Office of Research Administration – St. Michael's Hospital

For Internal Use Only

Date Discussion Took Place:
Discussion with:
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ADDENDUM 4 (CONTRACT ASSESSMENT FORM):

PRIVACY (DATA OR HUMAN BIOLOGICAL SAMPLES TRANSFER)

Complete and return a Research Contract Assessment Form to the appropriate Contracts staff to provide appropriate and relevant information pertaining to the agreement. The information provided will assist in expediting the development, review and/or negotiation of the privacy agreement.

Section 1: Project Details

What kind of personal information will be transferred?

Is the personal information identifiable? Yes No

Please explain

Are human biological samples being transferred? Yes No

Please explain

Who is the Provider of the personal information/biological samples?

Who is the Recipient of the personal information/biological samples?

Is the personal information/biological samples being transferred both ways (e.g., you are both Provider and Recipient)?

Please explain Yes No

Are or will there be any other agencies/companies involved in the study (e.g. Contract Research Organization)?

If yes, please describe the involvement.Yes No

Is this a single site study?Yes No

If SMH is a sub-site/sub-grantee/sub-contractor,

Name Lead Institution:

Name Lead PI:

Please provide any other factors that need to be taken into account in developing or reviewing the agreement (e.g. unique context, precedents/other agreements with source, timing, etc).

Is the publication clause acceptable? Yes No

If no, please explain.

Will other confidential information be provided (e.g., proprietary information)? Yes No

If yes, by whom? What might it be?

Are there pre-existing agreements related to the study?Yes No

Are there any students participating in this study? Yes No

If yes, will it form part of their thesis work? Yes No

(UofT guidelines require reduced publication delays for student thesis work. There may be questions about insurance coverage for non-employee students.)

Section 2: Conflict of Interest

Does the SMH Investigator or his/her family member(s) have one or more of the following interests?

Please note that if you select Yes to either of these questions, this information will be used for review under the Research Conflicts of Interest Policy available at .

No Yes, please contact Marianna Betro at x5521 for details and check all that apply:

Employment, consulting, ownership, or other financial interest in any entity that could benefit from the results of the study (including the funder, sponsor, owner of the study product, or entity that supplies products/materials for the study)

Member of the senior management (e.g. CEO or VP) or an officer or director of any entity that could benefit from the results of the study (including the funder, sponsor, owner of the study product, or entity that supplies products/materials for the study)

Inventorship, copyright or other ownership interest in the study product or a competitor product

Endorsement of the study product or a competitor product (i.e. my name, or my family member’s name, is associated in endorsing the product)

The SMH Investigator is responsible for asking all members of the research team (including co-investigators, research coordinators, research managers, research technicians, administrative staff, etc.) if they have any of the interests listed above.

Are there any disclosures to be made by other members of the research team?

No Yes, please contact Marianna Betro at x5521 for details.

If you answered yes to either of the above, has this information been disclosed in the REB application?

(Please note that we may contact the REB regarding details.)

No Yes

Section 3: Project Certifications

Will this project require a new REB approval?Yes No

If in doubt, please check with the REB Office before you answer this question.

If yes, when will the protocol be submitted to the REB? For which review date?

If no, please provide REB file number:

Biohazards

Are Biohazards involved in this project at SMH? Yes No

Will viral vectors be used/created?Yes No

Radioactive Materials

Does this project involve the use of radioactive materials?Yes No

If yes, please contact the Research Biosafety Committee.

Section 4: Budget Details

Is funding provided or to be paid under this Agreement?N/A Yes No

If yes, is the budget still under negotiation?Yes No

Please attach the budget for this Study, if applicable.

Revised: February 2009Page 1