going to the local convenience stores and asking the
owners what types of junk food the store normally stocks and which are the
biggest sellers. Identifiers will not be collected. This study would fall under
which of the following? - -Not Human Subjects
-This study would qualify as not human subjects because - -the data that
the student is collecting does not meet the definition of human subjects
research as stated by federal regulations. She is not collecting any
information about the store owners, but her study mainly seeks to find
information about the items in the store.
-The history of ethical regulations in human subjects research began with
the - -Nuremberg Code
-Nuremberg Code - -Prior to the Nuremberg Code in 1949, the U.S. did not
have a set of ethical regulations in human subjects research. The Nuremberg
Code paved the way in creating the human subjects research guidelines and
regulations we follow today.
-How can faculty researchers avoid undue influence of student subjects? - -
Avoid using their own students in their research
-Avoid using their own students in their research - -By recruiting students
from other classes, faculty researchers can minimize the potential of undue
influence. Students from the faculty's own classroom may feel coerced to
participate so to protect them, students who do not have any courses with
the faculty should be recruited when possible.
-Per federal regulations, which of the following elements must be included in
an informed consent document? - -All foreseeable risks and discomforts.
-The federal regulations require - -all foreseeable risks and discomforts
must be included in an informed consent.
-Which type of IRB review does not require an IRB approval but does require
a determination by the IRB or an IRB designee? - -Exempt
-Exempt research is - -research with human subjects. However, it is
"exempt" from the provisions stated in Title 45, Part 46, Subpart A (the
Common Rule). Federal guidance recommends that investigators not be
allowed to self-determine whether a study qualifies for exemption. Therefore,
