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Guidelines for the Clinical Research Study Impact Approval Form:
Sunnybrook Research Ethics Board (REB) Applications
This form is required for all Sunnybrook REB applications whereby the proposed research involves the
use of hospital resources and/or where research education and awareness is necessary. REB approval
will not be granted until all required authorizing signatures are obtained on the Clinical Research Study
Impact Approval Form and submitted to the Research Ethics Office.
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