IRB Submission requirements are as follows:
The following documents are required for IRB review. Please complete all the necessary forms. You may follow up with the IRB for further information.
Initial IRB Forms
|
WORD
|
PDF
|
| |
|
|
| Initial Application |
docx ✓ |
pdf ✓ |
| Consent Form Template |
docx✓ |
N/A |
| Assent Form |
docx ✓ |
N/A |
| Parental-Guardian Consent Form |
docx ✓ |
N/A |
| Research Proposal Outline (guide) |
docx ✓ |
pdf ✓ |
HIPAA Waiver of Authorization
–submit accordingly |
docx ✓ |
N/A |
| Notice of Privacy Practices (NOPP) |
docx ✓ |
pdf ✓ |
Notice of Privacy Practices (NOPP)
- Child Version |
docx✓ |
N/A |
| CITI Program Instructions |
N/A |
pdf ✓ |
| MRI Consent Form Standard Language |
docx ✓ |
|
| |
|
Covid-19 Related Information
|
| |
|
|
| Covid-19 Script |
docx✓ |
N/A |
| Covid-19 Participant Information |
docx✓ |
N/A |
| |
|
Submission Requirements
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| |
|
|
Submission copies – Full Board,
Expedited, Exempt |
N/A |
pdf ✓ |
| Submission Checklist |
N/A |
pdf ✓ |
| Submission Deadline |
docx✓ |
pdf ✓ |
| Attachment A – IRB Protocol submissions |
N/A |
pdf ✓ |
| Attachment B – Citations |
N/A |
pdf ✓ |
| Attachment C- PI Responsibility |
N/A |
pdf ✓ |
| |
|
Continuation Review requirements are as follows: All active human studies at Kessler Foundation must be reviewed by the IRB at intervals appropriate to the degree of risk but not less than annually, for continuation of approval. Review the IRB Deadlines and Meeting dates for submission.
Continuation Forms
|
| |
|
|
| Continuation Application |
docx ✓ |
pdf ✓ |
Adverse Event Forms
|
| |
|
|
|
| Adverse Event Log(form 5010a) |
|
docx ✓ |
pdf ✓ |
| Serious Adverse Event Report (form 5010b) |
|
docx ✓ |
pdf ✓ |
| Unexpected Adverse Event Report (form 5010c) |
|
docx ✓ |
pdf ✓ |
| Irregularities / Non-Compliance Form |
|
N/A |
pdf ✓ |
| Participant Suicide Ideation Form |
|
N/A |
pdf ✓ |
Other Forms
|
| |
|
|
| IRB Authorization Agreement(form 5010a) |
docx ✓ |
N/A |
| Authorization of Medical Release Form |
docx ✓ |
pdf ✓ |
| Media Consent Form |
N/A |
pdf ✓ |
| Reliance Agreement Form |
docx ✓ |
|
| |
|
