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Human Subjects

Amendments

For expedited and full board studies, investigators must obtain IRB approval prior to implementing any changes to the originally-approved study procedures or documents, regardless of the investigator's assessment of the importance of the change. For exempt studies, review and approval may not be required.

Amendments to Exempt Research:
Amendments are only necessary for exempt studies when the proposed modifications are substantive or change the study procedures such that the study no longer qualifies for exempt review.

See the Exempt Studies Guidance for more information on categories of exempt amendments that require review.

Amendments to Full Board and Expedited Research:
The IRB requires that any proposed changes in approved research be reviewed and approved prior to implementing these changes to determine whether the modified research continues to fulfill the criteria for approval.

Required Forms:

  • Any study forms, documents, or questionnaires affected by the Amendment
    **Please note that all changes to previously reviewed study documents should be marked using the track changes function in Microsoft Word.
  • Completed Amendment questionnaire in KC IRB

Amendments to Full Board and Expedited studies are categorized as either major or minor, and are distinguished based on the type of changes being proposed. For further guidance on determining whether an amendment is major or minor, please see below.

Major Changes in Approved Research

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Minor Changes in Approved Research

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Adding and Removing IU Affiliated Investigators:

Co-Investigator (Key Personnel) Updates: must be submitted as an Amendment to, and approved by, the Human Subjects Office. Key Personnel may not begin participation until approval is received from the HSO.

  • All Key Personnel must complete the required CITI modules and an annual Conflict of Interest (COI) disclosure form before approval will be granted.

Research Personnel (Non-Key) Updates: must be submitted to the HSO; however, prior approval is not required for research personnel to begin participation. Research personnel may begin work on the research as soon as the notification has been submitted.

  • Non-Key Personnel who are directly interacting with subjects must complete the required CITI modules. HSO staff will conduct periodic audits to ensure that all research personnel have completed this requirement.
  • Non-Key Personnel are not required to complete the annual conflict of interest disclosure in order to receive IRB approval.

Please view the instructions for adding non-key personnel in the Pdf KC IRB Amendment for Non-Key Personnel Training Guide

  • No forms or attachments may be revised with a Non-Key Personnel Update. If the changes to Non-Key Personnel require form/document revisions, this process is not applicable and an amendment must be submitted instead.

Adding Non-IU Affiliated Investigators:

See  Providing Review for Non-Affiliated Investigators

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