CITI TRAINING CERTIFICATION EXAM STUDY TEST GUIDE – EXPERTLY SOLVED
ALREADY GRADED A+
The Belmont Report's principle of respect for persons incorporates at least two ethical
conviction: first, that individuals should be treated as autonomous agents, and second
that:
persons with diminished are entitled to protection
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.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
Which is an example of a situation where deferential vulnerability might be a factor?
a physician recruiting his patients
A subject participates in a drug study because treatment is available at no or reduced cost,
and he could not otherwise afford it. This is an example of:
economic vulnerability
,Which is true of inducements in research?
Inducements constitute an "undue influence" if they alter a potential subject's decision-
making processes, such that they do not appropriately weigh the risk-benefit relationship
of the research.
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill
might be considered at especially high risk of harm for:
Situational cognitive vulnerability
Subjects with a serious illness may be at risk for exploitation because they may be
desperate for a possible cure. This is an example of:
Medical vulnerability
The expedited review process may NOT be used when the study procedures pose:
-more than minimal risk, even if the subjects are adults,
-the sponsor is in a hurry
-the study replicates previously approved research
Continuing review of an approved and ongoing protocol...?
Must occur within 12 months of the approval date
(even if no additional risks have been identified)
,Continuing review process must include:
-unanticipated problems
-number of subjects accrued
-recent relevant literature
-copy of current consent form
T/F
Officials of the institution may overrule an IRB approval
True, however no one may overrule if an IRB disapproved a protocol
An investigator wishes to study generational differences in coping mechanisms among
adults who experiences abuse as children. Adequate meausre will be instituted to obtain
consent and ensure that there is no breach of confidentiality. The most likely additional risk
is that some subjects may:
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 the
research, which would be the most helpful?
Obtain a waiver of documentation of informed consent
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research info from compelled disclosure
, Certificates of Confidentiality protect sensitive info provided by research subjects from:
civil, criminal, or administrative subpoena
T/F
Risk should be evaluated solely by the magnitude or severity of expected harm, not
probability
False: Risk must be determined by assessing magnitude (or severity) and probability (or
likelihood) of harm. Both elements must be considered.
Risks are specific to:
Time, situation, and culture
A researcher who is also a care provider needs to be very clear that a decision to
participate or not in a study will:
Not affect future care
T/F
The fact that a therapist has access to her clients' records as a clinician entitles her to use
info in the records for research purposes w/out parental permission nor child assent
False: S/he needs both parental permission & child assent
ALREADY GRADED A+
The Belmont Report's principle of respect for persons incorporates at least two ethical
conviction: first, that individuals should be treated as autonomous agents, and second
that:
persons with diminished are entitled to protection
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.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
Which is an example of a situation where deferential vulnerability might be a factor?
a physician recruiting his patients
A subject participates in a drug study because treatment is available at no or reduced cost,
and he could not otherwise afford it. This is an example of:
economic vulnerability
,Which is true of inducements in research?
Inducements constitute an "undue influence" if they alter a potential subject's decision-
making processes, such that they do not appropriately weigh the risk-benefit relationship
of the research.
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill
might be considered at especially high risk of harm for:
Situational cognitive vulnerability
Subjects with a serious illness may be at risk for exploitation because they may be
desperate for a possible cure. This is an example of:
Medical vulnerability
The expedited review process may NOT be used when the study procedures pose:
-more than minimal risk, even if the subjects are adults,
-the sponsor is in a hurry
-the study replicates previously approved research
Continuing review of an approved and ongoing protocol...?
Must occur within 12 months of the approval date
(even if no additional risks have been identified)
,Continuing review process must include:
-unanticipated problems
-number of subjects accrued
-recent relevant literature
-copy of current consent form
T/F
Officials of the institution may overrule an IRB approval
True, however no one may overrule if an IRB disapproved a protocol
An investigator wishes to study generational differences in coping mechanisms among
adults who experiences abuse as children. Adequate meausre will be instituted to obtain
consent and ensure that there is no breach of confidentiality. The most likely additional risk
is that some subjects may:
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 the
research, which would be the most helpful?
Obtain a waiver of documentation of informed consent
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research info from compelled disclosure
, Certificates of Confidentiality protect sensitive info provided by research subjects from:
civil, criminal, or administrative subpoena
T/F
Risk should be evaluated solely by the magnitude or severity of expected harm, not
probability
False: Risk must be determined by assessing magnitude (or severity) and probability (or
likelihood) of harm. Both elements must be considered.
Risks are specific to:
Time, situation, and culture
A researcher who is also a care provider needs to be very clear that a decision to
participate or not in a study will:
Not affect future care
T/F
The fact that a therapist has access to her clients' records as a clinician entitles her to use
info in the records for research purposes w/out parental permission nor child assent
False: S/he needs both parental permission & child assent
