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EXEMPTIONS 1, 2, AND 2a
in human subjects research
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University of Michigan IRB Collaborative
Exemptions 1, 2, and 2a
Certain sub-categories of research
• exempt from federal regulations governing IRB operations
• exempt under UM’s flexibility initiative
•
•
no greater than
minimal risk
not federally funded
not FDA-regulated
Exempt research does not require
•
•
ongoing IRB oversight through continuing review
specific approval of processes or consent materials
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Exemptions 1, 2, and 2a
UM policy requires IRB staff or
the Office of Research to confirm
exemption eligibility via a
streamlined eResearch
application.
Exempt
determinations do
not require review by
•
•
convened IRB
expedited review
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Exemptions 1, 2, and 2a
Research
•
•
on educational methods
based on survey and interview methodologies
may be eligible for
• federal exemption category 1
• federal exemption category 2
• UM flexibility initiative exemption category 2a
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Exemptions 1, 2, and 2a
Federal exemption category 1
Research conducted in established or commonly accepted educational settings,
involving normal educational practices, such as (i) research on regular and special
education instructional strategies, or (ii) research on the effectiveness of or the comparison
among instructional techniques, curricula, or classroom management methods.
Education settings
• most often schools
• any place where instruction takes place
Normal educational practices
•
activities that typically occur in a classroom
or other educational setting
•
•
•
•
test development
experimentation with instructional methods
evaluation of classroom or school activities
assessment of attitudes about learning or curriculum
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UMHS Clinical Simulation Center mannequin
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Exemptions 1, 2, and 2a
Federal exemption category 2
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation of public behavior, unless: (i) information
obtained is recorded in such a manner that human subjects can be identified, directly or through
identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside
the research could reasonably place the subjects at risk of criminal or civil liability or be damaging
to the subjects’ financial standing, employability, or reputation.
If particularly sensitive,
data must be recorded anonymously.
Data collection methods are limited to
• educational tests
• surveys, interviews, focus groups
• observation of public behavior
Examples:
• web-based or in-person surveys of adults
• study drawing on Twitter posts
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Exemptions 1, 2, and 2a
Research not eligible for exemption 2
• survey/interview studies involving minors
• studies involving physical or behavioral interventions
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Exemptions 1, 2, and 2a
University of Michigan flexibility initiative
exemption category 2a
•
•
•
minimal risk
adults
non-invasive intervention
•
•
•
•
•
•
•
video
story
economic game
computer program
experimental tool
exposure to stimuli
data collection via
•
•
•
•
•
survey
interview (including focus groups)
test
observation
physiological measurements
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Exemptions 1, 2, and 2a
Research not eligible for exemption 2a
• more than minimal risk
• federal funding
• other regulatory or contractual restrictions
•
•
FDA-regulated components
NIH Certificate of Confidentiality
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Exemptions 1, 2, and 2a
Exemption categories
1, 2, and 2a
References
http://www.irb.umich.edu/application/exempt.html
http://medicine.umich.edu/medschool/research/office-research/institutional-reviewboards/guidance/exempt-research
http://www.hhs.gov/ohrp/policy/faq/exempt-research-determination/index.html
http://www.irb.umich.edu/education/downloads/IRB-HSBS_Newsletter_Spring_2013.pdf
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THANK YOU.
Lark Speyer
IRBMED
Cindy Shindledecker
IRB-HSBS
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