A Copy of the Synopsis/Protocol for the Research Project

REQUEST FOR LAB/PATHOLOGY APPROVAL
Why is the Request for Lab/Pathology Program Approval necessary?
Laboratory/pathology involvement is necessary for research studies that involve sample collection from in-patients within HSN and may be necessary for out-patients at HSN clinics. Research study protocols are reviewed for the level of Lab or Pathology involvement required.
Examples:
If tissue specimens will be collected for research purposes during a surgical procedure in the Operating Room, Anatomical Pathology and the Operating Room must review and approve the study.
If blood specimens will be collected for research purposes during a surgical procedure in the Operating Room, the Anesthesia Program must review and approve the Research Study.
When are Requests for Program Approval made?
Prior to commencing work on a research project, researchers are required to interact with appropriate site/department/unit/program leadership regarding the study requirements. Requests for Program Approval is intended to facilitate communication about the feasibility of new research projects and cost recovery between the study team and affected hospital programs.
Instructions to Complete the Request for Program Approval:
1. Populate the attached Request for Program Approval with your project information
2. Attach the following to complete the Request:

a copy of the synopsis/protocol for the research project
a copy of the Laboratory/Pathology Manual (if applicable)

3. Submit the full package to the person responsible for the program, (i.e. Manager, Lead Administrative Director, or Executive Director). Depending on your project, there may be more than one program involved and you will require a separate package for each program. (Note: If your project involves Health Records, Pharmacy, Lab/Pathology, or Diagnostic Imaging, please ensure the program-specific form is used.)
4. Return the completed form(s) to the Research Services Office and keep a copy for your records
Assistance
If you require assistance to complete the Request for Program Approval, please contact the Research Services Office at 705-523-7300 ext. 1926 or by email at:
REQUEST FOR LABORATORY/PATHOLOGY APPROVAL
Project Title:
Attach: Synopsis/Protocol & Research Intake Form
Principal Investigator (PI):
Main Project Contact:
If not the same as the PI
Project Contact Phone #: / Project Contact Email:
Date Submitted for Signature:
RESOURCES REQUESTED
Estimated Number of Patients:
☐ Inpatient ☐ Outpatient / Collection supplies provided by: ☐ Researcher ☐ Lab
IMPACT/RESOURCES REQUESTED
**only list if above standard of care / FREQUENCY
e.g. / Pathologist completes specialized form
Dry ice
Urine collection / 8 patients x 2 visits (form takes 15 minutes)
Samples batched shipped q3 months
Once
1.
2.
3.
Managers/Directors - Please read carefully
When approached by a researcher/research team regarding a research project which will involve your unit/program, ensure that they have provided enough information to evaluate the project’s impact.
APPROVAL
PROGRAM DECLARATION
Please note that the expected turn-around time for review and sign off is two (2) weeks.
As evidenced by my signature below, my program is aware of the research project being proposed and acknowledges that this program is supportive of the research and able to accommodate and support the project as set out herein.
Program Manager/Director:
Program/Unit:
Date of Approval:
Please print Manager/Director’s Name:
Please retain a copy of this document for your records and return the original to the Principal Investigator.

Version 2_26Feb2018