Duty to inform

(1) Before obtaining consent, the physician responsible must inform the person concerned about the nature, significance and implications of the genetic examination. The person concerned must be given a reasonable period for reflection, after being informed, before deciding on consent.
(2) The information must cover, in particular, 1. the purpose, nature, scope and informative value of the genetic examination, including the results obtainable with the intended genetic examination product within the purpose of the examination; this also includes the significance of the genetic characteristics to be examined for a disease or health disorder, and the possibilities of avoiding, preventing or treating it, 2. the health risks associated, for the person concerned, with knowledge of the result of the genetic examination and with the obtaining of the genetic sample required for it, and, for pregnant women, also the health risks associated with the prenatal genetic examination and with the obtaining of the genetic sample required for it, for the embryo or foetus, 3. the intended use of the genetic sample and of the examination or analysis results, 4. the right of the person concerned to withdraw their consent at any time, 5. the right of the person concerned not to know, including the right not to take notice of the examination result, or parts of it, but instead to have it destroyed, 6. in the case of a genetic screening examination, informing the persons concerned of the result of the assessment of the examination by the Genetic Diagnostics Commission under section 16(2).
(3) The physician responsible must document the content of the information given before the genetic examination.