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Storage and Backup
|
How will the data be stored and backed up during the research?
|
Pseudo anonymised technical data from the monitoring campaign, technical data from the surveys, social data from questionnaires and interviews will all be securely stored on the UCL N drive (100GB of centrally managed storage). No personal or sensitive data will be held on UCL N drive. Backups are made every night of all files created or modified since the preceding night's backup. Sensitive and personal data, such as personal and contact details of participants will be stored on the UCL Data Safe Haven. This service provides a technical solution for storing, handling and analysing identifiable data. It has been certified to the ISO27001 information security standard and conforms to the NHS Information Governance Toolkit.
|
dfed6528bb429bbdf07ea01d9487ad51
|
dmponline.dcc.ac.uk
|
Storage and Backup
|
How will you manage access and security?
|
Only the principal investigator (Dr Cliff Elwell) and the main researcher (Cairan Van Rooyen), will have access to all data stored on the UCL N drive and UCL Data Safe Haven.
|
dfed6528bb429bbdf07ea01d9487ad51
|
dmponline.dcc.ac.uk
|
Selection and Preservation
|
Which data are of long-term value and should be retained, shared, and/or preserved?
|
Pseudo anonymised technical data from the monitoring campaign, technical data from the surveys and social data obtained from questionnaires and interviews are all of long-term value and will be retained, shared and preserved. In line with the expectations of the EPSRC, this data will 'be securely preserved for a minimum of 10 years from the date that any researcher ‘privileged access’ period expires or, if others have accessed the data, from last date on which access to the data was requested by a third party.'
|
dfed6528bb429bbdf07ea01d9487ad51
|
dmponline.dcc.ac.uk
|
Selection and Preservation
|
What is the long-term preservation plan for the dataset?
|
The data discussed above will be uploaded to the UK data service website, where it will be made freely available to others, including researchers outside of the EEA. This data will be fully anonymised and stored on UCL’s long-term Research Data Repository.
|
dfed6528bb429bbdf07ea01d9487ad51
|
dmponline.dcc.ac.uk
|
Data Sharing
|
How will you share the data?
|
Data will be archived and shared in line with EPSRC’s expectations, where: "Publicly funded research data should generally be made as widely and freely available as possible in a timely and responsible manner"; Within 12 months of the data being created, appropriately structured metadata, describing the research data will be published. Following any publications, and on the successful completion of the PhD, all data generated from this research will be uploaded to the UK data service website, where it will be made freely available to others, including those outside of the EEA. https://www.ukdataservice.ac.uk/deposit-data Data will be uploaded with documentation and relevant meta-data to allow future use of the data.
|
dfed6528bb429bbdf07ea01d9487ad51
|
dmponline.dcc.ac.uk
|
Data Sharing
|
Are any restrictions on data sharing required?
|
Yes. Data will only be shared following any publications and on the successful completion of the PhD, including any viva corrections.
|
dfed6528bb429bbdf07ea01d9487ad51
|
dmponline.dcc.ac.uk
|
Responsibilities and Resources
|
Who will be responsible for data management?
|
Both the principal investigator (Dr Cliff Elwell) and the main researcher (Cairan Van Rooyen), will be responsible for data management.
|
dfed6528bb429bbdf07ea01d9487ad51
|
dmponline.dcc.ac.uk
|
Responsibilities and Resources
|
What resources will you require to deliver your plan?
|
Access to UCL N drive - free for UCL students. Access granted. Access to UCL Data Safe Haven - free for UCL students. Application in progress. Access to the UK data service website - free. Application at a later date. The PhD is funded by EPSRC and Public Health England. There will be no further requirement for funding to deliver this data management plan.
|
dfed6528bb429bbdf07ea01d9487ad51
|
dmponline.dcc.ac.uk
|
Manchester Data Management Outline
|
Who will act as the data custodian for this study, and so be responsible for the information involved?
|
Anisa Visram
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Project details
|
What is the purpose of your research project?
|
Hearing aids (HA) are the current gold standard management for most permanent hearing loss. There are over 50,000 children with a hearing loss (HL) and many of whom are hearing aid users. HA are assessed to ensure they provide benefits regarding speech intelligibility to the user and are programmed to optimally aid the user. However, there is often a drop in HA usage when paediatric patients reach their teenage years. Our study aims to understand the factors affecting teenager HA usage and from those responses develop a rehabilitative framework to improve audiology services. Our study will be a long-form 1 hour interview with hearing-impaired teenagers who were issued HA, regardless of their usage. The parents of teenager HA users. As well as professionals who work with teenage HA users. The teenagers can share their lived experience on factors affecting their HA usage. Parents provide a third party perspective having observed their child’s HA usage throughout different stages of their life. As for professionals, we will interview teacher’s of the deaf and paediatric audiologists who have experience of working with many hearing-impaired children throughout different age groups and might see similar factors affect HA usage.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Project details
|
What policies and guidelines on data management, data sharing, and data security are relevant to your researchproject?
|
I will be using the University of Manchester data management, data sharing, and data security policies and guidelines.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Responsibilities and Resources
|
Who will be responsible for data management?
|
Sumeya Abdi [email protected] Anisa Visram [email protected]
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Responsibilities and Resources
|
What resources will you require to deliver your plan?
|
I will be using Microsoft Teams to host the interviews and record the audio. I will be using my training fund to pay for costs of the study For example, paying participants £10 per hour for their efforts as amazon vouchers.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Data Collection
|
What data will you collect or create?
|
Interview recordings will be saved as .mp3 but will be destroyed as soon as it is transcribed. It will be approximately 5GB. Interview transcripts will be stored as docx. It will be approximately 2GB Coded Transcript File will be stored as docx. It will be approximately 2GB
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Data Collection
|
How will the data be collected or created?
|
I will record the audio only from the online meeting. The participants will be made aware of that the recording has begun. I will delete the audio recording after the transcription has been completed and anonymised.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Documentation and Metadata
|
What documentation and metadata will accompany the data?
|
Participant information sheet: documents that explain the research project what their participation entails and how the data will be processed. Assent Forms: Signed forms from the participants themselves. These will be encrypted and securely stored. Interview Guide: A copy of the interview questions or guide, including any prompts or follow-up questions used during the interview. Coding Scheme: Documentation of thematic or qualitative coding used in data analysis, including definitions for each code or theme. Software Used: Details on any software or tools used for data analysis, which can help with reproducibility. Ethical Review Board Approval: The approval document, reference number, and date.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Ethics and Legal Compliance
|
How will you manage any ethical issues?
|
One ethical issue is that we will be recording the interviews in order to accurately transcribe the information. The participants will be made aware of the audio recording before the interview begins. The video of the meeting will not be recorded but participants can switch off their camera if that helps them. It will be explained that the recording of the interview will be destroyed after it is transcribed and any identifiable information such as names or age will be removed in the transcription process. Some participants may feel uncomfortable with being recorded so even though it is clearly stated in the consent form, it is important to make it clear when the recording has begun and to give participants an opportunity to withdraw consent if they change their mind. Participants will be told that if at a later date, they withdraw from the study, the recording and transcript will be destroyed. This is until the data has been anonymised then it won’t be possible to do so. We have decided to only take teenage participants who have attended mainstream education. As most deaf teenagers attend mainstream education, we hope for the study to be representative of the majority of deaf teenagers. School is a big factor in a child’s life and non-mainstream educational facilities can lead to different experiences that might impact responses. For example, understanding the impact of peer stigma on hearing aid usage is difficult if participants attend a home school or one-on-one educational arrangements. The majority of teenagers with hearing loss attend mainstream education therefore with a small sample we don’t want to over-represent a niche experience. By recruiting only from teenagers who attended mainstream, we also can reduce participants who may have additional needs that are severe enough to impact their ability to participate in the study. We also plan on excluding participants who don’t speak English at a fluent level. Hearing loss can be a difficult barrier to overcome in terms of communication and if we include participants who don’t speak English then it adds to the complexity of the communication. With long-form interviews, keeping participants engaged can be difficult so having to communicate through an interpreter whilst also considering hearing loss can add to difficulty. We also want to ensure that the consent is informed when we are contacting potential participants to assess their interest as our researchers are only able to speak English. Our written information will all be written in English and will be sent out as such. As we do not have resources to translate information or interpret during the session therefore we will exclude non-English speakers. By excluding non-fluent English speakers, we are excluding experiences that are valuable and add unconsidered elements to barriers faced by hearing aid users. I believe it is something that can be explored in more detail in future research. There is a potential for participants to become distressed recalling the impact of hearing aids on their lives. We have a plan in place to support participants if they become distressed with a step-by-step guide on how to support the participants. The participants will be given written consent forms that go through in detail what they are consenting to by agreeing. It explains how the data will be processed and used. Prior to the consent form, they will have been given a participant information sheet which goes into further depth on the research purpose and how the data will be used. The audio from the interviews will be transcripted and during the transcription process, any identifiable information will be removed from. The audio data will then be destroyed. This will be undertaken by the chief investigator who will also be undertaking the interview. Any documents containing identifiable information e.g. consent forms and the pseudonymisation key will be encrypted and stored in a locked folder within the chief investigators university approved onedrive. We have applied for ethical review by the committee of the Division of Psychology, Communication and Human Neuroscience within the School of Health Sciences and the faculty of the Faculty of Biology, Medicine and Health. To ensure we meet the University of Manchester’s ethical standards.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Ethics and Legal Compliance
|
How will you manage copyright and Intellectual Property Rights (IPR) issues?
|
According to the University of Manchester policy, IP created as part of a thesis or dissertation will be the property of the student. Therefore this project will remain my property.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Storage and backup
|
How will the data be stored and backed up?
|
The data will be stored on the student's University-approved onedrive during the project, and in the longer term on university approved servers accessible by the supervisor (i.e. OneDrive or Research data storage). Any personal or confidential data will be encrypted.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Storage and backup
|
How will you manage access and security?
|
The p drive or onedrive is only accessible to the student. In the longer term the data will be stored on OneDrive (or Research data storage) in folders accessible only to the supervisor.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Selection and Preservation
|
Which data should be retained, shared, and/or preserved?
|
Anonymised data, excluding interview transcripts, will be retained for data quality purposes and for potential further analysis. Audio recordings will be destroyed after transcription. Personal data in the form of the recruitment log and ID key will be deleted at the end of the study except in the case where explicit consent has been give to retain this data. Consent forms will be kept and stored electronically (along with emails confirming consent) for 5 years following study completion. All data stored beyond the lifetime of the project will be stored on secure servers approved by the University, that is Research Data Storage or OneDrive.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Selection and Preservation
|
What is the long-term preservation plan for the dataset?
|
The fully anonymised and non-identifiable data and analysis (excluding interview transcripts) will be stored beyond my submission in an online research repository.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Data Sharing
|
How will you share the data?
|
The anonymised data and analysis will be made available on an online research repository.
|
b2d7d5af0e1df288d35ce6a2802281c6
|
dmponline.dcc.ac.uk
|
Assessment of existing data
|
Provide an explanation of the existing data sources that will be used by the research project, with references
|
No relevant data already exists as we are using creative data outputs
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Assessment of existing data
|
Provide an analysis of the gaps identified between the currently available and required data for the research
|
There has never been creative data like that which we are collecting
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Information on new data
|
Provide information on the data that will be produced or accessed by the research project
|
We are collecting experiential data in the form of creative writing and journal writing in response to motherhood objects
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Quality assurance of data
|
Describe the procedures for quality assurance that will be carried out on the data collected at the time of datacollection, data entry, digitisation and data checking.
|
Creative data will be kept verbatim to ensure it remains true to the author.
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Backup and security of data
|
Describe the data security and backup procedures you will adopt to ensure the data and metadata are securely storedduring the lifetime of the project.
|
All data will be password protected and only accessed by the events team. It will be backed up on the university One-drive.
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Management and curation of data
|
Outline your plans for preparing, organising and documenting data.
|
Data will be used in conversation with participants, for example, they will decide how their writing is displayed.
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Difficulties in data sharing and measures to overcome these
|
Identify any potential obstacles to sharing your data, explain which and the possible measures you can apply toovercome these.
|
Participants will consent to their data being displayed, which can be done anonymously if they wish.
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Consent, anonymisation and strategies to enable further re-use of data
|
Make explicit mention of the planned procedures to handle consent for data sharing for data obtained from humanparticipants, and/or how to anonymise data, to make sure that data can be made available and accessible for futurescientific research.
|
Particpants will sign a consent form which sets out what they are agreeing to. If request is made for data to be anonymised, names will be changed.
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Copyright and intellectual property ownership
|
State who will own the copyright and IPR of any new data that you will generate.
|
Copyright will remain with the authors.
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Responsibilities
|
Outline responsibilities for data management within research teams at all partner institutions
|
Lauren Hayhurst is responsible for collecting, storing and sharing the data.
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Preparation of data for sharing and archiving
|
Are the plans for preparing and documenting data for sharing and archiving with the UK Data Service appropriate?
|
Data (creative writing extracts) will be shared with participants via email.
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Preparation of data for sharing and archiving
|
Is there evidence that data will be well documented during research to provide highquality contextual informationand/or structured metadata for secondary users?
|
Method of collection will be through creative writing exercises and the work produced will be shared voluntarily by the participant.
|
1d5b856d8cd39ffe00c0a889f6d49774
|
dmponline.dcc.ac.uk
|
Manchester Data Management Outline
|
If you are storing personal information (including contact details) will you need to keep it beyond the end of theproject?
|
Data will be collected and stored in accordance with the General Data Protection Regulation (GDPR), the Data Protection Act 2018, the University of Manchester’s Privacy Notice for Research Participants and Research Data Management Policy. A Data Management Plan for the D’NOTE study will be registered with DMPonline . Personal information Participants’ names, place of work, and professional contact details are personal information that is already in the public domain. These details will be collected and stored in a file on the University of Manchester’s secure P:Drive server. During consent-taking, participants will be given the options of (a) being contacted with the study findings when the research is completed and (b) being contacted about future related research. Both are optional. Once the D’NOTE steering committee have published the research findings and disseminated these findings to any participants who requested a copy, participants’ personal contact details will be destroyed, unless participants consented to be contacted about future related research (in which case, contact details will be securely stored for 5 years and then destroyed). During consent-taking for the online questionnaire and online consensus workshop, participants will also be given the opportunity to be recognised as a co-author for their role as ‘investigator’ during data construction in the expert workshop. If participants consent to this role, this means that their name and place of work will be personal information that is subsequently reported in the study outputs (e.g., when named as a co-author of a peer reviewed journal article reporting the study and the DN reporting guideline). If participants do not consent to this role, their involvement will be kept anonymous and confidential. However, the identities of participants will necessarily be known to the other participants attending the workshop. Electronic consent processes (in the online questionnaire and consent form emailed to participants prior to the consensus workshop) will record participants’ names and personal contact details (e.g., email address) so that they can be contacted regarding research activities and study arrangements. The consent files will be stored in a password-protected, encrypted file on the University’s secure P:Drive server for up to 5 years after the research findings have been published, at which point the files will be destroyed. The above is in line with the University's Research Data Management Policy and Record Retention Schedule. Only members of the D’NOTE steering committee will have access to the above data. However, individuals from the University of Manchester or regularly authorities may need to look at the data to make sure that the research is being carried out appropriately. Anonymised personal data Participants’ data generated during the research will be linked to and labelled with an identification (ID) number. Specifically, the ID numbers will be used to anonymise participants’ online questionnaire responses, the online consensus workshop transcript(s), and other data collected during the workshop that can be exported directly (e.g., private voting of the proposed reporting guideline items; any messages sent by participants using the Microsoft Teams ‘chat’ function). The online consensus workshop will be audio- and video-recorded using Microsoft Teams for later transcription through Microsoft Teams. The transcript will be checked for accuracy using the recordings. All identifying information (e.g., personal, place or organisation names) in the dataset will be replaced or deleted. Participants will therefore be anonymous. The consensus workshop will be recorded and transcribed so that the D’NOTE steering committee have a record of the key topics, ideas, and opinions shared during discussion. This will inform the writing group activities when drafting the DN guideline as well as subsequent study report writing. It is not expected that anonymised participant quotes will be used in study outputs. However, if quotes are used, we will minimise personal identifying information as much as possible to reduce the risk of identifying the participant in the quote. A file containing participants’ names and ID numbers (the ‘key’) will be stored in a password-protected, encrypted file on the University’s secure P:Drive server, separately to all other data collected in the study, which will be stored in password-protected, encrypted files on the University’s Research Data Storage Server. Should participants wish to withdraw their data, it will be possible to identify their data using their ID number. However, once analysis of the online questionnaire data and, separately, consensus workshop data is completed the files linking participants’ names to their ID number will be destroyed as this data will no longer be needed. Beyond this point, participants will no longer be able to withdraw their questionnaire exercise data or consensus workshop data from the study, as it will no longer be possible to re-identify their data once the file containing their names and linked ID numbers has been destroyed. However, upon request by participants, it may still be possible to redact specific data (e.g., a specific view or opinion shared) after this point, if it can be identified in the consensus workshops transcripts. Researchers facilitating the discussions at the online consensus workshop will also take field notes. This is to capture the subtle aspects of the interactions but also means that the D’NOTE steering committee will have a back-up record of the key topics, ideas, and opinions shared during discussion, in case the audio- and video-recordings were to fail. These notes will not record any personal identifiable information. This will be checked and any identifiable information will be redacted. It will not be possible to identify and withdraw specific participants’ data from field notes. The research data will be password-protected, encrypted, and stored on the University’s Research Data Storage Server for up to 5 years after the last research report has been published, at which point the data will be destroyed. Only members of the D’NOTE steering committee will have access to the above data. However, individuals from the University of Manchester or regularly authorities may need to look at the data to make sure that the research is being carried out appropriately.
|
293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Manchester Data Management Outline
|
Who will act as the data custodian for this study, and so be responsible for the information involved?
|
Dr Hannah Long
|
293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Project details
|
What policies and guidelines on data management, data sharing, and data security are relevant to your researchproject?
|
Data will be collected and stored in accordance with the General Data Protection Regulation (GDPR), the Data Protection Act 2018, the University of Manchester’s Privacy Notice for Research Participants , Research Data Management Policy and Record Retention Schedule.
|
293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Responsibilities and Resources
|
Who will be responsible for data management?
|
Dr Hannah Long (Chief Investigator) will have overall responsibility for data management and she will ensure that data is stored in the correct manner.
|
293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Responsibilities and Resources
|
What resources will you require to deliver your plan?
|
Access to the University’s Research Data Storage Server will be required to securely store the research data. At the end of the project, the data will be archived in a data repository service such as ReShare (UK Data Service) or Figshare (University of Manchester).
|
293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Data Collection
|
What data will you collect or create?
|
The study will generate data via a rapid scoping exercise and collect data via an online questionnaire; an audio- and video-recording of an online workshop; private voting responses given during the workshop; a transcript of the conversation between participants at the workshop (including any comments in the 'chat' function; and written feedback on a Word document from participants to Hannah Long (the CI). Also, personal data (e.g., names and contact details) already in the public domain will be collected.
|
293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Documentation and Metadata
|
What documentation and metadata will accompany the data?
|
The study team will create a record of the data produced over the course of the study, including its format and how it is being securely stored. This will include (but is not limited to) all study documents (e.g., study protocol, invitations, participant information sheets, consent forms, questionnaire format, workshop materials) and materials and all study data (e.g., consent forms, responses to the questionnaire, workshop transcript)
|
293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Ethics and Legal Compliance
|
How will you manage any ethical issues?
|
Ethical approval will be obtained from the University of Manchester Research Ethics committee. Potential participants will receive an email with a study invitation, participant information sheet, and consent forms to participate in the online questionnaire and online consensus workshop. The participant information sheet will describe the aims and procedure of the study, to give potential participants enough information to allow them to make an informed decision as to whether to take part. The initial email and study materials will include the contact details (i.e., email address) of the lead researcher (HAL) so that potential participants can contact her with any questions and/or to express an interest in taking part in the study. Participants will be asked to provide their informed consent on two occasions: prior to the online questionnaire and prior to attending the online consensus workshop. Consent procedures will be built into the online questionnaire hosted on Qualtrics/Microsoft Forms, such that participants can only proceed to the questionnaire once their electronic consent has been provided. A consent form (Microsoft Word document) will be emailed to participants before the online consensus workshop, to be completed and returned by email prior to attending the workshop. Participants will be explicitly informed in the participant information sheet about how their data will be used in the D’NOTE study. Participants will be offered the opportunity of group authorship of the study outputs. Participants who consent to group authorship will be named and listed as part of the D’NOTE group on all study outputs, which include a peer-reviewed journal article of the DN reporting guideline, archived study data, and any other study outputs (e.g., conference proceedings). Participants who do not consent to this role will remain anonymous and confidential in all study outputs. However, the identities of all participants will necessarily be known to the researchers and fellow participants. This offering is in line with the CRediT authorship taxonomy; participants who consent will classified as an ‘investigator’ for their collective role in constructing the data through their participation (i.e., ‘performing data collection’) (22). This classification includes group authorship of the study outputs in acknowledgement of participants’ contributions It is important to note that the D’NOTE group is distinct from the writing group, which will be responsible for preparing the study outputs (for which participants have the option to claim group authorship). The opportunity for group authorship will be introduced in the study invitation and further explained in the participant information sheet. Participants will be explicitly informed in the participant information sheet of the conditions that must be met to qualify for group authorship, which include completing all research activities and providing feedback on the draft DN reporting guideline. Overall, we do not anticipate there being any significant risks to participants or researchers during this study. It is unlikely that the discussions between participants at the online consensus workshop will involve sensitive topics, as the research tasks are entirely academic in nature. The only likely inconvenience to participants is the time taken to participate in the study. As such, we do not anticipate any undue discomfort or distress to participants during this study. However, should participants express any distress during the online consensus workshop, we will follow the University of Manchester’s Managing Distress policy. This will involve offering the participant the chance to take a break and to leave the workshop without needing to give a reason, and we will emphasise that there are no consequences to withdrawing from the study if participants wish.
|
293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Ethics and Legal Compliance
|
How will you manage copyright and Intellectual Property Rights (IPR) issues?
|
The University of Manchester will own the copyright and IPR of any data generated in the study.
|
293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Storage and backup
|
How will the data be stored and backed up?
|
Participants’ names, contact details, and ID numbers (the 'key') will be securely stored on the University of Manchester’s secure server (P:Drive). The consent files will be stored in a password-protected, encrypted file on the University’s secure P:Drive server for up to 5 years after the research findings have been published, at which point the files will be destroyed. All other data collected in the study, which will be stored in password-protected, encrypted files on the University’s Research Data Storage Server (on Hannah Long's University account). Both the University’s P:Drive and Research Data Storage Server are backed up regularly and automatically.
|
293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
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Storage and backup
|
How will you manage access and security?
|
Data will be collected and stored in accordance with the General Data Protection Regulation (GDPR), the Data Protection Act 2018, the University of Manchester’s Privacy Notice for Research Participants , Research Data Management Policy and Record Retention Schedule. Participants’ names, contact details, and ID numbers (the 'key') will be securely stored on the University of Manchester’s secure server (P:Drive). The consent files will be stored in a password-protected, encrypted file on the University’s secure P:Drive server for up to 5 years after the research findings have been published, at which point the files will be destroyed. All other data collected in the study, which will be stored in password-protected, encrypted files on the University’s Research Data Storage Server (on Hannah Long's University account). Hannah Long will have primary access, as data custodian. Internal study team members based at the University of Manchester can request shared access to the files hosted on the University’s Research Data Storage Server. External study team members (collaborators) will not have access to these data. No data will be stored on personal laptops or external storage devices.
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293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Selection and Preservation
|
Which data should be retained, shared, and/or preserved?
|
The data will be stored in accordance with the University's Research Data Management policy and Records Retention Schedule. For auditing purposes, consent forms containing the participants’ names will be retained and preserved for up to 5 years after the research findings have been published. It is anticipated that the D’NOTE study data will be made publicly available where possible. Participants will be given the option (during consent taking) to have their anonymised data (i.e., online questionnaire responses, online consensus workshop voting responses, consensus workshop transcripts, and ‘chat’ transcript) securely archived in a data repository service such as ReShare (UK Data Service) or Figshare (University of Manchester) for use in future research, teaching, and learning. No personal information will be shared and participants will not be identifiable. This is optional and will only be done with participant’s explicit consent to archive their data. The data of any participants who do not consent to their data being made public will be redacted from the dataset. This redaction will be done after data analysis and before anonymisation (i.e., before the files linking participants’ names to their ID number are destroyed – see Anonymised personal data above).
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293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Selection and Preservation
|
What is the long-term preservation plan for the dataset?
|
It is anticipated that the D’NOTE study data will be made publicly available in a data repository service (such as ReShare (UK Data Service) or Figshare (University of Manchester)) for use in future research, teaching, and learning. For auditing purposes, consent forms containing the participants’ names will be retained and preserved for up to 5 years after the research findings have been published. After this point, the consent forms will be destroyed.
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293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Data Sharing
|
How will you share the data?
|
Following study completion, the results will be presented at academic conferences and published in a suitable Open Access peer- reviewed journal. This report will be disseminated widely through the academic and research community. It is anticipated that the study data will be made publicly available in a data repository such as ReShare or Figshare. Consent procedures for this study will involve statements on sharing data with individuals at the University of Manchester, from regulatory authorities, in study outputs e.g. published journal articles, and in the data archive. This is explicit in the participant information sheets.
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293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Data Sharing
|
Are any restrictions on data sharing required?
|
Individuals who wish to access the archived data will need to be registered with ReShare (UK Data Service) or Figshare.
|
293f648a13a8c152af22230a18953ada
|
dmponline.dcc.ac.uk
|
Data description
|
What data will you create?
|
The Research Data Management (RDM) Online course was done and used to help complete this form. Data description This study will generate new data from two focus group studies and a Delphi study. Data description for each appears separately in the table below: Brief description of data File Type Number Size Personal/ commercial Focus group studies: Focus group recordings .Mp4 Max 10 x 90 mins ~10GB Personal Transcripts .docx Max 10 <1GB Anonymous NViVo project file .nvp 2 <1GB Anonymous Completed demographic questionnaires paper/ .docx Approx. 48 <1GB Personal Excel spreadsheet .xlsx 2 <1GB Anonymous Delphi survey study: Completed Delphi surveys .docx 40 <1GB Anonymous Excel spreadsheet .xlsx 1 <1GB Anonymous
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1a9a073574f7dfc42098db8476931786
|
dmponline.dcc.ac.uk
|
Data collection / generation
|
What are your methodologies for data collection / generation? How will you ensure data quality? What data standardswill you use?
|
I will be generating new data in this study. Existing datasets will not be used. I will be collecting the following data: - Qualitative data from focus groups to be analysed thematically. - Quantitative data from demographic questionnaires, without identifiable data such as name, DOB, home or work address. - Quantitative data from Delphi surveys, without identifiable data. All data will be anonymised before analysis. Once audio recordings have been transcribed, they will be deleted from devices. The study will comply with the General Data Protection regulation (GDPR) Data Protection Act 2018, which requires all personal data to be anonymised as soon as it is practical to do so. A unique study ID number will be given to each participant for all study documents and electronic databases. The documents and database will also use their initials (of first and last names separated by a hyphen or a middle name initial when available) to prevent miss-assignment of data. In order to ensure data quality, there will be controlled organisation of the data, with naming conventions, version control and a well- structed organisation of folders. This will be maintained by the local researcher. Topic guides, questionnaires and surveys will be developed by the local researcher (PhD student) alongside the supervisory team and PPI collaborator. They will be assessed by the research team, colleagues and PPI advisory group members for usability, face validity and content validity. To ensure data consistency, the same topic guides, questionnaires or surveys will be used for each participant relevant to the study component they were recruited to. Topic-guides will be semi-structured however. Data entry validation will be conducted by the local researcher through double checking inputted data against raw data.
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1a9a073574f7dfc42098db8476931786
|
dmponline.dcc.ac.uk
|
Data storage and security
|
Where and how will data will be stored, backed-up, transferred, and secured during the active phase (short to mediumterm) of research?
|
We will use UoN-provided storage for our working data. UoN licenses Microsoft Teams, allowing for secure and controlled sharing of data among the research team. Microsoft Teams encrypts data both in transit and at rest and is approved against the University’s Handling Restricted Data Policy. The service provides several layers of automatic back up and, in a disaster scenario, files can be recovered. Access to data stored in MS Teams is via secure log-in with multi-factor authentication. Audio data will be recorded on a digital recording device, transferred to and stored on Teams using an encrypted UoN laptop. All paper-based research data will also be transferred to and stored on Teams using an encrypted UoN laptop. All paper- based research data will initially be stored in a site file at UoN in a secure cabinet. Keys to the secured cabinet will only be kept in a location known to the local researcher. Any data analysis will be performed on encrypted UoN laptops with anonymised data. Once data is transferred to Teams, it will be deleted from devices and hardcopies will be destroyed.
|
1a9a073574f7dfc42098db8476931786
|
dmponline.dcc.ac.uk
|
Data management, documentation, and curation
|
What are your principles, systems, and major standards for data management and creation? What metadata anddocumentation will you keep?
|
Data will be carefully organised and maintained by the local researcher. A file naming schema will be employed, which will include the data description/ title of data file, version, date , for ease of sorting. Spaces will not be used in file names to ensure ease of access across programs. Folders will be organised in a clear structure. Data will be stored on Microsoft Teams supported by UoN in separate folders labelled “FocusGroups” and “Questionnaires”. Each folder will contain a sub-folders for raw data, processed data and metadata. Metadata will be used for ease of understanding and use of data by others. As well as automatically generated metadata for files, metadata will also be added by the local researcher on all files in an additional page on word docs for transcribed data, an additional sheet on excel for imported survey and questionnaire data and an annotation on NViVo for coded data. This: title, description of contents, authors, date created, format. Within files, data will be checked for clarity and ease of understanding, including: column titles, codes, units, transcribed data etc. There will also be a masterfile of metadata made on excel, with a list detailing all data files for the study. This will include details of the storage structure. Study level documentation will be available in the study protocol, thesis and any written publications, to aid the understanding, reuse and validation of datasets. Templates will be provided for all consent forms, focus group topic guides, questionnaires and surveys to aid reproducibility.
|
1a9a073574f7dfc42098db8476931786
|
dmponline.dcc.ac.uk
|
Ethics & Privacy
|
Are there any ethical or privacy related issues associated with your data?
|
Personal data will be collected during this project, and the project has considered ethical and legal implications in its data storage, as well as appropriate security of personal data. All participants will agree to data collection and to long-term retention, archiving, and sharing of their anonymised data. Research will follow standard ethical procedures of the Faculty of Medicine and Health Sciences and the University of Nottingham. Specific aspects will be considered by the Faculty ethics committee as appropriate. In particular, the creation of data from focus groups and questionnaires will require ethical approval, including consent forms outlining the storage and use for research purposes of data, including access to those data by project researchers and other researchers, both during and after the life of the project. Participants will be informed that they can withdraw their participation at any stage during or after the observations. As we will be working with personal data we will ensure that we comply with the Data Protection Act 2018, including GDPR requirements. This will include providing research participants with the relevant privacy information and ensuring appropriate safeguards for the storage and handling of data are in place. In the event of participant disclosure or incidental findings, personal data may need to be shared. In these instances, this will be discussed with the participant and informed consent will be sought prior to doing so. This procedure will be detailed in the PIS. If participants agree for their contact details to be kept for the purpose of receiving study results at the end of study, their name and preferred contact details will be stored on a separate database from study data under strict access controls.
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1a9a073574f7dfc42098db8476931786
|
dmponline.dcc.ac.uk
|
Data preservation
|
How will you ensure the long term storage and preservation of data?
|
All anonymised research data created by the project will be deposited in the UoN research data archive (https://rdmc.nottingham.ac.uk) . Data will be archived upon completion of each study component within the larger study project and before publication of outputs for each study component. For each published dataset, a DOI will be issued by the repository. Data will be archived with the study protocol to facilitate discoverability and reuse.
|
1a9a073574f7dfc42098db8476931786
|
dmponline.dcc.ac.uk
|
Data sharing and access
|
How will the data generated be shared and published?
|
All data for which consent to share has been obtained will be shared via UoN data archive under a CC-BY license. Any data which is deemed to be personally or commercially sensitive will be assessed on a case-by-case basis to determine whether it can be shared. There will be no need to update the data past the project period. All published outputs will contain a Data Availability Statement including the datacite DOI that directs to the relevant data set E.g. ‘all ___ data are available via the Nottingham Research Data Management Repository (DOI).” Data will be released at the same time as any published outputs underpinned by the data or by one year from the end of the project. As per The Dunhill Medical Trust, the Grant Holder i.e. the local researcher (PhD student), will ensure that all peer-reviewed (primary) research publications arising from the Grant Project are made available via appropriate open access publishing sites (e.g. Europe PubMed Central) within six months of publication. A contribution will be provided at the discretion of the Trust towards open access fees levied by publishers who support the open access model.
|
1a9a073574f7dfc42098db8476931786
|
dmponline.dcc.ac.uk
|
Roles & responsibilities
|
Who will be responsible for managing data, data security, data quality, and data security both during the award andpost-award?
|
The Chief investigator will be the custodian of the data, responsible for collecting and analysing the data. The UoN will be responsible for storing and archiving the data. All data, personal or otherwise, will only be accessed by the local investigator and other authorised representatives from UoN and any host institution for monitoring and/or audit of the study to ensure compliance with regulations. No patient identifiable information will be shared unless necessary. The participant will be informed that their information may be shared for the above reasons in the information sheet and will be required to give consent for this before taking part in the study.
|
1a9a073574f7dfc42098db8476931786
|
dmponline.dcc.ac.uk
|
Relevant policies
|
What are the relevant institutional, departmental or study policies on data sharing and data security?
|
We will ensure that our research aligns with the requirements of the University's Research Data Management Policy, Information Security Policy, Code of Research Conduct and Research Ethics. As we are working with personal data, we will abide by the University’s Handling Restricted Data Policy and Data Protection Policy. All third party commercial data or new data that may be suitable for commercial exploitation will be protected by the University's Intellectual Property policy.
|
1a9a073574f7dfc42098db8476931786
|
dmponline.dcc.ac.uk
|
IPR
|
Who will own the copyright and IPR of any data that you will collect or create? Will you create a licence(s) for its useand reuse? If you are planning to use existing data as part of your research, do any copyright or other restrictionsdetermine its use?
|
Any Intellectual Property Rights are owned by the (host) Institution. This is confirmed in the funder’s IP agreement.
|
1a9a073574f7dfc42098db8476931786
|
dmponline.dcc.ac.uk
|
Budgeting
|
What are the costs or funding required for capturing, processing, storing, and archiving your data?
|
Costs have been estimated by the R&I finance team at NUHT, the host organisation. These have been included in the funding for capturing, processing, storing, and archiving data. It is anticipated that £2,879.28 at the end of the 3 year fellowship will cover the storing/ archiving and monitoring of data and £8000 will cover open access costs for publications. These funds will be transferred from NUHT, the Host organisation to UoN, the Sponsor organisation, as part of a collaboration agreement. As per the funder, a contribution will be provided at the discretion of the Trust towards open access fees levied by publishers who support the open access model.
|
1a9a073574f7dfc42098db8476931786
|
dmponline.dcc.ac.uk
|
General Information
|
Registration number at the Swedish Research Council
|
KBF 2019-00446
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Description of data – reuse of existing data and/or production of new data
|
How will data be collected, created or reused?
|
Data will be prospectively collected in an electronic Case Report Form (eCRF). Blood samples (Plasma and Peripheral Blood Mononuclear Cells) will be collected and stored in a biobank. All data collected is pseudonymised Responsible Biobank: KI Biobank COVID-19-HBO, Institution agreement (2020-12-03) Biobank applications: RBC 2020-682 (2020-12-03)
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Description of data – reuse of existing data and/or production of new data
|
What types of data will be created and/or collected, in terms of data format and amount/volume of data?
|
Pseudonymised patient data. Demographics, medical history including COVID-19 specific history, physical parameters, blood tests, secondary infections, viral load, radiology, concomitant medications will be recorded and saved in the eCRF. The eCRF data will be exported as comma separated values (.csv). Some study specific blood tests will be stored in a biobank for later analysis with microRNA arrays, qPCR, Affymetrix NGS and functional tests of PBMC. All biobank samples are stored in Freezer PRO, all data from subsequent analysis are stored in ELN.
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Documentation and data quality
|
How will the material be documented and described, with associated metadata relating to structure, standards andformat for descriptions of the content, collection method, etc.?
|
The trial is conducted according to ICH-GCP, monitored by an external CRO.
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Documentation and data quality
|
How will data quality be safeguarded and documented (for example repeated measurements, validation of data input,etc.)?
|
Only study officials with sufficient training and delegation by the Principal (local) Investigator at each site will have access to data entry. Data entered will be monitored by the CRO according to the Monitoring plan. Source data is pre-determined, saved and can be validated.
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Storage and backup
|
How is storage and backup of data and metadata safeguarded during the research process?
|
Source data is specified in a Source data Location Agreement. Most source data are saved digitally in the medical journals except for a few exemptions (such as demography; race) when eCRF is the source data. For informed consent the printed and signed form is the source data and for exclusion criteria a signed worksheet is used as source data.
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Storage and backup
|
How is data security and controlled access to data safeguarded, in relation to the handling of sensitive data andpersonal data, for example?
|
All sensitive and personal data is handled according to GDPR and hospital routines for digital of storing patient data. Only the study officials have access to the psedonymisation key, that is stored in a fire safe locker. A digital backup is stored regularly on a KI server with access limited to study officials.
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Legal and ethical aspects
|
How is data handling according to legal requirements safeguarded, e.g. in terms of handling of personal data,confidentiality and intellectual property rights?
|
A Clinical Trial Agreement between KI and the trial sites regulate the confidentiality and intellectual property rights. All data is handled according to ICH-GCP, GDPR, local routines and regulations. Sensitive personal data will be handled according to KI:s guidelines (https://staff.ki.se/gdpr) and data will be pseudonymized and a key will be kept separately from the data. Responsible Biobank is KI biobank, Institution agreement (2020-12-03) There is a multicenter agreement for Biobank with Regional Biobank Centre Stockholm-Gotland (2020-682) where all samples in Sweden will be stored until release to KI Biobank
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Legal and ethical aspects
|
How is correct data handling according to ethical aspects safeguarded?
|
All data is handled according to ICH-GCP, GDPR, local routines and regulations. An informed consent form (ICF) is signed off before any collection of data is started. The trial is approved by Etikprövningsmyndigheten (EPM) (2020-01705)
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Accessibility and long-term storage
|
How, when and where will research data or information about data (metadata) be made accessible? Are there anyconditions, embargoes and limitations on the access to and reuse of data to be considered?
|
The full study protocol, statistical plan and consent form will be publicly available. Data will be available on patient level; data will be pseudonymised, the full dataset and statistical code will be available upon request. A full description of the intended use of the data must be sent to the corresponding author for review and approval. Participant consent for data sharing is conditioned and new ethics approval may be required.
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Accessibility and long-term storage
|
In what way is long-term storage safeguarded, and by whom? How will the selection of data for long-term storage bemade?
|
Data will be stored according to KI guidelines and according to ICH-GCP for clinical trials.
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Accessibility and long-term storage
|
Will specific systems, software, source code or other types of services be necessary in order to understand, partake ofor use/analyse data in the long term?
|
For understanding of RNA sequencing data for the small cohort of 20 patients additional software will be required but the code will be shared upon request.
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Accessibility and long-term storage
|
How will the use of unique and persistent identifiers, such as a Digital Object Identifier (DOI), be safeguarded?
|
No DOI will be stored outside the servers unless part of open access publications in which case it will not be protected outside of the regulations of the publisher
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Responsibility and resources
|
Who is responsible for data management and (possibly) supports the work with this while the research project is inprogress? Who is responsible for data management, ongoing management and long-term storage after the researchproject has ended?
|
Data management is included in the OH costs for researchers at KI. The datamanager will dedicate labour to ensure the data fulfill FAIR principles.
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
Responsibility and resources
|
What resources (costs, labour input or other) will be required for data management (including storage, back-up,provision of access and processing for long-term storage)? What resources will be needed to ensure that data fulfilthe FAIR principles?
|
Data management is included in the OH costs for researchers at KI. The datamanager will dedicate labour to ensure the data fulfill FAIR principles.
|
d5a613f2cf843e2d0bc47b32f6edacd2
|
dmponline.dcc.ac.uk
|
General Information
|
Name applicant and project number
|
Neha Mungekar
|
24cc1c35d28eaee6d65ad45378a02afd
|
dmponline.dcc.ac.uk
|
General Information
|
Name of data management support staff consulted during the preparation of this plan and date of consultation.
|
Eduard Klapwijk <[email protected]>
|
24cc1c35d28eaee6d65ad45378a02afd
|
dmponline.dcc.ac.uk
|
1. What data will be collected or produced, and what existing data will be re-used?
|
How much data storage will your project require in total?
|
Audio files and transcribed pdfs and photographs
|
24cc1c35d28eaee6d65ad45378a02afd
|
dmponline.dcc.ac.uk
|
2. What metadata and documentation will accompany the data?
|
Indicate which metadata will be provided to help others identify and discover the data.
|
First, the metadata and documentation (including keywords) will be added to a repository. Additionally, the code sheet and semi- structured interview questionnaire will help others identify and discover data. Open access publications authored by the lead investigator will also be placed on the EUR data repository website, accompanied by full details, including author list and date, as well as DOI link where the open access paper can be downloaded. The open-access manuscript will include notes on the division of roles among authors, indicating who analyzed the data and the date on which the manuscript was accepted. The papers will also have a link to the data documentation on the repository.
|
24cc1c35d28eaee6d65ad45378a02afd
|
dmponline.dcc.ac.uk
|
3. How will data and metadata be stored and backed up during the research?
|
Describe where the data and metadata will be stored and backed up during the project.
|
Data will be stored in multiple repositories: - EUR SURFdrive - Designated EUR laptops of researchers with proper encryption. - EUR OneDrive synchronization The backup will be stored on GoogleDrive, accessible only to myself and my supervisor +Promoter
|
24cc1c35d28eaee6d65ad45378a02afd
|
dmponline.dcc.ac.uk
|
3. How will data and metadata be stored and backed up during the research?
|
How will data security and protection of sensitive data be taken care of during the research?
|
All research data will be stored on the hard drive of designated desktop or laptop computers that are password protected. The hard drives on these computers will be encrypted. Data stored on other platforms will be protected by SURFconnect authentication.
|
24cc1c35d28eaee6d65ad45378a02afd
|
dmponline.dcc.ac.uk
|
4. How will you handle issues regarding the processing of personal information and intellectual property rights and ownership?
|
How will ownership of the data and intellectual property rights to the data be managed?
|
The project is part of a consortium with Indian and Dutch educational and research institutions. The project Water4Change is jointly funded by NWO and DST, India. The public data generated through the lead investigator’s research work will be owned by EUR/DRIFT
|
24cc1c35d28eaee6d65ad45378a02afd
|
dmponline.dcc.ac.uk
|
5. How and when will data be shared and preserved for the long term?
|
In which repository will the data be archived and made available for re-use, and under which license?
|
The metadata will be shared in the EUR data repository, under a CC-BY license.
|
24cc1c35d28eaee6d65ad45378a02afd
|
dmponline.dcc.ac.uk
|
6. Data management costs
|
What resources (for example financial and time) will be dedicated to data management and ensuring that data willbe FAIR (Findable, Accessible, Interoperable, Re-usable)?
|
None. The EUR repository is a service provided by the University and hence is not financed by the project.
|
24cc1c35d28eaee6d65ad45378a02afd
|
dmponline.dcc.ac.uk
|
Assessment of existing data
|
Provide an explanation of the existing data sources that will be used by the research project, with references
|
The objective of this project is to answer the question “who benefits from development programs”. In order to carry out this research, we will be (1.a) handling and (1.b) transforming previously published de-identified datasets of randomized controlled trials (RCTs). This includes collecting metadata for each RCT dataset and writing estimation code. Based on those datasets, we will produce the main outputs: a replication package that contains (2) a newly created dataset with our estimation results which will the basis for our analysis and corresponding (3) analysis replication code and (4) a research paper that describes our research findings. No new primary research data will be collected throughout the tenure of this grant. (1.a) Previously published datasets Our sample of studies are drawn from the Datahub for Field Experiments in Economics and Public Policy , specifically from Innovations for Poverty Action (IPA) and the Abdul Latif Jameel Poverty Action Lab (J-PAL). Each contains tabular type data from previously- conducted and published RCTs conducted by affiliates of the organization, over 200 datasets in total (with some overlap). We expect one-third to one-half will be usable for our method. The datasets come in different formats such as tex-files, Stata-files or Excel files. J-PAL and IPA have high standards for data publication, follow ethics requirements and assist the dataset owners during the publication process to protect human subjects. They specifically check for the risk of personal identifying information (PII) during that process. Therefore, we have high confidence that the data meets ethics standards, is already free of PII and therefore does not bring risk of publicising PII. The default license for data published on the J-PAL dataverse and to our understanding also on the IPA dataverse is CC0 1.0 Universal, which allows users to "copy, modify, distribute and perform the work, even for commercial purposes, all without asking permission." Accordingly, we are allowed to transform and distribute the datasets.
|
bb2f2a9033bc3275be5e027f2e823695
|
dmponline.dcc.ac.uk
|
Assessment of existing data
|
Provide an analysis of the gaps identified between the currently available and required data for the research
|
We are relying extensively on currently available data. In order to answer our research question as proposed in this application, we are required to transform the previously published datasets and create an aggregate results dataset based on our estimation strategy outlined in the proposal. It is also important to treat each original dataset in the same way to achieve comparability of results and in order to aggregate them. To the best of our current knowledge, this question has not been addressed before the way we do and no currently existing dataset contains this aggregate information. Therefore, we are required to create the outputs mentioned in section 1 - namely a new results dataset, the research paper and the corresponding estimation code in R.
|
bb2f2a9033bc3275be5e027f2e823695
|
dmponline.dcc.ac.uk
|
Information on new data
|
Provide information on the data that will be produced or accessed by the research project
|
(1.b) Derived Previously Published Datasets Based on the previously published datasets from (1.a), we will create for each study a transformed dataset. If possible, we will use automated procedures to read in metadata but information about the study might have to be collected manually by reading the accompanying information. We will use the software R to produce readable CSV-files (or a similar international standard to save tabular data) containing the metadata and transformed databases for each study. We may realise that a dataset for which we have started collecting metadata cannot be grinded into our approach. We will then abandon it during the process and not transform it. (2) Results Dataset Based on the already published datasets, we will create a new tabular dataset with aggregate results and metadata from the original RCTs. Since this dataset only contains aggregate information from the originally published datasets, we even further limit the risk of handling data containing PII. The dataset will be a CSV-file (or a similar international standard to save tabular data). We will use the software R to estimate and analyse those results. (3) Code We will use the software R to read the datasets, produce our results and analyse them. (4) Research paper We will produce a research paper that describes our findings in a PDF document. We consider that all of these data are of long-term value and can be shared with exception of the abandoned previously published datasets (see (1.b) above). The relevant metadata and derived datasets from the studies that we actually use in the analysis for the paper will be shared along with the Results dataset and code. A readme file in an appropriate format such as PDF will be included in the replication package to guide potential users.
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bb2f2a9033bc3275be5e027f2e823695
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dmponline.dcc.ac.uk
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Quality assurance of data
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Describe the procedures for quality assurance that will be carried out on the data collected at the time of datacollection, data entry, digitisation and data checking.
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As described above, we consider the previously published datasets of excellent quality due to the high standards at J-PAL and IPA for data curation. In order to create the derived data, we will use a standardized estimation code in R to ensure that each dataset is treated the same way. In order to capture the metadata from the originally published dataset, we will provide detailed step-wise instructions for anyone working on the creation of those including the research assistant. Where applicable, we will also apply data validation techniques such as using multiple choice answer options. We use peer review to ensure quality. The code is jointly monitored, written and reviewed by the team. The research assistant and metadata entries are supervised by a team member.
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bb2f2a9033bc3275be5e027f2e823695
|
dmponline.dcc.ac.uk
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Backup and security of data
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Describe the data security and backup procedures you will adopt to ensure the data and metadata are securely storedduring the lifetime of the project.
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Due to the non sensitive nature of our used, transformed and created data, we do not expect to implement additional security measures. Should we unexpectedly find PII in the previously published datasets, we will inform the repository and the data owner, subsequently not use this version of the data and destroy our copies of the data until the data owner republish a new, fully de- identified version of the data. For short-term storage during the tenure of the grant, we will use a combination of local and secure cloud computing resources as appropriate for the project, and keep a copy on institutional storage at Queen Mary (for backup and redundancy). We will have access to QMUL’s OneDrive for Business (ODfB) and SharePoint to store data for collaboration. In addition, we will have access to the QMUL HPC research storage platform. We will ensure at least two copies of data exist on two separate storage platforms. According to QMUL IT policies, all data stored on these two platforms are subject to routine backup and there are processes in place to ensure that the data is recoverable with minimal backup in case of system failure. During the drafting process, the research paper describing our findings will be stored as .tex document on overleaf.
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bb2f2a9033bc3275be5e027f2e823695
|
dmponline.dcc.ac.uk
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Management and curation of data
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Outline your plans for preparing, organising and documenting data.
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We seek to prepare our data for future sharing and re-use as described further in section 10. We will ensure that all data are well organized and that the replication package contains a detailed readme file to facilitate re-use and increase transparency.
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bb2f2a9033bc3275be5e027f2e823695
|
dmponline.dcc.ac.uk
|
Difficulties in data sharing and measures to overcome these
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Identify any potential obstacles to sharing your data, explain which and the possible measures you can apply toovercome these.
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Due to the non sensitive nature of our used, transformed and created data, we do not expect any major risks to data sharing. We address the data specific risks (risk of losing data due to IT problems, delay in data sharing and finding PII in the previously published datasets) in the relevant sections and explain how we aim at dealing with these situations.
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bb2f2a9033bc3275be5e027f2e823695
|
dmponline.dcc.ac.uk
|
Consent, anonymisation and strategies to enable further re-use of data
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Make explicit mention of the planned procedures to handle consent for data sharing for data obtained from humanparticipants, and/or how to anonymise data, to make sure that data can be made available and accessible for futurescientific research.
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Due to the non sensitive nature of the data as described in section 1, no additional procedures need to be put in place to be able to share the data.
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bb2f2a9033bc3275be5e027f2e823695
|
dmponline.dcc.ac.uk
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Copyright and intellectual property ownership
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State who will own the copyright and IPR of any new data that you will generate.
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We will share the derived datasets and the replication package data under the license CC0 1.0. For the derived datasets, we will always make sure we comply with the license of the original data publication. For example, should we unexpectedly find a dataset that is under another license than CC0 1.0 that does not allow us to distribute the data, but use and modify them, we will only publish the replication code but not the transformed data. Intellectual property remains with the authors. For the paper, once accepted for publication, we would make the paper open access according to the journal rules. Intellectual property remains with the authors.
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bb2f2a9033bc3275be5e027f2e823695
|
dmponline.dcc.ac.uk
|
Responsibilities
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Outline responsibilities for data management within research teams at all partner institutions
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Our team is committed to protecting the confidentiality and integrity of those included in this research and seek to make our data open access and encourage secondary analysis. All team members and every research assistant working on this project will follow the data management plan outlined below. This will be ensured during regular meetings and research assistant supervision.
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bb2f2a9033bc3275be5e027f2e823695
|
dmponline.dcc.ac.uk
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Preparation of data for sharing and archiving
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Are the plans for preparing and documenting data for sharing and archiving with the UK Data Service appropriate?
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(1.b) Derived Previously Published Datasets For long-term storage, we will (re-)publish the derived datasets at the UK Data Service Repository under the license CC0 1.0, acknowledging the data owner and original data repository using appropriate citation (e.g. DOIs). We will transform the data in a suitable long storage format as required by the repository. We aim at completing this three months after the end of the award, except where this conflicts with the policies of the journal our paper will be published in. In such a case we would ask for an embargo in line with principle 5 of the ESRC Research Data Policy. (2) Results Dataset We will follow the same procedures as for the previously published datasets (including license and timeline). Since this dataset only contains aggregate information from the originally published datasets, we even further limit the risk of publishing data containing PII. For our prior project Bernard et al. (2023), we created an interactive website to disseminate our results. We plan to create a parallel site for this project as well so that users, policy makers, academics or even teachers, can investigate the results themselves, or get a quick and user-friendly overview of the main results using summary statistics. (3) Code The code will be stored via Github and made openly available for re-use as part of the replication package either on the Github project website or alongside the results dataset on the data repository. (4) Research paper We will share the PDF working paper with our research community as a working paper. We then have the intention to submit this paper for publication in a high-impact economics journal ensuring that all data used and the funder are appropriately acknowledged and point to the replication package. Once accepted, we would make the paper open access according to the journal rules.
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bb2f2a9033bc3275be5e027f2e823695
|
dmponline.dcc.ac.uk
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Preparation of data for sharing and archiving
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Is there evidence that data will be well documented during research to provide highquality contextual informationand/or structured metadata for secondary users?
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For documentation and findability, we make sure to use informative metadata to describe all outputs and create a DOI for the replication package in accordance with the repository to comply with the FAIR principles.
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bb2f2a9033bc3275be5e027f2e823695
|
dmponline.dcc.ac.uk
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0. Administrative questions
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Name of data management support staff consulted during the preparation of this plan.
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My faculty data steward, Janine Strandberg, has reviewed this DMP on 26 September 2024
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81c5547d38a03c279980a82ecd51e046
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dmponline.dcc.ac.uk
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IV. Legal and ethical requirements, codes of conduct
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How will ownership of the data and intellectual property rights to the data be managed?
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For projects involving commercially-sensitive research or research involving third parties, seek advice of your Faculty Contract Manager when answering this question. If this is not the case, you can use the example below. Data received from the questionnaire is bundled in type of organisation. Email adresses will not be saved in the dataset.The bundled results will be used in the report, presentation and discussions. After the project has been finished, datasets will be deleted. The report will be free to acess on the TU Delft repository.
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81c5547d38a03c279980a82ecd51e046
|
dmponline.dcc.ac.uk
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V. Data sharing and long-term preservation
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What data will be publicly shared?
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Only data results and conclusions can be shared. The dataset will not be shared.
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81c5547d38a03c279980a82ecd51e046
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dmponline.dcc.ac.uk
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