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All
research,
involving human
subjects conducted at MRI
Institutions MUST go through the
MRI IRB. However; some
minimal risk research may be
eligible for Exemption from IRB
review. This referred to
as granting "Exempt
Status" to a
protocol/research activity.
The IRB, not the investigator, has the authority to
determine and confirm ?Exempt
Status?.
Therefore, a ?Request
for Exempt Status? form
MUST be submitted to the IRB to
allow confirmation of ?Exempt
Status? of the research
activity.
Please
read the Guidelines for
Requesting "Exempt Status
for a Protocol in their
entirety. If, subsequent
to reading the Guidelines, the
research activity is determined
to be eligible for "Exempt
Status", please complete
the "Request for Exempt
Status" review form below
Important
Information:
- The
above form is an application
for Exemption from IRB
Review only.
Granting of "Exempt
Status" for a protocol
in no way negates the
requirement for informed
consent or HIPAA
authorization, where
applicable.
- The
form should be utilized for
minimal risk research
activities eligible for
exemption from IRB review as
indicated in the Exempt
Categories listed on the
"Request for Protocol
Exemption" form and
Guidelines above.
- The
IRB, not the investigator,
has the authority to
determine and confirm exempt
status. Therefore, a
"Request for Protocol
Exemption" form MUST be
submitted to the IRB to
allow confirmation of
"Exempt Status" of
the research activity.
- Research
activities may NOT begin
until a letter granting
"Exempt Status" to
the protocol is received.
- If
?Exempt Status? is
granted, amendments or
modifications to the
protocol may NOT be
implemented until submitted
to the IRB for confirmation
that the amendment or
modification does not in any
way alter the existing
Exempt Status of the
protocol.
Implementation of the
amendment or modification
may NOT occur until a letter
granting approval for
continued Exempt Status of
the protocol (with the
inclusion of the amendment
or modification) is
received.
- HIPAA
requirements still apply to
the Use/Disclosure of
Protected Health Information
(PHI) specifically for
research purposes.
Please see the
18
identifiers that constitute
PHI. Please
carefully review the HIPAA
Decision Matrix to
determine whether or not
HIPAA documentation is
required for the research
activity. When in
doubt, please contact ORA
staff for guidance."
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