Human Subjects Forms

This page contains quick links to the forms and templates commonly utilized by BU researchers in IRB submissions. For more information about the policies governing the use of these forms, please reference our Policies and Procedures for Working with Human Subjects.

Initial Submission Forms

Before you begin preparing your submission using the forms listed here, you’ll want to determine if IRB approval is needed and then review our guidance for submission.

• Exempt New Application
• Expedited/Full Review Board New Application
• Research with Human Subjects Determination Form
• 118 Determination Form
• Informed Consent Template
• Assent Form Template
• Research Data Repository New Application

Continuing Review & Annual Check-in Forms

• Continuing Review/Progress Report Form

Amendment & Modification Forms

Before you make an amendment request, you’ll want to review our guidance on amendments and modifications and our guidance for adding external investigators.

• Amendment Request Form
• Clarification Form (for Exempt Studies Only)
• Staff Amendment Form

Incident Report Forms

• Event Form (Replaces Deviation & Unanticipated Problems Form)

Reliance Agreements for Multisite Studies Forms

• Individual Investigator Agreement Form
• Single IRB Request Form

Supplemental Forms

• Appendix A – International
• Appendix B – Drugs
• Appendix C – Device
• Appendix D – Samples
• Appendix E – Genetics
• Appendix F – MRI
• Appendix G – Request for Waiver of HIPAA Authorization
• Individual Investigator Agreement Form
• Attestation Form for Translation of Study Documents
• Final Report Form
• Request for Modification Response Form
• CRC IRB Engagement Checklist
• Supplemental Form – Enrollment of Adult Participants with LARs
• Video Use Consent Form