Stakeholders, roles and responsibilities in the life sciences

Related guidelines:

The roles and responsibilities of the researchers and research support staff participating in a research project must be clear at each stage of the project.

The participants in a research project engage in regular dialogue. They define their roles and responsibilities in a suitable way and adapt them where necessary. Adaptations are likely to be needed if the focus of a participant’s work changes.

Researchers adopt a responsible approach to the constitutionally guar- anteed freedom of research. They comply with rights and obligations, particularly those arising from legal requirements and contracts with third parties, and where necessary seek approvals and ethics statements and present these when required. With regard to research projects, the potential consequences of the research should be evaluated in detail and the ethical aspects should be assessed. The legal framework of a research project includes documented agreements on usage rights relating to data and results generated by the project.

Researchers maintain a continual awareness of the risks associated with the misuse of research results. Their responsibility is not limited to compliance with legal requirements but also includes an obligation to use their knowledge, experience and skills such that risks can be recognised, assessed and evaluated. They pay particular attention to the aspects associated with security-relevant research (dual use). HEIs and non-HEI research institutions are responsible for ensuring that their members’ and employees’ actions comply with regulations and promote this through suitable organisational structures. They develop binding ethical guidance and policies and define procedures to assess ethical issues relating to research projects.

Where possible and practicable, researchers conclude documented agreements on usage rights at the earliest possible point in a research project. Documented agreements are especially useful when multiple academic and/or non-academic institutions are involved in a research project or when it is likely that a researcher will move to a different institution and continue using the data he or she generated for his or her own research purposes. In particular, the researcher who collected the data is entitled to use them. During a research project, those entitled to use the data decide whether third parties should have access to them (subject to data protection regulations).

In the life sciences, findings are usually produced as a result of collaboration between numerous individuals and institutions, so the roles and responsibilities of those involved have to be clearly defined at the start of a project, in particular so as to agree on roles with regard to planned publications. When planning projects, there must be transparency as to the commercial or other interests of those involved, and conflicts of interest must be avoided. This includes disclosing sources of funding for the research as well as any other circumstances that may affect the independence of the research.

Legal aspects and obligations arising from cooperation with commercial partners should be contractually regulated in advance. In this connection, it is important to set down an agreement that ensures that knowledge is gained freely and without influence, also establishing which findings can be published and reused.

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Stakeholders, roles and responsibilities in the life sciences

Stakeholders, responsibilities and roles

Legal and ethical frameworks, usage rights

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Stakeholders, roles and responsibilities in the life sciences

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