Secondary use of personal health data … The data management and release plan should include public accessibility of the analyzed data and repository (e.g., bioRxiv.org). data sharing under the Intelligence Services regime in Part 4 of the DPA. NACO Data Sharing Guidelines, December 2018 Page 3 Key Protocols: 1. 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. We recommend that data should be shared using established standards and existing resources where possible. Investigators are encouraged to consult with NIAID program officers to determine which unique reagents, such as microbial strains or clones, should be deposited at the BEI Resources Repository or other approved public repositories. Requests for embargo of data are not encouraged and must be justified in the data management and sharing plan submitted to NIAID, requiring prior NIAID approval. GUIDE TO DATA SHARING (revised 1 February 2018) 3.3 In the context of data sharing, especially for activities like big data analytics, it can sometimes be challenging for organisations to determine the purposes for sharing data at the outset, and whether fresh consent is required for the sharing. Neither the Data Protection Act (DPA), nor this code of practice, apply to that type of sharing. All software developed using NIAID funds must be released under the Open Source Initiative-approved, non-viral, open source license. The code covers the two main types of data sharing: • systematic, routine data sharing where the same data sets This can ensure the responsibilities of both parties, along with intellectual property, citation and publication rights are agreed at the outset. We acknowledge that the investigators who generated the data have a legitimate interest in benefiting from their investment of time and effort and we therefore support the initial investigator having a reasonable period of private use of the data but not prolonged exclusive use. This information should include such information as the methodology used to collect data, definitions of variables, units of measurement, any assumptions made, the format of the data, file type of the data etc. 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. NIAID is committed to rapid release of experimental data including genomic and other large-scale data types and, in addition, recognizes that clinical data and other metadata associated with the genomic, omics, and other data are valuable research resources. Since 1999, federal granting agencies are required to ensure that all data produced under federally-funded awards must be made available to the public. It could include the objectives, what data are requested, timelines for use, intellectual property and publication rights etc. It is therefore our policy that all data generated as a result of our funding be considered for sharing and made as widely and freely accessible as possible whilst safeguarding intellectual property, the privacy of patients and confidential data. 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 Collaboration, Education, and Test Translation (CETT) Program's Guidelines for Data Collection and Sharing: Specifies that de?identified clinical data will be submitted and stored at the NIH for future distribution for research purposes. Plans will be reviewed and approved by NIAID. Other data types not specifically addressed above, including expression data, immunological data, proteomic data, other omics data, unpublished primary and secondary data, and models and other digital work products are expected to be rapidly deposited into publicly accessible repositories, as included in the data management and sharing plan and approved by NIAID. the latest public health information from CDC, Autoimmune Lymphoproliferative Syndrome (ALPS), Characterizing Food Allergy & Addressing Related Disorders, Prevention, Treatment & Control Strategies, Strategic Partnerships & Research Capacity, Primary Immune Deficiency Diseases (PIDDs), Partnership for Access to Clinical Trials (PACT), Division of Allergy, Immunology, and Transplantation, Division of Microbiology and Infectious Diseases, Dr. Joseph Kinyoun The Indispensable Forgotten Man, Dr. Joseph Kinyoun: Selected Bibliography, Baricitinib Plus Remdesivir Shows Promise for Treating COVID-19, NIH Announces Restructured HIV Clinical Trials Networks, findable, accessible, interoperable, and reproducible (FAIR) standards for data release, Sharing Data From Large-scale Biological Research Projects: A System of Tripartite Responsibility. If the principal investigator has doubts over scientific validity of the proposal or the requestor's ability to analyse/interpret data correctly, this should discussed with the requestor. Whilst there may be a delay in the release of data due to the application process, appropriate intellectual property protection should not hinder data sharing and may be the best way of ensuring that patient (and public) benefit is delivered. These data are expected to be released within nine months of generation and validation or upon publication, whichever comes first. Data sharing may be initiated by a data custodian; however it is generally initiated by a request to a data custodian for data. Supports and encourages data sharing: The journal encourages authors to share their research data and when relevant, authors are encouraged to deposit data in a suitable public repository. Data sharing does not necessarily mean public access. Investigators carrying out research involving human participants must ensure that consent is obtained to share information; furthermore the necessary legal, ethical and regulatory permissions regarding data sharing should be in place prior to disclosing any data. In general, all research proposals expected to generate significant data should include a data management plan. Any reasons why there may be restrictions on data sharing, for example; Development arrangements with our Commercial Partnerships team including intellectual property protection and commercialisation, Proprietary data – restrictions due to collaborations with for profit organisations International policies governing the sharing of data collected outside of the UK. Every effort must be made to protect the identity of participants and, prior to sharing, data should be anonymised. This includes the broad application of next-generation sequencing, including for example RNAseq, ChIPseq, TnSeq, SNP profiling, among many others. Instead they should be used to ensure that the principles of the policy are adhered to. A data enclave provides a controlled secure environment in which eligible researchers can perform analyses using restricted data resources. If data sharing is not appropriate, applicants must include a clear explanation why. Data resulting from processing and analysis (e.g., metagenomic relative abundances) should be made available to the public within nine months of generation and validation or upon acceptance of a manuscript for publication, whichever comes first. Research 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. 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. The Parenteral Drug Association, doing business as PDA, is a global association with its main office located at 4350 East West Highway, Suite 600, Bethesda, MD 20814, USA. 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. “[Journal] requires, as a condition for publication, that the data supporting the results in the paper will be archived in an appropriate public repository. The Trusted Data Sharing Framework spells out best practices for companies to share data that complies with privacy guidelines, while still allowing data to be shared between them. Data access forms; Data sharing agreements; Data sharing guidelines; Enhancing responsible data sharing; Field Companion: Sectoral Questions for Location Assessment. 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. Whenever possible, studies should seek broad consent for general research use of the samples and consent should not limit the types of users who may access the data. A minority of repositories provide qualitative data sharing guidelines. Investigators can share their data by transferring it to a data archive facility to distribute more widely to the scientific community, to maintain documentation and meet reporting requirements. Managing Data Sharing. Investigators are encouraged to discuss their plans for data and resource sharing with NIAID program officers. For further guidance on managing data access a… To support this researchers are strongly encouraged to utilise community standards to describe and structure data, (e.g. Awardees are encouraged to manage and disseminate their source code through an open revision control and source code management system such as GitHub. NIAID has made a significant informatics investment for basic and applied research resources in allergy, immune-mediated, and infectious diseases. All applicants seeking funding from CRUK will be required to submit a data sharing plan as part of their research grant proposal. For all data collected through National AIDS Control Program (NACP), NACO/SACS is the custodian. Details on sharing should be documented in the resource sharing plan. Investigators are encouraged to discuss their plans for data and resource sharing with NIAID program officers.