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Personnel Changes

Changes to Study Team Members, Co-Investigators, and the Principal Investigator require IRB approval of a study modification. All personnel must register in eIRB+ and have up-to-date Human Research Protections Training reflected in their eIRB+ profile before they can be added to a study. 

Changes to the Primary Contact individuals listed on the Guest List (Study Access List), or individuals with Study Submission Rights do not require a modification and may be updated at any time. See eIRB+ Access Permissions for more information.  


Changing Study Team Members and Co-Investigators

The addition or removal of Study Team Members and Co-Investigators must be made in the section of the eIRB+ study application titled “Study Team Members”. To update the "Study Team Members" section, create a new Modification and select "Study Team Member Information" for the modification scope.

Modifications that involve only the addition of internal Study Team Members or the removal of any personnel will receive automatic IRB approval upon submission. All other personnel changes will undergo the normal IRB review process.  

Tips:

  • Personnel should be added as either a Study Team Member or a Co-Investigator, but not both.
  • Individuals who are not engaged in human research (see the Worksheet: Engagement Determination (HRP-311)) should not be added to the Study Team Members page. For example:
    • Regulatory coordinators who do not interact with participants nor have access to identifiable participant data or biospecimens.
    • Individuals who perform professional services that they typically perform for non-research purposes and do not administer any study intervention.
    • Individuals who perform data or biospecimen analyses but only have access to de-identified data and biospecimens.
  • Personnel changes may also require changing other study documents housed in eIRB+, including the protocol, consent document, and recruitment materials. In such cases, these documents should also be revised during the modification process by selecting “Other parts of the study” for the modification scope.

Note: Adding personnel to the Study Team Member list will not give that individual access to make changes to the eIRB+ study or receive eIRB+ notifications regarding the study. A person must be added to the Study Access List with “Edit” privileges to be able to make changes to the study. Only the PI and Primary Contact receive eIRB+ notifications regarding the study.

Changing the Principal Investigator

Changing the Principal Investigator (PI) can only be made in the section of the eIRB+ study titled “Basic Information.” To change the PI, create a new Modification and select “Other parts of the study” for the modification scope.

Tips:

Note: The PI is automatically granted access to create and edit study applications, receive all eIRB+ communications from the IRB, and submit initial applications and clarification requests.