The investigator is responsible for giving adequate information to subjects about the trial. The current version of the Declaration of Helsinki (Appendix 1), and International Ethical Guidelines for Biomedical Research Involving Human Subjects (2) should be followed. The nature of the investigational pharmaceutical product, its stage of development and the complexity of the study should be considered in determining the nature and extent of the information that should be provided.
Information should be given in both oral and written form in a language understandable to the subject. The protocol should state when and by whom such information will be provided, and how the provision of information should be recorded.
Informed consent must be obtained according to the principles described in Section 3.3.
The investigator should also supply subjects with, and encourage them to carry with them, information about their participation in the trial and information about contact person(s) to contact in an emergency situation.