History and Ethical Principles - SBE CITI Training
questions with complete solutions
If disclosure of a subject's involvement in a specific research study can be potentially
harmful to the subject, and the consent form is the only record linking the subject to
the research, which of the following would be most helpful: - ANSWER Obtain a
waiver of documentation of informed consent.
The primary purpose of a Certificate of Confidentiality is to: - ANSWER Protect
identifiable research information from compelled disclosure.
Additional safeguards that may be included in a social and behavioral study may
include: - ANSWER Remove all direct identifiers from the data as soon as possible.
A researcher wants to do a web-based survey of college students to collect
information about their sexual behavior and drug use. Direct identifiers will not be
collected; however, IP addresses may be present in the data set. Risk of harm
should be evaluated by: - ANSWER Both the magnitude (or severity) and the
probability (or likelihood) of harm.
Identify the example of when situation and time are key to assessing risk of harm in
a research study: - ANSWER Asking women if they have had an abortion
Which of the following studies would need IRB approval? - ANSWER Studies
collecting identifiable information about living individuals.
Identify one way faculty researchers can possibly avoid undue influence of student
subjects? - ANSWER Avoid recruiting their own students in the research
Under the U.S. Department of Health and Human Services (HHS) and U.S. Food
and Drug Administration (FDA) regulations, what is the Institutional Review Board
(IRB) charged with? Select all that apply. - ANSWER - Protecting the rights and
welfare of human subjects.- Assuring that researchers follow all applicable
institutional policies and federal regulations related to research with human
subjects.- Reviewing subject recruitment materials and strategies.
Where could student researchers and/or student subjects find additional resources
regarding the IRB approval process? Select all that apply. - ANSWER - Faculty
Advisor/Research Mentor
- IRB Office
In the U.S., the first federal regulations for human subjects research began in 1981
with the codification of the ________. - ANSWER Common Rule
,Which of the following is an example of how the principle of beneficence can be
applied to a study employing human subjects? - ANSWER Determining that the
study has a maximization of benefits and a minimization of risks.
Which of the following are the three principles discussed in the Belmont Report? -
ANSWER Respect for Persons, Beneficence, Justice
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: - ANSWER Persons with diminished autonomy are entitled to
protection.
Your informed consent form must describe _______. - ANSWER All foreseeable
risks and discomforts.
A student plans on interviewing 15 principals in neighboring high schools. The
student plans to collect data about the personal experiences the principals have had
with disruptive students, including the types of disciplinary actions that were taken
(including decisions they may have personally made) and their feelings or thoughts
regarding whether those actions were appropriate. The research data collected could
have an impact on the principals' careers. The student will collect identifiers. This
study would be subject to which type of review? - ANSWER Convened Review
The Belmont principle of beneficence requires that: - ANSWER Risks to subjects
are reasonable in relation to anticipated benefits.
An example cited in the Belmont Report (The National Commission 1979) stated that
"During the 19th and early 20th centuries the burdens of serving as research
subjects fell largely upon poor ward patients, while the benefits of improved medical
care flowed primarily to private patients." This is an example of a violation of which
Belmont principle? - ANSWER Justice
According to the Belmont Report, the requirement that the benefits and burdens of
the research are equitably distributed, expresses the principle of: - ANSWER Justice
A study was submitted to the IRB designed to evaluate the effect of background
noise on an individual's ability to concentrate and answer questions. The IRB
approved the study and consent form. The consent form includes all the required
information. The use of a consent form is an example of the Belmont principle of: -
ANSWER Respect for persons
Humphreys' collecting data for the Tearoom Trade study under the pretense that he
was a lookout is an example of a violation of the principle of: - ANSWER Respect for
persons
A medical record is an example of: - ANSWER Private information
A researcher is interested in assessing risk-taking by individuals. The researcher is
sitting on a bench near a busy four-way stop intersection. She plans on recording the
number of bike riders wearing a safety helmet and whether they stop at the
, intersection before proceeding in order to correlate use of safety apparel with risk-
taking. This collection of information is an example of: - ANSWER Public behavior
According to the federal regulations, human subjects are living individuals about
whom an investigator conducting research obtains information through interaction or
intervention with the individual, and uses, studies, or analyzes the information; or: -
ANSWER Obtains, uses, studies, analyzes, or generates identifiable private
information.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? - ANSWER A cognitive psychologist
enrolls undergraduate students for a computer-based study about the effect of mood
on problem-solving behaviors.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? - ANSWER An experiment is proposed
on the relationship between gender-related stereotypes in math and the subsequent
performance by males and females on math tests.
Which of the following statements about the relationship between an institution and
the institution's IRB(s) is correct? - ANSWER Officials of the institution may overrule
an IRB approval.
According to the federal regulations, research is eligible for exemption, if: - ANSWER
The research falls into one of eight categories of research activity described in the
regulations.
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS
regulations provides additional protections for which of the following vulnerable
populations? - ANSWER Prisoners
According to federal regulations, the expedited review process may be used when
the study procedures pose: - ANSWER No more than minimal risk and the research
activities fall within regulatory categories identified as eligible.
Continuing review of an approved and ongoing study posing more than minimal risk
that was initially approved by a convened IRB: - ANSWER Must occur within 12
months of the approval date.
What statement about risks in social and behavioral sciences research is most
accurate: - ANSWER Risks are specific to time, situation, and culture.
A researcher wishes to study generational differences in coping mechanisms among
adults who experienced abuse as children. Adequate measures will be instituted to
obtain informed consent and ensure that there is no breach of confidentiality. The
most likely additional risk is that some subjects may: - ANSWER Experience
emotional or psychological distress.
If disclosure of a subject's involvement in a specific research study can be potentially
harmful to the subject, and the consent form is the only record linking the subject to
questions with complete solutions
If disclosure of a subject's involvement in a specific research study can be potentially
harmful to the subject, and the consent form is the only record linking the subject to
the research, which of the following would be most helpful: - ANSWER Obtain a
waiver of documentation of informed consent.
The primary purpose of a Certificate of Confidentiality is to: - ANSWER Protect
identifiable research information from compelled disclosure.
Additional safeguards that may be included in a social and behavioral study may
include: - ANSWER Remove all direct identifiers from the data as soon as possible.
A researcher wants to do a web-based survey of college students to collect
information about their sexual behavior and drug use. Direct identifiers will not be
collected; however, IP addresses may be present in the data set. Risk of harm
should be evaluated by: - ANSWER Both the magnitude (or severity) and the
probability (or likelihood) of harm.
Identify the example of when situation and time are key to assessing risk of harm in
a research study: - ANSWER Asking women if they have had an abortion
Which of the following studies would need IRB approval? - ANSWER Studies
collecting identifiable information about living individuals.
Identify one way faculty researchers can possibly avoid undue influence of student
subjects? - ANSWER Avoid recruiting their own students in the research
Under the U.S. Department of Health and Human Services (HHS) and U.S. Food
and Drug Administration (FDA) regulations, what is the Institutional Review Board
(IRB) charged with? Select all that apply. - ANSWER - Protecting the rights and
welfare of human subjects.- Assuring that researchers follow all applicable
institutional policies and federal regulations related to research with human
subjects.- Reviewing subject recruitment materials and strategies.
Where could student researchers and/or student subjects find additional resources
regarding the IRB approval process? Select all that apply. - ANSWER - Faculty
Advisor/Research Mentor
- IRB Office
In the U.S., the first federal regulations for human subjects research began in 1981
with the codification of the ________. - ANSWER Common Rule
,Which of the following is an example of how the principle of beneficence can be
applied to a study employing human subjects? - ANSWER Determining that the
study has a maximization of benefits and a minimization of risks.
Which of the following are the three principles discussed in the Belmont Report? -
ANSWER Respect for Persons, Beneficence, Justice
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: - ANSWER Persons with diminished autonomy are entitled to
protection.
Your informed consent form must describe _______. - ANSWER All foreseeable
risks and discomforts.
A student plans on interviewing 15 principals in neighboring high schools. The
student plans to collect data about the personal experiences the principals have had
with disruptive students, including the types of disciplinary actions that were taken
(including decisions they may have personally made) and their feelings or thoughts
regarding whether those actions were appropriate. The research data collected could
have an impact on the principals' careers. The student will collect identifiers. This
study would be subject to which type of review? - ANSWER Convened Review
The Belmont principle of beneficence requires that: - ANSWER Risks to subjects
are reasonable in relation to anticipated benefits.
An example cited in the Belmont Report (The National Commission 1979) stated that
"During the 19th and early 20th centuries the burdens of serving as research
subjects fell largely upon poor ward patients, while the benefits of improved medical
care flowed primarily to private patients." This is an example of a violation of which
Belmont principle? - ANSWER Justice
According to the Belmont Report, the requirement that the benefits and burdens of
the research are equitably distributed, expresses the principle of: - ANSWER Justice
A study was submitted to the IRB designed to evaluate the effect of background
noise on an individual's ability to concentrate and answer questions. The IRB
approved the study and consent form. The consent form includes all the required
information. The use of a consent form is an example of the Belmont principle of: -
ANSWER Respect for persons
Humphreys' collecting data for the Tearoom Trade study under the pretense that he
was a lookout is an example of a violation of the principle of: - ANSWER Respect for
persons
A medical record is an example of: - ANSWER Private information
A researcher is interested in assessing risk-taking by individuals. The researcher is
sitting on a bench near a busy four-way stop intersection. She plans on recording the
number of bike riders wearing a safety helmet and whether they stop at the
, intersection before proceeding in order to correlate use of safety apparel with risk-
taking. This collection of information is an example of: - ANSWER Public behavior
According to the federal regulations, human subjects are living individuals about
whom an investigator conducting research obtains information through interaction or
intervention with the individual, and uses, studies, or analyzes the information; or: -
ANSWER Obtains, uses, studies, analyzes, or generates identifiable private
information.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? - ANSWER A cognitive psychologist
enrolls undergraduate students for a computer-based study about the effect of mood
on problem-solving behaviors.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? - ANSWER An experiment is proposed
on the relationship between gender-related stereotypes in math and the subsequent
performance by males and females on math tests.
Which of the following statements about the relationship between an institution and
the institution's IRB(s) is correct? - ANSWER Officials of the institution may overrule
an IRB approval.
According to the federal regulations, research is eligible for exemption, if: - ANSWER
The research falls into one of eight categories of research activity described in the
regulations.
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS
regulations provides additional protections for which of the following vulnerable
populations? - ANSWER Prisoners
According to federal regulations, the expedited review process may be used when
the study procedures pose: - ANSWER No more than minimal risk and the research
activities fall within regulatory categories identified as eligible.
Continuing review of an approved and ongoing study posing more than minimal risk
that was initially approved by a convened IRB: - ANSWER Must occur within 12
months of the approval date.
What statement about risks in social and behavioral sciences research is most
accurate: - ANSWER Risks are specific to time, situation, and culture.
A researcher wishes to study generational differences in coping mechanisms among
adults who experienced abuse as children. Adequate measures will be instituted to
obtain informed consent and ensure that there is no breach of confidentiality. The
most likely additional risk is that some subjects may: - ANSWER Experience
emotional or psychological distress.
If disclosure of a subject's involvement in a specific research study can be potentially
harmful to the subject, and the consent form is the only record linking the subject to
