Review and approval process
Before any research activity can take place at a Covenant facility, it must go through an operational and administrative review. The first step for any researcher is to submit a Covenant application form.
Why apply for review and obtain approval before conducting research?
Covenant's policy on research outlines several reasons why review and approval are required before conducting research:
- Covenant subscribes to the ethical principles outlined in the national Tri-Council Policy Statement (TCPS2), the National Institutes of Health (NIH) core values for research integrity and research practices outlined within the International Council for Harmonization Good Clinical Practice (GCP) guidelines for clinical research.
- The Alberta Health Information Act (HIA) requires Covenant Health as a custodian to maintain responsibility for access, collection, use and disclosure of health information under its purview, including for research purposes. To safeguard patient privacy and safety in compliance with legislation and best practice, review and current approval from an Alberta HIA-designated ethics board are required. We also engage in Section 54 agreements with researchers to identify and clarify those conditions as outlined above.
- Site access agreements may be needed for studies where the principal investigator — and research personnel under their supervision — does not have Covenant privileges and requires access to Covenant sites.
- Operational review is required to ensure that any research study in context is feasible, any negative impacts on patient care and staffing are mitigated and capacity or resourcing is assessed for appropriate supports for clinical health research conducted in Covenant facilities.
- Covenant complies with Accreditation Canada Leadership Standards, which includes the organization's ethical and operational due diligence related to research.
- Covenant is a health system partner with, and separate legal entity to, Alberta Health Services. This means that any legal contracts, Section 54 agreements or site access agreements required for compliance must be negotiated with Covenant directly.
Supporting information
Research study checklist Covenant Health research policy Covenant Health research procedure Agreement by researcher in favor of custodian (HIA agreement) General Guidelines for Accessing Paper Records in Health Records Departments Participant recruitment guidance for research Vanessa's Law, SAEs, RLS and how they apply to researchers at Covenant Health Submit a final reportContact
Wayfinding and approval process
Development, grants and knowledge exchange
researchprojects@covenanthealth.ca
Operations, reporting and relationships
researchmanager@covenanthealth.ca