The Karma Data Access Process
Karma is the world’s best-characterized breast cancer cohort. Karma collects data and bio-samples each time a participating woman comes for mammography screening or clinical mammography at participating hospitals. This typically happens every 18 to 24 months. For women diagnosed with breast cancer additional bio-samples are collected (at selected hospitals only). Furthermore, the Karma cohort is updated with data from Swedish quality registers every 6 months.
For detailed description of data and biomaterial collected, please click the “Sources” tab.
1. Browse the Karma Research Platform (on-line data)
To register for free access to the Karma Research Platform, please click on “REGISTER HERE” to the right. Beware that it is not allowed to publish results based on browsing the Karma Research Platform. For questions please send an email to firstname.lastname@example.org.
“With the Karma Research Platform you can quickly find out how Karma can strengthen your research with access to unprecedented real life data and bio-samples”
2. Apply for withdrawal of phenotype data and/or biomaterial
Apply for Karma phenotype data and biomaterial in two steps:
- Fill in the Karma Material and Data Transfer Agreement and send to Karma
- Pay the administrative fee invoice which Karma will send
The application will be processed as soon as the administrative fee is received.
3. The approval process
Preparing a recommendation.
When the application is received in good order, an interative process will start between the Karma Research Platform Manager and the applicant. The applicant will receive comments and suggestions and update the Material Transfer Agreement accordingly.
Send recommendation for approval.
The Karma Research Platform Manager will send a recommendation to the Data Access Committee for decision. Requests for phenotype data will be decided directly by the Principal Investigator and the co-PI. Requests for biomaterial will further involve the Karma Data Access Committee. Karma will apply the following evaluation criteria for request of withdrawals:
- Scientific sound, i.e. the scientific method is scientific sound
- Novelty, i.e. the proposed research has the potential to deliver something new
- Track-record, i.e. preliminary data exists alternatively only limited test data set is asked for
- Power, i.e. the request is neither over- nor under powered
- Funding, i.e. appropriate funding exists to finalize the proposed research in a timely manner
All documentation in the application process will be archived by the Karma Research Platform Manager.
4. Withdrawal of phenotype data and biomaterial
The applicant will earn export access from the Karma Research Platform Manager to download the data directly from the Karma Research Platform. In some special data cases the Karma Research Platform Manager will handle the withdrawal manually and send it to the applicant in a corresponding way.
Karma Research Platform Manager will ask the Karma Database Administrator to connect phenotype and biomaterial and place an order at the KI Biobank holding the Karma sample collection.
|Browse access to Karma Research Platform||Free||Free|
|Administrative fee||500 EUR||Please contact Karma|
|Withdrawal fee||2.000 EUR +
2 EUR/participant +
|Please contact Karma|
6. General terms and conditions to access Karma phenotype data and biomaterial
The following general terms and conditions prevail between applicants/co-applicants (jointly referred to as “applicants” below) and Karma for transfer of material and/or data from Karma. By signing the Karma Material and Transfer Agreement, the applicants acknowledge that they agree to and accept the following conditions for the transfer of material and/or data from Karma:
1. The applicants may only use the material/data for the purposes listed in the description of the research project in this application
2. The applicants agree to return all material and unused portions of material, including extracted DNA, to Karma within 6 months after the completion of the research project
3. If consent is withdrawn for issued material, applicants will be informed of the relevant sample numbers and asked to return them. Results obtained from material that have already been used for research need not be destroyed
4. The applicants agree to provide Karma with any results or data arising from the use of the material and/or data
5. The applicants agree not to transfer material and/or data to any third party not approved by Karma. Any transfer to third party requires a new application
6. The applicants are forbidden to transfer their rights or obligations according to this contract without prior, written approval from Karma
7. The applicants hereby warrants that all work in relation to the samples will be carried out in compliance with all applicable laws, regulations, guidelines and any approval from an Ethics Review Board
8. The provided material and/or data are encoded and applicants will not attempt to identify any individual from the material and/or data provided. Should the applicant inadvertently identify any individual, they will neither record this fact nor share the identification of that individual with any other person, and nor will they attempt to contact the individual themselves
9. The applicants are responsible for taking the necessary technical and organizational measures to protect the material and/or data from unauthorized access. Any user should be bound by professional secrecy
10. The applicants will ensure that any publication or presentation that is based (in whole or in part) on any material and/or data obtained from Karma will include an acknowledgement of Karma and Märit and Hans Rausing Initiative Against Breast Cancer
11. This contract falls under Swedish law. Conflicts arising from this contract will be settled in a Swedish court of law