Apply for U-CAN material

Ethics approval and biobank application

U-CAN sample collection material can be made available to researchers and companies, Swedish and foreign alike, with the prerequisite of an approved Swedish ethical permit for the study in question.

In order for samples to be extracted, a formal application concerning samples and data must be submitted to – and approved by – the respective biobank that holds the samples. To get the biobank application approval, the study must be deemed feasible, relevant and be considered of high scientific quality when audited by U-CANs scientific review groups.

Local U-CAN representative

Research projects lead by other research principals than U-CAN-affiliated universities (i.e. an external party) are required to include at least one local representative from the relevant U-CAN diagnosis group in the study. This benefits both parties: the external part gains a resource connected to U-CAN that might facilitate access to data or management of local logistics, while the internal representative benefits from their volunteer work with U-CAN in the form of collaborations and publications.

One or more local U-CAN representatives must therefore always be invited to participate in the scientific work and be given the possibility to meet the rules of co-authorship stated by ICMJE (opens in new window) when publications using U-CAN material are concerned.

Cost coverage

Users of U-CAN material need to self-finance any/all costs in connection with extraction for research. As a general rule, academic researchers only pay for the direct costs arising from the data and sample extraction itself (work hours, freight costs et cetera). Companies pay, in addition to the aforementioned, a sum to cover the full cost recovery for the costs generated by U-CAN while collecting and storing the requested material and accompanying data. Costs for companies are calculated for each study/research project based on the type and quantity of material requested, on the required workload or administration needed on U-CAN's part, and lastly on the size of the requested data.

Agreements

Formal agreements for e.g. transfer of samples and data (MTA/DTA), non-disclosure agreements, regulation of IP, future use of generated research data etc may be required for researchers and companies to access samples and data. The specific agreements that are needed are determined on a case-by-case basis.

When the study is completed

Upon publishing the results, the researcher shall state clearly that samples and/or data come from U-CAN, and refer to U-CAN using the following reference:

Glimelius B, et al. U-CAN: a prospective longitudinal collection of biomaterials and clinical information from adult cancer patients in Sweden. Acta Oncol. 2018; 57(2):187-194 (link to the article on PubMed).

When a scientific article is published, the researcher should report this to U-CAN so that it can be included in our reporting and on the U-CAN website.

Data reuse for U-CAN studies

Following publication, data from the study should upon request from U-CAN be made available for further research. Access to datasets can then be applied for through U-CAN and the requests are reviewed according to the application handling process described below.

Is the study feasible using U-CAN material?

We highly recommend contacting U-CAN in order to investigate the accessibility of desired samples and data ahead of submitting an ethical application or biobank application. For this purpose there is a special form, the “U-CAN pre-project form” where requests regarding sample types, sample size and clinical parameters are specified in order for U-CAN to easier assess whether or not the project is feasible within the framework of existing U-CAN cohorts.

The filled out pre-project form is sent to U-CAN, and not to the biobank.

Study design and project plan

Studies that use U-CAN material must be of high scientific quality. Based on this, U-CAN has developed study design guidelines that are recommended to all researchers as support when designing their project plan, preferably even before writing an ethical application. The guidelines are in the form of a checklist for both the applying researchers and the review groups that will evaluate the application on scientific grounds.

Read the U-CAN guidelines for study design

Important points to consider prior to an ethical permit application

In order for the Biobank application to be approved it must be explicitly stated in the ethical permit that the intention is to use U-CAN material. In the case of an existing, previously approved, ethical permit lacking a reference to U-CAN, the researcher must ammend the permit to include this information. Plan the study design carefully with regards to the numbers of samples and study participants, and the needs for data from the U-CAN database to ensure that the study aims can be fulfilled.

• U-CAN can only approve access to in maximum the same number of samples as specified in the ethical permit. Should you at a later stage need to complement with more patients or samples than initally granted by the ethical permit, this will require an ammendment to permit.
  
• Regarding identifying and/or sensitive personal data (for instance personal registration number/social security number or variants thereof), clinical data or questionnaire data, U-CAN can only disclose personal information or other types of data from our database if the requested data variables are explicitly listed in the ethical application.
  

Send the U-CAN application to the biobank that holds the samples

The application (including all forms and appendices) should be sent directly to the relevant biobank/biobanks (for example Uppsala Biobank and/or Biobank North), and not to U-CAN. The biobanks will, as part of their handling process, forward your application to U-CAN.

If the application is for already existing analysis data where no access to new samples is needed, the application should be sent directly to U-CAN in Uppsala or Umeå by e-mail. Attach the ethical permit.