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Guideline 11

Methods and standards

To answer research questions, researchers use scientifically sound and appropriate methods. When developing and applying new methods, they attach particular importance to quality assurance and the establishment of standards.


The application of a method normally requires specific expertise that is ensured, where necessary, by suitable cooperative arrangements. The establishment of standards for methods, the use of software, the collection of research data and the description of research results is essential for the comparability and transferability of research outcomes.

Methods and standards in the life sciences

Many methods used in life science projects are subject to limitations. When selecting a method, it is important to consider its strengths and weaknesses; this should be documented and compensated for by means of the appropriate controls.

Research in the life sciences is subject to considerable methodological diversity as well as rapidly emerging technical advancements and developments in measurement and analysis methods. The comparability and verifiability of methods is highly relevant in the life sciences when it comes to the reproducibility of results. When using established methods, there are usually standards that have to be used and applied. New methods have to be suitably validated (statistically; based on inter-laboratory tests or by publishing training data sets for AI methods, etc.). Work units should establish Standard Operating Procedures (SOPs) internally or adopt an SOP-based approach.

In the case of clinical research questions and reference to medical devices, there may also be specific requirements for standardised processes and methods so as to meet the requirements for medical product testing.

In order to be able to effectively plan and evaluate the significance and validity of research results at all, it is important in most questions in the life sciences to integrate statistical methods and approaches (e.g. power calculation, case number planning).

When using data sets, materials or samples as the basis for research projects, the relevant databases, repositories or biobanks very often share information and advice on standardised use, where relevant also for the purposes of later documentation and archiving of one’s own data and samples. For this reason, it is a good idea to make use of the advisory services offered by these infrastructures at the project planning stage.

The comment belongs to the following categories:

GL11 (Life sciences)