CLINICAL RESEARCH STUDY IMPACT APPROVAL FORM
Full Study Title:
Short Title / Code: Protocol #:
Approved Board of Record: REB #:
If CTO Qualified REB chosen, specify site:
Principal Investigator (PI) Name (type in or print clearly):
This form is required for all Research Ethics Boardapplications whereby the proposed research involves the use of Sunnybrook hospital resources and/or where research education and awareness is necessary.
IMPORTANT- INSTRUCTIONS FOR SUBMISSION:
- If submitting the REB application to the Sunnybrook REB:
- Submit this completed form with the REB application to the Sunnybrook REB
- If submitting the REB application to the Clinical Trials Ontario (CTO) Qualified REB:
- Submit this completed form to Quality Assurance and Education, Sunnybrook Human Research Protections Program (HRPP), Room C823 or C827.
Steps to determine and obtain Program/Department/Division Authorizations:
It is an institutional requirement that all clinical research studies obtain approval from each program/department/division impacted in any way by the study.
- PI identifies each Program/Department/Division where the study involves the use of hospital resources and/or where research education and awareness is necessary, and provides each Primary Contact with the following documents:
- Summary document outlining the impact for each selected area (e.g. a chart outlining the impact on nursing staff time, length of stay, plan to conduct in-service etc.)
- Department specific forms as applicable (e.g. Lab Research Form; Medical Imaging Forms)
- Study Protocol (if requested by the Primary Contact person)
- The Primary Contact is responsible for approaching the appropriate individual(s) within the Program/Department/Division to review the relevant study documents listed above and for obtaining the appropriate authorizing signatures.
- Authorizing signatories are responsible for ensuring the appropriate review has taken place before signing the form.
- A signature below attests that the Authorizing Signatory has received full information about the study’s impact and has agreed to the conduct of this study in their area(s) of responsibility as per the negotiated agreement with the PI. Please note that the expected turn-around time for review and sign off is 2 weeks.
Principal Investigator Attestation:
I have reviewed the form and determined that this study involves hospital resources, and/or patient care areas, and/or staff. I attest that to the best of my knowledge I have indicated the areas where authorizations are necessary and have obtained the appropriate signatures as indicated on the form. I confirm that although REB approval may have been issued, study activation will not occur until all required authorizations are obtained and submitted.
I have reviewed the form and attest that this study does not involve any hospital resources, patient care areas or staff and that NO authorizations are required for the conduct of this study. (Submit page 1 and 2 only).
PI Signature:______Date:
(yyyy.mmm.dd)
Director / Michael McRitchie / Signature: / Date:
(yyyy.mmm.dd)
Brain SciencesProgram
(e.g., Stroke, Mental Health) / Primary Contacts:
Beth Linkewich – Stroke Research
Lois Fillion – all other Brain Sciences Research
Operations Director / Lois Fillion(signature required for all Brain Sciences Program Research including Stroke) / Signature: / Date:
(yyyy.mmm.dd)
Director, Regional Stroke Program / Beth Linkewich / Signature: / Date:
(yyyy.mmm.dd)
Community Program
(e.g., Medical Units, Geriatric Day Hospital, HIV Clinic, etc.) / Primary Contact: Lois Fillion
Operations Director / Lois Fillion / Signature: / Date:
(yyyy.mmm.dd)
Family Practice Unit / Primary Contact: Dr. Mary Tierney
Director PCRU / Dr. Mary Tierney / Signature: / Date:
(yyyy.mmm.dd)
Health Data Resources / Primary Contact: Research Department x5923
Signature on this form not required. Contact HDR for required forms.
Holland MSK Program
(e.g., Holland Centre, SCIL, Fracture Clinic) / Primary Contact: Anne Marie MacLeod
Operations Director / Anne Marie MacLeod / Signature: / Date:
(yyyy.mmm.dd)
Holland MSK Program
(e.g., Holland Centre, SCIL, Fracture Clinic) / Primary Contact: names below with an asterisk* as needed
Pharmacy / Frayda Gorenstein* / Signature: / Date:
(yyyy.mmm.dd)
Signature below by Operations Director is required following review and sign off by the above contacts
Operations Director / Anne Marie MacLeod* / Signature: / Date:
(yyyy.mmm.dd)
Imaging (Medical/Radiology) / Primary Contact:Cindy Matheson
Director
*Note: Use of PET-CT at OCC also requires signature from Radiation Oncology Imaging if used during OCC time slot / Henry Sinn / Final Approval Signature: / Date:
(yyyy.mmm.dd)
Imaging – Research *excluding IRCCI – see Schulich Heart Program / Primary Contact: names below with an asterisk* as needed
Research MRI / Ruby Endre*, Technologist / Signature: / Date:
(yyyy.mmm.dd)
Dr. Kullervo Hynynen,
Director / Signature: / Date:
(yyyy.mmm.dd)
Other research imaging (i.e. U/S and elastography),specify: / Dr. Kullervo Hynynen*,
Director / Signature: / Date:
(yyyy.mmm.dd)
Infection Prevention & Control / Primary Contact: Natasha Salt
Director / Natasha Salt / Signature: / Date:
(yyyy.mmm.dd)
Information Services / Primary Contact:Oliver Tsai
Director / Oliver Tsai / Signature: / Date:
(yyyy.mmm.dd)
Laboratories (select below) / Primary Contact:names below with Asterisk * as needed
Anatomical Pathology/Molecular ServicesManager / Gail Sanders* / Signature: / Date:
(yyyy.mmm.dd)
Primary Contact: Susan Baeshka *
Clinical ChemistryManager / Tammie Taylor* / Signature: / Date:
(yyyy.mmm.dd)
Transfusion Medicine & Tissue Banking Manager / Connie Colavecchia* / Signature: / Date:
(yyyy.mmm.dd)
Primary Contact: Susan Baeshka *
Hematological Pathology Manager / Jacqueline King* / Signature: / Date:
(yyyy.mmm.dd)
Lab Information Systems / Suzanne Waldman* / Signature: / Date:
(yyyy.mmm.dd)
MicrobiologySupervisor / Laura Baillie* / Signature: / Date:
(yyyy.mmm.dd)
Molecular Diagnostic Labs / Dr. David Cole* / Signature: / Date:
(yyyy.mmm.dd)
Outpatient Phlebotomy and ECGs / Anne Marie Phillips, Supervisor / Signature: / Date:
(yyyy.mmm.dd)
Suzanne Waldman*, Manager / Signature: / Date:
(yyyy.mmm.dd)
Specimen Management (i.e. separating, packaging & shipping to an external lab) / Suzanne Waldman* / Signature: / Date:
(yyyy.mmm.dd)
Odette Cancer Centre Program
(e.g. T wing, Surgical Oncology, Medical Oncology, etc.) / Primary Contact: names below with an asterisk* as needed
Cancer Genetics High Risk Program / Dr. Andrea Eisen / Signature / Date:
(yyyy.mmm.dd)
Chemotherapy Unit / Kirsty Albright* / Signature: / Date:
(yyyy.mmm.dd)
Radiation Therapy / Steve Russell* / Signature: / Date:
(yyyy.mmm.dd)
Dr. Greg Czarnota, Chief of Radiation Oncology / Signature: / Date:
(yyyy.mmm.dd)
Physics / Dr. Stephen Breen* / Signature: / Date:
(yyyy.mmm.dd)
Dr. Claire McCann / Signature: / Date:
(yyyy.mmm.dd)
Dr. Greg Czarnota, Chief of Radiation Oncology / Signature: / Date:
(yyyy.mmm.dd)
Radiation Oncology
Imaging
(1.5T MRI, CT, PET-CT)
*Note: Use of PET-CT at OCC also requires signature from Dept. Medical Imaging if used during Dept. Medical Imaging time slot / Steve Russell* / Signature: / Date:
(yyyy.mmm.dd)
Dr. Stephen Breen / Signature: / Date:
(yyyy.mmm.dd)
Dr. Greg Czarnota,
Chief of Radiation Oncology / Signature: / Date:
(yyyy.mmm.dd)
Odette Cancer Centre Pharmacy / Shenur Jamani* / Signature: / Date:
(yyyy.mmm.dd)
Manager / Flay Charbonneau / Signature: / Date:
(yyyy.mmm.dd)
Primary Nursing/ Access to Outpt Clinic(s) / Sherrol Palmer-Wickham* / Signature: / Date:
(yyyy.mmm.dd)
Cystoscopy Suite / Denyse Henry* / Signature: / Date:
(yyyy.mmm.dd)
Oncology Inpatient Unit / C2 – Eleanor Miller*
C6 – Steffanye Michaelson*
D6-Mary Glavassevich* / Signature: / Date:
(yyyy.mmm.dd)
Breast Centre / Fiona McCullock* / Signature: / Date:
(yyyy.mmm.dd)
Other: / Signature: / Date:
(yyyy.mmm.dd)
Other: / Signature: / Date:
(yyyy.mmm.dd)
Signatures below are required following review and sign off by the above contacts (e.g. post OCC service agreement(s))
Operations Director / Janice Stewart* / Signature: / Date:
(yyyy.mmm.dd)
Medical Director, Clinical Research/Trials,Odette Cancer Center / Dr. Claire McCann* / Signature: / Date:
(yyyy.mmm.dd)
OR & Related Services
(e.g. Pre-Admission, Same Day Surgery, OR, PACU, Short Stay Unit, Regional Processing Centre, Transfusion Medicine, Endoscopy, Colposcopy, Medical Outpatients, etc.) / Primary Contact: Cynthia Holm
Operations Director / Cynthia Holm / Signature: / Date:
(yyyy.mmm.dd)
Pharmacy / Primary Contact:John Iazzetta
Coordinator Drug Information Service (e.g. acute care, Veterans Centre, Outpatient Pharmacy) / Dr. John Iazzetta / Signature: / Date:
(yyyy.mmm.dd)
Photography -Medical / Primary Contact:Doug Nicholson
Manager / Doug Nicholson / Signature: / Date:
(yyyy.mmm.dd)
Plexxus / Primary Contact: Elizabeth Deveau
Director, Purchasing / Elizabeth Deveau / Signature on this form not required. See FAQs on Research Ethics Pages for Plexxus instructions.
Privacy Office / Primary Contact: Jeff Curtis
Chief Privacy Officer / Jeff Curtis / Signature on this form not required. Contact the Privacy Office if a Privacy Impact Assessment is required.
Schulich Heart Program / Primary Contact: names below with an asterisk* as needed
Cardiology and CV units, E2 labs, Cath labs, Inpt. ECGs + Interpretation, ECHO, etc. / Operations Director Susan Michaud* / Signature: / Date:
(yyyy.mmm.dd)
IRCCI – Imaging Research Centre for Cardiac Intervention / Research Director:
Graham Wright* / Signature: / Date:
(yyyy.mmm.dd)
St. John’s Rehab Program / Primary Contact: Dr. Larry Robinson
Director, St. John’s Rehab Research Program / Dr. Larry Robinson / Signature: / Date:
(yyyy.mmm.dd)
TECC Program
(e.g. Emergency Department, D5, C5, CrCU, CVICU, RTBC, D4ICU, B5ICU, etc.) / Primary Contact: Debra Carew
Operations Director / Debra Carew / Signature: / Date:
(yyyy.mmm.dd)
Veterans Centre
(all K and L Wing) / Primary Contact:Teresa Korogyi
Acting Operations Director / Teresa Korogyi / Signature: / Date:
(yyyy.mmm.dd)
Women & Babies Program
(e.g. M4 and M5) / Primary Contact: names below with an asterisk* as needed
NICU Pharmacy / Carla Findlater* / Signature: / Date:
(yyyy.mmm.dd)
Signature below by Operations Director is required following review and sign off by the above contacts
Operations Director / Jo Watson* / Signature: / Date:
(yyyy.mmm.dd)
Other : / Primary Contact:
Director / Signature: / Date:
(yyyy.mmm.dd)
Other : / Primary Contact:
Director / Signature: / Date:
(yyyy.mmm.dd)
NOTE: Add additional sheets for any areas not listed above
Form Version date: 2018-02-27Page 1 of 7