etikprövningslagen

The Act (2003:460) on Ethical Review of Research Involving Humans, commonly known as the etikprövningslagen, is a Swedish law that governs ethical review of research. Its primary purpose is to protect the integrity, health, and dignity of individuals participating in research. The law establishes the framework for ethical review committees, the types of research that require review, and the procedures involved.

Under the etikprövningslagen, research involving human subjects or biological samples taken from humans must undergo ethical review before it can commence. This includes studies involving clinical trials, surveys, interviews, and any research where personal data is collected and processed. The law aims to ensure that research is conducted in a responsible and ethical manner, respecting the autonomy and well-being of participants.

Ethical review committees, appointed by the Swedish Ethical Review Authority (Etikprövningsmyndigheten), are responsible for assessing research proposals. These committees evaluate various aspects of the research, such as the informed consent process, the potential risks and benefits to participants, data protection measures, and the overall ethical justification for the study. Researchers must submit detailed applications outlining their research design, methodology, and ethical considerations.

The etikprövningslagen also addresses issues related to genetic research, research on vulnerable populations, and the use of sensitive personal data. It emphasizes the importance of transparency and accountability in research practices. Researchers who fail to comply with the law may face consequences, including the prohibition of their research. The law is a crucial instrument for maintaining public trust in scientific research and ensuring that it serves societal benefit without compromising individual rights.