Data access and publication guidelines YOUth
YOUth is part of the research theme Dynamics of YOUth of Utrecht University and UMC Utrecht Brain Center.
www.uu.nl/youthcohort
This Data Access Protocol is written in consultation with the YOUth Executive Board, the YOUth data management team, the CID work package 1, and the University Library Utrecht.
DISCLAIMER: this is a living document that will be amended and updated regularly.
Consequently, no rights can be derived from the text of this publication.
Version October 28, 2019.
Table of Contents
1 General ... 3
2 Definitions ... 4
3 Data ownership ... 8
4 Conditions of data use ... 8
5 Contribution in return for access to YOUth data ... 9
6 Data request procedure ... 9
7 Data access for verification purposes ... 11
8 Publication guidelines ... 11
9 Additional researcher responsibilities ... 14
10 Appendices ... 15
10.1 Data Request form YOUth (version 4.0, October 28, 2019) ... 15
Annex 1: Form contributions to YOUth ... 18
10.2 Allocation of PhD students to YOUth ... 20
10.3 YOUth Internship Protocol ... 23
Annex: Model Agreement Internships YOUth ... 26
10.4 Pre-publication checklist YOUth (version 1.0, September 3, 2019) ... 33
1 General
The YOUth cohort is part of the Consortium on Individual Development (CID). CID examines how the environment (family characteristics, parents and siblings, peers, and broader societal
influences including media) and child characteristics (genetic makeup, temperament, and pre- and peri-natal factors) affect the development of social competence and behavioural control. CID was one of the six teams to receive a grant from the Dutch Science Foundation (NOW, grant number 024.001.003) to collaborate over a period of ten years. The grant is part of the Gravitation Programme by the Ministry of Education, Culture and Science (OCW) to fund highly ambitious research programs that have the potential to bring about international breakthroughs. At Utrecht University, CID is tightly connected to Dynamics of Youth (DoY), one of Utrecht University's four strategic themes. Since May 2013, CID unites top-tier researchers from several disciplines, each with unique and relevant expertise in development research, working at seven Dutch universities and University Medical Centers. YOUth represents one of the four work packages of CID (WP1), is part of Utrecht University’s strategic theme ‘Dynamics of YOUth’ (DoY) and is executed by Utrecht University (UU; coordinated by the Faculty of Social and Behavioral Sciences) and the University Medical Center Utrecht (UMCU).
YOUth is a large-scale longitudinal cohort study following children from the city of Utrecht and its surrounding areas in their development from pregnancy until early adulthood. The YOUth cohort focuses on neurocognitive development involved in two core characteristics of behavioural development: social competence and behavioural control. YOUth includes children from the general population to cover the whole range of variation in behavioural development, ranging from uncomplicated development, through problem behaviour, to psychiatric disorders. To
understand why some children develop problematic behaviour, and others show resilience, YOUth measures a broad range of biological, child-related and environmental determinants.
YOUth conducts repeated measurements at regular intervals (i.e. 'waves'). Specifically, the study has two inclusion moments: YOUth Baby & Child and YOUth Child & Adolescent. The first group, YOUth Baby & Child, includes 3000 pregnant women at 20 weeks of pregnancy, and their partners.
Recruitment has started in July 2015 and is still ongoing. The children that are being born from these pregnancies visit our Child Research Center at several moments during their lives and are followed for at least 6 years. The second group, YOUth Child & Adolescent, includes 3000 children aged 8, 9 or 10 and their parents. These children visit our Child Research Center every three years, for at least three times. YOUth applies a flexible longitudinal design to the cohorts, meaning that children will be measured at broader age ranges (3-year age ranges) at each wave. The main benefit of the flexible age design is that it will provide more detailed information on the neurodevelopmental curves over time.
An extensive data set is generated, including 3D-ultrasound sweeps of the fetal brain, eye tracking, EEG, (f)MRI, computer tasks, cognitive measurements and parent-child observations. We also collect a broad range of questionnaires on behaviour, personality, health, lifestyle, parenting, child development, use of (social) media and more. Finally, (umbilical) blood samples, buccal swabs, saliva and hair samples are collected at each visit, and stored in the UMC Utrecht Biobank. A complete overview of the data collection can be found [here]. Our catalogue with item-level descriptions is available upon request.
In YOUth, Open Science plays an important role. YOUth encourages and facilitates extensive and appropriate use of its data by bona fide research organizations and bona fide researchers. To promote this, YOUth goes to great lengths to produce high quality, FAIR (Findable, Accessible, Interoperable and Reusable), and thereby sustainable data while safeguarding the privacy of participants. YOUth also strives to increase openness, integrity, and reproducibility of the science performed with its data. YOUth therefore envisions that the process, content, and outcomes of research performed with its data are openly accessible by default. YOUth also strongly encourage researchers to pre-register their study and publication plans prior to analysis and publication.
The objective of this document is to outline in detail the conditions, procedures and processes involved in accessing YOUth data and in publishing with YOUth data1. This document is written in consultation with the YOUth Executive Board (consisting of the Scientific Director/Cohort
Representative, the Leader of the CID work package 1, the Executive Director, and the Project Manager), the Data Management Committee (consisting of members of work package 1 of CID and scientific stakeholders), the CID work package 1, and the University Library Utrecht.
2 Definitions
Bona fide: Bona fide research can be considered to be as follows:
• An intention to generate new knowledge and understanding using rigorous scientific methods (including discovery
research, development and validation of methodology and technology, validating and challenging previous findings, and pilot research). And...
• An intention to publish the research findings and share the derived data in the scientific community, without restrictions and with minimal delay, for wider scientific and eventual public benefit. And...
• The intended activities are not inconsistent with legal and ethical requirements or widely recognised good research practice.
In practical terms, a research project or proposal that has been approved by a recognised funder should normally be considered to be “bona fide”.
A bona fide research organisation is one that has the capability to lead or participate in high quality, ethical research. It will have a public commitment to adhere to recognised research and information governance good practice. (It is not a requirement that such research is the primary business of that organisation, or that all of the research undertaken by that organisation is
1 Please note that this document only applies to the actual YOUth data and not to data obtained in pilot studies preceding the YOUth data collection phase. A separate data request form for pilot data is available upon request by the Secretary.
published. Nor is it a requirement that the organisation be publicly funded.)
A bona fide researcher is a person with
• the professional expertise and experience to conduct bona fide research and a formal relationship with a bona fide research organisation that requires compliance with
appropriate research governance and management systems.
CID: Consortium on Individual Development.
Cohort description paper: The paper describing the design of the YOUth cohort. Link to the paper will be added when available.
Data manager: The person responsible for the intake, quality control, storage and distribution of the YOUth data.The Data Manager also evaluates data requests in terms of practical feasibility and privacy concerns.
Data Management Committee: The Data Management Committee (DMC) evaluates data requests, taking into account the evaluation of the Data Manager. This committee consists of members of work package 1 of the CID consortium. A list of the members can be found on the YOUth researcher's website2.
Data lock: A subset of the data that is locked on a specific date and handed out to YOUth researchers for data analysis.
Data package: Well-structured folder consisting of (raw) data, syntax file(s), Readme.txt file (explaining methods and structure of the data package), and a version of the paper in word and pdf. A researcher is responsible for securing and archiving its data package together with a metadata scheme in the Yoda repository.
Data set: A collection of data. YOUth has data sets for each wave (single experiments and questionnaires).
Domain controller: For each research domain, one researcher is ultimately
responsible for its data quality, training of research assistants, etc.
A list of domain controllers is available on the YOUth researcher's website3.
Executive Board: The people responsible for the daily management of YOUth. The Executive Board consists of the Scientific Director / Cohort Representative, the Leader of CID work package 1, the Executive Director, and the Project Manager.
FAIR data principles: Findable, Accessible, Interoperable and Reusable data.
Findable: metadata and data should be easy to find for both humans and computers. Machine-readable metadata are essential for automatic discovery of datasets and services.
• Data are described with rich metadata.
• (Meta)data are assigned a globally unique and persistent identifier (for example a DOI).
• (Meta)data are registered or indexed in a searchable resource.
2 https://www.uu.nl/en/research/youth-cohort-study/about-us/youth-researchers
Accessible: it should be possible for humans and machines to gain access to your data, under specific conditions or restrictions where appropriate. FAIR does not necessarily mean that data need to be open! In cases where the data cannot be made openly accessible, it is still possible to make the metadata publicly
available.
• The repository used to share data assigns persistent identifiers by which data can be retrieved.
• The access procedure includes authentication and authorisation steps, if necessary.
• Metadata are accessible, wherever possible, even if the data are not.
Interoperable: to speed up discovery and uncover new insights, research data should be easily combined with other datasets, applications and workflows by humans as well as computer systems.
• When possible, well-known and preferably open formats and software are used.
• Relevant standards for metadata are used.
• Community agreed schemas, controlled vocabularies, keywords, thesauri or ontologies are used where possible.
Reusable: Research data should be ready for future research and future processing, making it self-evident that findings can be replicated and that new research effectively builds on already acquired, previous results.
• The data are well-documented to support proper data interpretation.
• The data have a clear and accessible data usage license so others know what kinds of reuse are permitted.
• The data have provenance information to make clear how, why and by whom the data have been created and processed.
• The data (and metadata) meet relevant domain standards.
Publication: An article, abstract or presentation at professional meetings, summarizing with the purpose to disseminate research findings to the scientific community.
Research domain: A combination of measurements with a similar experiment type (e.g. EEG, questionnaires) that can span multiple waves.
Research question: A well-defined and specific question that includes determinant, outcome and domain (the group of people that you want to generalize the results of the study to). A research question should be answerable in one publication.
Subset: A set of data that is still incomplete and does not contain all participants of a specific wave.
Verification: (An attempt) to exactly reproduce results of analyses conducted by others, using the same analysis script and exact same data set.
Wave: All pregnant women and children visit the center at regular time intervals. These visits are called “waves” and for the participants
“Rondom xx”, where xx stands for the average age of the children in that specific wave.
Yoda: A service that provides Utrecht University researchers and their partners with a workspace and an archive that enables them to collaborate, deposit, publish, and securely preserve research data (long term). YOUth uses Yoda for various purposes including data access and archiving of data packages. For more information, please visit https://yoda.uu.nl.
YOUth: Youth Of Utrecht cohort including children and their parents living in the city of Utrecht and its surrounding areas.
3 Data ownership
Data ownership lies with UU and the UMCU, as described in the Consortium Agreement of CID and the Additional Agreement on Data (both available upon request from the Project Manager).
Data ownership remains with these parties at all times and cannot be transferred to other parties.
User rights are limited to (non-exclusive) access to the data set specified in the data request and to use of this data set as specified in the data request. Any data generated through an approved project must be returned to the resource to encourage ongoing use by the research community.
4 Conditions of data use
• The YOUth Executive Board grants data access for dedicated research questions only. The research question should be precisely specified in the data request form. It is not allowed to use data for exploratory analyses or research questions that are not specified in the data request form.
• Output of the research specified in an accepted data request should be limited to a single paper in a peer-reviewed journal, a report, thesis, or other form of scientific output. With this policy, YOUth aims to prevent piecemeal publication. This is defined as the unnecessary submission of findings from the same study in piece by piece fashion, rather than as an integrated single report (APA, 2010). The planned output should therefore be specified in the data request form. . Submissions of conference abstracts do not need to be specified in the proposal and do not follow the same rules as other publications, unless this is the primary mode of publication in your research field (e.g. computer science).
• Access to YOUth data can only be granted by the Executive Board after positive evaluation of the data request by both the Data Manager and the Data Management Committee.
• Access to data can only be granted when the research question falls within framework of YOUth and within the limits specified in the informed consent provided by the participants of YOUth.
• Access to biological materials can only be granted after additional approval from the
“Toetsingscommissie Biobanken” of the UMC Utrecht. The standard access protocol of TCBio needs to be followed (https://www.umcutrecht.nl/nl/Ziekenhuis/Professionals/Centrale- Biobank or contact TCBio@umcutrecht.nl)
• In principle, data will be made available in data locks twice a year. This means that twice a year, the data is released on a specific date and that all approved data request projects will receive the released data on the same day. A researcher can indicate on the data request form that he/she wants to be informed when a new lock becomes available.
• In case of conflicting requests, individuals or teams with a more prominent role in the development, inclusion, and/or continuation of YOUth are given priority for analysis of the same dataset.
• YOUth uses a maximum of 2 data requests per primary applicant at the time. Data requests for verification do not count towards this maximum.
• YOUth acknowledges the importance of collaboration with other (cohort) studies and stimulates collaboration in (inter)national consortia. However, data access for use in
(collaboration in) consortia cannot be granted to an individual researcher. When a researcher wishes to collaborate in a larger consortium with YOUth data, they forward a request to the Executive Board of YOUth for evaluation
• Requests for collaboration with YOUth follow a separate procedure. This procedure is currently in development. Documents regarding this procedure will be published on the website as soon as they are finalized.
5 Contribution in return for access to YOUth data
As the funding YOUth receives does not cover the costs of providing support for individual projects, nor of providing high quality data storage and access, YOUth maintains a ‘quid pro quo’
principle in granting access to YOUth data. This means that data can only be requested by researchers who contribute to YOUth either in time, or another significant contribution. When time or another significant contribution is not feasible, a financial contribution may be considered.
• Time: In return for data access, scientific personnel or students can be allocated to
contribute to the continuation of YOUth. For each data request, scientific personnel need to contribute 500 hours (including training time) of their time. . In case of multiple data requests, Contribution will be in proportion to the number of data requests (e.g. for a PhD-thesis based on 4 data requests, 2000 hours need to be contributed). For detailed information regarding contribution in time, please see Appendix 10.2 and 10.3.
• Other contributions: The Executive Board will consider other forms of contribution in return for access to YOUth data. These forms of contribution need to be of significant importance to the maintenance of YOUth. Examples of these forms of contribution include use of equipment or other facilities, access to data that are relevant for YOUth, or method development.
• Financial contribution: If a contribution in time or another significant contribution to the maintenance of YOUth is not feasible, access to YOUth data may be obtained through a financial contribution. The size of the financial contribution depends on the type and amount of data requested.
Please note that project amendments and pre-access information (i.e. tailored information not available from the website) require additional time from the Executive Board, the Data
Management Committee, and the Data Manager and are therefore also subject to some form of contribution. The amounts of time (or financial contribution) will be specified in the next version of this document.
6 Data request procedure
When a researcher wishes to access YOUth data, they need to submit an online data request form (see Appendix 10.1) This data request should provide a detailed description of the background, research questions and methods of the proposed study. Students and PhD-students van only submit data requests in consultation with their supervisor.
An overview available data and a prospectus containing detailed information on all measurements is provided on the YOUth Researcher’s website. In addition, a catalogue providing details on item- level is available upon request from the Data Manager. Applicants select the data they wish to obtain access to in the online data request form.
The Data Management Committee evaluates the data request using the following guidelines:
• Does the specified research question fall within framework of YOUth?
• Does the specified research question fall within the limits specified in the informed consent provided by the participants of YOUth?
• Can the research question be addressed with the requested YOUth data?
• Can the research question be addressed with the proposed study design?
• Is the proposed study logistically feasible?
• Is the study scientifically relevant?
• Does the researcher have the expertise necessary to correctly analyze the requested data and to report the results?
• Will biological samples be used? If so:
o Is the volume requested reasonable and to what extent does it deplete the resource?
o should these samples be used to address the proposed research question?
If the data request involves the use of biological samples, the applicant needs to apply for
additional approval from the “toetsingscommissie Biobanken” (TCBio) of the UMCU. This approval can only be obtained after approval of the data request by the YOUth Executive Board. The
applicant needs to fill out the application form of the TCBio, which can be found on the TCBio website (https://www.umcutrecht.nl/nl/Ziekenhuis/Professionals/Centrale-Biobank). Materials that need to be included in the application for the TCBio (informed consent forms, brochures, etc.) can be provided by our data manager.
All submitted data requests will be sent to the Project Manager. The Project Manager evaluates whether the data request is complete and whether it falls within the framework of YOUth and within the limits of the Informed Consent provided by participants. In addition, the Project Manager consults with the Data Manager to assess the practical feasibility and risk of disclosing identifiable information. In case of a positive initial evaluation, the Project Manager selects
members of the Data Management Committee to review the request. These members of the Data Management Committee need to return their review to the Project Manager within two weeks.
The reviewers may ask for additional information or request changes in the proposal. In case of disagreement between reviewers, a teleconference will be held to resolve disagreement(s). Based on the reviews, the Executive Board will then decide whether to approve or disapprove the
request. The Executive Board aims to notify the applicant of its decision within two weeks of receiving the reviews from the Data Management Committee. However, the process may take longer for complex requests (e.g. requests involving biological samples) or for any request submitted during public holidays or lecture-free periods at the UU.
If a data request is approved, the data manager generates a dataset and provides a Data Transfer Agreement (DTA) which has to be signed by the by a representative of the applicant’s
institution3(). As soon as the Data Manager has received the signed DTA and, if applicable, access fees have been paid, the Data Manager will make the requested data available through a secure data transfer process.
An application for an amendment to the original data request needs to be completed online if any of the following circumstances:
• The applicant wishes to conduct other analyses than those that were specified in the original data request
3 only applicable for researchers from a different legal entity than the UU
• The applicant needs to change the start or end date
• The applicant requires additional data
• Additional researchers need to access the data
• The applicant changes institution
• There is a change of funding source
The required changes can only be made after approval from the Executive Board.
All data requests will be published on the YOUth researcher’s website in order to provide a searchable overview of past, current, and pending data requests. By default, the publication of submitted and pending data requests includes he names and institutions of the contact person and participating researchers as well as a broad description of the research context.
After approval of a data request, the complete request (including hypotheses and proposed analyses) will be published. If an applicant has reasons to object to the publication of their complete data request, they should notify the Project Manager, who will evaluate the objection with the other members of the Executive Board and the Data Management Committee. If the objection is rejected, the researcher may decide to withdraw their data request.
7 Data access for verification purposes
Researchers who publish with YOUth data are responsible for the replicability and verifiability of their research. When journal editors, reviewers, or other researchers wish to obtain access to the data to verify results, the original applicant can submit an online data request for verification linked to their original request. In this data request for verification, the contact details of the person requesting the data for verification should be provided.
The evaluation of the data request for verification will follow the same procedure as an original data request. When the data request for verification is approved, a representative of the
institution of the person requesting the data for verification needs to sign a specific Data Transfer Agreement. This Data Transfer Agreement states that the data can only be used for verification purposes and that publication about anything other than the results of the verification attempt is prohibited.
8 Publication guidelines
1. Prior to publication, the Executive Board reads all papers to check confidentiality is
protected, to ensure that the paper will not bring YOUth into disrepute, and if the paper is in line with the original data request. In addition, the Executive Board may provide advice and feedback to the authors where they feel this might be helpful, but their role is not to provide formal peer review. The authors are not duty bound to follow this advice.
2. The Executive Board checks if all necessary authors are included on the paper. In principle, at least the YOUth researcher responsible for the specific research domain (i.e. domain
controller) should be listed. Please visit our researcher’s website4 for a list of domain controllers.
Where possible, Early Stage Researchers, in particular post-docs and PhD students, shall be given priority as Lead Authors. For authorship credits YOUth strongly encourages
researchers to follow the Vancouver protocol5.
3. We encourage researchers to include “YOUth Cohort Study” either as keyword or as corporate author on publications. We appreciate that not all publications allow this (e.g.
papers using data from several consortia), but we encourage it wherever possible.
4. The YOUth cohort will only be mentioned in the Acknowledgements section with the following paragraph:
“YOUth is funded through the Gravitation program of the Dutch Ministry of Education, Culture, and Science and the Netherlands Organisation for Scientific Research (NWO grant number 024.001.003). YOUth is part of (and partly funded by) the research theme
Dynamics of YOUth of Utrecht University and of the UMC Utrecht Brain Center”.
5. The cohort description paper describes the design of the YOUth cohort in detail. A link to the paper will be added when available.
6. YOUth fully supports the (Dutch) National Plan Open Science (www.openscience.nl).
Therefore, we encourage researchers to publish their papers in open access journals.
Authors should be aware of the possibility to use Creative Commons licenses.
7. The researcher is responsible for securing and archiving the data package in Yoda prior to publication. A data package is a well-structured folder consisting of (raw) data, syntax file(s), Readme.txt file (explaining methods and structure of the data package), and a version of the paper in word and pdf. The researcher places this data package within Yoda and fills in the metadata scheme in the web portal of Yoda at the folder level that is to be archived. After the metadata form has been filled in, the researcher ‘submits’ the data package for archiving. The data manager checks the data package and metadata form, and can ask the researcher for clarification when needed. After approval by the data manager, the data package and metadata form will be archived in the Yoda vault and cannot be changed.
Optional: If desired, the researcher can request to publish the metadata form after
archiving it in Yoda. Publishing means that a DOI is assigned to the metadata form, making it findable and accessible to others. Note that this does not mean that the actual data is published; only the metadata is published. Access to the actual underlying data can only be requested through the formal process. Each request for publication of the metadata form is evaluated by the data manager.
8. After securing your data package in the Yoda vault, you are responsible for securely destroying any data and/or derivatives from your own workplace. For help, please contact the data manager (r.scholten@uu.nl).
4
5 Ann Intern Med. 1997;126:36-47.
9. In case of a press release or interview, we ask you to contact the Executive Board in
advance. They can redirect you to the YOUth Communication team who can assist you with the media coverage.
10. The Executive Board may ask you to prepare a summary of your work for our funders. We may also ask you to write a lay summary, e.g. for our newsletter for participants or for our website.
11. Please send a copy of the final submitted paper and any revised versions to the Secretary of the Scientific Director (I.Bleeker@uu.nl).
12. Please send the publication details to the Secretary of the Scientific Director (I.Bleeker@uu.nl).
13. YOUth logo to be used on all communication materials:
Footer to be used on e.g. flyers, posters, letters, etc.:
YOUth is an initiative of:
14. If you wish to add any additional remarks regarding the publication process, you can insert it here.
A pre-publication checklist for publishing papers with YOUth data is provided in Appendix 10.4.
9 Additional researcher responsibilities
It is important to note that the Executive Board does not consider overlap in research questions when evaluating data requests. The YOUth researcher’s website provides an up-to-date list of publications based on YOUth data and an overview of all pending and approved data requests. It is the applicant’s responsibility to determine whether any other researchers are addressing or have addressed the same research questions.
All projects requesting YOUth data should be appropriately funded. When funding is contingent on the data request being approved, it is the applicant’s responsibility to submit a data request in time.
10 Appendices
10.1 Data Request form YOUth (version 4.0, October 28, 2019) Introduction
The information you provide here will be used by the YOUth Executive Board, the Data Manager, and the Data Management Committee to evaluate your data request. Details regarding this evaluation procedure can be found in the Data Access Protocol.
All data requests will be published on the YOUth researcher’s website in order to provide a searchable overview of past, current, and pending data requests. By default, the publication of submitted and pending data requests includes he names and institutions of the contact person and participating researchers as well as a broad description of the research context.
After approval of a data request, the complete request (including hypotheses and proposed analyses) will be published. If an applicant has reasons to object to the publication of their complete data request, they should notify the Project Manager, who will evaluate the objection with the other members of the Executive Board and the Data Management Committee. If the objection is rejected, the researcher may decide to withdraw their data request.
Section 1: Researchers
In this section, please provide information about the researchers involved with this data request.
- Name, affiliation and contact information of the contact person
- Name and details of participating researchers (e.g. intended co-authors) - Name and details of the contact person within YOUth (if any)
1. Contact person for the proposed study:
Name:
Institution:
Department:
Address:
Email:
Phone:
+ for other participating researchers Section 2: Research context
In this section, please briefly describe the context for your research plans. This section should logically introduce the next section (hypotheses). As mentioned, please note that this section will be made publicly available on our researcher’s website after submission of your request.
Please provide:
- The title of your research plan
- A very brief background for the topic of your research plan - The rationale for and relevance of your specific research plan
- The specific research question(s) or aim(s) of your research (Please also provide a brief specification)
- A short description of the data you request
References can be added at the end of this section (optional).
Title of the study
Background of the topic of your research plan, rationale, relevance (max. 500 words)
The specific research question(s) or aim(s) of your research
Summary of the data requested for your project: Please indicate which data you request to answer your research question.
Section 3: Hypotheses
In this section, please provide your research hypotheses. For each hypothesis:
- Be as specific as possible
- Provide the anticipated outcomes for accepting and/or rejecting the hypothesis
Section 4: Methods
In this section, you should make clear how the hypotheses are tested. Be as specific as possible.
Please describe:
- The study design and study population (Which data do you require from which subjects?) - The general processing steps (to prepare the data for analysis)
- The analysis steps (How are the data analysed to address the hypotheses? If possible, link each description to a specific hypothesis)
- Any additional aspects that need to be described to clarify the methodological approach (optional)
Study design, study population and sample size (e.g. cross-sectional or longitudinal;
entire population or a subset; substantiate your choices) References (optional)
Hypotheses
General processing steps to prepare the data for analysis
Section 5: Data request
In this section, please specify as detailed as possible which data (and from which subjects) you request.
Data request for the purpose of:
Analyses in order to publish
Analyses for data assessment only results will not be published) Publication type (in case of analyses in order to publish):
Article or report PhDthesis
Would you like to be notified when a new data lock is available?
Yes No
Upon approval of a data request, the complete request will be made publicly available on our researcher’s website by default.
Do you agree with publishing the complete request on our researcher’s website after it is approved?
Yes
No. Please provide a rationale
Specific processing and analysis steps to address the hypotheses
Additional methodological aspects (optional)
Annex 1: Form contributions to YOUth
As the funding YOUth receives does not cover the costs of providing support for individual
projects, nor for providing high quality data storage and access, YOUth maintains a ‘quid pro quo’
principle in granting access to YOUth data. This means that data can only be requested by researchers who contribute to YOUth either in time, or another significant contribution. When time or another significant contribution is not feasible, a financial contribution may be considered.
• Time: In return for data access, scientific personnel or students can be allocated to contribute to the continuation of YOUth. For each data request, scientific personnel need to contribute 500 hours (including training time) of their time. . In case of multiple data requests,
Contribution will be in proportion to the number of data requests (e.g. for a PhD-thesis based on 4 data requests, 2000 hours need to be contributed). For detailed information regarding contribution in time, please see Appendix 10.2 and 10.3 of the Data Access Protocol.
• Other contributions: The Executive Board will consider other forms of contribution in return for access to YOUth data. These forms of contribution need to be of significant importance to the maintenance of YOUth. Examples of these forms of contribution include use of equipment or other facilities, access to data that are relevant for YOUth, or method development.
• Financial contribution: If a contribution in time or another significant contribution to the maintenance of YOUth is not feasible, access to YOUth data may be obtained through a financial contribution. The size of the financial contribution depends on the type and amount of data requested.
Type of contribution the applicant wishes to make to YOUth in return for data access:
☐ Time
☐ Other contribution
☐ Financial contribution
Contribution in time:
☐ PhD student
☐ Other contribution, namely: ______________
Number of hours to be contributed _______________
Other contribution:
Detailed description of the proposed contribution:
________________________________________________________________________________
________________________________________________________________________________
_______________________________________________
Financial contribution:
Amount: €
Signature YOUth manager
Name:
Date:
Signature:
10.2 Allocation of PhD students to YOUth YOUth PhD student protocol – Child Research Center
The YOUth cohort offers a unique training place for PhD students. Within YOUth, PhD students can gain experience with imaging and neuropsychological measurements in children and their parents participating in one of our two longitudinal studies: YOUth Baby & Child (aimed at pregnant women, babies and toddlers) and YOUth Child & Adolescent (aimed at children from 8 years old).
In the Baby & Child study, we perform Eye tracking, EEG, and behavioral observations. In the Child
& Adolescent study, we do MRI (fMRI, sMRI, and DTI), computer tasks, and IQ subtests as well as Eye tracking and behavioral observations. Furthermore, PhD students are able to gain experience in all facets of performing research: recruitment and retention, measurements, data quality controls, data analyses, and outreach.
As the funding YOUth receives does not cover the costs of providing support for individual
projects, nor for providing high quality data storage and access, YOUth maintains a ‘quid pro quo’
principle in granting access to YOUth data. This means that data can only be requested by
researchers who contribute to YOUth either in time, money or another significant contribution. In this document we specify the procedure and the conditions for contribution in time by PhD students.
Procedure PhD student appointment
If a researcher wants to appoint a PhD student to YOUth, a form (Checklist PhD students, Annex) must be filled in which indicates which tasks the PhD student will perform for YOUth.
For the specific activities for data collection, i.e. measurements on the participants, the PhD student is directed by the logistics manager.
Conditions for YOUth PhD student/postdoc
• Working within the YOUth cohort for 2 days a week for 3 years (total 30% of the appointment period, with a full-time appointment of 4 years, that is 1.2 FTE (2,000 hours)). Work includes:
o Taking (pilot) measurements o Contribute to data quality controls o Manage and prepare lab rooms
o Able to be called up in the event of illness of a research assistant. This will be for half a measurement day and will be compensated in the subsequent period and only applies to the period in which the PhD student/postdoc is performing measurements for YOUth.
• Since we perform measurements for YOUth 6 days a week, the PhD student/postdoc will also be deployed on Saturdays. Flexibility for the evenings can be requested.
• Possibly supervising students who do an internship at YOUth.
• Possibly involvement in recruitment for YOUth and outreach.
• Attendance at meetings and training moments in the context of YOUth.
• Possible support of the YOUth team where desired and in accordance with the availability of the PhD student/postdoc for YOUth.
• PhD students are supervised by their promotors and co-promotors. For the practical work at the Child Research Center (i.e. for YOUth data collection), the PhD students are managed by the logistics managers. The available time of the PhD student for YOUth will be determined in consultation with the promotor/daily supervisor of the PhD student.
Data access guidelines for PhD students/postdocs
• For a complete thesis, a PhD student has to contribute for at least 2,000 hours on YOUth.
• In all other cases, contribution for data access will be in proportion to the amount of data requested
o This applies for PhD students who only want to write one or two articles on YOUth data, and not their complete thesis
o This applies for postdocs who want to write on YOUth data
§ One needs to contribute for at least 500 hours per application, excluding training time.
§ One application is considered to result in 1 output, e.g. an article, report or thesis
Annex: Checklist for PhD student appointments and postdoc appointments Name PhD student/postdoc:
With the appointment of this PhD student/postdoc [ I’m aware that:
• He/she will work within the YOUth cohort for 2 days a week for 3 years (total 30% of the appointment period, with a full-time appointment of 4 years, that is 1.2 FTE (2,000 hours)).
• He/she may be trained for all measurements, including scanning participants in the MRI and sampling blood.
• He/she may be called on Saturdays and in the evenings.
• He/she must be able to speak Dutch fluently.
These provisions apply to all PhD students and postdocs appointed within the 2nd phase of CID PI budgets, unless otherwise agreed with the cohort representative.
Name applicant: YOUth executive director:
Jacobine Buizer
Signature: Signature:
Date: Date:
10.3 YOUth Internship Protocol
YOUth internship protocol – Child Research Center
The YOUth cohort offers a unique training place for students. Within YOUth, interns can gain experience with imaging and neuropsychological measurements in children and their parents participating in one of our two longitudinal studies: YOUth Baby & Child (aimed at pregnant women, babies and toddlers) and YOUth Child & Adolescent (aimed at children from 8 years old).
In the Baby & Child study, we perform Eye tracking, EEG, and behavioral observations. In the Child
& Adolescent study, we do MRI (fMRI, sMRI, and DTI), computer tasks, and IQ subtests as well as Eye tracking and behavioral observations. Students can indicate their preference for one of our studies.
The practical experience that the YOUth cohort offers in the area of (f)MRI, Eye tracking, and EEG is unique. YOUth is therefore particularly interesting for students from:
• The bachelor and master Neuropsychology
• The master Neuroscience and Cognition
• The master Epidemiology
• Educational Sciences
• General Social Sciences
• UMC Utrecht, including the Brain Center Rudolf Magnus and the division of Woman & Baby Conditions from YOUth:
• The possibilities for the practical deployment of trainees must be able to fit in logistically.
Therefore, only a limited number of places per turn-on moment can be made available by YOUth. (The number of places will be determined by the YOUth organization per inflow moment, depending on the intake of participants and the staffing of personnel.)
• Trainees are trained to be able to measure independently within YOUth Baby & Child or within YOUth Child & Adolescent. Training is according to the existing training plans and under guidance of experienced research assistants and/or PhD students. The same training requirements apply to trainees as to research assistants and PhD students.
• Interns must be qualified to work with parents and children. Within the Child Research Center, application rounds are held to select qualified candidates. Students can apply by sending a CV and motivation letter.
• Trainees must speak Dutch well in order to be able to carry out measurements independently.
• Participants must agree to attend or carry out measurements by trainees.
• Trainees cannot practice clinical skills that fall outside the standard measurements of the YOUth study.
• The first assessor/scientific supervisor of the trainee must have a PhD degree and working at Utrecht University. Supervision of the trainee is always concerned within the scientific department and not with the YOUth staff.
• If you wish, the YOUth organization can complete an evaluation regarding the practical functioning of the trainee. A format must be provided for this.
• YOUth is not able to offer trainees a workplace within the Child Research Center (laptop or desktop). When trainees are not involved in the measurement of a child and his/her parents, they cannot work in the Child Research Center. The YOUth organization is not responsible for the time spent by the trainee if a measurement is cancelled.
• Interns are registered with us at least 2 months in advance. This time is needed for administrative matters and to plan the job interview at the Child Research Center.
Period
• Trainees come for a minimum period of 6 months (in some cases 5 months is allowed).
• Interns are available for measurements within YOUth a minimum of 2-3 days per week. On these days they must be available for measurements throughout the day. No other things can be scheduled by the trainee on a measuring day.
• Trainees are also available on Saturdays and can be present at the Child Research Center early (7:30 am).
• During the summer period (4 weeks during the summer holidays) there are no
measurements for YOUth so interns are not able to work for YOUth during these weeks.
• Within YOUth, we know fixed starting dates for trainees from the master Neuroscience &
Cognition and Neuropsychology. For trainees from other studies, starting dates will be discussed.
o Master Neuroscience & Cognition – From December 1st [submit vacancy text June/July]
o Master Neuropsychology – From September [submit vacancy text June/July]
Other activities within the YOUth cohort
In addition to carrying out measurements, YOUth offers the possibility to perform other activities within this longitudinal, human cohort (e.g. scheduling participants or helping with recruitment activities). The possibilities for this work depend on the background of the trainee, the expertise of the supervisor and the organizational possibilities within YOUth.
How does the procedure work?
YOUth can deliver vacancy texts for internships. Interns then apply via a CV and motivation letter to YOUth. YOUth makes a selection from these applications and conducts job interviews,
preferably together with the scientific supervisor from the program. From this follows the selection of trainees.
Data accessibility
If it is mandatory for internships that interns also analyze data, they basically use data sets other than YOUth data. Should there be a desire to analyze YOUth data, the rules for the YOUth Data Access Protocol apply. Summarized, this means that:
• Interns may only work with (pilot) data that have been officially requested and assigned by their supervisor (PhD student, postdoc, UD, UHD, professor, etc.). The YOUth data access procedure applies to requesting data
o A PhD student who fully writes his/her thesis on YOUth data spends 2000 hours of his/her time on measurements for YOUth.
o Converted to 1 paper, 500 hours must be measured for YOUth by a PhD student or postdoc.
o When a UD, associate professor or professor does not have PhD students or
postdocs who can/want to measure for YOUth, they can have trainees measure for YOUth to meet the requirements for data access. In total, trainees will have to measure for 1,000 hours for YOUth to get data access for 1 publication on YOUth data. In practice, this number of hours will be paid by several trainees per
UD/UHD/professor.
§ If, for example, a trainee performs measurements for a period of 6 months for 2 whole days per week, this is equal to approximately 384 hours.
§ If, for example, an intern carries out measurements for a period of 9 months for 3 whole days per week, this equals approximately 864 hours.
§ Trainees require more selection and training time and guidance; hence the factor 2 with respect to a PhD student or postdoc (these measure 500 hours for 1 paper, trainees measure 1,000 hours for 1 paper).
o It is not possible for PhD students or postdocs to exchange their own time for measurements within YOUth for hours that trainees measure within YOUth.
o If a UD, associate professor or professor does not have PhD students or postdocs who can/want to measure for YOUth and cannot provide trainees who can measure for 1,000 hours, they can submit a data request for 1 publication against €10,000 fee. This amount of money equals the hours of work otherwise done.
• In addition, students may work on data that have been released for quality control to the relevant domain controller (specified and recorded within the YOUth organization), who is his/her supervisor. This is only for quality analysis purposes and cannot be published.
• Interns will always include a standard disclaimer in their thesis and will never publish the results of analyzes on YOUth data, not even from their thesis.
DISCLAIMER THESIS INTERNS: The data described in this thesis is part of the YOUth cohort and may therefore not be made public, for example by publishing them or otherwise making them available to others. If you want to use data for disclosure, permission of the YOUth data management committee is required, and this data request protocol must be followed for analyses in order to publish.
Internships not including practical work at the Child Research Center:
ONLY FOR YOUTH SENIOR RESEARCHERS (THOSE RESPONSIBLE FOR THE DOMAINS):
In some cases, it is conceivable that a YOUth senior researcher wants to supervise students without letting them work practically at the Child Research Center. For example, he/she only wants to let the trainee work on scoring certain data and cooperating with data quality checks for which he/she is responsible within YOUth and for which he/she received data from the YOUth data manager.
In those cases, it is enough to fill in and sign the Model Agreement Internships YOUth and send this to the executive director. The above-mentioned conditions (e.g. on minimum period and starting date) are not necessarily applicable.
However, please keep in mind that for those data the following disclaimer is applies:
DISCLAIMER DATA ACCESS QUALITY CONTROL AND DESCRIPTIVE DATA: These data can only be used for data quality control analyses or descriptive data analyses only and may not be made public, for example by publishing them or otherwise making them available to others. If you want to use data for disclosure, permission of the YOUth data committee is required, and this data request protocol must be followed for analyses in order to publish.
Annex: Model Agreement Internships YOUth Personal information student
Name: …..
Student number: …..
Educational program: …..
Address: …..
Postal code, city: …..
E-mail address: …..
Phone number: …..
Details Educational institute Name of institution: …..
Faculty: …..
Address: …..
Postal code, city: …..
Name of academic supervisor: …..
N.B. The first assessor/scientific supervisor of the trainee must have a PhD degree and working at Utrecht University.
Phone number: …..
E-mail address: …..
Details of organization offering the internship Name of organization: YOUth cohort study
Student intern work address: Child Research Center (CRC)
Genèvelaan 4-6 UMC Utrecht Phone number: 0800 – 400 30 40
E-mail address: youth@youthonderzoek.nl
Name supervisor CRC: Femke Everaarts Gwen Schouw
N.B. Supervision of the trainee is always concerned within the scientific department and not with the YOUth staff. Only for the practical work at the Child Research Center (i.e. for YOUth data collection), the trainees are managed by the logistics managers.
E-mail address: F.M.Everaarts@uu.nl G.I.Schouw@uu.nl
Internship agreement Part I
Article 1: Learning objectives and intern responsibilities
• The objectives of this internship are for the student to experience the practical application of the theoretical knowledge they have acquired and to acquire new knowledge and skills.
The organization offering the internship and Utrecht University will ensure that the student intern will be assigned tasks and responsibilities commensurate with the student's abilities and his or her learning objectives for the period of internship. This internship agreement is therefore not an employment contract.
• Learning objectives: skills and knowledge to be acquired, as defined by the academic supervisor.
• Student intern responsibilities: tasks assigned to help the intern attain his or her learning objectives, as defined by the internship supervisor in consultation with the academic supervisor.
Article 2: Guidance and evaluation
• Utrecht University (or the relevant study unit or Faculty) shall designate an academic supervisor to take responsibility for the internship and the organization offering the internship shall designate an internship supervisor. If any problems arise, the internship supervisor shall contact the academic supervisor.
• At the end of the internship, Utrecht University will require the student intern to submit a report, the specifications for which will be made available to the student before the internship starts. The organization offering the internship will receive a copy of this report.
• The organization offering the internship will provide the student intern with an evaluation of his or her internship, when desired by the academic supervisor and when a format for this evaluation is provided.
Article 3: Internship details
• The number of ECTS credits to be awarded upon completion of this internship is: XXX The final decision on whether to award these credits rests with the academic supervisor.
• The internship will last from XXX until XXX, except on (parts of) days that the staff at the organization offering the internship is off work.
• The daily working schedule of the organization offering the internship will apply to the student as well.
The minimum number of hours the student intern will work each week will be: XXX
• The student intern will be absent from the organization offering the internship on: XXX
• The student intern agrees to abide by all house rules set by the organization offering the internship.
• The student intern will receive compensation for expenses each month in the amount of € XXX, if applicable
• The student intern will receive compensation for travel expenses in the amount of € XXX, if applicable
• Besides compensation for expenses, the student intern will receive a financial reward of € XXX per day/week/month*, if applicable
