Informed consent: General principles

  • Human studies including collection of samples, genetic and other data are only carried out after the research volunteer has given free and informed consent.
  • A human study involving research volunteers who are not able to give informed consent can only be carried out if it is for their direct benefit. In this case, the consent must be given by a legal representative (guardian). However, the participant should be involved in the decision making process. Exceptionally, research with no direct benefit may take place under the condition that this kind of research cannot be carried out on individuals who are capable to give consent and no objection was made by the individual; authorisation has been given by the legal representative, and the research entails only minimal risk and minimal burden for the research volunteer concerned. [see 2, Article 15-1, ii, iii, iv and v; 15-2 and 15-3]
  • The participant has the right to withdraw the consent at any time without any consequences.
  • Information and consent must be documented
  • If storage of samples is planned, the consenting process should include the biobanking aspects (see Guideline 8 ff., section Biobanks)

Relevant documents

[ 1 ] Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo 4.IV.1997
[ 2 ] Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research
[ 50 ] Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin