1. To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.
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U-MIC

2. Exemption changes under the revised Common Rule (2018)
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U-MIC
University of Michigan IRB Collaborative

3. Exemption changes Exempt research
subset of research involving human subjects
does not require comprehensive IRB review per full regulatory criteria
not subject to continuing review
amendments required only if changes could alter exempt determination
does not lessen investigators’ ethical obligations
including human subjects protections training
PEERRS or equivalent
distinct from “not regulated”
not considered research involving human subjects
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U-MIC

4. 2017 revisions to the Common Rule
Exemption changes
2017 revisions to the Common Rule
scheduled to become effective January 19, 2018
changes to existing exemption categories
addition of some new categories
opportunity to
streamline IRB application (HUM)
utilize eRRM "smartform logic“/routing functionality
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U-MIC

5. Exemption changes Standard application type renamed
“Human Subjects research involving interaction or intervention”
Exemption screener questions in this application
help identify whether an exemption category applies
route application along exemption paths
or comprehensive IRB review
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U-MIC

6. Exemption changes Secondary Use application renamed
“Secondary research uses of private information and/or biospecimens”
routes secondary use studies through correct IRB review/determination path
not regulated
exempt
comprehensive IRB approval
Developed by:
U-MIC

7. Exemption changes Self-determination letter of exemption
investigators may generate Self-determination letter
for some studies qualifying for exemption 1, 2, or 3
main interaction/intervention exemptions
Situations that don’t qualify for self-determination
PHI for screening
projects involving deception
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U-MIC

8. Exemption changes Exemption 1: Educational Exemption
applies to research conducted in educational settings
involving normal educational practices
benefit students/support that setting’s curriculum
revised Common Rule clarifies eligibility language
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U-MIC

9. Exemption changes
Exemption 2: Surveys, Interviews, Educational Tests, Focus Groups, and Observation of Public Behavior
applies to research confined to interactions involving
educational tests
cognitive
diagnostic
aptitude
achievement
survey/interview/focus group procedures
observation of public behavior
Not allowed:
interventions
specimen collection
other data collection methods
Applicability to research with children is limited.
Revised Common Rule expands scope to include collection of sensitive and identifiable data
if a “limited IRB review” approves the study’s plans to protect subject privacy and data confidentiality
“Limited IRB review” does not address full IRB regulatory criteria.
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U-MIC

10. Exemption changes Exemption 3: Benign Behavioral Intervention
new exemption
permits benign behavioral intervention on adult subjects in conjunction with data collection methods employed in Exemption 2
may include
alterations in subject’s physical or sensory environment
computer game
must be brief
may not involve medical or physical intervention
not even non-invasive monitoring (e.g., blood pressure cuff, EEG)
applies mainly to studies of
psychological states and processes
cognition, ideas, and attitudes
behavior
Not allowed:
specimen collection
linking to additional data sources
research involving deception
unless subjects are advised in advance that deception will be employed
Sensitive/identifiable data permissible with “limited IRB review” approval of privacy/confidentiality protection plans
Developed by:
U-MIC

11. Exemption changes
Exemption 4: Secondary Research with Identifiable Private Information and/or Biospecimens
revised Common Rule expands exemption 4 to facilitate secondary-use-only research on
identifiable private information/biospecimens that have been/will be generated
for non-research purposes
from research other than proposed study
includes
studies where identifiers are accessed, but no direct or indirect identifiers are recorded
secondary analysis of Protected Health Information (PHI)
Medical chart review may qualify if Privacy Board review grants HIPAA authorization waiver.
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U-MIC

12. Exemption changes
Exemption 5: Federal Research and Demonstration Projects /
Exemption 6: Taste and Food Quality Evaluation and Consumer Acceptance Studies
rarely used at U-M
Exemptions 7 and 8
new
used in conjunction with revised Rule’s Broad Consent concept
U-M not implementing “Broad Consent”
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U-MIC

13. Exemption changes under the revised Common Rule (2018)
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U-MIC

14. Thank you. Lark Speyer Brian Seabolt IRBMED
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U-MIC