Necessary Forms and Documents to Submit a Proposal
Specific instructions are provided below each form. Microsoft Word versions of electronic documents are preferred for easier commenting and revisions, except for application forms and recruitment advertisements. Do not submit hard copies unless specifically requested by the IRB Office.
Initial IRB Submissions
Please submit one copy of each of the documents below (as applicable) via email to [email protected].
Initial Application Form (docx, pdf)
- Include all required signatures (the signature from Dr. DeLuca will be obtained by the IRB after submission)
Research Protocol Outline (guide) (docx, pdf)
This document must be used for all studies that have not undergone external scientific review, and will be sent by the IRB to the Research Review Committee.
- Protocols that have undergone scientific review and are being submitted for IRB review only are NOT required to use the Research Protocol Outline format
- However, investigators should ensure that the protocol includes the types of information specified in the outline (such as inclusion/exclusion criteria, recruitment methods, anticipated risks, strategies to mitigate risk). This information is required to help the IRB address human research considerations
- Alternatively, investigators may submit the Research Protocol Outline as the main document and attach the full grant narrative as an appendix. Investigators are encouraged (though not required) to consider this approach when:
- The protocol narrative submitted to the funder is very brief and is missing much of the information specified in the protocol outline
- Or when the protocol includes considerable administrative information that is not directly relevant to ethical review
Informed Consent Documents
- Choose from among the following template forms to add to your study submission – as applicable.
- Adult Consent Form (docx)
- Parent/Guardian Consent Form (docx)
- Child Assent Form (docx)
- For use along with the Parent/Guardian Consent Form for studies enrolling participants aged 12 and younger
- MRI Consent Form – standard language (docx)
- Integrate this language into the consent form for studies conducting MRI
Notice of Privacy Practices (NOPP) Acknowledgement Forms (If Protected Health Information is being collected)
- NOPP Acknowledgment Form for Adults (docx)
- NOPP Acknowledgement Form for Parents/Guardians of Children (docx)
Request for Waiver of HIPAA Authorization (docx)
- A Request for Waiver of HIPAA Authorization allows investigators to seek approval to collect protected health information without obtaining authorization from the participant (via an informed consent document)
- Examples of situations where a waiver might be needed include:
- Reviewing medical records to determine which patients are appropriate to approach about a study
- Conducting a telephone screen to check basic eligibility criteria before consenting a participant
- Conducting a chart review study when obtaining informed consent is not practicable or might introduce bias
- Include investigator signature
Advertisements (if applicable)
- New recruitment flyers must use Kessler Foundation-approved templates available through Canva
- See Guide for Creating Recruitment Flyers in Canva for help on creating study advertisements using approved templates
- Advertisements created in Canva should be exported to PDF for submission to the IRB
- See Policy 5013 for guidance on advertisements
Current CITI Certificates
- Include all study team members if not previously submitted to the IRB Office
Continuation Application
Please submit one copy of each of the documents below (as applicable) via email to [email protected].
Continuation Application (docx, pdf)
- Include all required signatures
Informed Consent Documents
- Include these documents unless you have received an approved exemption from obtaining informed consent
- Submit a current clean copy and a revisions-marked copy (if changes are requested)
- Revisions in Word documents should be shown using tracked changes
- A revisions-marked copy is unnecessary if the only update to the consent form is the version date
- Omit the consent form if study recruitment is complete (indicate this in your application or cover memo)
Research Protocol
- Submit current approved copy if no changes have been made
- Submit clean and revisions-marked copies if modifications are proposed
Advertisements (if applicable)
- Submit unstamped versions only
- Submit clean and revisions-marked copies if modifications are proposed
- Use Adobe Acrobat comments to highlight and note changes in Canva advertisements submitted for review
Adverse Event Logs
- Use if new adverse events took place since the last continuation
- See Adverse Event section below for log template
Amendment Application
Please submit a copy of each of the documents below (as applicable) via email to [email protected].
Amendment Application (docx, pdf)
- Include all required signatures
- Submit both current clean copy and revisions-marked copy of any changed documents
- Revisions in Word documents should be shown using tracked changes
- For revised Canva ads, use Adobe Acrobat comments to highlight and note changes
Adverse Event Reporting
Please submit one electronic copy of each applicable form with all required signatures to [email protected]. See Policy 5010 for adverse event reporting guidance.
Adverse Events Log (form 5010a) (docx)
- Include all required signatures
