CASES_ONLY

These data can only be used for Research purposes by investigators affiliated with a public sector research.

Definitions Applicant: An investigator affiliated with a public research organization based elsewhere who is applying to access data collected as part of this project. Access Agreement: An agreement developed by the DAC which contractually binds the parties involved in accessing the data. An executed Access Agreement is necessary to obtain access to data. Data Creators: The designated DAC is also the research team responsible for the collection of the data. Details can be found in the next URL (“http://bionit.ugr.es/pages/presentacion”). Research: Research means any scientific investigation on the various dimensions of childhood, health and obesity involving our data. User: Applicants that have received the necessary approvals to access the present data. Data Access Principles and Policies The rights, privacy and consent of participants must be protected and respected at all times. The confidentiality and the security of data and must be safeguarded at all times. These data are resources that will be used optimally to support research to benefit children population. These data can only be used for Research purposes by investigators affiliated with a public sector research. Exclusive access rights to these data will not be granted to any Applicant for any Research. All Applicants will be required to follow the Access Procedures determined by EGA. Approved Applicants (users) will be required to return derived variables and/or results back to the DAC within a time frame. Data management for access purposes will be cost zero to the DAC. Intellectual Property The present DAC do not claim any ownership of, or exploitation rights to any intellectual property resulting from Research conducted with these data. Indeed, given the public nature of the EGA platform, it aims to promote a wide and accessible distribution of knowledge developed through the use of this resource and achieve maximum public benefit. Thus, data users are strongly encouraged to make their results (including research tools) rapidly and widely available to the scientific community. Regarding genetic inventions, data users are strongly encouraged to follow the “Guidelines for the Licensing of Genetic Inventions” developed by the Organization for Economic Cooperation and Development (OECD) when licensing their intellectual property (presently found at: http://www.oecd.org/dataoecd/39/38/36198812.pdf). According to these guidelines, exclusive licensing practices should be limited to situations where such practices are absolutely necessary. Access Requests An access procedure including a notice of intent to submit an application as well as a full application process will be available on the EGA website. As a general principle, the applicant must be explicit about the proposed research use of the data and complete with the designated DAC the available data access agreement (DAA). Obligations of approved data Users Research Quality: Users have a responsibility to enhance the value of the data by conducting high quality ethical research. Formal scientific peer and ethical review of research proposals are important aspects of assuring quality and feasibility. Return of Results (a) Return of results of analyses to the DAC by Users. To ensure ongoing enrichment of the dataset, data users will be required to return to the database results from specified analyses carried out using the downloaded data. The specific results to be returned will be determined at the time of the application review. The exact nature of results to be returned and the time period within which this has to be done will be determined, in collaboration with the User, by the DAC. These returned results will be made available by the DAC to other Applicants requesting access to the data. This will allow future investigators access to enriched data and enable them to build upon previous research. (b) Return of Individual results of analysis conducted by Users to participants As a general policy, the DAC will not return individual research results from analyses conducted by Users back to participants. Nevertheless, the DAC may decide to return validated results back to participants where such information is determined to be critical for the care of the participant. The decision regarding this return, whether and what to return will be taken by the DAC in consultation with the affiliated Ethics committes and the relevant research ethics boards. In any situation in which results of analyses are returned to participants this will be managed by the DAC not by the User who, in keeping with the data access policies, will not have contact information for participants. DAC Acknowledgement in Publications Full acknowledgement of the source of these data samples must be included in any publications that arise from access to, and use of, the data. This acknowledgement must reference EGA platform but also the DAC who has uploaded these data. All publications must include at a minimum the following acknowledgment for DAC sources of funding: “This research was made possible using the data collected by Concepción Aguilera and collaborators from the research group BIONIT (CTS-361) of the University of Granada. These data are available in the EGA platform with identifier ...........” The specific wording of the acknowledgement to the EGA should be consulted directly with the platform managers.