CITI Training: Students Research
Students in Research
Which of the following studies would need IRB approval?
A. Studies that involve cadavers.
B. Studies collecting identifiable information about living individuals.
C. Studies that use data collected for internal department use only and the aim of the
study is quality improvement for the department only.
D. Studies that use publicly available census data from the years 1890-1910.
B. Studies collecting identifiable information about living individuals.
If a study intends to collect identifiable or information about a living individual, you would
need IRB review and approval.
Students in Research
A student is conducting a research project that involves the use of a survey. The survey
asks subjects about their highest level of education, political affiliation, and views on
various social issues. The student will not collect identifiable information. This study
would be subject to which type of review?
A. Convened Review
B. Determination for Exemption
C. Expedited Review
D. Not Human Subjects
, B. Determination for Exemption
This study would qualify for a determination for exemption (under Category 2). This
exemption category states that any research study involving educational tests, surveys,
interviews, or observations of public behavior can be deemed exempt, unless the data
is recorded in a way that identifies human subjects, directly or through identifiers linked
to the subjects, and disclosure of any human subjects' responses outside the research
could reasonably place participants at risk of criminal or civil liability or damage their
financial standing, employability, or reputation.
Students in Research
Which type of IRB review does not require an IRB approval but does require a
determination by an individual designated with that task (such as an IRB member or
experienced staff person)?
A. Exempt
B. Expedited
C. Convened/Full Board
A. Exempt
Exempt research is human subjects research that is "exempt" from the Common Rule
provisions. Per federal guidance, the recommendation is that researchers should not be
able to self-determine whether a study qualifies for exemption. Institutional policy should
clearly designate who is responsible for making exemption determinations – and it could
be an IRB member or experienced staff person with knowledge of the exemption
categories and the research activity. Expedited and convened reviews both require IRB
approval.
Students in Research
Students in Research
Which of the following studies would need IRB approval?
A. Studies that involve cadavers.
B. Studies collecting identifiable information about living individuals.
C. Studies that use data collected for internal department use only and the aim of the
study is quality improvement for the department only.
D. Studies that use publicly available census data from the years 1890-1910.
B. Studies collecting identifiable information about living individuals.
If a study intends to collect identifiable or information about a living individual, you would
need IRB review and approval.
Students in Research
A student is conducting a research project that involves the use of a survey. The survey
asks subjects about their highest level of education, political affiliation, and views on
various social issues. The student will not collect identifiable information. This study
would be subject to which type of review?
A. Convened Review
B. Determination for Exemption
C. Expedited Review
D. Not Human Subjects
, B. Determination for Exemption
This study would qualify for a determination for exemption (under Category 2). This
exemption category states that any research study involving educational tests, surveys,
interviews, or observations of public behavior can be deemed exempt, unless the data
is recorded in a way that identifies human subjects, directly or through identifiers linked
to the subjects, and disclosure of any human subjects' responses outside the research
could reasonably place participants at risk of criminal or civil liability or damage their
financial standing, employability, or reputation.
Students in Research
Which type of IRB review does not require an IRB approval but does require a
determination by an individual designated with that task (such as an IRB member or
experienced staff person)?
A. Exempt
B. Expedited
C. Convened/Full Board
A. Exempt
Exempt research is human subjects research that is "exempt" from the Common Rule
provisions. Per federal guidance, the recommendation is that researchers should not be
able to self-determine whether a study qualifies for exemption. Institutional policy should
clearly designate who is responsible for making exemption determinations – and it could
be an IRB member or experienced staff person with knowledge of the exemption
categories and the research activity. Expedited and convened reviews both require IRB
approval.
Students in Research
