(i) Ethical approval (application as well as approval) for this project.
(ii) Research plan (should not exceed 2 pages), including the following headings:
a) Background.
b) Objectives and scientific rationale.
c) Method (including the analysis as planned and the analytical methods).
d) State if the project link to already published work within Betula (see
www.umu.se/betula/).
e) Time schedule for implementation.
(iii) Data request (state which data and/or biological samples that is needed to address the research question/-s*)
* List the variables that are of interest for the planned study. A list of available variables can be found in the Betula codebook at the Maelstrom research catalogue here.
The following conditions are included in the agreement reached between the applicant and Umeå University via the steering committee for Betula. Applicant refers in this context to the main applicant.Before data can be distributed, the applicant must, by signature, approve and accept the terms below. Hereby, the applicant commit to use the obtained data solely for the purposes specified in the ethical approval, project plan and as outlined in the Data Transfer Agreement (DTA) with the proviso that the study so is approved.
1. The applicant may only conduct non-commercial basic, clinical and epidemiological research on the obtained material. The applicant is thus prohibited to on their own accord apply for patent, sell or transfer patent rights or in other ways commercialize results without a renewed agreement with Umeå University via the steering committee of the Betula study. This also include to commercialize or patent downstream-, follow-up and spin-off research, as well as transferring of rights and obligations to third parties. If the applicant subsequently intends to use research findings in downstream, follow-up and spin-off research, the terms and conditions are to be governed by a renewed agreement with Umeå University via the steering committee for Betula.
2. All handling of data, specific samples and related data will be based on encoded and de-identified material. The applicant guarantee that they will protect the identity of the participants in the Betula study and to make sure that samples and data files containing data from the Betula study are stored and handled securely. The applicant commit to, in all management of samples and associated data, respect the Betula study’s specific coding system. It must, during the whole research time, be possible for the holder of the code key (PI for the Betula study) to derive samples and data.
3. The applicant will not transmit samples, associated data, derived data or data generated by analysis to a third party, unless approved by Umeå University via the steering committee for the Betula project.
4. Subject to that usual criteria for co-authorship are met, (a) representative(-s) for the steering committee of the Betula project should be offered co-authorship.
5. The applicant will keep the steering committee of Betula updated on how the work on the data from Betula is progressing on a yearly basis (sent to mikael.stiernstedt@umu.se).
6. Published articles and reports that are entirely, or in part, based on Betula data and/or samples shall at no later than the date of publication be reported to the steering committee for the Betula project (to mikael.stiernstedt@umu.se) to be updated in the publication list on the Betula webpage. In all manuscripts and publications, the assessment point (W1-W6) and sample (S1-S6) should be clearly stated. In the acknowledgement should, at the least, the following text be used: “This publication is based on data collected in the Betula prospective cohort study, Umeå University, Sweden. The Betula Project is supported by Knut and Alice Wallenberg foundation (KAW) and the Swedish Research Council (K2010-61X-21446-01)“. For studies on biological material and dementia diagnostics, the following text can be added: “In addition, grants were provided through a regional agreement between Umeå University and Region Västerbotten on cooperation in the field of Medicine, Odontology and Health.”
7. If the approved project not is progressing as expected or in the event of that the applicant do not comply with the agreement reached between the parties, Umeå University via the Betula steering committee has the right to terminate cooperation and request that samples, associated data, analytical data and derived data are returned to the steering committee for Betula, unless otherwise agreed. The applicant shall confirm that this has been done via a written confirmation.
8. At the end of an agreement between the applicant and Umeå University via the steering committee of Betula, a copy of all data (delivered data, analytical results as well as derived data) shall be sent to the steering committee of Betula. All other copies of these data shall be destroyed. Any remaining sample volumes, as well as extracted DNA, must, at completion of the study and at the applicant’s expense, be returned to Betula sample collection, unless otherwise agreed. The applicant shall confirm that this has been done via a written confirmation.
