ForewordPreamble

Principles

Guideline 1: Commitment to the general principlesGuideline 2: Professional ethicsGuideline 3: Organisational responsibility of heads of research institutionsGuideline 4: Responsibility of the heads of research work unitsGuideline 5: Dimensions of performance and assessment criteriaGuideline 6: Ombudspersons

Research Process

Guideline 7: Cross-phase quality assuranceGuideline 8: Stakeholders, responsibilities and rolesGuideline 9: Research design

 

Guideline 10: Legal and ethical frameworks, usage rightsGuideline 11: Methods and standardsGuideline 12: DocumentationGuideline 13: Providing public access to research resultsGuideline 14: AuthorshipGuideline 15: Publication mediumGuideline 16: Confidentiality and neutrality of review processes and discussionsGuideline 17: Archiving

Non-Compliance with Good Research Practice, Procedures

Guideline 18: Complainants and respondentsGuideline 19: Procedures in cases of alleged research misconductImplementation of the Guidelines
ForewordPreamblePrinzipienGuideline 1: Commitment to the general principlesGuideline 2: Professional ethicsGuideline 3: Organisational responsibility of heads of research institutionsGuideline 4: Responsibility of the heads of research work unitsGuideline 5: Dimensions of performance and assessment criteriaGuideline 6: OmbudspersonsForschungsprozessGuideline 7: Cross-phase quality assuranceGuideline 8: Stakeholders, responsibilities and rolesGuideline 9: Research designGuideline 10: Legal and ethical frameworks, usage rightsGuideline 11: Methods and standardsGuideline 12: DocumentationGuideline 13: Providing public access to research resultsGuideline 14: AuthorshipGuideline 15: Publication mediumGuideline 16: Confidentiality and neutrality of review processes and discussionsGuideline 17: ArchivingNichtbeachtung guter wissenschaftlicher Praxis, VerfahrenGuideline 18: Complainants and respondentsGuideline 19: Procedures in cases of alleged research misconductImplementation of the Guidelines
Keyword Index
The Code of Conduct
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The following comment refers to this/these guideline(s)

Guideline 9

Research design

Researchers take into account and acknowledge the current state of research when planning a project. To identify relevant and suitable research questions, they familiarise themselves with existing research in the public domain. HEIs and non-HEI research institutions ensure that the necessary basic framework for this is in place.

Explanations:

Methods to avoid (unconscious) distortions in the interpretation of findings, e.g. the use of blinding in experiments, are used where possible. Researchers examine whether and to what extent gender and diversity dimensions may be of significance to the research project (with regard to methods, work programme, objectives, etc.). The context in which the research was conducted is taken into consideration when interpreting findings.

Guideline 13

Providing public access to research results

As a rule, researchers make all results available as part of scientific/academic discourse. In specific cases, however, there may be reasons not to make results publicly available (in the narrower sense of publication, but also in a broader sense through other communication channels); this decision must not depend on third parties. Researchers decide autonomously – with due regard for the conventions of the relevant subject area – whether, how and where to disseminate their results. If it has been decided to make results available in the public domain, researchers describe them clearly and in full. Where possible and reasonable, this includes making the research data, materials and information on which the results are based, as well as the methods and software used, available and fully explaining the work processes. Software programmed by researchers themselves is made publicly available along with the source code. Researchers provide full and correct information about their own preliminary work and that of others.

Explanations:

In the interest of transparency and to enable research to be referred to and reused by others, whenever possible researchers make the research data and principal materials on which a publication is based available in recognised archives and repositories in accordance with the FAIR principles (Findable, Accessible, Interoperable, Reusable). Restrictions may apply to public availability in the case of patent applications. If self-developed research software is to be made available to third parties, an appropriate licence is provided.

In line with the principle of “quality over quantity”, researchers avoid splitting research into inappropriately small publications. They limit the repetition of content from publications of which they were (co-)authors to that which is necessary to enable the reader to understand the context. They cite results previously made publicly available unless, in exceptional cases, this is deemed unnecessary by the general conventions of the discipline.

Research design in the life sciences

There is a relatively high risk of (unconscious) bias in the interpretation of results or in the selection of certain results due to the complex nature of the subjects of study in the life sciences. At the same time, research carried out on living organisms or in sensitive ecosystems involves an obvious ethical and legal responsibility. The same amount of care needs to be taken in the project planning phase and in establishing appropriate quality assurance measures as in the implementation and publication of the results. The time and cost involved in implementing quality assurance measures can be considerable in the life sciences, so it is vital to allow for this when planning. Approaches to validation need to be considered, especially when results were based on mainly in silico analysis.

Validity of results is determined by research design, the statistical parameters used and well-planned documentation of data and findings. For this reason, methods to avoid bias in the interpretation of findings should be used wherever possible, e.g. the blinding or pre-registration of trials and studies in a clinical setting.

The choice of research approach is crucial in terms of the validity of the findings, as well as their compatibility and generalisability. The choice of methodology and modelling system should be carefully assessed; the advantages and disadvantages should be openly stated and reflected on in the evaluation. Used models should be valid and a robust research design applied.

Statistical planning is essential in all areas and is all the more important, the more the approach is based on previously established knowledge which is to be put to the test. A particular challenge here is that statistical requirements often conflict with ethical requirements when it comes to performing studies on humans or animals. A high degree of standardisation when carrying out studies on living organisms fundamentally involves the risk that the findings cannot be transferred to other contexts due to the limited genetic diversity, social context, climate, etc. and the lack of variability of these parameters. Researchers should undertake their own independent assessment to determine whether a research question is experimental or confirmatory.

Considerations on how to deal with the research data generated by the project should be taken into account during the planning phase, as should the aspect of making data sets available for use afterwards.

Helpful suggestions in planning animal experimental studies according to the 3Rs Principle can be viewed at:

NC3Rs

The comment belongs to the following categories:

GL9 (Life sciences) , GL13 (Life sciences)

Keywords:

biasFAIR principlespre-registrationquality assurancereplication/reproductionvalidityblinding

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