Comment on:

The following comment refers to this/these guideline(s)

Guideline 9

Research design

Researchers take into account and acknowledge the current state of re- search 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 10

Legal and ethical frameworks, usage rights

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.

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).

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.

Explanations:

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.

Utilisation of existing data sets in medicine/the life sciences

Both the secondary utilisation of collected research data and the use of routine data are essential components of compatible and resource-saving research practice. Access to the data is a fundamental requirement, but it is equally important for researchers to check whether such data sets are already available before collecting new data. This is important firstly in order to assess the state of knowledge by obtaining an overview that is as complete as possible, and secondly it is essential with regard to the ethical consideration of the animal and human models used.

The German Portal for Medical Research Data (FDPG) operated by the Medical Informatics Initiative (MII) serves as a central point of contact for researchers who wish to carry out a project using routine data drawn from German university medicine and other affiliated sites. This platform can be used for requesting and using both data and biospecimens. In addition to providing an overview of data sets, the platform offers a straightforward way of checking whether a sufficient amount of data is available to address a specific research question across all sites based on feasibility enquiries. Standardised processes are available to apply for and use the data and biospecimens. In addition, the project register ensures transparent presentation of research projects.

In the current funding period of the MII, there are also plans to integrate additional data sets from the outpatient and regional sector as well as from health insurance companies and medical registers.

The comment belongs to the following categories:

GL9 (Life sciences) , GL10 (Life sciences) , GL11 (Life sciences)

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