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When the IRB requires modifications to research to
secure approval, verification of those modifications
by an IRB chair or experienced IRB reviewer without
review by the convened IRB represents review by the
expedited procedure, and should comply with regulations
and guidance governing such review. This process is
sometimes referred to as “contingent approval.” When
the IRB grants contingent approval, the IRB should
have in mind a clearly defined protocol that it is
willing to approve. This protocol does not exist in
final form, but represents the submitted protocol
with specific required modifications. The IRB should
document the required modifications so that an IRB
chair or experienced IRB member can judge whether
the revised protocol matches the one the IRB was willing
to approve.
Examples
of how NOT to document changes required
under a “Req. Mod”:
- “Explain
why participants less than 18 years of age will
be allowed to participate”
- “Provide
additional justification for the use of placebo”
- “Clarify
whether participants will be offered counseling
services at the end of the study”
- “Indicate
how often the data and safety monitoring board will
meet,” or
- “Provide
animal data for the study drug.”
Instead
the IRB should provide the investigator specific modifications
required to secure approval. Examples of HOW
TO document changes required under a “Req
Mod”:
- “Participants
must be 18 years or older.”
- “Drop
the placebo controlled arm of this study.”
- “Offer
psychological counseling all participants at the
study’s conclusion.”
- “Require
CAT scans every three months.”
- “Require
the data and safety monitoring board to meet every
three months.”
- “Include
in the consent all side effects listed in the investigator’s
brochure.”
The
IRB may be less specific the required modifications
may be reviewed using the expedited procedure. For
example, “Rewrite the content of the consent into
lay language,” “Modify advertisements according to
IRB policy,” or “Submit quality of life surveys for
review.”
When
the committee votes to defer further action on the
study, the investigator’s responses should be reviewed
at a convened IRB meeting. For example, the convened
IRB should review responses to provide an acceptable
data monitoring plan, rewrite major portions of the
consent document to include specific information about
the study, its risks, procedures, etc., or include
a rationale for the number of study participants.
AAHRPP
warns that IRBs should exercise caution before delegating
to an IRB member or committee the authority to negotiate
changes without review of those changes by a convened
IRB. In these instances, the IRB should take care
that the changes required are very specific and only
require that the individual member(s) confirm that
the changes were made.
Reference:
AAHRPP Evaluation Tool
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