The SNAC-Kungsholmen Population Study updated Organization of The SNAC-Kungsholmen Project 2. SNAC-Kungsholmen Population study 3
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1 The SNACKungsholmen Population Study updated Contents Organization of The SNACKungsholmen Project 2 SNACKungsholmen Population study 3 Ethical Principles 4 Data, Publications and Conference Presentations 5 Rules for Research Collaboration 6 Blood & Brain Bank 7 Common Acknowledgment 8 Appendix Application Form 1
2 The SNACKungsholmen Population Study updated Organization and Responsibilities Board of Stockholm Gerontology Research Center (Äldrecentrum) Sven Erik Wånell appointed by the board of Äldrecentrum to have the overall responsibility, and in charge of all employerrelated questions, such as decisions concerning employment, salary, employee duties, and work environment Management group collaborate with responsible authorities. Members: Sven Erik Wånell (Chairman), Gunnel Rohlin (City of Stockholm), Kerstin Ohlsson (Kungsholmen District Council), AnnChristin Krauss (Stockholm County Council), Eva Pilenvik (Stockholm County Council, Health Care Provision), Bengt Winblad (ARC/Äldrecentrum), Mats Thorslund (ARC/ Äldrecentrum), Laura Fratiglioni (project leader), Mårten Lagergren (project leader). Adjunct members: Tina Kiderud (coordinator), Eva von Strauss (advisor, viceproject manager). SNACK Population Study Laura Fratiglioni project leader (Eva von Strauss vice project leader) Responsible for overseeing that the SNACK Population Study is carried out in accordance with established scientific requirements, and that PUL* and other legislation is observed so that work is conducted in line with good research ethics. Responsible for appraisaltalks with the physicians and nurses. Research group; responsible for the development of questionnaires, data management, processing and analysis: Laura Fratiglioni (organiser/director), Miia Kivipelto, Lars Bäckman, Agneta Herlitz, Johan Fastbom, Eva von Strauss, and Bengt Winblad. Tina Kiderud administrative coordinator (Gunilla Svanhagen vice coordinator); responsible for daily work activities of the data collection, booking appointments, ensuring that the participants are received and examined in an appropriate way, managing the archives etc. Lars Bäckman responsible for appraisaltalks with the test leaders/psychologists. Erika Jonsson Laukka responsible for continuous supervision of the test leaders/psychologists. Annika Garmén responsible for continuous supervision of the physicians, clinical work and diagnoses. Maria Wahlberg responsible for the computer systems in collaboration with Lena Ragert Blomgren SNACK Care System Study Mårten Lagergren project leader Responsible for ensuring that the Care System Study is carried out in accordance with established scientific requirements, and that PUL* and other legislation is observed so that work is conducted in line with good research ethics. Responsible for appraisaltalks with the Care System Study personnel. Reference group; consultation group with Kungsholmen District Council and contact within Stockholm County Council. * law on personal data based on EU legislation 2
3 The SNACKungsholmen Population Study updated SNACKungsholmen Population study Project leader: Laura Fratiglioni The staff members of the SNACKungsholmen Population Study (SNACK) work with: Collecting data Analysing data Presenting and publishing of results Representing the SNACK within and outside the Gerontology Research Center The following research fields are represented: Geriatric Epidemiology Psychology Social/caring Pharmacoepidemiology Geriatric Medicine The various fields cooperate depending on the objectives of the research. Field leaders are appointed by the Project leader and research group who consider both qualifications and ability to devote time. Research Group A Research Group coordinates the activities, is responsible for contact with the participants and their relatives, conducts monthly meetings and has the overall responsibility for the premises. The Field leaders, together with the Project leader form the Research Group. The Group has regular meetings on set dates thus offering the members of the Project a chance to influence what subjects are to be on the agenda. Objectives for the Research Group: To examine and approve the research plans and programs presented by internal and external researchers To be informed about all activities going on within the SNACK Population Study To distribute information to all members of the SNACK Population Study To plan and outline the continuing work for the SNACK Population Study Composition of the Research Group Project leader: Laura Fratiglioni Vice project leader : Eva von Strauss Field leaders within: Medicine: Laura Fratiglioni Psychology: Lars Bäckman/ Social/caring: Eva von Strauss Pharmacoepidemiology: Johan Fastbom Geriatric Medicine: Bengt Winblad/ Miia Kivipelto 3
4 The SNACKungsholmen Population Study updated Ethical Principles Guiding principles for all researchers working with the data of the SNACK Ppopulation Study are specified below by the Swedish Council for Research in the Humanities & Social Sciences (HSFR HumanistiskSamhällsvetenskapliga Forskningsrådet). Members of the SNACK follow these principles. The Principle of Autonomy: Each participant in the study (irrespective of cognitive condition, social class, ethnic group, language problems etc.) has a right to his/her own decision and to say yes or no to each individual part of the planned study. When informed consent cannot be obtained from the individual (e.g. people suffering from a dementia disease) it will be obtained from the nextofkin or from a close friend. The Principle of Integrity: Each participant in the study has a right to be respected for his/her own views, wishes and values. These two main principles of selfdetermination lead to: The Rule of Consent: The participant should be informed about the nature, duration and purpose of the whole study that he/she is expected to participate in. All the different parts of the study shall be thoroughly described and fully understood by the participant. The participant should also have fully understood that he/she at any time can discontinue the examination or interview without pressure or sanctions. The information should be both written and verbal. The Demand for Research: Society has a right to good quality research concerning important research areas. This demand can sometimes partly conflict with the rule of consent and the principles of autonomy and integrity. The conflict between society s need for good research and individuals right to integrity and protection against intrusion should be made known, balanced and handled with consideration. In the research plan, these principles described above (the principle of autonomy, the principle of integrity and the rule of consent) and the conflict between the demand for research and those principles should be discussed. 4
5 The SNACKungsholmen Population Study updated Data Data, Publications and Conference Presentations General: The fundamental principle of the SNACK is a desire to operate internally and externally with other organizations following the rules stated in this document: A contract for external use of our data must be made and signed by the applicant and the Project leader of the SNACK Population Study after discussion with the Research Group. A project description must be attached to the application (see Rules for Research Collaboration, page 6, Ethical Principles, page 4, and application form, see Appendix). An application for future use of the SNACKdatabase should be sent to the Research Group even when applying for funds. Specified: For distribution of data "The Health and Medical Services Act" are applicable under the jurisdiction of "The Individual and Secrecy Act. When applying for research funds, include costs for receipt of the material that have been approved by the Research Group. Results related to copyright or patent must be discussed with the Field leader concerned before material can be released. A written list specifying all applicable restrictions related to the copyright must be made out. A list of all people working with data from SNACK Population Study is available, which includes also the specific variables researchers are working with. The list is organized and updated by the datamanager. The person responsible for the data shall have a complete and uptodate database available. Everyone who has corrected a data file must leave a copy to the person responsible for the data (data manager). Rules and directions must be available to allow distribution of the corrected data (within the Gerontology Research Center or external). People working with electronic data bases are responsible for giving updated versions to the data manager. Publications and Conference Presentations Coauthorship follows the general rules according to Guidelines for Publication Ethics at the Karolinska Institute, 2004 ( Specific cases should be discussed in the Research group. The Acknowledgement should include a common statement (see page 8) and specific thanks to those members of SNACK Population Study who have contributed with a significant effort. When the manuscript has been accepted, a copy shall be given to the archivist responsible. Each field leaders has the responsibility to guarantee the quality of the publications. Same rules apply to lectures and presentations. 5
6 The SNACKungsholmen Population Study updated Rules for Research Collaboration These guidelines are meant to protect the participants of the SNACK Population Study as well as to guarantee an optimal and high quality utilization of the data collected in the Project. For external and internal researchers who wish to study the project material the following will apply: A written application for data must be submitted (see Appendix) A research plan with a detailed specification of methods, background, objectives as well as a comment on ethical issues. A copy of the application to the ethics committee must be enclosed. Each researcher is responsible to control whether the planned study can be included in earlier approvals by the ethics committee, otherwise a new application has to be sent in. When an external researcher wishes to use data from the of the SNACK Population Study, he/she contact first one of the field leaders to investigate if collaboration is possible. The application includes also a description of how the results will be published, in what type of journal and how it will be presented in relation to other data. In consultation with the Research Group, the PI of the proposed study decides coauthorships. When the goals are of scientific nature, at least one researcher from SNACK Population Study research group must be part of the study, to guarantee the correct use, both from a scientific and ethical point of view, of the SNACK Population Study data. When the goals of collaboration are of private nature (i.e. companies), an agreement covering the costs for the provided data must be made following the Karolinska Institute s rules. Please take contact with the KI office for contracts. Every application for funds for a study where material from the SNACK Population Study is included must be approved by the Research Group. To access data: The research plan needs prior approval by the Research Group of the SNACK Population Study. Consideration will be given to the extent to which the SNACK Population Study can gain from the cooperation. The data are provided for a limited period of time and only for the specific aims reported in the application. The applicant needs to fulfill the form and a list of variables following the denomination reported in the code book. Direct contact with the data manager is necessary. For internal researchers the following is also required: Anything made public, for instance, lectures, publications and abstracts need prior presentation to respective field leader. 6
7 The SNACKungsholmen Population Study updated Blood and MRI Bank The SNACK Population Study is in charge of a Blood Bank. At each examination, in connection with the blood test, blood cells have been taken for future analysis. The material has been refrigerated to 72 o C and stored in freezers at the Huddinge University hospital. A sample of the population underwent also MRI examination To take part of the material from the blood bank a written application must be submitted together with a research plan (see Rules for Research Collaboration, page 6). Responsible of the Blood Bank: Operative chief: Laura Fratiglioni Caroline Graff Responsible of the MRI Bank: Operative chief: Laura Fratiglioni LarsOlof Wahlund 7
8 The SNACKungsholmen Population Study updated Common Acknowledgement The Swedish National study on Aging and Care, SNAC, ( is initiated and financially supported by the Ministry of Health and Social Affairs, Sweden in collaboration with the participating County Councils, Municipalities and University Departments. It is a longitudinal study with two parts: a population study with a comprehensive data collection including people from 60 to 96 years of age and a study of health care and social service to people 65 years of age or older. It has four sites; Kungsholmen, Stockholm; Nordanstig, the County of Gävleborg; Karlskrona, the county of Blekinge and the Region of Skåne and five of the municipalities there, Eslöv, Hässleholm, Osby, Malmö and Ystad. We are grateful to the participants, the participating counties and municipalities and also to the Stockholm Gerontology Research Centre, the Geriatric Development Centre at Malmö University Hospital, Blekinge Institute of Technology and Lund University, Departments of Nursing and Community Medicine. 8
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