JDRF/WT DIL: human genetic data access agreement

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 diabetes and related research - Neil Walker, Head of Data Services.

Notes on use:

With increased understanding that genotype 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):

some, like HapMap, have publication guidelines, but no formal constraint on data use - the subjects were told their genotypes would be available via the world wide web, and the relevant IRBs did not challenge the likely informedness of the consent so gained;
more commonly, some, like the NCBI's dBGaP (Genotype and Phenotype) database, require evidence of both suitabilty of applicant and purpose, requiring a fairly detailed submission from a scientist from whom it would accept a grant application;
many smaller groups in effect choose both recipients and purpose, and insist that data is only shared collaboratively, with MTAs to give accountability.

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 diabetes and closely related diseases, or on statistical methods that may be used for that purpose. 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.

Human genetic data access agreement

In response to the Recipient's request for access to the Data (as defined below), the University of Cambridge, acting through the JDRF/WT Diabetes and Inflammation Laboratory ("JDRF/WT DIL") asks that the Recipient agrees to the following:

1. Definitions:

Data means all and any human genetic data obtained from the JDRF/WT DIL. Explicitly, Data does not include samples or biological materials.
Data Subject means person, irrespective of state of health to whom Data refers and who has been informed of the purpose for which the Data is held and has given his/her informed consent thereto.
Registered User means a researcher who has previously completed this Access Agreement and has received acknowledgement of its acceptance.
Criteria means the following eligibility criteria:
Data can be shared with Bona Fide Researchers working to advance the understanding and treatment of diabetes and related diseases, or on statistical methods that may be applied to that purpose.
Bona Fide researcher may be defined one of two ways. For access to Data held solely under the control of the JDRF/WT DIL, it means a person who has authored a relevant peer-reviewed article that we can locate on PubMed, and who is still working in the field. Where Data on JDRF/WT DIL Data Subjects is held as part of a wider consortium, the decision as to who is or is not a Bona Fide Researcher is the primary responsibility of the consortium data access committee.

2. Purpose:

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.

3. Development of Statistical Methods:

The JDRF/WT DIL is keen to promote development of new approaches in statistical analysis that may then be applied to diabetes and related diseases. Statisticians may therefore apply for Data.

4. Confidentiality:

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.

5. Data Protection:

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.

6. Access and Governance:

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.

7. Errors:

The Recipient agrees to notify the JDRF/WT DIL of any errors detected in the Data.

8. Data reissue:

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.

9. Publications:

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.

10. Termination of agreement:

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 genetic 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.

11. Legal statement:

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.

12. Governing Law:

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.

Recipient:

To be completed by all applicants - copy and add extra pages if required:

Name

Institution

Address

Telephone

Email

Signature

Date

Name
Institution
Address
Telephone
Email
Signature
Date

Authorised Signature for Recipient's Institution

Name

Title

Signature

Date

Authorised Signature for Recipient's Institution
Name
Title
Signature
Date

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:

Name

Institution

Telephone

Email

Signature

Date

Name
Institution
Telephone
Email
Signature
Date

Please send completed forms to:

Professor John Todd
JDRF/WT Diabetes and Inflammation Laboratory
Cambridge Institute for Medical Research
University of Cambridge
Wellcome Trust/MRC Building
Addenbrooke's Hospital
Cambridge, CB2 0XY

Tel: +44 (0) 1223 762103
Fax: +44 (0) 1223 762102
Web: http://www-gene.cimr.cam.ac.uk/todd/

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 2.2, 27th July 2007: - revision history
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.