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Expert | Description | Metroline Steps |
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Institutional Review Board (IRB) / Medical Ethics Review Committee (METC) | Evaluate research protocols and ensure the research complies with regulatory requirements and ethical standards. For research to which the WMO (Medical Research Involving Human Subjects Act) is applicable, evaluation must be done by an accredited METC or by the CCMO (Central Committee on Research Involving Human Subjects). <On access policies applicable to the resource> | |
Leads a clinical trial or research project. Responsible for following the data management requirements and guidelines of the organisation and/or funder. Decisions regarding data management are documented in the DMP (data management plan). |
A FAIR data steward is a data steward with specialistic FAIR skills/knowledge
[HANDS]
In short, the responsibilities of the key players are:
Principle Investigator or research leader (=Principal Data Steward): responsible for research, hence for the data stewardship in a particular research project, but can delegate certain data stewardship tasks such as data management and FAIRification to dedicated data stewards (see below).
Researcher involved in a project: responsible for the execution of good data stewardship.
UMC Board: end responsible for research data stewardship within the institute.
UMC: responsible for offering all researchers support in data stewardship, such as policies, training, tools, technical solutions and organisational support, for instance by appointing institutional data stewards and project data stewards.
Institutional data stewards and project data stewards: offer advice on good data stewardship and certain data stewardship tasks may be delegated to these data stewards.
What are the responsibilities of the Principle Data Steward?
You:
are accountable and responsible for your research data;
are in control of the complete research data flow;
collaborate with patient organisations throughout your research;
reuse existing data when possible;
protect research quality and reproducibility;
protect the privacy and safety of study subjects;
apply the FAIR Principles as much as possible;
think ahead about rights of third parties, proprietary data and intellectual property rights;
share your data responsibly.
What are the responsibilities of my UMC?
Your institution has a duty of care when it comes to data stewardship. Your UMC is accountable for having adequate policies (e.g., a Data Governance Policy), facilities and expertise around data management and data stewardship. It is your UMC's responsibility that you as a researcher are informed about these policies, facilities and expertise.
Your institute has:
professionals that provide the procedures and technical systems for data stewardship (e.g., institutional/operational data stewards, data managers, IT-specialists, statisticians, protein sequence experts);
institute managers, who govern and facilitate the professionals;
supervisory bodies such as medical-ethical review committees and privacy officers;
data collections from patients and citizens.
Responsibilities of the managers at your UMC:
facilities for data stewardship (e.g., data protection, storage, interoperability);
financial means for data stewardship and expert employees;
organisation, policy, standard procedures, practical measures, etc.;
training the employees who work with data.
Responsibilities of professionals that support data stewardship are
to provide, advise and support the use of terminologies, IT-standards and e-infrastructure that promote data sharing, data integration, etc.;
data curation and archiving.
Expertise requirements for this step
To be able to define your team, you need to know the goals and steps for your project.
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Expertise requirements for this step
To be able to define your team, you may need the experts described below.
Project manager. Knows the goals of the project and can help decide what team members are necessary to reach those goals.
HR. Involved when hiring new people.
Practical examples from the community
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Further reading
Plan is om deze sectie weg te laten en alles te verwerken de teksten
Resource below is about organising a workshop. Could be more relevant for one of Fieke’s resources somewhere? Toolkit for building your dream team: “a resource intended to make it as easy as possible to organise a workshop aimed at raising awareness of and facilitating discussion around the diversity of roles that contribute to research”. […] “[t]he knowledge sector is now looking towards a team-based approach bringing together more overtly diverse team members with specific skills in funding, research design, data analysis, data management, software development, research ethics, political relationships, dealing with business, interdisciplinarity, communications etc.” https://research-dream-team-toolkit.readthedocs.io/en/latest/index.html