IRB Forms

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

     
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 ✓

Amendment Forms

     
Amendment 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 ✓
     

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 ✓