Pharmlines

Publication

1. Subject to the terms of this paragraph and with due observance of articles 6.6 and 9.4, Recipient and the members of the Research Group are entitled to publish the Outcomes in scientific journals or printed scientific meetings. The first publication will be a joint publication, coordinated by Recipient in which UG will be co-author as described in the SOP (Annex C) if the criteria for authors are met, as stated in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, established by the International Committee of Medical Journal Editors (ICMJE). Publications have to match the research questions stated in the Research Proposal. If the Recipient wishes to publish a publication (abstract or poster or manuscript), based on the received dataset, that falls outside of the scope described in the Research Proposal, Recipient should first contact Lifelines and UG.  

2. Recipient will inform Lifelines and UG of a contemplated publication at least 30 days prior to the contemplated submission date in order to allow Lifelines and UG to verify that such publication does not contain Research Outcomes caused by incorrect use of Research Material, to verify that any data in the proposed publication is published on such a level that traceability to individuals is impossible, and that the publication is in accordance with the communication guidelines of Lifelines and UG, and the SOP of the UG (Annex C). 

3. Reasonable comments by Lifelines and/or UG given within a maximum of 30 days after receiving the contemplated publication, will be addressed in the publication. 

4. Furthermore, Lifelines and/or UG may make a reasoned written request to Recipient that publication be delayed for an additional period of sixty (60) days (following the 30-day review period) in order to enable Lifelines and/or UG to take steps to protect its proprietary information and/or intellectual property rights and know-how. Recipient shall not unreasonably withhold its consent to such a request. 

5. Immediately after publication of the Outcomes by Recipient, Lifelines and UG will publish such publication on their websites, clearly labelled as Outcomes of the Research with a unique project code for unambiguous identification linking it to the Research and under acknowledgement of the Principal Investigator and other relevant members of the Research Group.  

6. In the event that Recipient has not published the Outcomes within 12 months after completion of the Research and article 6.6 does not apply to Recipient, Lifelines and UG are, in view of their policy to make results of research by use of data and material of Lifelines and/or IADB.nl publicly available, entitled to publish the Outcomes on their websites, again clearly labelled as Outcomes of the Research with a unique project code for unambiguous identification linking it to the Research and under acknowledgement of the Principal Investigator and other relevant members of the Research Group. 

7. In order to make Lifelines and UG visible in PubMed searches, Recipient shall acknowledge the Lifelines and UG in the title, and abstract, and methods section of all publications relating to Outcomes, by referring in the title to “Pharmlines Initiative” and to include the following sentences in the methods section:  
"Lifelines is a multi-disciplinary prospective population-based cohort study examining in a unique three-generation design the health and health-related behaviours of 167,729 persons living in the North of The Netherlands. It employs a broad range of investigative procedures in assessing the biomedical, socio-demographic, behavioural, physical and psychological factors which contribute to the health and disease of the general population, with a special focus on multi-morbidity and complex genetics.”   
“The University of Groningen IADB.nl pharmacy prescription database is a growing database that contains prescription data for more than 20 years from 1996 till 2017 from approximately 70 community pharmacies and covers an estimated population of 700,000 patients. Registration in the database is irrespective of health care insurance and age, gender and prescription rates among the database population have been found to be representative of the Netherlands as a whole, and the database has been widely used for research. Each person is individually tracked throughout the database period and prescription records contain information on the date of dispensing, the quantity dispensed, the dose regimen, the number of days the prescription is valid, the prescribing physician and the Anatomical Therapeutic Chemical code (ATC code). Each patient has a unique anonymous identifier; date of birth and gender are known. Due to the high patient-pharmacy commitment in the Netherlands, the medication records for each patient are virtually complete, except for over the counter (OTC) drugs and medication dispensed during hospitalization.” 
In addition, the following references must be used in scientific papers to refer to the Pharmlines Initiative and the Lifelines cohort: 
Rahmat Sediq, Jurjen van der Schans, Aafje Dotinga, Rolinde Alingh, Bob Wilffert, Jens HJ Bos,  C. (Nynke) C.M. Schuiling-Veninga, Eelko Hak. Concordance  assessment of self-reported medication use in the Netherlands three-generation Lifelines Cohort Study with the pharmacy database IADB.nl: The PharmLines Initiative. Clin Epidemiol, 2018, 10: 981-989, and 
Stolk RP, Rosmalen JG, Postma DS, et al. Universal risk factors for multifactorial diseases: Lifelines: a three-generation population-based study. European Journal of Epidemiology 2008;23:67-74,  or  
Scholtens S, Smidt N, Swertz MA, et al. Cohort Profile: Lifelines, a three-generation cohort study and Biobank. Int J Epidemiol. 2014, 44:1172-1180. 
In the event that one or more of the references as stated herein are not allowed by the publisher of the scientific article, Lifelines and UG may, upon written request by the Principal Investigator, waive one or more of such references to adhere to the publication policies of such publisher.  

8. In its publication, Recipient shall acknowledge the regional funds that have made the start of Lifelines possible as well as the funds for the IADB.nl by using the following language:  
“The Lifelines Biobank initiative has been made possible by funds from FES (Fonds Economische Structuurversterking), SNN (Samenwerkingsverband Noord Nederland) and REP (Ruimtelijk Economisch Programma)” and “The IADB.nl is funded by the University of Groningen.” 

9. If the authors wish to express their thanks, the following statement may be used under Acknowledgements: “The authors wish to acknowledge the services of the Lifelines Cohort Study, the contributing research centres delivering data to Lifelines, and all the study participants, and the participating IADB.nl pharmacies for kindly providing their data for research.”  
In its publication, Recipient shall acknowledge that the Lifelines study protocol is approved by the medical ethical committee of the University Medical Center Groningen, and that all Lifelines participants have each signed an informed consent stating that he/she approves use of his/her (anonymized) data and material for scientific purposes. Data of the IADB.nl is collected according to the national and European guidelines on privacy with human data valid at the time of collection.  

10. Publications will be in accordance with international recognized scientific and ethical standards concerning publications and authorship, including the ICMJE guidelines. Copyrights concerning publications of the Research remain with the authors thereof, regardless of any other provisions regarding intellectual property rights.