Assessing Risk - SBE, CITI Questions
and Answers
A general requirement for informed consent is that no informed consent may include any exculpatory
language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights
or releases or appears to release those conducting the research from liability for negligence. Which of
the following statements in a consent form is an example of exculpatory language? Correct Ans-
Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal
redress for any research-related injuries.
A criterion for waiving informed consent is that, when appropriate, subjects are provided additional
pertinent information after the study. In which of the following studies would it NOT be appropriate to
provide subjects with information about missing elements of consent: Correct Ans-A study in which
subjects were assigned to study activities based on an undesirable or unflattering physical characteristic
as assessed by members of the research team.
A waiver of the requirement for documentation of informed consent may be granted when: Correct
Ans-The only record linking the subject and the research is the consent document and the principal risk
is a breach of confidentiality.
As part of the consent process, the federal regulations require researchers to: Correct Ans-Provide
potential subjects with information at the appropriate reading comprehension level.
Which of the following constitutes both a breach of confidentiality (the research data have been
disclosed, counter to the agreement between researcher and subjects) and a violation of subjects'
privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
Correct Ans-A faculty member makes identifiable data about sexual behavior available to graduate
students, although the subjects were assured that the data would be de-identified.
When a focus group deals with a potentially sensitive topic, which of the following statements about
providing confidentiality to focus group participants is correct? Correct Ans-The researcher cannot
control what participants repeat about others outside the group.
,Data are made anonymous by Correct Ans-Destroying all identifiers connected to the data.
In a longitudinal study that will follow children from kindergarten through high school and will collect
information about illegal activities, which of the following confidentiality procedures would protect
against compelled disclosure of individually identifiable information? Correct Ans-Securing a
Certificate of Confidentiality.
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file
contains charts of aggregated numerical data from a research study with human subjects, but no other
documents. The consent form said that no identifying information would be retained, and the researcher
adhered to that component. Which of the following statements best characterizes what occurred?
Correct Ans-There was neither a violation of privacy nor a breach of confidentiality.
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: Correct Ans-Obtain a waiver of documentation of informed consent.
The primary purpose of a Certificate of Confidentiality is to: Correct Ans-Protect identifiable research
information from compelled disclosure.
Additional safeguards that may be included in a social and behavioral study may include: Correct Ans-
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: Correct Ans-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:
Correct Ans-Asking women if they have had an abortion
Which of the following studies would need IRB approval? Correct Ans-Studies collecting identifiable
information about living individuals.
,Identify one way faculty researchers can possibly avoid undue influence of student subjects? Correct
Ans-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.
Correct Ans-- 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. Correct Ans-- 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 ________. Correct Ans-Common Rule
Which of the following is an example of how the principle of beneficence can be applied to a study
employing human subjects? Correct Ans-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? Correct Ans-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: Correct Ans-Persons with
diminished autonomy are entitled to protection.
Your informed consent form must describe _______. Correct Ans-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? Correct Ans-Convened Review
The Belmont principle of beneficence requires that: Correct Ans-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? Correct Ans-Justice
According to the Belmont Report, the requirement that the benefits and burdens of the research are
equitably distributed, expresses the principle of: Correct Ans-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: Correct Ans-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: Correct Ans-Respect for persons
A medical record is an example of: Correct Ans-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: Correct Ans-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: Correct Ans-Obtains, uses, studies, analyzes, or
generates identifiable private information.
and Answers
A general requirement for informed consent is that no informed consent may include any exculpatory
language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights
or releases or appears to release those conducting the research from liability for negligence. Which of
the following statements in a consent form is an example of exculpatory language? Correct Ans-
Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal
redress for any research-related injuries.
A criterion for waiving informed consent is that, when appropriate, subjects are provided additional
pertinent information after the study. In which of the following studies would it NOT be appropriate to
provide subjects with information about missing elements of consent: Correct Ans-A study in which
subjects were assigned to study activities based on an undesirable or unflattering physical characteristic
as assessed by members of the research team.
A waiver of the requirement for documentation of informed consent may be granted when: Correct
Ans-The only record linking the subject and the research is the consent document and the principal risk
is a breach of confidentiality.
As part of the consent process, the federal regulations require researchers to: Correct Ans-Provide
potential subjects with information at the appropriate reading comprehension level.
Which of the following constitutes both a breach of confidentiality (the research data have been
disclosed, counter to the agreement between researcher and subjects) and a violation of subjects'
privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
Correct Ans-A faculty member makes identifiable data about sexual behavior available to graduate
students, although the subjects were assured that the data would be de-identified.
When a focus group deals with a potentially sensitive topic, which of the following statements about
providing confidentiality to focus group participants is correct? Correct Ans-The researcher cannot
control what participants repeat about others outside the group.
,Data are made anonymous by Correct Ans-Destroying all identifiers connected to the data.
In a longitudinal study that will follow children from kindergarten through high school and will collect
information about illegal activities, which of the following confidentiality procedures would protect
against compelled disclosure of individually identifiable information? Correct Ans-Securing a
Certificate of Confidentiality.
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file
contains charts of aggregated numerical data from a research study with human subjects, but no other
documents. The consent form said that no identifying information would be retained, and the researcher
adhered to that component. Which of the following statements best characterizes what occurred?
Correct Ans-There was neither a violation of privacy nor a breach of confidentiality.
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: Correct Ans-Obtain a waiver of documentation of informed consent.
The primary purpose of a Certificate of Confidentiality is to: Correct Ans-Protect identifiable research
information from compelled disclosure.
Additional safeguards that may be included in a social and behavioral study may include: Correct Ans-
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: Correct Ans-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:
Correct Ans-Asking women if they have had an abortion
Which of the following studies would need IRB approval? Correct Ans-Studies collecting identifiable
information about living individuals.
,Identify one way faculty researchers can possibly avoid undue influence of student subjects? Correct
Ans-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.
Correct Ans-- 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. Correct Ans-- 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 ________. Correct Ans-Common Rule
Which of the following is an example of how the principle of beneficence can be applied to a study
employing human subjects? Correct Ans-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? Correct Ans-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: Correct Ans-Persons with
diminished autonomy are entitled to protection.
Your informed consent form must describe _______. Correct Ans-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? Correct Ans-Convened Review
The Belmont principle of beneficence requires that: Correct Ans-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? Correct Ans-Justice
According to the Belmont Report, the requirement that the benefits and burdens of the research are
equitably distributed, expresses the principle of: Correct Ans-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: Correct Ans-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: Correct Ans-Respect for persons
A medical record is an example of: Correct Ans-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: Correct Ans-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: Correct Ans-Obtains, uses, studies, analyzes, or
generates identifiable private information.
