Expedited

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Expedited Exempt Studies

• Caren J. Frost, Ph.D., M.P.H.
• IRB Vice Chair
• IRB Retreat
• August 3, 2007

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Purpose of Breakout Session

• Review expedited and exempt categories
• Examine how these studies differ from full board
  reviewed studies
• Provide examples of expedited and exempt studies
• Discuss questions about these types of studies

3
Categories of Expedited Studies

• Involve nine research categories
• Clinical studies of drugs when an investigational
  new drug application is not required

• Medical devices that do not require an
  investigational device exemption application
  and/or is cleared/approved for marketing and is
  being used according to its cleared/approved
  labeling

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Categories Continued

• Collection of blood by finger stick, heel stick,
  ear stick, and/or venipuncture
• Healthy, nonpregnant adults weighing at least 110
  pounds with no more than 37 tablespoons of blood
  (550 milliliters) in 8 weeks
• Other participants 3.4 tablespoons (50
  milliliters) or 0.28 teaspoons (3 milliliters)
  per pound, whichever is less
• Collections no more than twice per week

5
Categories Continued

• Prospective collection of biological specimens by
  noninvasive means
• Hair nail clippings
• Teeth during regular patient care and when the
  come out naturally
• Excreta and external secretions
• Uncannulated saliva, etc.

• Collection of data through noninvasive means
  without general anesthesia or sedation
• Routinely collected in clinical practice (not
  x-rays or use of microwaves)
• Medical devices can be considered if
  cleared/approved for marketing

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Categories Continued

• Research involving data, documents, records,
  specimens that have been collected or will be
  collected for nonresearch purposes (medical
  treatment and/or diagnoses)
• Collected of data from voice, video, digital, or
  image recordings
• Research on individual or group characteristics
  or behavior using surveys, interviews, oral
  history, focus groups, etc. (social and
  behavioral science research in general terms)

7
Categories Continued

• Research that is continuing and has already been
  approved by a convened IRB when
• The study is closed to enrollment of new
  participants
• No participants have been enrolled and no
  additional risks have been identified
• Remaining study activities are related to data
  analysis only
• Continuing research when the previous categories
  do not apply but wherein the IRB has determined
  that the research is no more than minimal risk
  and no additional risks have been identified

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Minimal Risk Determination

• Expedited studies are those that
• Fit one of the earlier mentioned categories
• Present no more than minimal risk to human
  participants
• Although a study may be categorized in one of the
  categories, the study may not be minimal risk
• What is minimal risk?
• How do you (the reviewer) determine if a study is
  minimal risk?

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Examples of Expedited Studies
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Exempt Studies

• Exempt studies must fall into one of the
  following six categories
• These studies usually involve already collected
  data, i.e., from a registry or a database wherein
  the participants cannot be identified, and/or for
  educational quality assurance and/or comparisons

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Categories of Exempt Studies

• Research conducted in established or common
  educational settings
• Research involving the use of educational tests,
  surveys, interviews, or observations of public
  behavior

• Research involving use of methods in category 2
  if the participants are elected or appointed
  public officials or candidates for office, and/or
  for whom confidentially will be maintained for
  participants

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Categories Continued

• Research involving already collected data,
  documents, records, pathological specimens, or
  diagnostic specimens if these are publicly
  available and/or participants cannot be
  identified
• Research conducted by department and/or agency
  heads as regular program evaluation(s) to ensure
  service delivery of public programs

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Categories Continued

• Taste and food quality evaluation and consumer
  acceptance studies
• Wholesome foods without additives
• Food ingredients that are at or below the FDA
  approved levels

• Finally, for most exempt studies the following
  must also be true
• Research is not subject to FDA regulations
• Research does not involve prisoners
• Research meets the Universitys ethical standards
  for conducting research

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Examples of Exempt(Why expedited and not exempt?)
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Studies Requiring Convened Board Review

• Moderate and higher risk studies
• Determined at time of application submission
  or/and by IRB staff
• Reviewer may make a determination of minimal risk
  in some instances
• Biomedical studies that are invasive to
  participants
• Minimal risk studies that do not fit into any of
  the 9 categories and a convened board determines
  that it is minimal risk

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Materials Needed for Review

• Application on ERICA
• Protocol and/or Study Summary
• Consent forms
• Adult consent (HIPPA, if necessary)
• Parental permission
• Assent (ages 7 to 17 years, as applicable)

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Materials Continued

• Questionnaires, surveys, guided interview
  schedules, etc.
• Support letters from assisting agency
• Researchers resume and/or curriculum vitae
• Other pertinent documents for understanding scope
  and context of study

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Questions Further Discussion