Guidelines for the Clinical Research Study Impact Approval Form:
Ontario Cancer Research Ethics Board (OCREB) Applications

This form is required for all Ontario Cancer Research Ethics Board (OCREB) applications whereby the proposed research involves the use of hospital resources and/or where research education and awareness is necessary. OCREB approved studies must not be activated until all required authorizing signatures are obtained on the Clinical Research Study Impact Approval Form and submitted to the Clinical Studies Resource Centre.

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: 2012-01-20