Research Administrative Approval Process
Health System Access Administration Approval Process: Step-by-Step Guide
If you are conducting a clinical research study and need to access AHS’ provincial data, network resources such as Connect Care or, require support from or are conducting study activities such as recruitment in AHS operational areas, you will need administrative approval from the Health System Access (HSA) team at Alberta Health Services. See the step-by-step process below to understand the administrative approval process. For more information about Health System Access visit the AHS Provincial Health System Access webpage.
UCalgary researchers can submit a new AHS Resources & Facilities request through IRISS. For detailed instructions on how to complete the AHS request form please visit the IRISS - AHS page.
To process your request, the following sections of the form must be completed before submission:
- Operational Approval: If your research study requires Alberta Health Services operational resources including use of AHS facilities, patients, or staff, you will need Operational Approval from each relevant area. Identify the areas you will work with and details of all research activities occurring in the area(s) on your application. Health System Access facilitates operational approval for AHS facilities across all zones in Alberta, except for the Edmonton Zone. Operational Approvals for clinical studies taking place within the Edmonton Zone are processed by NACTRC and must be requested separately. For more information visit the NACTRC website.
- Data Systems Approval: The data within AHS can be made available for research purposes under certain terms and conditions and can be accessed either by data extraction (done by an AHS data analyst) or by direct access to an AHS data system. If your study requires access to AHS data, please specify the type of data required and the desired type of access in your application.
- Department Information & Purchase Services: Various AHS Purchased Services departments support research on a fee-for-service basis. These departments include Pharmacy, Laboratory Services, Diagnostic Imaging, Health Information Management and more. If your study is utilizing any of these departments specify this in your application and reach out to the purchase service area directly. For a list of AHS purchased services and contacts visit Health Evidence & Innovation - Purchased Services page.
Upon submitting the AHS request form in IRISS, an HSA advisor will be assigned to review and process your request. This assessment process includes addressing operational approval requests for AHS sites, requests for data access, negotiating data transfer agreements, and supporting contracts with sponsors or university partners that are processed by UCalgary CSM Legal. During the review process HSA Advisors may seek more information from researchers. After the review, if operational or data access is requested for research purposes, the HSA Advisor will initiate the required data access agreement and/or operational approval (see Steps 3 and 4 below). All data access and operational approval decisions will be made in adherence to AHS policies. The HSA advisor will communicate the decision outcome to researchers via IRISS and notify relevant data stewards
The Status of your application and the name of the HSA Advisor assigned to your file can be viewed in IRISS under the AHS Resources & Facilities tab.
When requesting data access for a clinical study, researchers must enter into an agreement with AHS for data disclosure. These agreements may take the form of a Clinical Trial Agreement (CTA), Sub-Site Agreement or a Data Disclosure Agreement (DDA). The HSA advisor will provide additional guidelines and details on the appropriate agreement for the study and facilitate the request.
When operational impacts are identified as part of the initial application or during the review the assigned HSA Advisor will provide a summary of the impacts to management of each AHS clinic or department where study activities are occurring. The respective AHS manager will assess whether their area can support the clinical research.
Once studies have obtained operational approval and data systems agreements have been formalized, the HSA advisor will grant the final administrative approval. This approval will allow researchers to begin their study within AHS facilities
For any questions regarding the administrative approval process email research.administration@albertahealthservices.ca .
