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When is IRB Review Required?
All
proposed research that involves (1) intervention or
interaction with human subjects, (2) the collection
of identifiable private data on living
individuals and/or (3) data analysis of identifiable
private information on living individuals requires
review and approval by the IRB prior
to the initiation of the research.
What is a Human subject?
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 (45 CFR 46)
What is Research?
Research
is defined by the U.S. Department Health and Human
Services as “a systematic investigation, including
research development, testing and evaluation,
designed to develop or contribute to generalizable
knowledge.” (45 CFR 46)
When in doubt, contact the
IRB Manager to help determine whether a
particular project is “research” as defined by the
University
of Maryland
and by federal regulations.
Please note: Research that is limited to the
collection of private information on individuals
requires prior approval. If the research is
exempt, the application must be approved by the IRB
Manager or the IRB Co-Chair before data collection
begins. If the research is non-exempt, the
application must be approved by the IRB before data
collection for exempt research begins.
When is IRB Request for Determination of
Non-Human Subject or Non-Research form required ?
The
Request for Determination of Non-Human Subject or
Non-Research Form may be used by faculty,
staff and students who are not sure whether their
activity requires IRB review. You may mail the form
to the IRB Office via campus mail or bring the form
to the IRB office which is located in 2100 Lee
Building.
Faculty and staff who submit a completed
Request for Determination of Non-Human Subject or
Non-Research Form to the IRB will receive
written documentation on whether the activity
requires IRB review.
Questions, comments, and/or suggestions should be
directed to
irb@umd.edu
IRB Process
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