Additional instructions for protocols where the Principal
Investigator is not an NKI employee
In the protocol itself
ALL protocol procedures must be specifically described,
including the location(s) where these procedures will
take place.
In the Consent Form
The first line of the consent must indicate that the
research study is being conducted by [state the name(s)
of the principal investigator(s)] under the auspices of
(state the name of the PI’s institution).
The NKI consent form must include and give a description
of ALL the procedures that will be done and where they
will be done (not just the MRI component) – OR
– a separate consent form must be submitted
detailing the procedures that will be done outside NKI.
If other components of the study will be at the PI’s
institution (or any other site), the NKI consent will be
considered an addendum to the main consent and
"Addendum to ________" must be added to the top
of the NKI consent.
Under "Medical Compensation for Research Related
Injuries" add the principal investigator’s
institution’s Medical Compensation Statement used in
their consent forms. Also, state that NKI assumes no
legal responsibility for any procedure other than the
ones that will be performed at NKI, including the
transportation of subjects to and from the MRI site.
Under "General Conditions" add the principal
investigator’s institution’s IRB person to
contact if participants would like to discuss their
rights as research subjects.
