Application for REB Approval to Access Retrospective Data for Research Purposes or Access for Administrative Purposes

SECTION 1a / Principal Investigator / Requestor Information: (MUST be a UHN Staff Member)
Name: / Title: / Telephone:
Department: / Site: / PMH
TGH
TWH / Fax:
Email: / Wing/Floor/Room:
Date of Request: / //
(DD/MM/YYYY)
Principal Investigator/Requestor Signature: / Date of Signature:
______/ ______/ ______
(DD/MM/YYYY)
SECTION 1b / Co-Investigator(s) / Co-Requestor(s) Information:
Name(s): / 1.
2.
3. / Title: / 1.
2.
3. / Telephone: / 1.
2.
3.
Department: / 1.
2.
3. / Site: / 1. PMH TGH TWH
Other:
2. PMH TGH TWH
Other:
3. PMH TGH TWH
Other: / Fax: / 1.
2.
3.
Email: / 1.
2.
3. / Wing/Floor/
Room: / 1.
2.
3.
Co-Investigator(s) / Co-Requestor(s) Signature: / Date of Signature (DD/MM/YYYY):
SECTION 1c / Data Abstractor(s) Information: (To be completed by the individual who will be abstracting the data requested)
Same as Principal Investigator/Requestor Same as Co-Investigator/Co-Requestor
Name(s): / 1.
2. / Title: / 1.
2. / Address: / 1.
2.
Institution: / 1.
2. / Telephone: / 1.
2.
Department/Division: / 1.
2. / Email: / 1.
2.
Confidentiality Agreement
I, the undersigned, agree to adhere to the UHN policy on Information and Data Security (Policy # 1.40.007) and understand that a breach of this policy will be just cause for termination of my employment and /or affiliation with this hospital. I agree that all health information, which I may have access to, is to be dealt with in keeping with the policies and procedures of the University Health Network with respect to confidentiality. If identifying information is collected, the information will be kept secure and identifiers removed at the completion of collection. I also accept full responsibility for protection of information that has been collected by a delegate on my behalf.
Data Abstractor(s) Signature: / Date of Signature (DD/MM/YYYY):

Application for REB Approval to Access Retrospective Data for Research or Administrative Purposes Page 1 of 4

Version-May2005

SECTION 2 / Type of Data Request (check only one)
Multidisciplinary (Non-Oncology) Research
Submit 1 original and 1 copy of this form to the Research Ethics Board (REB) office for review. / Oncology Research
Submit 1 original (with signatures) and 1 electronic copy (without signatures) of the application and all attachments to the Cancer Registry and Data Access Committee (CRDAC) for review. Once approved by the CRDAC, the CRDAC will submit a copy of the application to the REB for review. / Oncology Administrative
Submit 1 copy to the CRDAC for review.
SECTION 3 / Data to be extracted from (check all that apply)
Clinical Records / Enterprise Data Warehouse / Cancer Registry / Database
Specify:
SECTION 4 / Project Summary
Project Title:
Primary objective and hypothesis of the study:
List specific data requested:
(Attach data collection forms, if applicable)
Provide study summary and outline analyses (maximum 250 words):
* Attach additional page if necessary.
Proposed number of research subjects: / UHN: Other sites:
Proposed start date of project: / //
(DD/MM/YYYY) / Proposed termination date: / //
(DD/MM/YYYY)
Date range of requested data under review (e.g. 22/01/1984 to 22/07/1984) / Start: / //
(DD/MM/YYYY) / End Date: / //
(DD/MM/YYYY)
How will this be funded?
(Check all that apply. Submit all grants and contracts to the Office of Grants and Contract Services for review and Signature) / Grant
Specify funding source: / Industry
Sponsor: / Internal
Specify funding source: / No Funding Required
SECTION 5 /

Information Protection: Patient Identifying Data

Will this data be transferred external to UHN? / Yes
No
If yes, where:
How will the confidentiality be protected?
Multicentre Study? / Yes
No
If yes, identify the coordinating site:
Will this data be reported publicly? (e.g. publication) / Yes
No
Will the data being collected be used now or in the future for commercial purposes? / Yes
No
N/A
If yes, please provide details:
Have you already developed a list of specific patients? / Yes
No
If yes, please indicate how patients were identified:
Is patient-identifying data required? / Yes
No
If yes, please justify:
Please indicate the type of patient identifying data: (check all that apply)
UHN Medical Record Number Patient Number Address Date of Birth
Provincial Health Card Number (OHIN) Visit Number Telephone Number Family Members Names
Will this data be linked to any other data? / Yes
No
If yes, please provide details:
Will data be anonymised? / Yes
No
If no, please justify:
How will security and confidentiality of the data be protected, maintained and retained?
SECTION 6 /

Cancer Registry – Complete only if applicable

Disease Site(s) grouping requested:
Check data elements required from the registry for the sample: (indicated additional info required in the blank space)
MRN Name, first and last Date of Birth
Sex Managing Physician Primary Site
Date of Initial Diagnosis Laterality Histology
Date of Initial Contact Clinical Stage Pathological Stage
Date of Surgery Surgery Performed Date Radiation Started
Radiation Date Chemo started Chemo
Date of Last Contact Vital Status Cancer Status
SECTION 7 /

MULTIDISCIPLINARY (NON-ONCOLOGY) RESEARCH REQUEST / ONCOLOGY ADMINISTRATIVE REQUESTS

Divisional/Department Head Signature:
Department: / Print Name: / Date:
______/ ______/ ______
(DD/MM/YYYY)
SECTION 8 /

ONCOLOGY RESEARCH REQUESTS ONLY

Disease Site Group Leader Signatures
Site Group Leader: / Print Name: / Date:
______/ ______/ ______
(DD/MM/YYYY)
Site Group Representative, Dept. Surgical Oncology: / Print Name: / Date:
______/ ______/ ______
(DD/MM/YYYY)
Site Group Representative, Dept. Medical Oncology: / Print Name: / Date:
______/ ______/ ______
(DD/MM/YYYY)
Site Group Representative, Dept. Radiation Oncology: / Print Name: / Date:
______/ ______/ ______
(DD/MM/YYYY)
Other Participating Specialty: / Print Name: / Date:
______/ ______/ ______
(DD/MM/YYYY)
Department Head Signatures
Department Head, Dept. Surgical Oncology: / Print Name: / Date:
______/ ______/ ______
(DD/MM/YYYY)
Department Head, Dept. Medical Oncology: / Print Name: / Date:
______/ ______/ ______
(DD/MM/YYYY)
Department Head, Dept. Radiation Oncology: / Print Name: / Date:
______/ ______/ ______
(DD/MM/YYYY)
SECTION 9 /

Office Use Only

Cancer Registry & Data Access Committee
Approved Not Approved Pending with revisions
Comments:
Chair, Cancer Registry & Data Access Committee
or Designate: / Print Name: / Date:
______/ ______/ ______
(DD/MM/YYYY)

Application for REB Approval to Access Retrospective Data for Research or Administrative Purposes Page 1 of 4

Version-May2005