Exome sequences of three individuals from the EXCEED study

We welcome requests for collaboration and data access by contacting the study management team via exceed@le.ac.uk

Data Access Policy 1 Management structure 1.1 Independent Scientific Advisory Board • Members are the EXCEED Principal Investigator and a group of independent expert members. • Other members of the research team or advisors with specialist knowledge may be consulted and invited to attend meetings. • The Advisory Board will meet twice a year, this will comprise of one face to face meeting and one teleconference. • Responsible for: o Providing specialist advice and guidance to the EXCEED study Scientific Committee through the Principal Investigator and Scientific Director o Providing strategic oversight of the study progress and long term plans o Considering and providing a forum for discussion of any issues of concern o Ensuring governance, ethical issues and the rights of participants are fully considered o Providing advice on appropriate dissemination of results o Considering and addressing the potential equal opportunity impacts of research team decisions o Treating all sensitive data and discussions confidentially 1.2 Scientific Committee • Members are investigators on the EXCEED study, scientists leading key work programmes and independent representative from the participant group. • Other members of the research team or advisors with specialist knowledge may be consulted and invited to attend meetings. • May meet up to four times a year face-to-face or by teleconference, or business may be conducted primarily by email where appropriate. • Responsible for: o Providing oversight of the EXCEED study and the work of the Executive committee o Supporting the Scientific Director and Principal Investigator with the strategic direction and scientific aims of EXCEED o Reviewing and approving (or rejecting) proposals for collaboration or data access, Data/Materials Transfer Agreements (DMTAs) and publication checklists; where appropriate or referred by the Executive committee o Provide a forum for discussion of any item or issues of concern o Report to the ISAB on the progress and development of the EXCEED cohort 1.3 Executive Group • Members are investigators on the study, primarily those with day-to-day involvement in the running of the study. • Other relevant parties, particularly those with expertise in governance and data sharing, may be involved on an ad hoc basis or co-opted for specific decisions. • The group will meet up to twelve times a year face-to-face or by teleconference. Meetings may be combined where appropriate with the Scientific Committee. • Responsible for: o Providing effective management of EXCEED study, including operational activities and strategic direction, with input and oversight from the scientific committee o Management of collaboration opportunities arising from the study, and implementation of the Data Access Policy o Reviewing and approving (or rejecting) proposals for collaboration or data access; where appropriate these may be referred to the Scientific Committee for review o Reviewing and approving (or rejecting) Data/Materials Transfer Agreements (DMTAs) and publication checklists o Make decisions that are fair and transparent and ensure the study conforms to the terms of ethical approvals and consent, protect confidentiality of participants, and maintain the study’s reputation o Reporting to the Scientific Committee on proposals received and the progress and outcomes of both the approval process and any resulting collaborations o Consulting the Scientific Committee on any update and amendments that may be required to the policy and procedures for collaboration and data access 2 Requests for data access • The EXCEED study encourages requests for collaboration from academic researchers (researchers or employees of an academic institution or the NHS). We are also open to requests for collaboration from commercial organisations with common scientific goals. • Access to the resource requires completion of a Data Access Proposal Form (Proposal Form) by the requesting researcher(s), including a lay summary of the proposed research. Informal guidance on submission will be available from the Executive Group. • The Executive Group will also make available on request a description of the EXCEED resource to support development of proposals. More detailed information on study variables will be made available once a proposal has been approved and DMTA signed and agreed. • Following submission of a proposal, the Executive Group will inform the researcher(s) of its decision within 30 days after the next scheduled meeting. • If there is a possibility of overlap with other groups already working on related topics using the EXCEED resource, the Executive Group may put researchers in touch with these groups and encourage them to discuss their plans before proceeding with the proposal, to avoid duplication. • The Executive Group may provide an estimated cost of the proposed use of the resource, but actual charges will be based on the final, approved Proposal Form. • If approved, a DMTA must be signed by the researcher(s) and their institution. The approved Proposal Form will be an appendix to the agreement. • Researchers are required to return a copy of the final dataset used in their analyses, any derived variables and descriptions of the variables. In general the expectation will be that these should be returned at the point of publication, or 12 months after the original dataset was provided, whichever is the earlier. Other investigators may then apply to access these. 3 Provision of data • Once a proposal is approved, a data coordinator from the EXCEED analysis team will be allocated, and will provide an overview of key variables and meta-data. • The final set of variables must be agreed and a signed DMTA received before the data coordinator provides the dataset. • The researcher(s) must abide by their responsibilities as defined in the DMTA. 4 Use of biological samples • Any proposal involving assays on biological samples should be informally discussed with the Executive Group prior to submission of a proposal, and well in advance of any funding application deadlines. • Decisions will take into account the amount of the stored sample required, the amount available, the scientific value of the proposed use and whether it will enhance the scientific utility of the resource for future research. • The samples to be provided will be set out in the approved Proposal Form. Samples will not be released until the DMTA is completed and signed. • Researchers may be required to use laboratories approved by the Executive Group and/or evidence of quality standards may be required. 5 Collection of new data • Participants have consented to re-contact. However, any new data collection will require separate funding and ethical approval. • Investigators are strongly encouraged to discuss plans informally at an early stage, and well in advance of any funding application deadlines. New data collection will generally require formal collaboration between EXCEED study investigators and the researchers(s) and as such the costs of EXCEED investigators’ time may be included in the overall cost of support. • Preliminary estimates of costs can be provided prior to completion of a Proposal Form, but actual charges will depend on the final, approved agreement. In considering whether any proposal should go forward to seek ethical approval, the Executive Group will take into consideration the availability of staffing and resources to support it, the relevance of the proposal to EXCEED’s scientific aims, and the potential burden/impact on participants. In the event of multiple proposals which cannot all be accommodated, the Executive Group reserves the right to defer consideration of proposals until an agreed date when all proposals received will be reviewed and prioritised based on the principles described above. • As a general principle, new data collection involving all participants or a large proportion of participants will usually be undertaken by the EXCEED team to allow coordination with any ongoing follow-up and reduce the burden on participants. The researchers requesting collection of, and access to, these new data would generally be expected to fund the cost of the new data collection. • It may be appropriate for data collection from a small number of participants (for example, in the case of a recall-by-genotype study) to be led by the collaborator. However, initial contact with participants will be made by the EXCEED team. Participants will then be free to contact the collaborator and their research team if they wish to participate in the new data collection. They will be free to decline or withdraw at any time. • All collaborators will be expected to abide by policies relevant to EXCEED, such as those on feedback of results, and any requirements from external funding bodies. • Collaborators are required to return a copy of the final dataset used in their analyses, any derived variables and descriptions of the variables. In general the expectation will be that these should be returned at the point of publication, or 12 months after the original dataset was provided, whichever is the earlier. Other investigators may then apply to access these. 6 Costs • Researchers will be expected to fund the costs of support for the proposed project, including staff time, and investigator time if appropriate. • If a funding application is being made by the researcher(s), a Proposal Form must be submitted well in advance of the deadline for submission of the funding application. Up to two months may be required for review and response to the proposal. Any approval in these circumstances will be subject to funding being obtained. • Commercial organisations may be charged a commercial rate. 7 Contact with study members and confidentiality • Contact details for participants will not be provided. New data collection from study participants will be facilitated by the EXCEED team in one of two ways described above. • Potentially identifiable details will not be provided. • For example, year and month of birth will be provided as standard. Data on location of residence may be provided as a derived variable at an appropriate level of resolution based on the scientific aims of the proposal. • If the standard variables are not sufficient, analysis may be undertaken by the EXCEED analysis team using code provided by the researcher. Any costs arising must be met by the researcher(s). Any such requests will be considered on a case by case basis. • Alternatively, it may be possible for researchers to access data within University of Leicester IT systems, subject to approval from all relevant University bodies. Any costs arising must be met by the researcher(s). Any such requests will be considered on a case by case basis. • Protecting confidentiality will be the primary concern when considering any such requests. Researchers will be bound to treat all participant information with absolute confidentiality, according to the terms of the DMTA. 8 Publication and publicity • Researchers are expected to publish their findings in journals providing open access unless there is a strong justification for not doing so. • Members of the Executive Group and/or their nominees should be included as co-authors on published papers, provided that they fulfil standard requirements for authorship. • The EXCEED Executive Group will advise on situations where members of the Executive Group do not meet criteria for co-authorship. • Researchers will include reference to the EXCEED study in publications as recommended by the EXCEED study. In due course this may include an accession number. For the time being researchers should assume that the EXCEED study should be mentioned in all abstracts reporting the research unless otherwise agreed. We will provide an agreed standard text in the acknowledgement section of research papers, including acknowledgement of EXCEED funders, and an optional additional acknowledgement of study participants and staff that can be included in keeping with any other cohorts in the same publication and the publisher’s requirements. • Manuscripts should be sent to EXCEED for review prior to submission for publication. This should be at least 14 days in advance of your planned submission date. This is for the purposes of assurance that confidentiality has been maintained, that any potential intellectual property has been disclosed, that it upholds the reputation of the study, and that authorship and acknowledgement requirements have been followed. • Conference abstracts need not be approved prior to submission, but should be provided to the EXCEED study. We reserve the right to request that a presentation is amended or withdrawn where it may impact on the reputation of the study. • Copies of all publications (including abstracts) should be provided once accepted/published. Researchers should also provide a short summary of any published papers to include on the EXCEED website and in reports to funders and in future funding applications. • All press releases must be approved by the Executive Group (and any relevant third parties). The researcher(s) will be expected to lead the response to media enquiries or interview requests but the Executive Group should be kept informed and may be involved. 9 Commercial Access and IP • Any commercial exploitation will be without payment to or acknowledgement of individual participants. • Charges applied to commercial partners will be in keeping with university policy. Commercial price negotiations will be undertaken by the University Research and Enterprise Division.