CITI Training: Revised Common Rule Questions With All
Correct Answers
Which of the following is accurate regarding electronic signatures? correct
answer -Specifically allowed by the Final Rule
The Final Rule added the requirement that: correct answer -Key
information essential to decision making receive priority by appearing at the
beginning of the consent document and being presented first in the consent
discussion.
Research approved on 1 September 2019 conducted by a regulated entity
would be subject to: correct answer -Final Rule (2018 Requirements)
The compliance date for cooperative review is: correct answer -Three
years from publishing the 2017 Final Rule in the Federal Register
Broad consent for storage, maintenance, and secondary research use may be
obtained: correct answer -In lieu of a full informed consent
The following category of research was added to the "Exempt Research"
section at 46.104: correct answer -Benign behavioral interventions
The two exempt research categories that always require limited IRB review as
a condition of exemption are: Storage or maintenance for secondary research
for which broad consent is required (Category 7) and which of the following?
correct answer -Secondary research for which broad consent is required
(Category 8)
The Final Rule's general compliance date is: correct answer -21 January
2019
The Final Rule revised the definition of "written or in writing" to clarify:
correct answer -That these terms include electronic formats
The definition of "research" was expanded to: correct answer -List
activities that are specifically deemed not to be research
, The Final Rule made revisions to the following definition: correct answer -
Human subject
Which of the following definitions was added by the Final Rule? correct
answer -Written or in writings
Why was adding the definition of public health authority important? correct
answer -Certain public health surveillance activities are now excluded from
the definition of research
The three new terms added to the definitions section include: correct
answer -Clinical trial, public health authority, and written or in writing
Benign behavioral interventions are activities that: correct answer -Pose
little risk of harm to subjects
Which of the following definitions remained unchanged in the Final Rule?
correct answer -Institutional Review Board (IRB)
Identify the new term added by the Final Rule that should be used for
determining which studies require posting of the IRB-approved consent form
used to enroll subjects: correct answer -Clinical trial
The term "vulnerable" was: correct answer -Not included in the definitions
section
Examples of vulnerable populations in the Final Rule no longer include:
correct answer -Pregnant women
Benign behavioral interventions were not defined, but described as which of
the following? correct answer -Interventions in conjunction with collecting
information from an adult subject through oral or written responses
(including data entry) or audiovisual recording if the subject prospectively
agrees to the intervention and information collection and certain conditions
are met
For general waivers or alterations of consent, the Final Rule: correct answer
-Did not change the four existing waiver conditions, but added a criterion
Correct Answers
Which of the following is accurate regarding electronic signatures? correct
answer -Specifically allowed by the Final Rule
The Final Rule added the requirement that: correct answer -Key
information essential to decision making receive priority by appearing at the
beginning of the consent document and being presented first in the consent
discussion.
Research approved on 1 September 2019 conducted by a regulated entity
would be subject to: correct answer -Final Rule (2018 Requirements)
The compliance date for cooperative review is: correct answer -Three
years from publishing the 2017 Final Rule in the Federal Register
Broad consent for storage, maintenance, and secondary research use may be
obtained: correct answer -In lieu of a full informed consent
The following category of research was added to the "Exempt Research"
section at 46.104: correct answer -Benign behavioral interventions
The two exempt research categories that always require limited IRB review as
a condition of exemption are: Storage or maintenance for secondary research
for which broad consent is required (Category 7) and which of the following?
correct answer -Secondary research for which broad consent is required
(Category 8)
The Final Rule's general compliance date is: correct answer -21 January
2019
The Final Rule revised the definition of "written or in writing" to clarify:
correct answer -That these terms include electronic formats
The definition of "research" was expanded to: correct answer -List
activities that are specifically deemed not to be research
, The Final Rule made revisions to the following definition: correct answer -
Human subject
Which of the following definitions was added by the Final Rule? correct
answer -Written or in writings
Why was adding the definition of public health authority important? correct
answer -Certain public health surveillance activities are now excluded from
the definition of research
The three new terms added to the definitions section include: correct
answer -Clinical trial, public health authority, and written or in writing
Benign behavioral interventions are activities that: correct answer -Pose
little risk of harm to subjects
Which of the following definitions remained unchanged in the Final Rule?
correct answer -Institutional Review Board (IRB)
Identify the new term added by the Final Rule that should be used for
determining which studies require posting of the IRB-approved consent form
used to enroll subjects: correct answer -Clinical trial
The term "vulnerable" was: correct answer -Not included in the definitions
section
Examples of vulnerable populations in the Final Rule no longer include:
correct answer -Pregnant women
Benign behavioral interventions were not defined, but described as which of
the following? correct answer -Interventions in conjunction with collecting
information from an adult subject through oral or written responses
(including data entry) or audiovisual recording if the subject prospectively
agrees to the intervention and information collection and certain conditions
are met
For general waivers or alterations of consent, the Final Rule: correct answer
-Did not change the four existing waiver conditions, but added a criterion
