Accessing Data 

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 the database. Contributors who fail to follow these guidelines will be prevented from future access to the database.

• All data is stored on a dedicated research data server at the Institute of Neurological Sciences in Glasgow. 
  

• Data is grouped anonymously and it will not be possible to tell from which centre the data originated. 
  

• Data will be searchable upon the project title which was responsible for the data to be collected. 
  

• As not all projects have funding which will allow data to be validated against original documentation.  Data will also be searchable upon whether it is "Validated" or "Not Validated".  
  

• Each individual within each centre who were directly responsible for collecting data within that centre will have complete and free access to their own 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

1. Those wishing to access the database have themselves  contributed data to the database.
   
   
2. Centres must contribute at least 5 "Core Dataset" patients per year to maintain database access in any given year.
   
    
3. Only the PI in each centre contributing data will have automatic access to the common database.  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.
   
   
4. Only "Validated" data should be used in analyses intended for publication or submission as an abstract to a local or international meeting.  See Appendix IV for an overview of the BrainIT Data Validation approach.
   
   
5. Unvalidated data may be accessed and used in analyses intended for hypothesis generation, but may not be used in analyses intended for publication.
   
   
6. 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 centre.
   
   
7. 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.
   
   
8. Patient data can be analysed just for hypothesis generation or analysed with the intention of publication. If a formal analysis intended for publication is planned, then the PI must first confirm that a similar analysis is not already being planned by another member by visiting the projects and analyses web page. If a similar analysis is not being planned then the PI must write a one-page specific and focused analysis plan and submit it via the web form tool found on the web-site. From that point onwards any other members wishing to perform a similiar analysis should collaborate with the group who first submitted the project proposal.
   
   
9. Before a completed analysis and manuscript is submitted for publication, the PI must upload the MS and a summary spreadsheet containing the raw data used in the final analysis which must include as the first column the Brain-IT codes identifying the patients used in the final analysis. This is required so that the steering group can confirm that only "Validated" data was used in the analysis. Manuscripts and data must be submitted 3-weeks prior to journal submission. This is to allow members who have contributed data to the database to make comments to the PI or to contribute to the analysis or manuscript should they wish. There is no requirement for the PI to respond to any of the comments, but should a member make a significant contribution to the design, analysis or writing of the manuscript, than it is the responsibility of the PI to ensure the member is a "Named Co-author" on the paper.
   
   
10. 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.
    
    
11. It is the responsibility of the Steering group to make sure that: Analysis proposals are focused and detailed. Where similar analyses are already proposed, current proposers will be encouraged to work with the group first proposing the analysis.
    
    
12. Analysis proposers complete the analysis and publish the results in a timely fashion. 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.
    
    
13. Data downloaded from the database by one centre for a given analysis must not be sent to any other centre.
    
    
14. Downloaded data for a specific and declared analysis must not be used for another analysis.
    
    
15. The database either whole or in part must not be sold to any organisation.
    

Guidelines for External Organisations or Individual Members Not from Data Contributing Centres Wishing to Access the BrainIT Database

External organisations or individuals not from data contributing centres may not have direct access to the common database, however, they may gain in-direct access through collaborating with a centre PI provided:

1. They (the representative(s) of the external research organisation) are themselves registered as BrainIT group individual members AND:
   
   
2. They (the external research organisation) have also agreed and signed to the same Database access criteria presented to the centre PI with whom they are collaborating.

In such a collaboration, the centre PI remains responsible for access to the database and for tracking any analyses resulting from the collaboration with external organisations or individuals not from data contributing centres.

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...& the Brain-IT  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.