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(externer Link)) must be obtained before detailed planning of the research project begins.

Assessing security-related aspects (dual use(externer Link)) 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.

Guidelines: The 3Rs Principle and the Validity of Scientific Research(externer Link)

Statement by the DFG’s Permanent Senate Commission on Fundamental Issues of Biodiversity (SKBV)(interner Link)