Considerations When Transfering Clinical Investigation Oversight to Another irb

Contains Nonbinding Recommendations 

 

 

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to subjects.  For subjects who are already enrolled (whether or not they are active), this may be 

accomplished in a number of ways, including sending a letter providing the relevant contact 

information.

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  For new subjects, the informed consent, assent, and/or parental permission form 

must be revised to reflect the new contact information.

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  The clinical investigator should 

promptly notify the IRB of any such administrative changes to the consent form.  

 

Other changes to the consent form may also be necessary, for example, if the receiving IRB 

requires modifications to the consent form at the site(s) under its jurisdiction as a condition of 

approval (e.g., changes in template language, changes in risks, etc.).

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  Depending upon the types 

of changes needed, they may be conveyed to the clinical investigator and sponsor as required 

modifications to secure IRB approval for the clinical investigation at that site or sites and may 

require reporting to FDA.

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