Please note, while this document has now been discussed, and the legal framework agreed, with the University of Cambridge's Research Services Division, we'd still welcome comments on its usability and applicability in furthering type 1 diabetes and related research - Neil Walker, Head of Data Services.
With increased understanding that anonymised individual-level data should only be shared in line with data subjects' consent, various data access arrangements have been put in place around data holdings.
The options in allowing access, seem to be to judge the suitabilty of an applicant (or not), and/or of their purpose (or not):
This Data Access Agreement is not like any of the above. It is a non-negotiable licence. The purpose from our side is simply to confirm the appropriateness of the applicant; and, from the applicant's, to reinforce the seriousness of the transaction.
Briefly, data can only be shared with bona fide researchers working on type 1 diabetes and closely related diseases, or on statistical methods that may be used for that purpose, or for replication. We define a bona fide researcher either as someone who has authored a relevant peer-reviewed article that we can locate on PubMed, and who is still working in the field, or as a successful applicant to a relevant, independent, data access committee.
We understand that in some cases groups of researchers will want to work together on the Data: each member of that group should sign an Agreement, and each remains separately responsible for upholding it.
A student or new researcher (to this field) may complete this form and access the Data, provided that a supervisor or employer who meets the Criteria (defined below) also completes a form, and countersigns the student's or new researcher's.
In response to the Recipient's request for access to the Data (as defined below), the University of Cambridge, acting through the JDRF/Wellcome Trust Diabetes and Inflammation Laboratory ("JDRF/WT DIL") asks that the Recipient agrees to the following:
The Recipient agrees to use Data only for the advancement of medical research, in line with the consent obtained from sample donors. The Recipient agrees to obtain permission in writing from JDRF/WT DIL before using Data for commercial research purposes. Commercial research purpose is where the Data is being used and developed by a business which aims to make money from the use and development of the Data.
The JDRF/WT DIL is keen to promote development of new approaches in statistical analysis that may then be applied to type 1 diabetes and related diseases. Statisticians may therefore apply for Data.
The Recipient agrees to preserve, at all times, the confidentiality of information and Data pertaining to identifiable Data Subjects. In particular, the Recipient undertakes not to use, or attempt to use the Data to deliberately compromise or otherwise infringe the confidentiality of information on Data Subjects and their right to privacy.
The Recipient agrees that they are covered either individually, or through their host institution, by Data Protection Act 1998 as amended from time to time or its national equivalent, and understand their duties under it in relation in particular to use and the rights of Data Subjects.
The Recipient agrees not to give access to Data, in whole or part, or any identifiable material derived from the Data, to others. The JDRF/WT DIL reserves the right to request and inspect data security and management documentation to ensure the adequacy of data protection measures in countries that have no national laws comparable to that pertaining in the United Kingdom. Currently UK law only recognises the national data protection laws of the EAA (the 25 EU members plus Iceland, Leichtenstein and Norway), and those of Switzerland.
The Recipient agrees to notify the JDRF/WT DIL of any errors detected in the Data.
The Recipient accepts that Data will be reissued from time to time, with suitable versioning. If the reissue is at the request of sample donors and/or other ethical scrutiny, the Recipient will destroy earlier versions of the Data.
The Recipient agrees to acknowledge in any work based in whole or part on the Data, the published paper from which the Data derives, the version of the data, and the role of the JDRF/WT DIL and its funders in its distribution. The Recipient agrees to use the acknowledgement wording provided for each Data in its publication. The Recipient will also declare in any such work that those who carried out the original analysis and collection of the Data bear no responsibility for the further analysis or interpretation of it.
The Recipient agrees that this agreement will terminate immediately upon any breach by the Recipient. The Recipient accepts that the changing ethical framework of human subject research may lead to alteration to the terms of this agreement or its withdrawal in extreme circumstances. The closure of the JDRF/WT DIL will not automatically terminate this agreement. In that event Data custodianship will revert to the University of Cambridge.
The Recipient agrees that the University of Cambridge the original data creators, depositors or copyright holders, or the funders of the Data or any part of the Data supplied bear no legal responsibility for their accuracy or comprehensiveness, and that the University of Cambridge and the original data creators, depositors or copyright holders, or the funders of the Data the depositor of any part of the Data supplied accept no liability for indirect, consequential, or incidental, damages or losses arising from use of the Data, or from the unavailability of, or break in access to, the service, for whatever reason. The Recipient understands that all the Data is protected by copyright and other intellectual property rights, such that duplication or sale of all or part of the Data on any media is not permitted.
This agreement shall be construed, interpreted and governed by the laws of England and Wales and shall be subject to the non exclusive jurisdiction of the English courts.
To be completed by all applicants - copy and add extra pages if required:
|Authorised Signature for Recipient's Institution|
If the Recipient does not meet the Criteria set out above, the following should be completed by a Registered User who does meet the Criteria and who is prepared to take responsibility for the Recipient's use of the Data. Typically this might be a student's supervisor, or a contract researcher's Head of Department:
Please send completed forms to:
Professor John Todd
JDRF/Wellcome Trust Diabetes and Inflammation Laboratory
Cambridge Institute for Medical Research
University of Cambridge
Cambridge Biomedical Campus
Wellcome Trust/MRC Building
Cambridge, CB2 0XY
Tel: +44 (0) 1223 762103
Fax: +44 (0) 1223 762102
The JDRF/WT DIL complies with the requirements of the Data Protection Act 1998 with regard to the collection, storage, processing and disclosure of personal information and is committed to upholding the Act's core Data Protection Principles.
Information collected under the Agreement will be used for the purposes of maintaining the Agreement, and may be used for statistical reporting.
Version 2.3, 30th September 2015: - revision history
Version 2.2, 27th July 2007:
Version 2.1, 7th October 2005:
Version 2, 14th February 2005:
Version 1, 19th December 2003:
The JDRF/WT DIL gratefully acknowledge that the idea of an Access Agreement - and even some of the phrases above - come from the continuing pioneering work in data sharing of the UK Data Archive.