The International Severe Acute Respiratory & emerging Infections Consortium (ISARIC) is a global collaboration aiming to ensure that clinical researchers have in place the necessary open access protocols and data-sharing processes that will allow them to respond to rapidly emerging diseases with epidemic or pandemic potential. The ISARIC Coordinating Centre is currently based at the University of Oxford. The University of Oxford serves as the entity executing this agreement with the data contributor.
ISARIC is facilitating the coordination of the Short PeRiod IncideNce sTudy of Severe Acute Respiratory Illness (SPRINT SARI) in collaboration with the Australia New Zealand Intensive Care Society Research Centre (ANZICS RC). The study supports ISARICs goal of improving the effectiveness of clinical researching globally during a pandemic.
2.1 The SPRINT SARI project is dependent on the submission of individual patient data. ISARIC respects the rights of researchers and institutions who may wish to share their data as a part of the SPRINT SARI.
2.3 By submitting SPRINT SARI data to ISARIC you agree that ISARIC and the SPRINT SARI Management Team will have access to your data on substantially the same terms as granted in these terms of submission. Current details of the SPRINT SARI Management Team can be viewed here.
3.1 In order to ensure compliance with its legal and ethical obligations, ISARIC requires that all submitted data:
(a) has been obtained in accordance with any laws and ethical approvals applicable in its country of origin;
(b) has been de-identified, so that any individual to which it relates cannot be identified from it.
3.2 You must have the authority to submit the data to be used in accordance with these terms of submission.
3.3 ISARIC reserves the discretionary right to delete any submitted data, in whole or in part, if it contains any information that would identify an individual.
3.4 In order to protect your data and safeguard the rights of the individuals to which it relates, ISARIC will take appropriate technical and organisational measures against unauthorised or unlawful processing of any submitted data and against the accidental loss or destruction of, or damage to, submitted data.
4.1 You will continue to own your data. ISARIC will not claim any rights of ownership in any data you may submit but, in order to allow the SPRINT SARI study to operate, it requires your permission to use the data for the purposes set out in these terms of submission.
4.2 By submitting data, you grant to ISARIC a right to use, copy, reformat and to make further analyses of your data in accordance with these terms of submission.
4.3 You may, at any time and for any reason, withdraw ISARIC’s right to use your data, but you accept that your data may have been used to prepare and/or create reports and analyses and that these reports and analyses cannot be withdrawn once they have been made available.
4.4 In the event that the ISARIC Coordinating Centre transfers from the University of Oxford to another entity, the rights you grant to ISARIC will be transferred to that entity.
5. USE OF DATA
5.1 Your data will be stored on a secure server and will be accessible only to you, anyone you may nominate, ISARIC and the SPRINT SARI Management Team.
5.2 Your data may be further processed by ISARIC and the SPRINT SARI Management Team and used in combination with other data to create aggregated data.
5.3 ISARIC and the SPRINT SARI Management Team may use aggregated data to create reports, and analyses, including:
(a) summary reports to define geospatial and temporal trends in the epidemiology and management of severe acute respiratory illness; and
(b) specialised analyses of pooled studies (for example, analyses in relation to a particular drug, patient group or time span).
(c) descriptive analyses of pooled data related to identifying risk factors for clinical severity of severe acute respiratory illness.
5.4 In the event that ISARIC receives a request to contribute data to an external project or collaborative analysis, it will not contribute or grant access to your data without your express permission except if requested by government or inter-government public health agencies as part of a response to an active outbreak; in which case ISARIC will inform the data contributor of any such access granted.
6. PUBLICATION OF DATA
6.1 Your submission of data to ISARIC does not affect your right to publish those data, which you may do entirely at your own discretion and without consent from or reference to ISARIC.
6.2 Data relating to severe acute respiratory illness is useful to inform public health response to emerging infections if it is up-to-date and, for that reason, ISARIC encourages you to submit your data at the time of collection. ISARIC will only use your data in an aggregated form, except that where you provide your express permission. ISARIC may include a high-level summary of your research on a data visualisation Explorer to demonstrate the location of sites, number of participants enrolled, causative pathogens and patient outcomes.
6.3 Reports and analyses created by ISARIC and the SPRINT SARI Management Team may be published or otherwise made publicly accessible, including through the ISARIC website. All reports and analyses will be sent to you for review in advance of release.
6.4 Your contribution to any SPRINT SARI publication will be acknowledged in accordance with the guidelines of the International Committee of Medical Journal Editors (www.icmje.org/ethical_1author.html).
7.1 These Terms of Submission were drafted in English. It has been translated into other languages for convenience only, and the English language text shall prevail.
8. YOUR CONCERNS
If you have any concerns about these terms of submission, please contact Laura Merson, ISARIC Data Lead at firstname.lastname@example.org.
You will find the Terms of Submission as related to the uploading of data and use of data uploaded to the Clires database here.