Appendix 1 Project Proposals
A brief project proposal must be drafted that includes a.) an abstract about the project, a brief analysis plan, data required for the project (cohorts and variables), the project timeline, and the individuals who will require data access for project.
Appendix 1a. Generation R Data Requests
Access to Generation R Data for FAMILY-related projects follows a multi-step process.
- A brief project proposal must be drafted (see Appendix 1).
- The project proposal is first sent to the data access committee via WP2. It will be briefly discussed at the SC meeting,
- One approved by the data access committee and SC, the data access request can proceed to the Generation R MT.
- Once approved by the GenR MT, access can be granted to the DRE workspace with GenR data by the GenR data manager (J Krikeb) once it has been confirmed that the partner has a.) filled in the consortium agreement addendum related to data access within the consortium and b.) each user who will be granted access has signed the Generation R confidentiality agreement.
- Access is granted for a period of XX months. If the project has not yet completed, access can be renewed with an addendum to the project proposal.
Appendix 1b. COPSYCH/COPSAC Data Request
Appendix 1c. ALSPAC Data Request
All FAMILY partners (and their known research teams) who have signed the consortium agreement as of MM-DD-YYYY (and the data access addendum) have been added to the ALSPAC data request, and can request data access via the data access committee with a brief project proposal. See Appendix 1 for info on the project proposal. After discussion by the SC, access will be granted to ALSPAC data by WP2.
For research staff not listed in the original ALSPAC data request, an addendum must be filed. We will file addendums twice per year, unless it is urgently necessary to file an extra addendum sooner. Contact WP2 staff if you have new research staff not listed in the original ALSPAC data request. The list can be found on the intranet (in development).
Appendix 1d. MoBa Data Request
Appendix 1e. MCS Data Request
Appendix 1f. UK Biobank Data Request
Appendix 1g. ABCD Data Request
Appendix 1h. HCP Data Request
Appendix 1i. PNC Data Request
Appendix 2. Data access / Publication request form
Data access /Publication request form
Please describe your scientific question for FAMILY by completing this form. The FAMILY Data Access Committee and the Steering Committee will evaluate your proposal. After approval, data access will be granted if needed.
|1. Project title
|Please add a descriptive project title here, from which the goal/topic of the Scientific Question (SQ) should be clear.
|2. Aims and objectives
|Please add a short description of the general aim & hypothesis to be assessed for this SQ and explain why it is important to address this SQ, and what is the benefit of doing this in the framework of FAMILY
|3. Study design & methods
|Please add a short overview of the number of subjects needed, inclusion/exclusion criteria to be applied, techniques and tools to be used, overall approach – including any risks and alternative approaches for assessing this SQ.
|4. Outcomes and Link to FAMILY
|Please add a comment on the expected outcomes for this SQ and how this links to the work done in the different WPs of FAMILY (and any relevant milestones/deliverables).
|Please add a general overview of timelines, including study start, key milestones, and expected delivery of results.
|6. Cohort(s) of interest from FAMILY
|Please indicate which cohort(s) and data types you are interested in. If no data is needed, please indicate NA
Data request form
|1. Principal investigator
|Please provide contact details for the PI for this SQ – This PI will also take responsibility for the monitoring of the work done for this SQ and reporting the results to the FAMILY Steering Committee.
|2. Key team members
|Please provide an overview of the key team members to be involved in solving this SQ.
I confirm to have all ethical and legal permissions for the conduct of my study / experiment.
I confirm that if data access is granted, the data will be used only for the purpose specified in this form.
In case, our study makes any incidental findings, I confirm to report them back to the FAMILY Data Access Committee who will consult with the data owner about relevant actions to be undertaken.
[Link to Document?]
Appendix 3. Pre-submission review and approval procedure.
During the Project and for a period of 1 year after the end of the Project, the dissemination of own Results by one or several Parties including but not restricted to publications and presentations, shall be governed by the procedure of the Grant Agreement Art. 26.2 subject to the following provisions.
Prior notice of any planned publication shall be given to the other Parties at least 45 calendar days before planned submission of the manuscript to the respective journal. The main author has to follow the following procedure (Appendix figure 1):
- The main authors, first and last authors, fill out the ‘data access’ or ‘publication’ (in case no data is necessary for the manuscript) request form (which can be downloaded from KEYWAYS) and send it to the Data Access Committee (as part of WP2) for a first eligibility check (e.g. is form filled out completely, overlap with other ongoing request, check if permissions to access/use data are in place, can research question be answered with requested data and is data available). When approved, it will be sent to the Project Management Office (PMO). The request form summarizes on 1-2 pages the proposed research, including the involved WPs, proposed authors, background, hypotheses, analyzed variables (if applicable), used methods, and key references.
- The PMO will forward the data access/publication request form to the Steering Committee who will review it within 14 days.
- Once approved by the Steering Committee, the planned manuscript will be entered into the FAMILY dissemination tracker by the PMO. An email will be sent to the general assembly to inform the FAMILY community of the new proposal.
- Subsequently, authors will analyze the data (if applicable), write the manuscript, and send a final draft, that is approved by all authors, to the PMO.Created to reflect actual contributions of involved researchers.
- The PMO informs the team leaders (representatives of an WP, an institution, or a cohort within FAMILY), who have officially 30 days to provide feedback.
- Any objection to the planned publication shall be made in accordance with the Grant Agreement in writing to the Coordinator and to the Party or Parties proposing the dissemination within 7 calendar days after receipt of the notice. If no objection is made within the time limit stated above, the publication is permitted.
Appendix Figure 1: Pre-submission review and approval procedure
Funded by the European Union, the Swiss State Secretariat for Education, Research and Innovation (SERI) and the UK Research and Innovation (UKRI) under the UK government’s Horizon Europe funding guarantee’. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union, or the European Research Executive Agency (REA), the SERI or the UK Research and Innovation (UKRI). Neither the European Union nor the granting authorities can be held responsible for them.