Data Access Criteria
About the BrainIT Data
The BrainIT data was collected prospectively as part of the EU Project grants:
QLCT-2002-001160 & IST-2007-217049.
The KIdsBrainIT data was collected prospectively as part of the EU Project grant:
ERA-NET award MR/R004498/1
Glasgow University who hosted the EU grants for the BrainIT datasets during the data collection phase of these projects qualifies as the Data Controller.
Edinburgh University who hosted the EU grants for the KidsBrainIT datasets during the data collection phase of these projects qualifies as the Data Controller.
Using our best endeavours and in accordance with GDPR we have:
- Implemented technical and organisational measures to ensure that the data is not identifiable and shared in a controlled and appropriate manner.
- Our ethics and consent documentation stated that the data would be used for future secondary analyses by Clinicians and Scientists as part of the BrainIT Group initiative.
Data Sharing and Access Protocol
Any such "open" database can only work if it is based, to some extent, on trust. Criteria have been
set and must be met by contributors to and analysers of the database. Contributors who fail to follow these
guidelines will be prevented from future access to the database.
All data is managed on a dedicated research data server.
Data is pseudoanonymised contains only pseudo-anonymous "StudyIDs". Dates for the new KidsBrainIT datasets are also pseudo-anonymised. Only categorical (from drop-down lists) data is collected. No free text is collected or stored. Using our best-endeavours, it will not be possible to tell from which centre the data originated nor identify a given patient.
Each individual within each centre who were directly responsible for collecting data within
that centre will have free access to their own pseudo-anonymised data.
Should individual data contributing members wish to access the joint database for their own
research, they may do so provided:
Database Access/Analysis Criteria
- Those wishing to access the database have themselves contributed data to the database.
- Only the PI in each centre contributing data will have automatic access to the project specific databases. Other individuals within centres contributing data may be given access to the
database at the discretion of the local PI, however, the local PI remains responsible for any
analyses performed on the data accessed from their centre. Where there is conflict
between the local PI and Individual members within the same centre, the BrainIT Steering
Group will determine which other individuals may access the joint database.
- Only "Validated" data should be used in analyses intended for publication or submission as
an abstract to a local or international meeting. See below for an overview of the
BrainIT Data Validation approach.
- Unvalidated data may be accessed and used in analyses intended for hypothesis
generation, but may not be used in analyses intended for publication.
- All data sent to the database must have been produced from research studies where the
protocols for those studies have been approved by the sending institution’s local ethics
committee. A copy of the letter of approval must be lodged with the BrainIT coordinating
committee. A copy of the letter of approval must be lodged with the BrainIT coordinating
centre.
- Individual patients must not be identifiable from the data sent to the database and the data
collection protocols used must conform to the Helsinki Accords and to GDPR.
- If no results have been uploaded to the web-site within 12 months of downloading
the data, the analysis plan will be removed from the site.
- Data downloaded from the database by one centre for a given analysis must not be sent to
any other centre.
- Downloaded data for a specific and declared analysis must not be used for another
analysis.
- The database either whole or in part must not be sold to any organisation.
Guidelines for External Research Organisations or Individual Access
Members Not from Data Contributing Centres or External research organisations may access the database but will require supervised access to the database, they may gain access through collaborating with a BrainIT centre PI provided:
- They (the individual or representative(s) of the external research organisation) have registered as BrainIT group individual members (which is free) AND:
- They have formerly agreed to the database access and publication criteria.
In such a collaboration, the centre PI remains responsible for supervising access to the database and for tracking any analyses resulting from the collaboration with Non profit making
external research organisations or individuals not from data contributing centres.
The Project PI remains responsible for ensuring the any publication resulting from the
analysis follow BrainIT publication criteria.
To access the data, send an email to the BrainIT Group Coordinator requesting access and a data access form will be sent to you. If a member of the Steering Group is willing to support your application, access privaleges will be granted subject to the BrainIT Data Access Criteria.
Joint Authorship Guidelines
If any data from the joint database was used in the analyses which subsequently formed
part of a published abstract or manuscript - reference to the "Brain-IT Group" must be
given in the Authors citation. Eg: A. Author1, A. Author2... "on Behalf of the Brain-IT Group'. Or alternativly:
"In Collaboration with the BrainIT Group" depending on the publication. Alternative wording, as rare exceptions to this
rule, can be used following discussion with the Steering Group.
An appendix to the manuscript should list the centre PI's who contributed data to the
relevant analysis. A list can be provided by the steering group.
As part of the normal BrainIT review process. All data contributors will be invited to
both review and to contribute towards any abstract or manuscript produced prior to
submission to a meeting or for publication. Those data contributors who made a
significant contribution to the design, analysis or writing of the abstract/manuscript will
also be named co-authors on the abstract or manuscript. The "Vancouver Publication
Guidelines" should be adhered to. Where there is uncertainty over whether a significant
contribution was made by a given data contributor - a final decision will be made by
majority vote of the steering group.
Attempts at publishing analyses of data from the database without adhering to all
the above criteria will result in the sending of a letter by the BrainIT steering group
to the editor of the journal. The PI's database access criteria will be revoked.