Addendum - Add Investigator(S)To PI Certification Form

Addendum - Add Investigator(s)to PI Certification Form

Use This Form ONLY to Add Investigators to a Previously Approved Study

Principal Investigators in Beth Israel Medical Center and St. Luke’s-Roosevelt Hospital Center use the Addendum – Add Investigators to PI Certification Formto declare the names of Investigators added to their project subsequent to submission of a complete PI Certification form, to affirm that the training has been accomplished and related documents submitted, and to affirm that a conflict of interest disclosure has been submitted for each added Investigator.This form should show only newly added Investigators. There is no need to repeat Investigator data already submitted. By the Principal Investigator’s signature on the Addendum-Add Investigator(s) to PI Certification form, the PI attests that conflict of interest declaration and training requirements have been met by all newly added Investigators.

For projects submitted to the Institutional Review Board prior to 8/24/12, Principal Investigators must submit a complete PI Certificationform to add Investigators to the project roster. See PI Certification form guidance for specific instructions.

BIMC Investigators: Submit completed form to

SLRHC Investigators:Submit completed form to

All four sections of this certification must be completed by the Principal Investigator in order to add an Investigator via Addendum for human subjects research to the Institutional Review Board or to the IACUC, or at other times as indicated in Institutional policy referenced below.

1.PRINCIPAL INVESTIGATOR AND PROJECT IDENTIFICATION

Principal Investigator’s Name: Protocol /IRB Number and Title of Proposal/Project:

2.ADDITIONAL INVESTIGATORS:

The following individuals have been added to the project subsequent to initial or annual IRB approval (attach additional page if needed). I have confirmed completion of on-line CITI conflict of Interest training for each Investigator. I have obtained confirmation from OGARA or from each Investigator that s/he submitted a Disclosure of Significant Financial Interests statement to the Institutional Official via COI-SMART or by email to OGARA within the past twelve months, and the Investigator indicates that s/he does not have undisclosed new interests.

ADDITIONAL INVESTIGATORS / TRAINING (Select One) / DISCLOSURE (Select One)
SFI Disclosure Form
Attached
Previously Submitted
Indicate Date
CITI Conflict of Interest Training / COI-SMART
SFI Disclosure Form
Attached
Previously Submitted
Indicate Date
CITI Conflict of Interest Training / COI-SMART
SFI Disclosure Form
Attached
Previously Submitted
Indicate Date
CITI Conflict of Interest Training / COI-SMART
ADDITIONAL INVESTIGATORS / TRAINING (Select One) / DISCLOSURE (Select One)
SFI Disclosure Form
Attached
Previously Submitted
Indicate Date
CITI Conflict of Interest Training / COI-SMART
SFI Disclosure Form
Attached
Previously Submitted
Indicate Date
CITI Conflict of Interest Training / COI-SMART
SFI Disclosure Form
Attached
Previously Submitted
Indicate Date
CITI Conflict of Interest Training / COI-SMART

3.Does any Significant Financial Interest disclosed by any Investigator listed above represent a real or potential conflict of interest with this submission?

Yes No

If YES, please provide details:

4. PRINICIPAL INVESTIGATOR CERTIFICATION

Enter your name in the box below and check yes to complete certification.

Do you certify that you and all Investigators noted above have complied with Federal and Institutional requirements for conflict of interest training, and for disclosure of significant financial interests as defined in the referenced policy?Yes No

Principal Investigator’s Name: Date:

References: BIMC Policy 2032A Objectivity in Research

SLRHC Policy A1-129 Conflict of Interest in Research

FOR INSTITUTION USE ONLY:

Reviewed by: Date:

Form Addendum-Add Investigator_v.02142013 page 1 of 2 pages