Human Subject Forms & Templates
| Forms |
| Exemption Determination Application |
|
RTF |
| Non-Exempt Application |
|
RTF |
| Non Regulatory Application |
|
RTF |
| Request for Amendment |
|
RTF |
| Continuing Review Form |
|
RTF |
| Closeout Report Form |
|
RTF |
| Adverse Event Form |
PDF |
RTF |
| Templates |
| Guidance on Writing Consent Forms |
PDF |
|
| Consent Template |
|
RTF |
| Assent Template (Ages 7-10) |
|
RTF |
| Assent Template (Ages 11-14) |
|
RTF |
| Assent Template (Ages 15-17) |
|
RTF |
| Parent Permission Form Template |
|
RTF |
| Addendums |
| Addendum 1 Expedited Categories and Determination |
|
RTF |
| Addendum 2 Research with Children |
|
RTF |
| Addendum 3 Research with Prisoners |
|
RTF |
| Addendum 3A Research with Prisoners |
|
RTF |
| Addendum 4 Alteration of Informed Consent Process |
|
RTF |
| Addendum 5 Waiver of Documentation of Informed Consent Process |
|
RTF |
| Addendum 6 Waiver of Informed Consent Process |
|
RTF |
| Addendum 7 HIPAA Authorization Form & Appendix A |
|
RTF |
| Addendum 8 Investigational Drugs, Other Drugs, & Devices |
|
RTF |
| Addendum 9 Blood, Tissue, Bodily Fluids, or Other Biological Specimens |
|
RTF |
| Addendum 10 Confidentiality Agreement |
|
RTF |
| Guidance |
| Application Instructions and Guidance |
PDF |
|
Adult Informed Consent Checklist |
PDF |
|
Parental Permission & Child Assent Checklist |
PDF |
|
Application Review Checklist |
PDF |
|
