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) N/A 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   

 

 

Submission Requirements

PDF

Submission copies – Full Board, Expedited, Exempt pdf
Submission Checklist pdf
Attachment A – IRB Protocol submissions pdf
Attachment B – Citations pdf
Attachment C- PI Responsibility 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

WORD

PDF

Continuation Application docx pdf 


Amendment application requirements are as follows:

All modifications or amendments to the study protocol must be reviewed and approved by the IRB. 

Amendment Forms

WORD

PDF

Amendment Application docx pdf

 

Adverse Event Forms

WORD

PDF

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 WORD PDF
IRB Authorization Agreement docx N/A
Adding Staff Approval Form docx pdf
Authorization of Medical Release Form docx pdf
Media Consent Form N/A pdf