Download Study Impact Approval Form Guidelines

Guidelines for the Clinical Research Study Impact Approval Form:
This form is required for all REB applications whereby the proposed research involves the use of Sunnybrook
hospital resources and/or where research education and awareness is necessary. These studies must not be
activated until all required authorizing signatures are obtained on the Clinical Research Study Impact Approval
Form and submitted.
IMPORTANT- INSTRUCTIONS FOR SUBMISSION:
1. If submitting the REB application to the Sunnybrook REB:
a. Submit this completed form with the REB application to the Sunnybrook REB
2. If submitting the REB application to an approved delegated REB of record (i.e. OCREB (Ontario Cancer
Research Ethics Board, TAHSN (Toronto Academic Health Science Network), CTO (Clinical Trials
Ontario)):
a. Submit this completed form to Quality Assurance and Education, Sunnybrook Human Research
Protections Program (HRPP), Room C823 or C827.
DEFINITIONS:
Principal Investigator (P.I.): The person responsible for the conduct of the clinical research at Sunnybrook.
Hospital Resources: Human and material resources including those which are currently paid by and/or
accessed through the hospital (e.g. diagnostic services, pharmacy, staff time, increased length of stay, space,
equipment and supplies).
Standard of Care: The usual treatments, interventions, and procedures which are part of patient care and may be
performed regardless of study participation.
Incremental Care/Cost: Research specific treatments, interventions, diagnostics and procedures that are above
and beyond the standard of care. Research study budgets must cover the incremental costs of all hospital
resources required for the research. Any treatments, interventions, diagnostics and procedures that are funded/
budgeted by the clinical trial sponsor are considered to be incremental care/costs.
REQUIREMENTS FOR THE REVIEW OF STUDY IMPACT RELATED TO CLINICAL RESEARCH:
Review of study impact, including hospital resource use and patient care implications, is a required part of clinical
research at Sunnybrook. Recovery for incremental costs must be incorporated into clinical research budgets.
Communication, awareness and education for all areas where the patients will be cared for during that research is
essential to the efficient completion of the research protocols and the safety and well being of research participants
and staff.

Hospital Resources: If any hospital resources are required for research purposes, approval must be obtained
from all areas involved (e.g. Laboratory services, patient care units/clinics).

Patient Care Areas: If the study involves the care of patients in a patient care area or clinic and/ or
Sunnybrook staff as participants (e.g. survey, interviews), authorization must be obtained from all areas
involved.

Drugs: If the study involves drug administration in Sunnybrook Acute Care/Veterans Centre, even if
dispensed directly to participants by the PI or designate, approval signature from the Coordinator of Drug
Information Services is required to ensure compliance with the institution’s drug prescribing policies. NOTE:
For investigator-initiated clinical drug trials, it is the PI’s responsibility to identify which drugs are standard of
care and those that are “research” (the latter are to be billed to the research budget).

Equipment: If the study involves the receipt of equipment from an external source, a “No Charge Purchase
Order” must be generated through the hospital’s purchasing agent (Plexxus) and the equipment approved by
Biomedical Engineering prior to use on humans.

Budgets: Research study budgets must cover the incremental costs of all hospital resources required for the
research.
Version: 2015-09-22