When to Apply Exempt and Expedited Review

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When to Apply Exempt and Expedited Review

• Ivor Pritchard, Ph.D.
• Institute of Education Sciences
• U.S. Department of Education
• Ivor.Pritchard_at_ed.gov

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Research

• Research means a systematic investigation,
  including research development, testing and
  evaluation, designed to develop or contribute to
  generalizable knowledge. .102(d)

3
Research

• Research means a systematic investigation,
  including research development, testing and
  evaluation, designed to develop or contribute to
  generalizable knowledge. .102(d)

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Human Subject

• Human subject means a living individual about
  whom an investigator (whether professional or
  student) conducting research obtains
• (1)data through intervention or interaction with
  the individual, or
• (2) identifiable private information.

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Human Subject

• Human subject means a living individual about
  whom an investigator (whether professional or
  student) conducting research obtains
• (1)data through intervention or interaction with
  the individual, or
• (2) identifiable private information. .102
  (f)

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Exempt/Covered Research

• Unless otherwise required by Department or Agency
  heads, research activities in which the only
  involvement of human subjects will be in one or
  more of the following categories are exempt from
  this policy
• Exemptions b(1-6) 101(b)

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Exempt Research

• Studies of normal educational practices in
  commonly accepted educational settings
• Research involving educational tests or passive
  observation of public behavior that is anonymous
  or benign
• Research involving surveys or interviews of
  adults that are anonymous or benign

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Exempt Research

• Research involving education tests, surveys,
  interviews, or observation of the public behavior
  
• if the subjects are public officials or
  candidates
• or if federal statute requires absolute
  confidentiality of identifiable information
• Research involving existing data from public
  sources
• Research involving existing data from nonpublic
  sources, if anonymously recorded

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Covered Research

• Research involving information from future
  records
• Research involving identifiable information drawn
  from existing nonpublic records
• Research involving identifiable and potentially
  harmful -
• Education tests
• Passive observation
• Surveys and interviews
• Research involving other forms of information
  collection

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Sometimes Covered, Sometimes
Exempt

• All research involving surveys or interviews
  involving children is covered under the
  Departments of Health and Human Services,
  Education, Defense, and Veterans Affairs.
• Research involving surveys or interviews
  involving children under other federal agencies
  is exempt if the data are anonymous or benign.

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Exempt if its only

• Research in one or more exempt research
  categories, for example, studies of normal
  educational practices in regular classrooms,
  using risk-free education tests.

• And not research in a covered research category,
  such as surveys or interviews of children or data
  from future records, or???????

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What is Expedited Review?

• Expedited Review applies the same standards as
  full Board review
• Expedited review is performed by the IRB Chair,
  or by one or more IRB members designated by the
  IRB chair
• Expedited Review can approve or modify a proposed
  activity, but not disapprove it.

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What makes a research activity eligible for
expedited review?

• The research activity must fit one or more
  categories of the FDA/DHHS Expedited Review
  Categories List.
• The research activity must involve no more than
  Minimal Risk.

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Expeditable Behavioral Research

• Data involving existing or future materials
  collected solely for nonresearch purposes
• Data from voice, video digital or image
  recordings made for research purposes
• Research on individual or group characteristics
  or behavior
• Research employing survey, interview, oral
  history, evaluation, etc. methods

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Minimal Risk

• Minimal risk means that the probability and
  magnitude of harm or discomfort anticipated in
  the research are not greater in and of themselves
  than those ordinarily encountered in daily life
  or during the performance of routine physical or
  psychological tests. (102(i))

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Information Sites

• U.S. Dept. of Education/Grants and Policy
  Oversight Staff http//www.ed.gov/offices/ocfo/hu
  mansub.html
• U.S. Dept. of Health and Human Services/Office of
  Human Research Protections http//ohrp.osophs.dhh
  s.gov/