Potential human subjects must be provided with written information on the research prior to being asked for consent. The following aspects must be covered (section 6, paragraph 3, section 7 and section 9 WMO):
- Aim, nature and duration of the research (how, what and why with regards to the study, but also which procedures, when, for how long and how often).
- The risks and objections to the research subject with regards to the research.
- The possibility to withdraw from the study during its course, taking into consideration any risks to the participant in doing so.
- The necessary information on the independent expert.
- The necessary information on the patient insurance.
The patient information must be written in such a manner that every participant can understand it. The language level of the texts must be written with the target group in mind (section 6 paragraphs 4 and 5 WMO).
In cases of research with subjects under the age of 16 years or incapacitated subjects the information for the research subjects must state that research will be stopped immediately on those who resist (section 4 paragraph 2 WMO). The information letter for the(se) group(s) must not omit a passage on resistance.
See the codes of conduct put together by the groups of professionals.