Human Subjects Forms

Medical Campus IRB

For the Medical Campus, please see BU Medical Campus IRB Guidance.

Charles River Campus IRB

New Application Forms

(NOTE:  Appendices are to be used as applicable.  Instructions on when to use Appendices are located within the Application Form)

Exempt New Application

Use to apply for the initial review of studies that can be reviewed by exempt procedures.

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Expedited/Full Review Board New Application

Use to apply for the initial review of studies that require review by Expedited or Full Board procedures.

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Research Data Repository New Application

Use when an investigator wishes to form a Research Data Repository

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Appendices A - International

Complete this form when conducting research outside of the United States.

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Appendices B - Drugs

Complete this form when conducting studies that include drugs.

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Appendices C - Device

Complete this form when conducting studies that include devices.

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Appendices D - Samples

Complete this form when conducting studies that include biological samples.

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Appendices E - Genetics

Complete this form when conducting studies that include genetic testing.

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Other Submission Forms

Amendment Request - (*Note, please use the Study Staff Amendment Form to add or remove staff)

Use to propose changes to previously approved research that was reviewed by Expedited or Full Board procedures.

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Attestation Form for Translation of Study Documents

For use when any study documents are to be administered in languages other than English.

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Clarification Form (for Exempt Studies Only)

Use to propose changes to previously approved research that was reviewed by exempt procedures.

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Continuing Review Application

Use to request annual re-approval for studies that were reviewed by Expedited or Full Board procedures (continuing review applications are not required for studies reviewed by exempt procedures).

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Event Form (NEW, replaces the Deviation & Unanticipated Problems Forms)

This form is to be completed to report: Unanticipated problems or adverse events involving risks to subjects or others, exceptions, deviations, new information, and other problems/events.

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Final Report Form

Use to officially close out any study with the following conditions:

  • The study is permanently closed to enrollment.
  • All subjects have completed all study procedures.
  • Data collection is complete.
  • Analysis of identifiable (directly or indirectly) data is complete.
  • All identifiers (including codes, links, or key to identifiers) have been destroyed.

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Request for Modification Response Form

Use to document the principal investigator’s response to IRB requests for additional information made during the review of an IRB submission.

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Study Staff Amendment Form

Use to add or remove staff to previously approved research that was reviewed by Expedited or Full Board procedures (study staff amendments are not required for research reviewed by exempt procedures).

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Consent Forms

Assent Form Template

For use when the study plan is to enroll children age 12 years and older. Consent of the parent is documented on the separate Consent Form.

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Attestation Form for Translation of the Consent Form

For use when any study documents are to be administered in languages other than English.

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Consent Form Template & Script

For use when the study plan is to enroll adults (18 years and older). Additionally, when children are to be enrolled, consent of the parent is documented on this form and assent of the child (12 years and older) is documented on the separate Assent Form.

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Video Use Consent Form

For use when the study plan includes videotaping of subjects.

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Single IRB Review Requests

Single IRB Review Request: Boston University is Institution A


(Considered on a case-by-case basis)

Use to request the BU CRC IRB to serve as the reviewing IRB: For research that involves a secondary institution where the primary investigation takes place at a BU facility, or the research is initiated by a BU investigator. The BU IRB may consider reviewing responsibilities in other situations as well. Call the IRB office to discuss the appropriateness of this request prior to submitting this form.

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Single IRB Review Request: Boston University is Institution B


(Considered on a case-by-case basis)

Use to request another institution’s IRB to serve as the reviewing IRB:

  • For research involving investigators from multiple institutions, but where the BU investigator serves as an awardee on the grant.
  • When the involvement of the BU investigator is limited to minimal risk activities (such as data analysis, specimen collection, etc.).
  • When the other institution’s IRB is more constituted to review a certain scope of research.

The BU IRB may consider referring reviewing responsibilities in other situations as well. Call the IRB office to discuss the appropriateness of this request prior to submitting this form.

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