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Guideline 10

Legal and ethical frameworks, usage rights

Researchers adopt a responsible approach to the constitutionally guaranteed 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.

Explanations:

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).

Legal and ethical framework, usage rights in the life sciences

There are many legal and ethical aspects that impact on research in the life sciences. Here is a selection of particularly relevant issues (without any claim to completeness or priority) which are currently subject to intense debate.

Respectful treatment of living organisms, the environment and the ecosystems being studied, reflection on risks and an awareness of ethical or legal issues are an indispensable part of research projects in the life sciences.

The essential ethical guiding principle in research involving animal experimentation is the 3Rs principle. Animal experiments may only be carried out if no other suitable methods are available to shed light on the respective research question and an indispensable minimum is applied in terms of the number of animals used and the stress to which they are exposed. Any design of an animal experiment must be based on the requirement to achieve the very highest degree of scientific validity and reproducibility of results while at the same time taking into account measures relevant to animal welfare. Appropriate planning is a prerequisite for meeting the requirements of the Experimental Animal Ordinance and obtaining approval from the competent animal welfare authority.

The ethical basis for medical research involving human subjects, including research on identifiable human material and data, is set out in the Declaration of Helsinki. Consultation with an ethics committee is generally required in these cases. International cooperation must take into account the legal and ethical framework conditions of all partner countries. In the case of personal, identifiable research data, the European General Data Protection Regulation (GDPR), the German Federal Data Protection Act and the Data Protection Act of the relevant federal state apply. In order to be able to use the data for research purposes, the individuals involved have to sign a specific declaration of consent. In any case, it is advisable to contact the local data protection officers in case of doubt in order to comply with data protection requirements.

When using genetic resources from other countries, possible disadvantages to the country of origin should be compensated for through the involvement of local research facilities or allowing those affected to participate, based on the principle of benefit sharing. Here the recommendation is to seek advice from the competent national authorities (focal points). Permission to use the resources of other countries (Convention on Biological Diversity, CBD) must be obtained before detailed planning of the research project begins.

Assessing security-related aspects (dual use) at the beginning of a project poses a significant challenge. In the case of research on and with highly pathogenic organisms and toxins, it is imperative to reflect on dual-use risks; in other topic areas, too, it may be advisable to seek out consultation with a committee for ethics in security-relevant research (KEF) – if there is one at the institution involved.

Since research findings in the life sciences are usually generated in teams, it has proven useful to ensure early consideration of how to handle usage rights with respect to the resulting research data and results, as well as licences and patents. The more people and institutions involved in a project, the more relevant these considerations are. Sample agreements of this nature, or advice on them, are often offered by operators of research data infrastructures.

The comment belongs to the following categories:

GL10 (Life sciences)

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