Data Request Policy
1. Purpose and Scope
This Data Request Policy defines how data collected in the RES-Q platform, either as part of RES-Q, or a participating program, can be obtained by a third party for secondary research purposes. This policy includes the necessary procedures, as well as the criteria, conditions, and limitations for requesting data exports from RES-Q. The goals of this policy are to clarify the accessibility of RES-Q data, and the provide a common process for making data requests.
2. Ethics Requirements and Review Procedures
As a registry, the underlying principle of RES-Q is that data collected as part of routine treatment should be used to improve the quality of stroke care whenever possible. However, regardless of whether this use is for quality improvements, data evaluation, or research, all activities must be conducted according to ethical principles and guidelines. RES-Q is a collaborative effort, and as such, participants in RES-Q will always have priority when requesting access for legitimate research purposes. These purposes would be in addition to data access rights already granted to authorized users, including hospital and national/regional rights to their own data. All requests for data by a third party need to be assessed by an ethics committee to determine the the level of ethical review required (full, low risk, or exemption), initiating a formal ethical review if required.
Potential considerations that would require a formal ethical review include:
- Activities which may potentially infringe on the privacy or professional standing of participants or institutions.
- Use of data beyond the initial scope or purpose of data collection.
- Intent to gather information about participants beyond that which is routinely collected.
- Testing of novel, or non-standard equipment or protocols.
- Randomisation of the use of control groups or placebos.
- Targeted data analysis involving minority/vulnerable groups which are separated from the main body of data.
Requests for data that meet any of these criteria, or are otherwise determined to require a formal review process will only be granted access to the data after all documentation and procedures described in this policy are completed and approved. It is recommended that requests for data be discussed with the RES-Q manager or the relevant program coordinator prior to submitting any ethics application.
All information held by RES-Q is confidential. All applicants which request data from RES-Q which have passed ethical approval proceedings will be required to sign a Conditions of Release document which fully details what the applicant can and cannot do with the data. This document will describe the process for review of any publications which utilize the data obtained from RES-Q.
4. Data Export Request Procedure
All requests for data to be exported from RES-Q must be submitted to the RES-Q manager, or the relevant program coordinator (which will subsequently communicate with the RES-Q manager as well). The RES-Q manager will evaluate the request to determine which data the request applies to (i.e. only RES-Q data, or other program data) in order to determine what documentation is needed to fully process the request. Once all required documentation is received from the applicant, including, but not limited to, project purposes, descriptions, and ethics clearances, the RES-Q manager will confirm receipt of the application and begin the review process. All involved program coordinators will be consulted during the review. If the application is approved at this level of review, it will then be sent to the RES-Q Management Committee for final approval. Data exports which have been approved through the above process will then be handled by the RES-Q data manager in compliance with RES-Q’s Data Security Policy. Only data which has been finalized in RES-Q, and moved from the live database to the archive will be available for export.
5. Request Requirements
All requests for data exports from RES-Q must be made in writing, and include the following information:
- Project title
- Principal Investigator/Co-Investigators
- Project Description; this should include the purpose, specific goals, background, methods for data analysis, source of funding, and the dissemination/publication plan
- A list of variables that will be used in the data analysis
- The required format for the requested variables
- All research ethics approval documentation, including letters of exemption if applicable
- Details of the support which will be required from RES-Q if the project is approved
- The project schedule, including the timeframe for initiation, receipt of data, completion, and submission for publication.
Information regarding the required support from RES-Q should be discussed with the RES-Q manager, or the relevant program coordinator prior to submitting any application to ensure that the requested resources are appropriate and available.
6. Review Criteria
The review process will evaluate the application and a determination will be made based on the following factors, and potentially others as is appropriate to the request:
- All relevant approvals and government clearances have been obtained.
- The availability of sufficient resources to fulfill the stated objectives within the given timeframe.
- The source of the request for data.
- The specified use of the requested data, and any results derived from it.
- Any overlap, conflict, or duplication of effort involving other projects, programs, or partners which are using data obtained from RES-Q.
Last updated: May 25th, 2018