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 docxDownloadable Word Document file pdf Downloadable PDF file
Consent Form Template docxDownloadable Word Document file N/A
Assent Form docxDownloadable Word Document file N/A
Parental-Guardian Consent Form docxDownloadable Word Document file N/A
Research Proposal Outline (guide) docxDownloadable Word Document file pdfDownloadable PDF file
HIPAA Waiver of Authorization
–submit accordingly
docxDownloadable Word Document file N/A
Notice of Privacy Practices (NOPP) docxDownloadable Word Document file pdfDownloadable PDF file
Notice of Privacy Practices (NOPP)
- Child Version
docxDownloadable Word Document file N/A
CITI Program Instructions N/A pdfDownloadable PDF file
MRI Consent Form Standard Language docxDownloadable Word Document file

 

     

Covid-19 Related Information

 

 

Covid-19 Script docxDownloadable Word Document file N/A
Covid-19 Participant Information docxDownloadable Word Document file N/A
     

Submission Requirements

 

 

Submission copies – Full Board,
Expedited, Exempt
N/A pdf Downloadable PDF file
Submission Checklist N/A pdf Downloadable PDF file
Submission Deadline docxDownloadable Word Document file pdf Downloadable PDF file
Attachment A – IRB Protocol submissions N/A pdf Downloadable PDF file
Attachment B – Citations N/A pdf Downloadable PDF file
Attachment C- PI Responsibility N/A pdf Downloadable PDF file
     

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 docxDownloadable Word Document file pdf Downloadable PDF file

Amendment Forms

 

 

Amendment Application docxDownloadable Word Document file pdf Downloadable PDF file
     

Adverse Event Forms

 

 

Adverse Event Log(form 5010a) docxDownloadable Word Document file pdf Downloadable PDF file
Serious Adverse Event Report (form 5010b) docxDownloadable Word Document file pdf Downloadable PDF file
Unexpected Adverse Event Report (form 5010c) docxDownloadable Word Document file pdf Downloadable PDF file
Irregularities / Non-Compliance Form N/A pdf Downloadable PDF file
     

Other Forms

 

 

IRB Authorization Agreement(form 5010a) docxDownloadable Word Document file N/A
Authorization of Medical Release Form docxDownloadable Word Document file pdf Downloadable PDF file
Media Consent Form N/A pdf Downloadable PDF file