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Read the frequently asked questions about our project, platform, and data sets.
General Questions
- What is the TB-IPD?
The TB treatment individual patient data platform (TB-IPD) is a collaborative initiative to support the generation of reliable evidence on the treatment of TB to inform future TB treatment guidelines. It is supported by the WHO Global TB Programme and maintained by UCL.
- How does it differ from the IPDs held at McGill University since 2008?
This project builds on two IPDs set up, managed and analysed at McGill University under the direction of Dr Dick Menzies. It differs in that data can be requested and accessed without having to work at McGill University under the oversight of Dr Menzies. We contacted previous contributors that contributed to the IPDs held at McGill for approval to transfer their dataset to the current IPD. We are also expanding the current IPD to include paediatric and trials data.
- Who are the members of the steering committee?
The Steering Committee details can be found in About us | Institute for Global Health - UCL – University College London and other links within our website. Therein we describe the current steering committee arrangement, which for now, comprises members of the secretariat.
- Who are the members of the Data Access Committee?
Data Access Committe is described in data_access_committee_tor_v2.0_13jul2023.pdf (ucl.ac.uk). The composition of the DAC is diverse, representative and flexible to support to start the work of the platform. Together with the secretariat, those in attendance represent both global south and global north voices. The data contributors themselves are nominated representatives of their consortia- representing even wider voices. The DAC also has civil society representation. The membership in subsequent years may very well be different and expanded.
Data Contribution Questions
- What will be the frame of IP rights arising from the use of the data from the data platform?
Intellectual property rights all remain with the data owners unless otherwise clarified in a separate agreement. This is explicit in the Data Access Agreement that researchers requesting the data need to sign.
- How will potential conflict of interest be managed into the governance of the data platform?
We are using WHO standard procedures for this. Members of the Data Access Committee will sign a Declaration of Interest form.
- How will the curator confirm that the depositor(s) has obtained prior approval (and how will the depositor justify that approval) from the competent authorities from the countries where the data have been collected? Including national Ethical Review Boards approval or waiver for specific studies.
McGill data: This has already gone through the McGill process, and contributors have also confirmed when publishing in PLoS Medicine and The Lancet. While some contributors wish to sign a new DSA (and will therefore sign the text indicated below), a small number of depositors to McGill have indicated they do not require a new DSA.
They had previously signed a Letter of Agreement with McGill saying that institutional ethics have been obtained where required. These studies were all published either in a Lancet or PLoS Medicine paper, which stated that the studies had been approved both by the McGill Ethics Board and local ethics boards where required. UCL has contacted the people identified as contacts in those papers and asked them to confirm that they have authority to decide to transfer the data to UCL and provided other names where relevant.Data requiring a new DSA: In general, we rely on data contributors to obtain necessary approvals and ask them to confirm this. Specifically, all new depositors (except a small number mentioned below) will sign the text in the Data Sharing Agreement that has been drawn up:
“7.1. The Data Owner warrants and undertakes that:
(a) it has the full, unrestricted, and unencumbered right, power and authority to provide to the Data Curator the Relevant Data for the Relevant Data to be used for the purposes contemplated by this Agreement, including the Purpose;(b) Relevant Data:
i. shall be provided in a fully anonymised form using the highest anonymisation standards and techniques so as to avoid possible re-identification of any of the Relevant Data; and
ii. has been collected in compliance with all applicable laws, statutes, rules, regulations and legal, ethical and/or medical standards or requirements;
(c) it has obtained all approvals, informed consents, licences and permits which are necessary for it to be able to share the Relevant Data, and for the Relevant Data to be used, for the purposes contemplated by this Agreement, including the Purpose;
(d) and where applicable, the Relevant Data has been reviewed by a competent institutional review board”
- How will the contributing countries and affected communities be associated in the governance?
The use of the IPD for research is governed by a Data Access Committee, composed of six members. Four of the committee members shall be representatives of the Data Owners. Two seats will be reserved for nominations from low- and middle-income countries, to ensure participation of national programs/public health and academia among committee members. These members of the Data Access Committee may be self-nominated and will be elected by a majority vote from all Data Owners.
The other two members will be a representative from the WHO Global TB Programme (voting), plus a non-voting representative of the Data Curator
Observers (non-voting) may be invited to provide expert input or to represent a data requestor, and other observers may attend at the discretion of the Data Access Committee.
- What is anticipated regarding benefit sharing with countries from which data have been collected including when these countries are not direct depositors?
Benefits: We hope that research using the data available in the DR-TB-IPD will increase global knowledge on best treatments, which we expect will lead to benefit for patients, communities and countries, in particular HBCs; it is in the interest of study participants that their generous contribution to the research enterprise is used to the maximum benefit by making it available to those who make reasonable requests for analysis with the aim to benefit future patients. Publications will be shared with all data contributors upon availability.
- How are data contributors acknowledged?
Acknowledgement: All data contributors will be acknowledged in the research that stems from the IPD data in accordance to Referencing Guidelines | Institute for Global Health - UCL – University College London.
Data Access Questions
- Who can request data access to the TB-IPD platform?
Anyone can request access to the data while abiding by the terms and conditions outlined in the Data Access Agreement, including data usage for non-commercial purposes only.
- How do I register for data access?
Data requesters will have to complete a Data Access Request Form (DARF) in which their proposed questions and analyses are explained, and reassurance given that they have appropriate permissions and systems to use the data ethically and securely. Once you have completed the DARF, please send it to igh.tb-ipd@ucl.ac.uk along with the lead applicant's CV.
- How do I know what data are available on the platform?
Please check Summary of datasets | Institute for Global Health - UCL – University College London for available datasets. We will update this page periodically. Data dictionaries of each dataset can be accessed in How the platform works | Institute for Global Health - UCL – University College London
- Who will analyze whether the data access request is in-line with the ethical approvals/ waivers obtained by Data Contributors?
The Data Access Committee is responsible for analyzing the data access request form, including whether it is in line with ethical approvals/waivers obtained by Data Contributors. The extent of the information that will be reviewed by the DAC is included in the data request form. We also describe the outcomes of the review process. The accompanying DAA outlines the responsibilities of the analyst. In addition to assessing the scientific soundness of requests, the role of the DAC will be to assess the information provided in these documents.
The DAC or the curator is not privy to individual contributors' conditions for sharing research data for secondary use. This assessment is best made by the data contributor at the time of sharing data with the curator and would be described in their data sharing plan as per institutional policy and as agreed with a sponsor/donor.
- How long will it take to process my access request?
Data Access Committee will conduct three meetings annually to evaluate data access request. A written response to each application will normally be provided within 30 days following the DAC meeting. Reasons for rejection (if applicable) will be provided in that response. Suggestions for improvement may also be made if the request is approved, but these are not obligatory.
- Is there a fee for requesting or contributing data?
No.
Data Protection and Security
- How is the platform hosted? Are any third-parties involved in hosting the platform data?
The UCL IPD will be situated within the UCL Data Safe Haven (DSH). The DSH has been certified to the ISO27001 information security standard and conforms to NHS Digital's Information Governance Toolkit. It uses a walled garden approach, where the data is stored, processed and managed within the security of the system, avoiding the complexity of assured end point encryption. A file transfer mechanism enables information to be transferred into the walled garden simply and securely.
Please find the scope and all relevant policies here: https://www.ucl.ac.uk/isd/it-for-slms/research-ig/approved-information-governance-documents. The DSH platform is hosted on-site, with a second site provided via a UK ‘Data Centre as a Service’. The off-site location is currently in Slough, just west of London. Details on this hosting can be found here: https://www.ucl.ac.uk/isd/support-staff/dcaas-data-centre-service.
In addition to the standard access control for these areas, the infrastructure is physically and logically isolated from other infrastructure with access control to the racks containing the DSH hardware.
Encryption measures: The IPD will be kept in flat files, and live copies of files within the Safe Haven are not encrypted.
All files are encrypted into backup where they are stored for 90 days. Any data entering and leaving the environment is encrypted in transit. Only authorised individuals have permission to export data). All data is encrypted in transit and at rest outside the data safe haven. Guidance for data outside of DSH where relevant can be found here: https://www.ucl.ac.uk/isd/sites/isd/files/migrated-files/SLMS-IG04a_Data_Handling_Guidance.pdf
Access controls: See https://www.ucl.ac.uk/isd/sites/isd/files/ucl-ig36_data_safe_haven_access_control_policy.pdf
MFA: You can find information on MFA here: https://www.ucl.ac.uk/isd/services/file-storage-sharing/data-safe-haven/data-safe-haven-user-guide-faqs
Physical security measures: As above related to hosting
Information security & data protection policies in place: See https://www.ucl.ac.uk/isd/it-for-slms/research-ig/approved-information-governance-documents
We would be happy to provide more detail in sections of the ISO27001 statement of applicability and related SOPs as needed.
- How will the data curators ensure the de-identification of deposited data?
We request that all data submitted contains no personal data except for the trial identifying codes. We require trial identifying codes for our data checking processes, but they will be removed from data exported for research.
The instructions given to data contributors will be specific. However, as part of our checks on received datasets, we actively check if identifying variables have been inadvertently included (e.g the contributor does not have capacity to manipulate data). If such data are found, we will either ask for the to be re-sent in the correct format, or where capacity lacks, we discuss with contributors how to proceed, including guiding them on the process.
- More generally, how will the data curator ensure compliance with the CIOMS guidelines 1, in particular Guideline 12 (p. 46)2? 1International Ethical Guidelines for Health-related Research Involving Humans Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) 2Guideline 12: Collection, storage and use of data in health-related research
As data curators, UCL are not the primary data collectors, and we are not storing the data for our own health-related research but will be facilitating onward sharing of the IPD to individuals/groups intending to do health-related research. The primary data collectors remain the custodians of the original data and need to be in full compliance of CIOMS or similar.
For storage of data, we do comply with the storage requirements outlined in Guideline 12. We also comply with the GDPR.
Please send any questions you have about our platform to igh.tb-ipd@ucl.ac.uk