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Protocol Modifications

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 an Office of Research Affairs 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:

  1. The Chairperson may approve the request as submitted.
  2. The Chairperson may request additional information.
  3. 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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Mount Carmel Health System  |  Columbus, Ohio

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