CITI Training: Revised Common Rule
46.116(b)(9) is a new required element of informed consent that specifically applies to
any research involving the collection of identifiable information or biospecimens. This
requirement is to include one of two statements about the collection of private
information or identifiable biospecimens for future research. An example of this new
required language is: - ANS - Your information or biospecimens will not be used or
distributed for future research studies even if the identifiers are removed.
A key change included in the Final Rule requires which of the following items to appear
at the beginning of the consent form and be presented first in the consent discussion? -
ANS - Key information
A new requirement was added at 46.116(b)(9) that specifically applies to any research
that involves the collection of identifiable private information or identifiable
biospecimens. This new requirement is to include one of two statements about future
research, including: - ANS - A disclosure that identifiers might be removed and the
de-identified information or biospecimens used for future research without additional
informed consent from the subject
A researcher wants to study a distinct native culture in Eastern Africa, where signing
forms is not the norm, to learn more about the prevalence and health effects of local
tobacco use methods in the region. For the IRB to approve this research study with a
waiver of documentation, the research must: - ANS - Present no more than minimal risk
to subjects and there must be an appropriate mechanism for documenting that informed
consent was obtained
According to 46.116, whose responsibility is it to provide more information when
requested by subjects, allow sufficient time and opportunity to discuss the research, and
answer questions to improve a subject's understanding? - ANS - Investigator
According to the Final Rule, broad consent is: - ANS - Permitted as an alternative to
standard informed consent
, An IRB may use the expedited review procedure to review research for which limited
IRB review is a condition of exemption. Who from this list could conduct the limited IRB
review? - ANS - IRB Chair
Benign behavioral interventions are activities that: - ANS - Pose little risk of harm to
subjects
Benign behavioral interventions were not defined, but described as which of the
following? - ANS - 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
Broad consent for storage, maintenance, and secondary research use may be obtained:
- ANS - In lieu of a full informed consent
Examples of vulnerable populations in the Final Rule no longer include: - ANS -
Pregnant women
Exempt Category 6 (Taste and Food Quality Evaluation and Consumer Acceptance
Studies) was the only that category that was: - ANS - Unchanged by the Final Rule
For general waivers or alterations of consent, the Final Rule: - ANS - Did not change
the four existing waiver conditions, but added a criterion
For research subject to Subpart C (Prisoners), the Final Rule exemptions do not apply
unless: - ANS - The research is aimed at involving a broader subject population that
only incidentally includes prisoners
he Final Rule introduces the term "key information." The Final Rule: - ANS - Does not
define this new term
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: - ANS
- Clinical trial
If a subject refused to consent to broad consent, an IRB may do which of the following?
- ANS - Not waive consent for the storage, maintenance, or secondary research use of
the subject's identifiable private information or identifiable biospecimens
46.116(b)(9) is a new required element of informed consent that specifically applies to
any research involving the collection of identifiable information or biospecimens. This
requirement is to include one of two statements about the collection of private
information or identifiable biospecimens for future research. An example of this new
required language is: - ANS - Your information or biospecimens will not be used or
distributed for future research studies even if the identifiers are removed.
A key change included in the Final Rule requires which of the following items to appear
at the beginning of the consent form and be presented first in the consent discussion? -
ANS - Key information
A new requirement was added at 46.116(b)(9) that specifically applies to any research
that involves the collection of identifiable private information or identifiable
biospecimens. This new requirement is to include one of two statements about future
research, including: - ANS - A disclosure that identifiers might be removed and the
de-identified information or biospecimens used for future research without additional
informed consent from the subject
A researcher wants to study a distinct native culture in Eastern Africa, where signing
forms is not the norm, to learn more about the prevalence and health effects of local
tobacco use methods in the region. For the IRB to approve this research study with a
waiver of documentation, the research must: - ANS - Present no more than minimal risk
to subjects and there must be an appropriate mechanism for documenting that informed
consent was obtained
According to 46.116, whose responsibility is it to provide more information when
requested by subjects, allow sufficient time and opportunity to discuss the research, and
answer questions to improve a subject's understanding? - ANS - Investigator
According to the Final Rule, broad consent is: - ANS - Permitted as an alternative to
standard informed consent
, An IRB may use the expedited review procedure to review research for which limited
IRB review is a condition of exemption. Who from this list could conduct the limited IRB
review? - ANS - IRB Chair
Benign behavioral interventions are activities that: - ANS - Pose little risk of harm to
subjects
Benign behavioral interventions were not defined, but described as which of the
following? - ANS - 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
Broad consent for storage, maintenance, and secondary research use may be obtained:
- ANS - In lieu of a full informed consent
Examples of vulnerable populations in the Final Rule no longer include: - ANS -
Pregnant women
Exempt Category 6 (Taste and Food Quality Evaluation and Consumer Acceptance
Studies) was the only that category that was: - ANS - Unchanged by the Final Rule
For general waivers or alterations of consent, the Final Rule: - ANS - Did not change
the four existing waiver conditions, but added a criterion
For research subject to Subpart C (Prisoners), the Final Rule exemptions do not apply
unless: - ANS - The research is aimed at involving a broader subject population that
only incidentally includes prisoners
he Final Rule introduces the term "key information." The Final Rule: - ANS - Does not
define this new term
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: - ANS
- Clinical trial
If a subject refused to consent to broad consent, an IRB may do which of the following?
- ANS - Not waive consent for the storage, maintenance, or secondary research use of
the subject's identifiable private information or identifiable biospecimens
