Data Sharing Guidelines Page 5 II. A refusal to share data in such circumstances must have clear justification. Identify the relevant data protection policies and guidelines. However, the investigators should also ensure other ways to share additional strains with the community, if needed. This may form the basis of a data sharing agreement (see below). NIAID expects that relevant clinical and associated metadata or any other type of data such as antibiotic resistance that are essential for the biological interpretation of genome sequence data and other omics and experimental data sets will be submitted and made publicly available through the appropriate NIAID-approved repository/knowledgebase at the same time as the experimental data. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Whenever possible the scripts and other artefacts used to generate the analyses presented in the paper should also be publicly archived. For these reasons, NIAID endorses rapid release of all these data sets and anticipates that generated data will be made freely available through NIH-approved repositories. The following points should be carefully considered prior to depositing a strain into BEI: The strategy and criteria for selecting strains for depositing into BEI must be outlined in the project plan. When a principal investigator is contacted with a request to share his/her data, they may ask the requestor to provide a brief research proposal on how they wish to use the data. We understand that unexpected intellectual property may arise during the course of the study and investigators may need to depart from their data sharing plan to protect intellectual property and for any other necessary steps to be taken. We expect data to be released no later than the acceptance for publication of the main findings from the final dataset (unless restrictions from third party agreements or IP protection still apply) or on a timescale in line with the procedures of the relevant research area. The Guidelines. We caught up with three of our researchers to find out why they’ve placed data sharing at the heart of their research programmes. Data which might have the potential to be exploited commercially or otherwise to deliver patient benefit should be discussed with your technology transfer office and our Commercial Partnerships team prior to data sharing. Researchers using shared data are also expected to acknowledge Cancer Research UK for supporting the original study. The code is complementary to other ICO guidance and codes of practice relating to data protection. Once the funding for a project has ceased researchers should preserve all data resulting from that grant to ensure that data can be used for followup or new studies. These data are expected to be released within nine months of generation and validation or upon publication, whichever comes first. Per NIH policy, the data will be available in this controlled access database for up to one year to investigators who submit a request with a 12-month publication embargo. In most instances, sharing data should be possible without compromising the confidentiality of participants but if there are circumstances where data needs to be restricted due to the inability to protect confidentiality this should be fully addressed in the data management and sharing plan. As a minimum, researchers using shared data are expected to acknowledge the investigators who generated the data upon which any published findings are based. Participants who do not consent to future use or broad data sharing may still participate in the primary study, if consistent with study design. Data can be shared by any of the following methods: Investigators sharing under their own auspices may securely send data to a requestor, or upload the data to their institutional website. It may incorporate privacy and confidentiality standards, as needed, to ensure data security at the recipient site and prohibit manipulation of data. Given the diverse nature of the research we support, the guidelines below do not prescribe precisely how and when investigators should share research data. Managing Data Sharing. Of the guidelines available, there is substantial variation in whether specific topics are addressed. GM-15-008 Data Sharing Guidelines. The investigator(s) can then continue to benefit from further reasonable periods of exclusive analysis while the dataset as a whole matures. PDA Chapters Data Sharing. They are consistent with current NIH data-sharing guidelines and genomic data sharing policy and underline the expectation that both human and nonhuman data be released in a timeline that is consistent with NIAID’s mandate to support basic and clinical research as well as to respond to public health emergencies. The volume, type, content and format of the final dataset, The standards that will be utilised for data collection and management, The metadata, documentation or other supporting material that should accompany the data for it to be interpreted correctly, The long-term preservation plan for the dataset Whether a data sharing agreement will be required. Every effort must be made to protect the identity of participants and, prior to sharing, data should be anonymised. Human research guidelines and policies; Data sharing agreements and data management plans; Elements of a data sharing agreement: An example. At CRUK, we are committed to ensuring that the data generated through its funding should be put to maximum use by the cancer research community and, whenever possible, is translated to deliver patient benefit. To enable this, applicants are encouraged to include with the dataset all the necessary information (metadata) describing the data and their format. Clinical data and metadata may be embargoed upon request and approval at NIAID-approved repositories such as the NCBI dbGAP for up to nine months or upon publication, whichever comes first and as agreed upon by NIAID. “[Journal] requires, as a condition for publication, that the data supporting the results in the paper will be archived in an appropriate public repository. data sharing under the Intelligence Services regime in Part 4 of the DPA. Plans will be reviewed and approved by NIAID. The collaborator providing the strains to the NIAID-funded projects will contact and submit deposition forms to BEI prior to sequencing of the strain. Every year, the MRC invests around £850 million of public money in research, the primary output of which is data. All raw genome or metagenome data generated using sequencing approaches should be submitted as rapidly as possible and no later than 45 calendar days after quality control to the Sequence Read Archive or, as appropriate, to dbGAP at the National Center for Biotechnology Information (NCBI)/National Library of Medicine/NIH. Single nucleotide polymorphisms (SNP) for human genomic data should be submitted as rapidly as possible to NCBI dbSNP and no later than 45 days from completion of standard quality control practices. Some topics, such as removing direct identifiers, are consistently addressed, while … Details on sharing should be documented in the resource sharing plan. For projects generating large-scale genomic data, the data management and sharing plan should also address compliance with the NIH Genomic Data Sharing (GDS) Policy. These may then be released to other discoverable repositories, as approved by NIAID. To basic research, clinical studies, surveys and other types of research supported by CRUK. We encourage the appropriate filing of patents and recognises that there may be a need to delay the release of data until patent applications have been filed. Data sharing. Analytical frameworks; Other tools; Data Sharing. common terminology, minimum information guidelines and standard data exchange formats). The OECD Principles and Guidelines for Access to Research Data from Public Funding (2007)3 promotes a culture of openness and sharing to increase “the return on public investments in scientific research,” exchange of good practice, awareness of the costs, benefits and This can ensure the responsibilities of both parties, along with intellectual property, citation and publication rights are agreed at the outset. For further guidance on managing data access and the development of data sharing agreements please refer to the 'Samples and Data for Cancer Research: Template for Access Policy Development' document. This includes data analysis performed without data generation or limited data generation by the center or research program. Full or partial genome and metagenome assemblies and their annotations should be submitted to GenBank either as individual samples or for defined cohorts of samples as rapidly as possible and no later than 45 calendar days after being generated and validated. However, we understand that an investigator may need to adapt the method and timelines for sharing during the course of the study – for example, when potential intellectual property arises unexpectedly. A minority of repositories provide qualitative data sharing guidelines. Please check the Submission Guidelines for the journal you wish to submit to for the appropriate data sharing policy, and check any funder requirements. Secondary use of personal health data … All applicants seeking funding from CRUK will be required to submit a data sharing plan as part of their research grant proposal. In general, all research proposals expected to generate significant data should include a data management plan. Data Management and Sharing Plans. We recognise that data sharing strategies will vary according to the type of data collected and thus do not specify the exact content and format of the data sharing plan. The guidelines call on all parties involved in mobility data-sharing to address the benefits and challenges associated with it; evaluate risks through impact assessments; consider anonymization and de-identification techniques for the data; engage consumer groups for their input; and identify the role third parties can play, among other recommendations. 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