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)

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

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

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Use when an investigator wishes to form a Research Data Repository

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

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Complete this form when conducting studies that include drugs.

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Complete this form when conducting studies that include devices.

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Complete this form when conducting studies that include biological samples.

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Complete this form when conducting studies that include genetic testing.

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Other Submission Forms

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

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

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

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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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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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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.
  • All identifiers (including codes) have been destroyed OR analysis and/or use of identifiable data is complete

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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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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

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

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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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For use when the study plan includes videotaping of subjects.

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Single IRB Review Requests


(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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(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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