Full Board Review

A study is considered as a FULL BOARD REVIEW category because the protocol is above minimal risk to subjects, does not meet the qualifications for exempt or expedited review, and must be reviewed by the convened IRB meeting, or does not fall in the other two review categories. If your subjects are considered a vulnerable population then they will need to be a Full Board Review. Those subjects include:

  • Minors (less than 18 years of age)
  • Prisoners or persons who are under criminal sanctions
  • Persons with diminished mental capacity (e.g., mental retardation, neurological, psychiatric or related disability)
  • Persons in a residential program (e.g., hospital, developmental center, group home, etc.)
  • Clients of a human service program (e.g., counseling center, clinic, etc.)

Levels of IRB Review

Full Board:

  • More than a minimal risk
  • Not covered under other review categories
  • Examples:
    • Intervention involving physical or emotional discomfort or sensitive data
    • Involve a survey of a protected group like pregnant women

Expedited:

  • No more than a minimal risk
  • Fits 1 of 9 expedited review categories
  • Examples:
    • Collections of non-invasive specimens
    • Research on existing documents like charts which were not originally part of research

Exempt:

  • No more than a minimal risk
  • Fits 1 of 6 exempt categories
  • Examples:
    • Research with de-identified records
    • Anonymous surveys that do not have a known risk

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