BUMC IS INSTITUTION A (THE IRB OF RECORD) COMPLETING

INSPIR Section

Requirements

Comments

All Sections

Complete the entire INSPIR application as you would for an Exempt, Expedited or Full Board Protocol (depending on the research) as the BUMC IRB will be reviewing the entire study

This form indicates the specific sections where additional information is needed for Single IRB review with BUMC being Institution A (the IRB of Record)

A3b- Cooperative Agreement

Choose from the pull-down list the institution with which BUMC will enter into an IAA

If the institution is not listed on the pull down email [email protected] and ask him to add the institution

A4 –

Co- investigators

List all persons from the deferring IRB who are engaged in research.

Provide documentation of human subjects training

*BUMC needs documentation of the initial human subjects training. Fax certificate to 617-638-7234 (Tasha)

Recertification certificate not needed for non-BUMC investigators

F2- Procedures

Clearly explain all procedures that are being done in the research. Clearly describe which activities are occurring at BUMC and which are occurring at the deferring institution.

This information is essential in making the determination about Single Site Review

Section H Risks

Clearly describe which risks will occur at the deferring site

Note: If the risks are greater than minimal at the deferring site or they involve more than confidentiality/ privacy issues then Single IRB review will probably not be approved.

Section S

Attach a copy of the Single IRB Review Request Form – fully completed and signed

Use the CRC request form if Charles River IRB will be Institution A

Use the non-CRC request form for other institutions.

Note: BUMC cannot do an IAA with the VA at this time

Submit

This may be submitted as part of a new IRB submission or as an amendment

If submitting as an amendment please ensure that all the fields listed above are modified in the INSPIR application.