Case #19: Adgang til biologisk materiale fra Regionernes Bio- og Genombank

Case #19: Access to data from the Bio- and Genome Bank Denmark

Case # 19: Access to data from the Bio- and Genome Bank Denmark Cases are examples of questions and inquiries we receive in the Guidance Function, which we would like to share for inspiration. A researcher contacted the Guidance Function with an inquiry about how to gain access to data at the Bio- and Genome Bank Denmark. The Bio- and Genome Bank Denmark covers the regional biobanks and works to secure biological material for the individual citizen’s own investigation and treatment and also aims to support health research.Currently, The Bio- and Genome Bank Denmark consists of 10 biobanks. These include 8 clinical biobanks: Danish Cancer Biobank, Danish Reuma Biobank,  Danish COVID-19 Biobank, Danish Genetic Biobank, Danish DermaBiobank, Danish Screening Biobank, Danish DiabetesBiobank and Danish Eye Biobank. Furthermore, RBGB also consists of biobanks with other functions, such as the Danish Blood donor Biobank and Danish Research Biobank. The structure of RBGB is being continually expanded and will in time consist of additional biobanks.You can initiate a collaboration with The Bio- and Genome Bank Denmark and gain access to their biological materials for research projects. The application process for accessing biological material is as follows: 1.Contact the Bio- and Genome Bank Denmark before the project is reported to the scientific ethics committee, the regional research record, and any other authoritiesIf a researcher intends to collect samples through the Bio- and Genome Bank Denmark, they are encouraged to contact them first. This is because the role of RBGB and the data flow must be described correctly, which the RBGB-secretariat can help with. 2.Report the project to the scientific ethics committee and the regional research record, and other potential relevant authoritiesAccording to Danish legislation, all research projects that contain human biological material must be approved by a scientific ethics committee before they can be carried out. Which scientific ethics committee the approval must be obtained from depends on the subject of the research project. If you want to read more about what must be reported to the various scientific ethics committees, you can find more information on their website (in Danish): Hvortil skal jeg anmelde? | Nationalt Center for Etik 3.Submit application form to the Bio- and Genome Bank DenmarkThe application form for the Bio- and Genome Bank Denmark is used for both regional and national enquiries.For regional or local enquiries, the application form must be sent to the local biobank centre or the RBGB-secretariat.When applying for samples and data from all over the country, the application form must always be sent to the RBGB-secretariat. 4.Access to materialBased on the application form, the secretariat in the Bio- and Genome Bank Denmark or the local center project manager makes a search for the material. The RBGB-secretariat is responsible for coordinating the collection and retrieval of samples for the applying project. Afterwards the relevant fractions will be found and sent to the agreed delivery address. For further information, please visit the Bio- and Genome Banks website: rbgb.dk (in Danish), alternatively you can visit RBGB english – Bio- and Genome Bank Denmark (regioner.dk) In this case, we guided the researcher in the application process and data access, and we passed on the contact information to the Bio- and Genome Bank Denmark, which the researcher could contact for further information. Please feel free to contact us if you need guidance in your research project. Our services are free, and we aim to reply to any inquiries within 2-4 working days.The Guidance Function offers first-level support for Danish and international researchers in need of help to navigate the requirements and processes surrounding research projects. News from the Guidance FunctionWe welcome your suggestions for content for the Guidance Function newsletter. Please submit any suggestions to info@vejledningsfunktionen.dk. Opening hoursMonday – Thursday between 10:00 – 14:00Friday between 10:00 – 13:00Tel.: (+45) 2494 7969

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Åbningstider i pinsen

Openinghours for Whitsun

Openinghours for Whitsun The guidance function will be closed on Whit Monday May 29, and will return to normal opening hours on Tuesday May 30.The Guidance Function services are free for both public and private clinicians and researchers, Danish as well as foreign.Contact the Guidance Function on info@vejledningsfunktionen.dk or call on +45 2494 7969Monday to Thursday at 10-14Friday at 10-13 We wish you a happy holiday.  News from the Guidance FunctionWe welcome your suggestions for content for the Guidance Function newsletter. Please submit any suggestions to info@vejledningsfunktionen.dk. Opening hoursMonday – Thursday between 10:00 – 14:00Friday between 10:00 – 13:00Tel.: (+45) 2494 7969

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Guides til dataadgang og godkendelser - nyt tiltag på Vejledningsfunktionens hjemmeside

Guides for data access and approvals – a new initiative on the Guidance function’s website

Guides for data access and approvals – a new initiative on the Guidance function’s website The Guidance Function offers first-level guidance on the requirements and permissions needed when applying for health data. The application process for data access and approvals is different depending on which data provider or legal agency you apply to. Therefore, the Guidance function has prepared some guides on the various application processes with the various data providers and legal agencies: Guide to data access and approvals | Vejledningsfunktionen The purpose of this initiative is to create an overview of the requirements and process steps involved in applying for health data and approvals and thus help researchers, clinicians and other stakeholders to gain access to health data or obtain approvals.We hope that this initiative can help to create a comprehensive overview of the various application processes and thus contribute to simplifying access to health data. Guides for data access and approvals will be updated with new data providers as we receive feedback from those we have been in contact with. If you have not been contacted by the Guidance Function, but think that your organisation would be suitable on the website, please contact the Guidance Function at info@vejledningsfunktionen.dk. The guidance function would like to thank all the various data suppliers and legal agencies who have contributed to this initiative. Opening hours Ascension DayThe Guidance Function is closed on the Danish holiday Ascension Day Thursday May 18 and will be back to regular opening hours Friday May 19. The Guidance Function services are free for both public and private clinicians and researchers, Danish as well as foreign.Contact the Guidance Function on info@vejledningsfunktionen.dk or call on +45 2494 7969 News from the Guidance FunctionWe welcome your suggestions for content for the Guidance Function newsletter. Please submit any suggestions to info@vejledningsfunktionen.dk. Opening hoursMonday – Thursday between 10:00 – 14:00Friday between 10:00 – 13:00Tel.: (+45) 2494 7969

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Vejledningsfunktionen afholder webinar omkring kliniske forsøg

The Guidance Functions is hosting online sessions about clinical trials

The Guidance Functions is hosting online sessions about clinical trials During spring of 2023, the Guidance Function is hosting a series of Danish online sessions regarding the different requirements and processes, researchers might encounter when applying for different types of data. The sessions consist of a brief introduction to the Guidance Function, a presentation of the session topic and a Q&A session. On May 12 at 13.00 – 13.30, we will conduct the webinar about clinical trials. Here, the focal point will be the most important requirements and processes that you must be aware of when you want to do clinical studies. The session is set to last 30 minutes and are directed towards researchers and other interested parties, who work with first-level guidance about the requirements and processes regarding access to health data. Register for the Danish webinar about clinical trials here: Tilmelding til webinar om Kliniske forsøg You can also see all the Danish upcoming webinars on the Guidance function’s website: Webinars | Vejledningsfunktionen The Guidance Function offers first-level guidance on the requirements and permissions needed when applying for health data. The Guidance Function services are free for both public and private clinicians and researchers, Danish as well as foreign. The Guidance Function is part of the public initiative The Research Health Data Gateway, and is a part of the new health data services initiated by the Ministry of the Interior and Health and Danish Regions. Looking forward to seeing you. News from the Guidance Function We welcome your suggestions for content for the Guidance Function newsletter. Please submit any suggestions to info@vejledningsfunktionen.dk. Opening hours Monday – Thursday between 10:00 – 14:00 Friday between 10:00 – 13:00 Tel.: (+45) 2494 7969

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Åbningstider Store Bededag

Opening hours Store Bededag

Opening hours Store Bededag The Guidance Function is closed on the Danish holiday Store Bededag Friday 5th of May and will be back to regular opening hours Monday 8th of May. The Guidance Function services are free for both public and private clinicians and researchers, Danish as well as foreign.Contact the Guidance Function on info@vejledningsfunktionen.dk or call on +45 2494 7969Monday to Thursday at 10-14Friday at 10-13 We wish you a happy Store Bededag.  News from the Guidance FunctionWe welcome your suggestions for content for the Guidance Function newsletter. Please submit any suggestions to info@vejledningsfunktionen.dk. Opening hoursMonday – Thursday between 10:00 – 14:00Friday between 10:00 – 13:00Tel.: (+45) 2494 7969

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