COMMON RULE WITH VERIFIED
QUESTIONS AND ANSWERS
GRADED A+ 2026 VERSION!!
Which of the following is accurate regarding electronic signatures? - answer-Specifically
allowed by the Final Rule
The Final Rule added the requirement that: - 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: - answer-Final Rule (2018 Requirements)
The compliance date for cooperative review is: - 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:
- answer-In lieu of a full informed consent
The following category of research was added to the "Exempt Research" section at
46.104: - 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? - answer-Secondary
research for which broad consent is required (Category 8)
The Final Rule's general compliance date is: - answer-21 January 2019
, The Final Rule revised the definition of "written or in writing" to clarify: - answer-That
these terms include electronic formats
The definition of "research" was expanded to: - answer-List activities that are
specifically deemed not to be research
The Final Rule made revisions to the following definition: - answer-Human subject
Which of the following definitions was added by the Final Rule? - answer-Written or in
writings
Why was adding the definition of public health authority important? - answer-Certain
public health surveillance activities are now excluded from the definition of research
The three new terms added to the definitions section include: - answer-Clinical trial,
public health authority, and written or in writing
Benign behavioral interventions are activities that: - answer-Pose little risk of harm to
subjects
Which of the following definitions remained unchanged in the Final Rule? - 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: -
answer-Clinical trial
The term "vulnerable" was: - answer-Not included in the definitions section
Examples of vulnerable populations in the Final Rule no longer include: - answer-
Pregnant women