- To assure the rights and well-being of human subjects participating in research are protected
- To educate researchers about how to improve study conduct
- To provide resources to the Research Community
Change of Principal Investigator
The amendment process for a change in study responsibility from one investigator to another usually requires the following information to be submitted to WIRB®.
- A letter stating that there will be a change in study responsibility. The new principal investigator should be named.
- A letter or fax from the sponsor indicating acknowledgment and approval of this change in responsibility.
- A completed WIRB Research Review Submission Form
- A letter accepting responsibility for the study
- A revised FDA Form 1572 [Statement of Investigator] (if applicable)
- A copy of the new investigator's Curriculum Vitae
- A copy of the new investigator's current medical license