| H-100 APPLICATION FOR NEW HUMAN RESEARCH REVIEW |
This form needs to be completed for full, expedite and exempt protocols. |
| MODEL CONSENT FORM |
Use this template for documentation of consent of the participants. |
| ELEMENTS OF CONSENT |
These are the required elements to obtain consent from participants. |
| MODEL ASSENT FORM |
Use this template for participants who are 9-14 and younger. Contact the RICRO for obtaining assent for children under 9 years of age. |
| EXEMPTION REVIEW CRITERIA |
Use these criteria to determine if your project meets the exempt category of review. |
| EXPEDITE REVIEW CRITERIA |
Use these criteria to determine of your project meets the expedite category of review. |
| H-101 CONTINUATION/CLOSURE FORM |
Complete this form for annual renewals or to close a protocol. Attach a summary of changes to the protocol and any consent forms or cover letters required as a condition of the original approval. |
| 118 DESIGNATION |
It is only applicable to projects for which risk/benefit determinations, recruitment, or consent processes, are not yet feasible; more definite projects need IRB review when submitted and are not eligible (whether funded or not) for a §118 designation. §118 designation is not an alternative to review until it is known whether a project is to be funded.
No human subjects may be involved until the application (H-100) has been reviewed and approved by the IRB. |
| SIGNIFICANT ADVERSE EVENT REPORT FORM |
Submit this form within 24 hours of the reportable event. |