ABSTRACT
In Sweden, the individual’s general right to autonomy or self-determination is protected by the Constitution. The general health care legislation in Sweden does not contain any explicit demand for consent to medical care and treatment. With very few exceptions, Swedish law does not lay down any specific demands concerning the form for a legally valid consent. The Transplant Act regulates the taking of organs and other biological materials from a human being, for transplantation or other medical purposes. It applies also to very small samples of blood or tissue. Medicinal Product Act section 13 deals with the clinical trials. Such trials may be conducted in connection with medical care and treatment, or without any such connection. The ethical guidelines used by the Research Ethics Committees are mainly those laid down in the Declaration of Helsinki and other internationally accepted guidelines on research ethics, as well as the Swedish Code for Physicians and other professional codes of conduct.
