CITI TRAINING, MODULES 1-24
BIOMEDICAL RESEARCH QUESTIONS
AND ANSWERS GRADED A+
o 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:
A. Persons with diminished autonomy should only participate in no more than minimal risk research.
B. Persons with diminished autonomy should be excluded from research.
C. Persons with diminished autonomy are entitled to protection.
D. Persons involved in research cannot financially benefit. - C. Persons with diminished autonomy 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?
A. Ensuring that persons with diminished autonomy are protected.
B. Providing detailed information about the study and obtaining the subject's consent to participate.
C. Determining that the study has a maximization of benefits and a minimization of risks.
D. Ensuring that the selection of subjects includes people from all segments of the population. - C.
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?
A. IRB Review, Federal Regulations, Declaration of Helsinki
B. Privacy, Confidentiality, Equitable Selection of Subjects
C. Informed Consent, Institutional Assurance, Researcher Responsibility
D. Respect for Persons, Beneficence, Justice - D. Respect for Persons, Beneficence, Justice
When an IRB is reviewing a research study and they are considering if a potential subject population is
vulnerable, they should consider:
A. Are there adequate resources to conduct the study?
B. Is there a power differential between researchers and subjects?
C. Has the researcher completed required training?
D. Are the research procedures greater than minimal risk of harm? - B. Is there a power differential
between researchers and subjects?
,Which is an example of a situation where deferential vulnerability might be a factor?
A. An army medical officer recruiting subjects among lower ranks
B. A college professor recruiting among their students
C. A physician recruiting patients to be subjects
D. An employer recruiting among persons who directly report to them - C. A physician recruiting patients
to be subjects
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be
considered at especially high risk of harm for:
A. Economic vulnerability
B. Situational cognitive vulnerability
C. Capacity-related cognitive vulnerability
D. Communicative vulnerability - B. Situational cognitive vulnerability
Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in
Subparts B, C, and D with additional protections:
A. Pregnant women, prisoners, and mentally disabled
B. Children, prisoners, and terminally ill
C. Prisoners, children, and elderly
D. Pregnant women, prisoners, children - D. Pregnant women, prisoners, children
The NBAC looks at characteristics individuals might have that would prevent them from being able to
provide voluntary informed consent. The traits may be thought of as falling into six broad areas:
cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective
research subjects who are not able to comprehend information, deliberate, and make decisions about
participation in a proposed research study have a:
A. Institutional vulnerability
B. Cognitive or communicative vulnerability
C. Physical vulnerability
D. Economic or social vulnerability - B. Cognitive or communicative vulnerability
The use of prisoners in research is a concern under the Belmont principle of Justice because:
A. Prisoners are less educated that the general population and have difficulty understanding research
B. Prisoners may not be used to conduct research that only benefits the larger society
C. Prisoners are not a representative sample of the general population
,D. Prisoners are not free to say no - B. Prisoners may not be used to conduct research that only benefits
the larger society
Which of the following is included in the Nuremberg Code:
A. Additional protection for vulnerable subjects
B. Equitable selection of subjects
C. Confidentiality of data
D. Voluntary consent - D. Voluntary consent
Which of the following brought increased public attention to the problems with the IRB system?
A. 1983 Presidential Commission Report
B. HHS Inspector General Report of 1998
C. "Shut Downs" by OHRP
D. Death of Research Subject (Jesse Gelsinger) - D. Death of Research Subject (Jesse Gelsinger)
Informed consent is considered an application of which Belmont principle?
A. Non-maleficence
B. Justice
C. Beneficence
D. Respect for Persons - D. Respect for Persons
The National Research Act of 1974
A. Required that all federal agencies have the same regulations governing human subjects research.
B. Identified guidelines to ensure the ethical conduct of research.
C. Established the National Commission.
D. Identified the basic ethical principles of human subjects research. - C. Established the National
Commission.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How
should the investigator proceed, with respect to the IRB, after the discovery of the adverse event
occurrence?
A. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and
procedures, using the forms or the mechanism provided by the IRB.
B. Report the adverse drug experience as part of the continuing review report.
C. Do not report the adverse drug experience to the IRB since it is a common adverse experience.
, D. Report the adverse drug experience to the IRB only if there are several other occurrences. - A. Report
the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using
the forms or the mechanism provided by the IRB.
How long is an investigator required to keep consent documents, IRB correspondence, and research
records?
A. As long as the investigator is at that institution
B. oFor oa ominimum oof othree oyears oafter ocompletion oof othe ostudy
C. oUntil odata oanalysis ois ocomplete
D. oUntil othe ostudy ois oclosed o- oB. oFor oa ominimum oof othree oyears oafter ocompletion oof othe ostudy
According oto ofederal oregulations, owhich oof othe ofollowing obest odescribes owhen oexpedited oreview oof
oa onew, oproposed ostudy omay obe oused oby othe oIRB?
A. oThe ostudy ois orequired ofor oa ostudent oresearch oproject
B. oThe ostudy oincludes oonly oresearch osubjects othat oare ohealthy ovolunteers.
C. oThe ostudy odoes onot orequire oinformed oconsent oor osurvey oinstruments.
D. oThe ostudy oinvolves ono omore othan ominimal orisk oand omeets oone oof othe oallowable ocategories oof
oexpedited oreview ospecified oin ofederal oregulations o- oD. oThe ostudy oinvolves ono omore othan ominimal
orisk oand omeets oone oof othe oallowable ocategories oof oexpedited oreview ospecified oin ofederal
oregulations
Amendments oinvolving ochanges oto oIRB-approved oprotocols odo oNOT oneed oprior oIRB oapproval oif:
A. oThey oonly oinvolve ochanges oto othe oconsent oform.
B. oThe ochanges omust obe oimmediately oimplemented ofor othe ohealth oand owell-being oof othe osubject.
C. oThey oare oeligible ofor oreview ousing oexpedited oprocedures.
D. oThe oinvestigator okeeps ocareful orecords oof oall ochanges oand oincludes othem oin othe ofinal oreport. o-
oB. oThe ochanges omust obe oimmediately oimplemented ofor othe ohealth oand owell-being oof othe osubject.
IRB ocontinuing oreview oof oa ogreater othan ominimal orisk oapproved oprotocol othat ois ocurrently oenrolling
osubjects omust:
A. oInclude ocopies oof oall osigned oconsent oforms.
B. oOccur oat oleast oannually.
C. oBe oconducted oby oan oexpedited oreview.
D. oOccur oonly owhen othe olevel oof orisk ochanges. o- oB. oOccur oat oleast oannually.
BIOMEDICAL RESEARCH QUESTIONS
AND ANSWERS GRADED A+
o 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:
A. Persons with diminished autonomy should only participate in no more than minimal risk research.
B. Persons with diminished autonomy should be excluded from research.
C. Persons with diminished autonomy are entitled to protection.
D. Persons involved in research cannot financially benefit. - C. Persons with diminished autonomy 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?
A. Ensuring that persons with diminished autonomy are protected.
B. Providing detailed information about the study and obtaining the subject's consent to participate.
C. Determining that the study has a maximization of benefits and a minimization of risks.
D. Ensuring that the selection of subjects includes people from all segments of the population. - C.
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?
A. IRB Review, Federal Regulations, Declaration of Helsinki
B. Privacy, Confidentiality, Equitable Selection of Subjects
C. Informed Consent, Institutional Assurance, Researcher Responsibility
D. Respect for Persons, Beneficence, Justice - D. Respect for Persons, Beneficence, Justice
When an IRB is reviewing a research study and they are considering if a potential subject population is
vulnerable, they should consider:
A. Are there adequate resources to conduct the study?
B. Is there a power differential between researchers and subjects?
C. Has the researcher completed required training?
D. Are the research procedures greater than minimal risk of harm? - B. Is there a power differential
between researchers and subjects?
,Which is an example of a situation where deferential vulnerability might be a factor?
A. An army medical officer recruiting subjects among lower ranks
B. A college professor recruiting among their students
C. A physician recruiting patients to be subjects
D. An employer recruiting among persons who directly report to them - C. A physician recruiting patients
to be subjects
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be
considered at especially high risk of harm for:
A. Economic vulnerability
B. Situational cognitive vulnerability
C. Capacity-related cognitive vulnerability
D. Communicative vulnerability - B. Situational cognitive vulnerability
Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in
Subparts B, C, and D with additional protections:
A. Pregnant women, prisoners, and mentally disabled
B. Children, prisoners, and terminally ill
C. Prisoners, children, and elderly
D. Pregnant women, prisoners, children - D. Pregnant women, prisoners, children
The NBAC looks at characteristics individuals might have that would prevent them from being able to
provide voluntary informed consent. The traits may be thought of as falling into six broad areas:
cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective
research subjects who are not able to comprehend information, deliberate, and make decisions about
participation in a proposed research study have a:
A. Institutional vulnerability
B. Cognitive or communicative vulnerability
C. Physical vulnerability
D. Economic or social vulnerability - B. Cognitive or communicative vulnerability
The use of prisoners in research is a concern under the Belmont principle of Justice because:
A. Prisoners are less educated that the general population and have difficulty understanding research
B. Prisoners may not be used to conduct research that only benefits the larger society
C. Prisoners are not a representative sample of the general population
,D. Prisoners are not free to say no - B. Prisoners may not be used to conduct research that only benefits
the larger society
Which of the following is included in the Nuremberg Code:
A. Additional protection for vulnerable subjects
B. Equitable selection of subjects
C. Confidentiality of data
D. Voluntary consent - D. Voluntary consent
Which of the following brought increased public attention to the problems with the IRB system?
A. 1983 Presidential Commission Report
B. HHS Inspector General Report of 1998
C. "Shut Downs" by OHRP
D. Death of Research Subject (Jesse Gelsinger) - D. Death of Research Subject (Jesse Gelsinger)
Informed consent is considered an application of which Belmont principle?
A. Non-maleficence
B. Justice
C. Beneficence
D. Respect for Persons - D. Respect for Persons
The National Research Act of 1974
A. Required that all federal agencies have the same regulations governing human subjects research.
B. Identified guidelines to ensure the ethical conduct of research.
C. Established the National Commission.
D. Identified the basic ethical principles of human subjects research. - C. Established the National
Commission.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How
should the investigator proceed, with respect to the IRB, after the discovery of the adverse event
occurrence?
A. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and
procedures, using the forms or the mechanism provided by the IRB.
B. Report the adverse drug experience as part of the continuing review report.
C. Do not report the adverse drug experience to the IRB since it is a common adverse experience.
, D. Report the adverse drug experience to the IRB only if there are several other occurrences. - A. Report
the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using
the forms or the mechanism provided by the IRB.
How long is an investigator required to keep consent documents, IRB correspondence, and research
records?
A. As long as the investigator is at that institution
B. oFor oa ominimum oof othree oyears oafter ocompletion oof othe ostudy
C. oUntil odata oanalysis ois ocomplete
D. oUntil othe ostudy ois oclosed o- oB. oFor oa ominimum oof othree oyears oafter ocompletion oof othe ostudy
According oto ofederal oregulations, owhich oof othe ofollowing obest odescribes owhen oexpedited oreview oof
oa onew, oproposed ostudy omay obe oused oby othe oIRB?
A. oThe ostudy ois orequired ofor oa ostudent oresearch oproject
B. oThe ostudy oincludes oonly oresearch osubjects othat oare ohealthy ovolunteers.
C. oThe ostudy odoes onot orequire oinformed oconsent oor osurvey oinstruments.
D. oThe ostudy oinvolves ono omore othan ominimal orisk oand omeets oone oof othe oallowable ocategories oof
oexpedited oreview ospecified oin ofederal oregulations o- oD. oThe ostudy oinvolves ono omore othan ominimal
orisk oand omeets oone oof othe oallowable ocategories oof oexpedited oreview ospecified oin ofederal
oregulations
Amendments oinvolving ochanges oto oIRB-approved oprotocols odo oNOT oneed oprior oIRB oapproval oif:
A. oThey oonly oinvolve ochanges oto othe oconsent oform.
B. oThe ochanges omust obe oimmediately oimplemented ofor othe ohealth oand owell-being oof othe osubject.
C. oThey oare oeligible ofor oreview ousing oexpedited oprocedures.
D. oThe oinvestigator okeeps ocareful orecords oof oall ochanges oand oincludes othem oin othe ofinal oreport. o-
oB. oThe ochanges omust obe oimmediately oimplemented ofor othe ohealth oand owell-being oof othe osubject.
IRB ocontinuing oreview oof oa ogreater othan ominimal orisk oapproved oprotocol othat ois ocurrently oenrolling
osubjects omust:
A. oInclude ocopies oof oall osigned oconsent oforms.
B. oOccur oat oleast oannually.
C. oBe oconducted oby oan oexpedited oreview.
D. oOccur oonly owhen othe olevel oof orisk ochanges. o- oB. oOccur oat oleast oannually.
