Data Sharing and Ownership Policy
1. General Overview
As a guiding principle, data collected in RES-Q is meant to be shared for the purposes of improving stroke care quality, with the goal of improving outcomes for patients. RES-Q is also meant to be a collaborative project, which means the policies and procedures related to how data is handled should be as open and transparent as possible. However, it is also important to acknowledge that there are limits to what types of data are shared, and how that data can be shared, based on both legislation and the decisions of professional societies participating in RES-Q. This document is intended to provide a general framework for RES-Q data ownership, sharing, and publication.
These policies pertain to data collected as part of the RES-Q program. Other programs which are collecting data utilizing the RES-Q platform should have their own policy documentation, and that documentation is considered authoritative with regard to data collected for those programs.
2. Data Types
All data collected within RES-Q should be de-identified. Patient data should be uploaded with a pseudonymized ID which does not contain any information connecting the data to a natural person. RES-Q can automatically generate this pseudonymized ID, or participating institutions can use their own pseudonymizing scheme.
Data collected within RES-Q can be divided into three general types, with only the first two types listed below being relevant to most participants.
1. Patient data: This is the raw data for individual patients entered into RES-Q using one of the available questionnaire forms.
2. Results data: This is a broad category covering all data derived from the patient data, but no longer attributable to any individual patient. This can include descriptive statistics, comparative statistics, graphs, presentations, or any other derived or aggregated data set.
3. User data: This is the data collected about each participant and their institution when they request to have an account created in RES-Q. This includes the user’s name, email address, institution name, and any relevant institution details.
3. Data Ownership
Ownership of data is generally dependent on the data type as described in the “Data Types” section. However, there are general principles which apply to all data types.
Data Destruction: Data which is submitted to RES-Q is intended to be kept in perpetuity for purposes of archival and retrospective analysis towards the purpose of evaluating and improving stroke care quality. For this reason, destruction of data in RES-Q is not generally permitted (more details can be found in the Data Security Policy document).
Data Auditing: The RES-Q platform maintains an auditable log of all changes made to records in the system. This change log is owned by RES-Q and is only accessible to authorized users.
Other policies are specific to the data type:
1. Patient Data
Patient data is owned by the hospital which contributed it. As such it can be added to, modified, viewed, and exported at the discretion of the contributing hospital. Only registered users associated with the contributing hospital, and RES-Q IT staff can access this data.
2. Results Data
Results data are categorized by aggregation level as either, hospital level, national/regional level, or international level data. Ownership is then dependent on which category the data pertains to.
- Hospital Level: This data is owned by the hospital whose patient data it was derived from.
- National/Regional Level: If this level exists, derived, comparative data from all hospitals is owned by the associated national/regional authority or professional society. The ownership and access rights should be discussed between all hospitals within the country/region, and the decisions should be communicated to RES-Q by an authorized national/regional coordinator.
- International Level: This level pertains to data which has been aggregated on a national/regional level and is the focus of research for the RES-Q program. The RES-Q committee acts as custodian for this data.
3. User Data
User data is owned by RES-Q with the explicit consent of the user. That consent can be withdrawn at any time, subject to similar approval processing times as the initial registration request (usually <48 hours).
4. Data Sharing
As discussed in the general overview, data collected in RES-Q is meant to be shared towards the purpose of improving the quality of stroke care in all participating countries. However, RES-Q is a collaborative tool, and as such, relies on input from participating sites to determine what and how data is shared.
Principles pertaining to this input are again dependent on data type.
1. Patient data
Sharing of patient data is done on an explicit “opt-in” basis. This means that patient data is only shared with authorized users from the hospital from which the data originated, unless an authorized user (the local PI or designated contact person) explicitly approves the sharing of that data with a third party.
This explicit approval can be made with a general data sharing agreement (a template can be downloaded from the Policies section) which permits ongoing data sharing with a third party. Approvals for data sharing can also be communicated via email from an authorized user, as long as the email explicitly states what data can be shared, and who the third party is which should receive it.
2. Results data
Sharing of results data is done on an explicit “opt-out” basis. This means that data which is generated from the processing of the patient data, but is no longer representative of any single person, can be shared for the stated purposes of the program, unless explicitly prohibited by the contributing hospital or country/region.
Sharing of data is prioritized by levels corresponding to ownership. This is a good faith policy, and it is expected that those with priority to share data will do so in a manner aligning with the goals of RES-Q.
- Hospital data: Results data pertaining to a specific hospital can always be obtained from RES-Q by the hospital and shared at the discretion of that hospital.
- National/Regional data: National/Regional data can be obtained by the authorized national/regional representative from RES-Q, and it is expected that this data will be subsequently shared, published, and utilized in collaboration with the contributing hospitals.
- International data: International data will be shared and published by RES-Q on behalf of the contributing organizations in a timely manner. Collaboration and participation in preparing this publication is welcomed and encouraged.
Any hospital, country, or region which wishes to restrict the sharing of results data derived from their patient data, should communicate this, in writing, to the RES-Q chair or RES-Q manager. An email from the PI, contact person, or national/regional representative is sufficient for this communication.
3. User data
Sharing of user data is only done for purposes deemed legitimate and consistent with the purpose of the program, with the approval of the program chair. To clarify this point, the RES-Q program chair may, for example, share user institution contact information with the ESO head office for purposes of conferring ESO Angels Awards; however, user data is not shared with private corporations for marketing purposes.
Last updated: May 25th, 2018