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All modifications to currently approved research are required to have IRB review
and approval before implementation. An Amendment/Revision Request Form must be
submitted to the IRB outlining each specific change. All
revisions to a consent form must be submitted to the IRB, including those not resulting from an amendment
(e.g., increase in compensation, an addendum, additional safety information,
etc.).
An amendment/revision may require full Committee review if the modification
is significant and affects the risks and benefits to research subjects. Changes
in the risks and benefits to subjects may require modifications to the consent
form and re-obtaining consent.
When a study is approved by the IRB, the IRB assigns an approval period. Investigators
may request modifications/changes to the study during that period, within limitation. Approval of a modification does not alter the date of the study's approval
period. Changes to a study may not be implemented until approved by the IRB.
Please contact a Human Subject Protection Office staff member at 614-546-4325
or irb@mchs.com with questions about modifying an approved study.
Changing Investigators
When changing investigators, the current principle investigator must submit
an Amendment/Revision Form indicating the change in responsibility and a
letter from the new investigator accepting responsibility for the research.
Changes in investigators may qualify for expedited review.
Once the IRB has received your Amendment/Revision/Modification Request, the
IRB has the following options:
- The Chairperson may approve the request as
submitted.
- The Chairperson may request additional information.
- The modification
may be referred to the full board for consideration.
When the modification is approved, the request form, signed by the Chairperson,
will be returned to the investigator.
Minor Changes
Examples of minor changes to a protocol include but are not limited to:
- Addition
or deletion of study team members
- Addition of procedures that do not significantly
increase risk to subjects, considering the original purpose and study design
of the approved protocol (e.g., new procedures that fall under any of the
expedited categories usually qualifying as minimal risk)
- Deletion of research
procedures that would thereby reduce the risk to no more than minimal (i.e.,
procedures now fall under any of the expedited categories)
- Addition of or
revisions to recruitment materials or strategies
- Administrative changes to
the approved documents (e.g., correction of typographical errors)
Significant Changes
Examples of significant changes to a protocol may include, but are not limited
to:
- Addition of a new and/or separate subject population (e.g., control
group, additional cohort, etc.)
- Addition of research procedures that
involve greater than minimal risk to subjects (e.g., addition of a new
drug to a treatment regimen, addition of invasive procedures, change in
route or frequency of drug administration, etc.)
- Addition of surveys/questionnaires/interview
procedures that could have adverse psychological consequences for subjects
or damage their financial standing, employability, insurability or reputation
- Deletion of follow-up visits that appear necessary for monitoring subject
safety and welfare
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