Below you will find the forms and templates required for submission by the IRB.
| New Study Submission |
| Instructions: |
Download and save each form. For check-boxes, use the mouse to click.
If you need help deciding if your study may qualify for Exempt status, use the following decision chart.
The "Standard Face Page" should be on the top of your submission. |
 |
New Study Submission Form |
|
Protocol Summary Form |
|
Standard Face Page |
|
Informed Consent Template (bottom of this page) |
| |
|
|
| Revisions Requested by the IRB/ Approved with Conditions |
| |
After the Principal Investigator submits a study, the IRB may ask for revisions or place conditions on the study before final approval is granted. For example, the IRB may request revisions after the IRB staff, designated IRB reviewers, or the Full Board reviews the study.
Instructions: To fulfill the conditions, print out and send your revisions to the IRB office (ENG 270). Complete the (a) Standard Face Page, marking the (b) Revisions Requested by the IRB box. (c) Print out and re-submit the pages of your protocol which require the revisions (e.g., if the revisions are only to the consent form, submit only the consent form). (d) submit a cover memo referencing the revisions by the corresponding item number in the attached email letter. (e) Highlight, bold, or underline each revision referencing them by the corresponding item number in the attached email. (f) Include a copy of the emailed letter requesting revisions. Once you have fulfilled the conditions, you will be notified by email with a formal letter attached that your protocol is approved. |
| |
|
|
| Continuing Review / Completions / Closeouts |
| Instructions: |
See Section C of the Continuing Review Form for instructions on what documents to include.
The "Standard Face Page" should be on the top of your submission. |
|
Continuing Review Form |
|
Protocol Summary Form |
|
Standard Face Page |
|
Informed Consent Template (bottom of this page) |
| |
|
|
| Modification/Amendment |
| Instructions: |
The "Standard Face Page" should be on the top of your submission. |
|
Modification/Amendment Form |
|
Standard Face Page |
|
Informed Consent Template (bottom of this page) |
| |
|
|
| Reportable Events |
| Instructions: |
Download and save each form. Each form is set to "form fields". Use the mouse or "tab" key to move from one grayed field to another; text will wrap around. For check-boxes, use the mouse to click.
The "Standard Face Page" should be on the top of your submission. |
|
Reportable Event Form |
|
Standard Face Page |
| |
|
|
| Informed Consent/Assent Templates |
| Instructions: |
Use the consent/assent template based on the appropirateness of your study. Multiple consent/assent forms may be required depending on your subject population. |
|
Informed Consent Instructions |
|
Adult Informed Consent Template |
|
Adult Informed Consent Template (Example) |
|
Parent and Child Consent Template (use for children ages 14 and up) |
|
Minor Assent Template (use for children ages 7-13) |
|
Online Survey Consent Template |
|
Letter Format Consent Template |
|
Short Version Consent Template |
