Please complete the following form if you wish to request continuation/renewal to an approved project. To complete this form, you will need to provide:
1. A cover letter that includes: (a) the complete title of your study, (b) your IRB approval number, (c) the date of your most recent approval, and (d) a brief statement of your request for continuation.
2. A brief protocol summary. Include in this section information regarding any deviations from the approved protocol since the last approval.
3. A brief status report including number of participants accrued, summary of unanticipated problems (e.g., withdrawal of subjects), and summary of any new information identified (e.g., risks or benefits) which may affect the willingness of current or future research participants to participate in the study.
4. A copy of the current informed consent document(s) (i.e., informed consent, parental permission, and children's assent or waiver documents as appropriate).
5. Evidence that the CITI training requirement is met for all listed on IRB application, if not already on file (including faculty sponsors).
Please direct any questions regarding this form to email@example.com.