University of Connecticut University of UC Title Fallback Connecticut

IRB Forms – InfoEd Submission

The following study protocol forms are to be used together with the IRB-1, IRB-5, IRB-7, IRB-9 protocol application forms when submitting study material to the IRB using the new InfoEd submission process implemented on June 16, 2014.

Note:  These forms may not be used with paper submissions.

Contact the IRB office at 6-8802 with questions regarding which form should be submitted.

Study Protocol Forms

IRB-1 Study Protocol and Data Security Assessment Form
IRB-1 instructions and Tips for completing the data security assessment form. Both forms are required and must be completed at time of submission.

IRB-5  Request for Exemption Study Protocol
Click here for instructions.

IRB-7  – Research Methods Course Protocol
Click here for instructions.

IRB-9 Ethnographic/Naturalistic Research Study Protocol
Click here for instructions.

Cumulative Inclusion Enrollment Report
Required at time of re-approval for studies funded by NIH or NSF.

Please note that the following application forms are now electronic and must be completed online through InfoEd:

  • IRB-1
  • Appendix A
  • IRB-1A
  • IRB-1B
  • IRB-1C
  • IRB-2
  • IRB-3
  • IRB-4
  • IRB-6
  • IRB-8

The Face Page is no longer required for InfoEd submission.

 

IRB Forms – Paper Submission

The following forms are to be used only when submitting study material to the IRB via paper submission (hand carry or sent through the mail).

Note:  these forms may not be used with the new InfoEd process.

Contact the IRB office at 6-8802 with questions regarding which form should be submitted.

 

Applications

IRB Face Page
(Checklist to file w/ each submission)

IRB-1 —  Protocol Application for the Involvement of Human Participants in Research: for Expedited or Full Board Review. Click here for instructions.

IRB-2 — Re-Approval/Completion. Click here for instructions. You must also file the Cumulative Inclusion Enrollment Report below if your study is funded by NIH or NSF.

IRB-5 — Request for Exemption from Continuing IRB Review. Click here for instructions.

IRB-9 — Protocol Application for Ethnographic/Naturalistic Research. Click here for instructions.

Appendix A — Personnel and Study Investigators Log/Personnel Amendment Form

 

Supplemental Forms

IRB-1A — Drug/Device
Complete this form if the proposed study involves the use of FDA approved drugs/devices, non-medical devices, investigational drugs/devices, biological agents, or proprietary products.

IRB-1B — Genetic Testing
Complete this form if the proposed study involves genetic testing.

IRB-1C — Treatment
Complete this form if the proposed study is a treatment study; that is, if the study holds forth the possibility of cure or therapy for the subject’s condition.

Culumlative Inclusion Enrollment Report
Required at time of re-approval for studies funded by NIH or NSF.

 

Additional Forms

IRB-3 — Amendments. Click here for instructions.

IRB-4 — Adverse Event/Unanticipated Event. Click here for instructions.

IRB-6 — Protocol Deviation Report. Click here for instructions.

 

Research Method Course Forms

IRB-7— Protocol Application. Click here for instructions.

IRB-8 — Re-Approval / Completion

 

IRB Reviewer Checklists

IRB-1 — New Submission Protocol Application Checklist

Re-Approval/Continuing Review Checklist

Amendment Review Checklist