RNAseq of whole blood in 359 idiopathic pulmonary arterial hypertension patients reveals biological heterogeneity

• DS DUO:0000007 (version: 2019-01-07)disease specific researchThis data use permission indicates that use is allowed provided it is related to the specified disease.ModifiersMONDO:0015924

National PAH Cohort Study Policy

To protect the interests of research participants, some datasets are only available to researchers after an application for access has been approved by a ‘Data Access Committee’. This data is called ‘controlled access’ data and approved researchers must agree to specific conditions for using it such as keeping it secure and only using it for approved purposes. Controlled access datasets are archived at the EGA (the European Genome-phenome Archive. The UK National PAH Cohort Study Data Access Committee will review requests for access to controlled access RNAseq data stored at the EGA by the National Data Coordination Centre. To apply for access to this controlled access data, please contact cohortcoordination [at] medschl[dot]cam[dot]ac[dot]uk. You will be asked to provide the following details: The principal applicant’s name, title, position, affiliation, email address, institutional website and mailing address. The name, title, position, affiliation, email address and mailing address of the applicant’s institutional representative. The name, title, position, affiliation, and email address of any personnel or students who need access to the data. Any other information needed for unique authentication of the applicant, personnel and students. A scientific abstract providing a brief (approx. 500-word) overview of the research to be carried out, including the proposed uses of the data requested. A list of three publications authored or co-authored by the principal applicant which are relevant to the current project. A lay summary describing the project to a general audience. A letter of ethics approval if required by the applicant’s country or home institution. ICSGC DTA Terms and Conditions Background Upon approval of the Application by the Committee, Cambridge will supply Data requested in the Application to the Recipient subject to the following terms and conditions (the “DTA terms”). [For the avoidance of doubt, any capitalised terms which are not defined here, are defined in the main Agreement]. 1. Definitions 1.1 Data Protection Laws: means the Data Protection Act 2018 as amended from time to time and any successor, subsidiary or accompanying legislation in the UK, and (for so long as and to the extent that the law of the European Union has legal effect in the UK) the General Data Protection Regulation (EU) 2016/679 and any other directly applicable European Union regulation relating to data protection and privacy. 1.2 Personal Data: shall have the meaning given in the Data Protection Laws, including but not limited to surname, initials, data of birth, address and postcodes, national insurance number, hospital number or NHS number. For the purposes of this Agreement, Personal Data includes Special Categories of Personal Data as defined under GDPR (Art 9). 1.3 Process: shall have the meaning given in the Data Protection Laws. 1.4 Results: means all information, techniques, results, data, design, technology, materials, inventions, algorithms and software, intellectual property and associated information identified or first reduced to practice or writing in the course of undertaking the Research Programme. 2. Subject to availability, Cambridge will use all reasonable endeavours to supply the Data but will not be liable for any inability to supply. 3. The Recipient shall use the Data solely for the purpose of the Research as described in the Application Form. The Recipient shall ensure that no one other than the Recipient and the employees under the direct supervision of the Recipient who have a need to have access to the Data for the purposes of the Research Programme shall have access to them, and ensure that those individuals are aware of and comply with this Agreement. 4. The Recipient shall comply with all applicable laws relating to the use, storage, transportation and disposal of the Data. Use of the Data by applicants which are not Partners must either be covered under the National Cohort Study of Idiopathic and Heritable PAH ethics approval or under the applicant’s own ethics approval for the Research. 5. The Recipient shall procure that each of its employees and students shall comply with these DTA terms as though they were the Recipient. 6. Should an individual donor or their next of kin modify or withdraw their consent in respect of the Data or any part thereof Cambridge will notify the Recipient and the Recipient shall discontinue using that part of the Data and return or destroy it in accordance with Cambridge’s instructions. 7. If any relevant ethics committee approval is withdrawn, or if the Recipient is in breach of the DTA terms the Recipient shall immediately cease all use of the Data and, at Cambridge’s discretion, promptly destroy or return all Data and provide written confirmation that this has been completed. 8. The Recipient shall not: a. attempt to obtain information identifying the individuals providing Data; b. or to link or attempt to link the Data to other data or information if doing so might create Personal Data c. sell the Data or any part thereof; d. transfer the Data (or any portion thereof) to any third party except as specified in the Application or with the subsequent written approval of the Committee 9. If the Data are transferred to any third party (a “Permitted Third Party”) as specified in the Application or with the subsequent written approval of the Committee, the Recipient shall procure that such Permitted Third Party complies with the DTA terms as though it was the Recipient. 10. Ownership and Use of Data a. Cambridge confirms that it is the custodian of the Data and it is entitled to provide Data to the Recipient for use as described in this Agreement. Nothing in this Agreement shall affect the ownership of the Data. b. Cambridge grants the Recipient a non-exclusive, non-transferrable licence to use the Data solely for use in the Research Programme as described in the Application Form, in accordance with all applicable laws. Except as provided for in clause 9, the Recipient shall not use the Data without the prior written consent of the Committee for any commercial purpose or commercially-sponsored/funded research, even if such purposes are being pursued by the Recipient. c. Neither the Recipient nor Cambridge transfers any right in or licence to any patents, copyrights, or other proprietary right owned prior to the approval of the Application or arising outside of the Research. If the Recipient makes or observes any new discovery, use, modifications, improvement or invention (“Invention”) relating to or arising from the use of the Data then the Recipient shall notify the Committee. The Recipient shall not make or seek to make any commercial gain from an Invention unless a revenue sharing agreement has been agreed with the Committee members, on fair and reasonable terms taking into account the contributions to the Invention. The Recipient shall promptly notify the Committee of any application for a patent or any other proprietary rights to protect an Invention. The Recipient shall grant each member of the Committee a non-exclusive, perpetual, sub licensable royalty free licence to use an Invention for teaching and Research purposes. d. The Recipient undertakes to notify the Committee as soon as reasonably practicable after becoming aware of any unauthorised or accidental access, use or disclosure of the Data and to cooperate with any investigation made by the Committee in connection with such access, use or disclosure 11. Data Protection and Security a. The Recipient shall comply with any additional reasonable security measures notified to the Recipient by Cambridge when transferring, storing and using the Data b. If the Data includes any identifiable Personal Data, the Recipient shall:-  take appropriate technical and organisational measures against the unauthorised or unlawful processing and/or use of the Data, any data derived from the Data and/or and all Confidential Information, against the accidental loss or destruction of, or damage to, such data and information.  restrict access to the Data, any data derived from the Data and all other Confidential Information to such of its employees who strictly need access to such Data and/or Confidential Information to undertake the Research Programme, and shall ensure that all such employees are reliable, and informed of the confidential nature of such Data and/or Information and the importance of processing it securely.  For the avoidance of doubt, the Recipient undertakes that it shall not disclose to a third party, whether in connection with the Research Programme or otherwise, any Data and/or Information contained in or derived from the Data which constitutes Personal Data 12. The Data is provided as a service to the research community without warranty of merchantability or fitness for a particular purpose or any other warranty, express or implied. 13. The Recipient shall acknowledge the contributions of the IPAH Cohort Study for the investigation of IPAH in all publications resulting from the use of the Data. Recommended wording for the methods or acknowledgement section will be supplied with the Data. If the Recipient wishes to include in a publication any information which has been provided by Cambridge and which was marked as confidential the Recipient must obtain written permission from Cambridge, providing a copy of the text to allow a reasonable period for review before publication takes place, such permission not to be unreasonably withheld or delayed. 14. The Recipient understands that the Data is confidential. The Recipient shall keep the Data securely by implementing organisational and technological measures appropriate to the nature and sensitivity of the Data to protect against unauthorised or accidental access, use or disclosure of the Data. This shall not apply to information to the extent it is in the public domain; was known, without any obligation of confidence from a source other than Cambridge; was developed independently by the Recipient; or is the subject of a valid court order or is otherwise required by law to be disclosed. These obligations of confidentiality and non-use shall survive termination of this Agreement for a period of five (5) years except to the extent there is any Personal Data which shall remain confidential indefinitely. 15. For the avoidance of doubt nothing in these DTA terms limits or excludes the liability of Cambridge for death or personal injury caused by its own negligence or for fraudulent misrepresentation. 16. The Committee members and their employees and student (each an “Indemnitee”) shall not be liable for any use by the Recipient of the Data. The Recipient agrees to indemnify and hold harmless each Indemnitee from any claims, costs, damages or liability due to or arising from the Recipient’s or any Permitted Third Party’s use, storage, handling or disposal of the Data or any breach of these DTA terms by the Recipient, except where caused by the gross negligence or wilful misconduct of such Indemnitee 17. Without prejudice to the Term the Committee may terminate this Agreement with immediate effect by written notice to the Recipient if the Recipient is in material breach of this Agreement and the breach: a. Cannot be remedied; or b. Can be remedied, but the Recipient fails to do so within 30 days starting on the day after receipt of the written notice. 18. The Recipient undertakes to delete all copies of the Data from its hard drives and moveable media and destroy all physical copies of the Data as soon as reasonably practicable on termination of this Agreement save that one copy of the Data may be kept if and for so long as the Recipient is required to keep such copy for the purpose of validation of the Results or publication thereof and for no other purpose. This obligation does not extend to automatically generated computer back-up or archival copies generated in the ordinary course of the Recipient’s information systems procedures, provided that the Recipient makes no further use of those copies.