Statements by ethics committees in medical research

Related guidelines:

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.

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).

Ethics committees advise medical researchers on ethical and legal aspects when living human beings, human material and tissue or personal data are involved. This ensures that the rights and safety of the subjects are protected in accordance with the Declaration of Helsinki. For this reason, approval by the responsible ethics committee is usually required for funding decisions.

Association of Medical Ethics Committees in Germany(externer Link)

Statements by ethics committees in medical research

Legal and ethical frameworks, usage rights

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Statements by ethics committees in medical research

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