CITI Training, Modules 1-24 (Biomedical
Research) Exam questions with correct
answers
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. |- |VERIFIED |ANSWER✔✔-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. |- |
VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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? |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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) |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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. |- |VERIFIED |ANSWER✔✔-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. |- |
VERIFIED |ANSWER✔✔-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. |For |a |minimum |of |three |years |after |completion |of |the |study
C. |Until |data |analysis |is |complete
D. |Until |the |study |is |closed |- |VERIFIED |ANSWER✔✔-B. |For |a |minimum |of |three |years |after |
completion |of |the |study
According |to |federal |regulations, |which |of |the |following |best |describes |when |expedited |review |of |
a |new, |proposed |study |may |be |used |by |the |IRB?
A. |The |study |is |required |for |a |student |research |project
B. |The |study |includes |only |research |subjects |that |are |healthy |volunteers.
C. |The |study |does |not |require |informed |consent |or |survey |instruments.
D. |The |study |involves |no |more |than |minimal |risk |and |meets |one |of |the |allowable |categories |of |
expedited |review |specified |in |federal |regulations |- |VERIFIED |ANSWER✔✔-D. |The |study |involves |no
|more |than |minimal |risk |and |meets |one |of |the |allowable |categories |of |expedited |review |specified |
in |federal |regulations
Amendments |involving |changes |to |IRB-approved |protocols |do |NOT |need |prior |IRB |approval |if:
A. |They |only |involve |changes |to |the |consent |form.
B. |The |changes |must |be |immediately |implemented |for |the |health |and |well-being |of |the |subject.
C. |They |are |eligible |for |review |using |expedited |procedures.
D. |The |investigator |keeps |careful |records |of |all |changes |and |includes |them |in |the |final |report. |- |
VERIFIED |ANSWER✔✔-B. |The |changes |must |be |immediately |implemented |for |the |health |and |well-
being |of |the |subject.
IRB |continuing |review |of |a |greater |than |minimal |risk |approved |protocol |that |is |currently |enrolling |
subjects |must:
A. |Include |copies |of |all |signed |consent |forms.
B. |Occur |at |least |annually.
C. |Be |conducted |by |an |expedited |review.
D. |Occur |only |when |the |level |of |risk |changes. |- |VERIFIED |ANSWER✔✔-B. |Occur |at |least |annually.
Research) Exam questions with correct
answers
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. |- |VERIFIED |ANSWER✔✔-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. |- |
VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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? |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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) |- |VERIFIED |ANSWER✔✔-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 |- |VERIFIED |ANSWER✔✔-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. |- |VERIFIED |ANSWER✔✔-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. |- |
VERIFIED |ANSWER✔✔-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. |For |a |minimum |of |three |years |after |completion |of |the |study
C. |Until |data |analysis |is |complete
D. |Until |the |study |is |closed |- |VERIFIED |ANSWER✔✔-B. |For |a |minimum |of |three |years |after |
completion |of |the |study
According |to |federal |regulations, |which |of |the |following |best |describes |when |expedited |review |of |
a |new, |proposed |study |may |be |used |by |the |IRB?
A. |The |study |is |required |for |a |student |research |project
B. |The |study |includes |only |research |subjects |that |are |healthy |volunteers.
C. |The |study |does |not |require |informed |consent |or |survey |instruments.
D. |The |study |involves |no |more |than |minimal |risk |and |meets |one |of |the |allowable |categories |of |
expedited |review |specified |in |federal |regulations |- |VERIFIED |ANSWER✔✔-D. |The |study |involves |no
|more |than |minimal |risk |and |meets |one |of |the |allowable |categories |of |expedited |review |specified |
in |federal |regulations
Amendments |involving |changes |to |IRB-approved |protocols |do |NOT |need |prior |IRB |approval |if:
A. |They |only |involve |changes |to |the |consent |form.
B. |The |changes |must |be |immediately |implemented |for |the |health |and |well-being |of |the |subject.
C. |They |are |eligible |for |review |using |expedited |procedures.
D. |The |investigator |keeps |careful |records |of |all |changes |and |includes |them |in |the |final |report. |- |
VERIFIED |ANSWER✔✔-B. |The |changes |must |be |immediately |implemented |for |the |health |and |well-
being |of |the |subject.
IRB |continuing |review |of |a |greater |than |minimal |risk |approved |protocol |that |is |currently |enrolling |
subjects |must:
A. |Include |copies |of |all |signed |consent |forms.
B. |Occur |at |least |annually.
C. |Be |conducted |by |an |expedited |review.
D. |Occur |only |when |the |level |of |risk |changes. |- |VERIFIED |ANSWER✔✔-B. |Occur |at |least |annually.
