Application form for access to data and biological samples Ref. 2016-02 Project title: Applicant: Other partners taking part in the project Names and work addresses: "Skilsmisse og selvvurderet mentalt helbred en kvantitativ undersøgelse af mental sundhed hos drenge i 7 og 11 års alderen. Name: Rasmus Bræmer Address: Stadion Allé 19, 4tv Carsten Obel, professor, læge, Ph.D Lena Hohwü, post. Doc., Ph.D, Cand. Scient. San. Institut for Folkesundhed, Aarhus Universitet Bartholins Allé 2, 8000 Aarhus C Project description (max 200 words) The description should contain 1) purpose, 2) method, material, data, 3) publishing and 4) up to 5 key words Formål Studiets primære formål er at undersøge associationen mellem skilsmisse og det selvvurderede mentale helbred blandt drengebørn i 7- og 11-års alderen. Herunder undersøges også, om hvorvidt moderen gifter sig igen med en ny mand har en effekt på drengenes mentale sundhed. Metode og materiale Studiet baseres på data fra den danske nationale fødselskohorte, Bedre Sundhed i Generationer. Studiepopulationen består af drengebørn i 7- og 11-års alderen, der har besvaret 7- og 11-årsundersøgelsen. Studiet inkluderer fødsler mellem 1996-2002. Af alle kvinder deltog 60% Publicering Studiet udføres som et led i et specialeprojekt ved Folkesundhedsvidenskab ved Aarhus Universitet. Det forventes, at studiet vil blive publiceret I et internationalt tidsskrift, hvor hovedforfatteren vil være undertegnede. Key words: Mental helbred, skilsmisse, drenge, mental børnesundhed 1
Time schedule: Project start: Data analyses terminated Final project report: Month Feb Year 2016 Month Jun Year 2016 Month Jun Year 2016 Please indicate articles planned and their approx title(s): Based on the data applied for, I plan to publish Article 1, titel: Er drengebørn af enlige mødre den rene gift? Kvantitativ undersøgelse af mental sundhed hos drenge i 7 og 11 års alderen Project protocol enclosed: yes Interview Data Are you applying for interview data? X yes 7-year follow-up 11-year follow-up Selection criteria: Max tre ubesvarede spørgsmål af SDQ i 7 års alderen Max tre ubesvarede spørgsmål af SDQ i 7 års alderen Specification of data required: (list of variables to be agreed with the DNBC data manager) 7-year follow-up 11-year follow-up No. of individuals concerned: Alle deltagende ved 7-års follow-up og 11-års follow-up 2
Biological Specimens Are you applying for biological specimens? yes: Please describe how your study design is adapted to make the best possible use of the biological specimens. Account for the feasibility of the analyses (requirements for transportation, treatment and storages must be taken into consideration). from 1st sample quantity from 2nd sample quantity from 3rd sample quantity Only a minimum quantity of blood necessary for the analyses in question will be handed out. Please te that DNA is t yet available from all participants. DNA must be extracted at Statens Serum Institut. Number of persons, selection criteria, time period: For what kind of analyses? (state purpose and method): Where are the laboratory analyses carried out?: References from the laboratory may be enclosed. Supplementary Data Collection Sample analyses results Will you be collecting supplementary data/biological samples from cohort members, or will new analyses data be generated? In you application to the Danish Data Protection Agency (DDPA) remember to state that you will return supplementary data to the DNBC Which kind of data/biological samples? No Yes Supplementary data and results from biological analyses, including geme-wide scans must be returned to the DNBC database after approval from the DDPA - and be made available for other scientists. If you are contacting DNBC participants by mail, this contact must be initiated by the DNBC secretariat. interview/questionnaire (to be enclosed) linkage with other registries (please specify) 3
biological specimens (please specify) How many individuals will be concerned? During which time period will collection take place? Other Approvals Is your project/data collection approved by: Danish Biomedical Research Ethics Committee yes (copy of approval to be enclosed) For your information: The DNBC is approved under 2012-54-0268 with the DDPA. Inform the DDPA about this number when you submit your project application to the DDPA. The Danish Data Protection Agency yes (copy of approval to be enclosed) Finances The invoice for the data file should be sent to: Name: Carsten Obel, professor, læge, Ph.D. Address: Institut for Folkesundhed, Aarhus Universitet Bartholins Allé 2, 8000 Aarhus C Is the project fully financed? No Yes, amount:? Name of the funding person/organisations: 4
Date and signature Date and signature: 11/1-2016 Rasmus Bræmer Save the application form to your harddisk and mail to dnbc-research@ssi.dk together with your protocol and other relevant documentation. Please state the applicant s name and date clearly in the protocol. 5