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Amendments
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amendments
When a study is approved by the IRB, the approval is generally for a
one-year period. Investigators may request amendments to the study during
that period, within limitations. Changes to the study protocol
may not be implemented until approved by the IRB.
amendments represent changes in the protocol, the risk benefit assessment
or the consent/authorization. The degree and significance of the changes
affect whether the modification receives full or expedited review. In
deciding whether changes are minor or major, the investigator considers
the purpose of the study (the hypotheses), the population to be enrolled
and the procedures to be performed. If the first of these three components
will be revised significantly, or if any two of the components will
be changed to some degree, then the changes may require submitting a
revised IRB application for full review.
Amendment procedures
- A letter to the IRB describing the change and the rationale.
- Any approach materials or documents given to participants that are
affected by the modification, such as consent and assent forms, approach
letters, telephone scripts or questionnaires.
When the modification is approved, a copy of the approval is sent to
the investigator.
Approval of an amendment does not alter the date of the study’s
approval period. Renewal notices are sent based on the approval period
previously assigned.
Please feel free to contact the IRB
Office with questions.
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