The IRB sends out renewal reminders to the principal investigator approximately two months before the study is due to expire. The renewal reminder includes instructions on how to access the status reports.
Below find a checklist of required changes to the template language. Please review it and incorporate the applicable language into your consent/assent/HIPAA forms before submitting the materials for continuing review. All changes should be tracked in Microsoft Word to facilitate IRB review.
- Pregnancy testing language should be revised if pregnancy testing is described in the current consent form. (See Section 8 of template consent and the language resource text; if the study uses a separate assent form, then add pregnancy language from the template assent.)
- Statement that research information will go into the medical record should be added, if appropriate (see Section 11 of template consent).
- Research-related injury language should be revised (see Section 13 of template consent).
- Payment-tracking language should be added if applicable (see Section 14 of template consent). The payment-tracking language relates to Office of Research Finance Policy 4.
- Statement about ClinicalTrials.gov should be added if applicable (see Section 15 of template consent). For information, see the ClinicalTrials.gov page on CHILD.
- Time of signature must be added for many signatures. You may use the new signature lines included in posted templates (see Section 17 of template consent; see last section of template assent; see permission section of HIPAA authorization.)
- All consent/assent templates and HIPAA templates are available on our website.