Informed consent
Informed consent is a cornerstone of research ethics by ensuring that participation happens as voluntary and transparent as possible.
Informed consent of participants
Why it matters
A carefully written information and consent form establishes transparency, so that participants understand the risks, benefits, and purposes of a study before they agree to contribute their data or time. In that sense, free and valid informed consent is an essential component of respect for individual autonomy.
How to receive valid informed consent?
Before participants enrol in a study, they must be informed in writing and sometimes additionally orally about the research project (objective, method, procedure), the expected risks and their rights during their participation. Following this information, the participants must provide written or otherwise documented consent to participate. Advice on this process can be found in our application form, the EU guidelines external page Ethics in Social Science and Humanities (Section 4) or in Article 16 of the external page Human Research Act in the case of biomedical research with participants.
The information sheet and consent form should be written in an inclusive language that is easy to understand. Please refer to the external page swissethics guidelines (German) for informing patients.
Whenever possible, the information sheet and consent form should be handed out in paper form (one copy each for the participant and the researcher). If informed consent is obtained digitally (mail/web/app), the application to the Ethics Commission must indicate how the study information is shown to participants directly (no links), and how consent is obtained (e.g. via consent button).
Signed consent forms or other records of consent should be kept separately and securely from other data by the principal investigator (PI) for at least 5 years beyond the completion of the study. Please clarify well in advance who will be responsible for archiving and the destruction of the consent forms in the event of a change of personnel.
Research involving children or adolescents
In addition to verbal or written information of participants in childhood or adolescence, their legal representatives (parents, legal guardians) usually receive the complete study information and sign the consent form. Please refer to the swissethics external page guidelines(German) and test with representatives of the age group whether the study information is comprehensible (e.g. terms such as "science" and "research" should be explained to children).
For research at schools, please clarify with the respective rectorate whether the research project must be approved by the rectorate in addition to the review by the Ethics Commission. For research with students at ETH Zurich, the guidelines on educational research apply.
Deception and partial disclosure
Researchers should provide a prospective participant with full disclosure of all information necessary for making an informed decision to participate in a research project. Withholding or omitting information from participants (e.g., about the methods or objective) or the use of deception for methodological reasons entail risks for participants and the researchers’ reputation. However, if certain socially relevant research questions cannot be answered without the use of these means, they may be approved by the Ethics Commission.
Examples of incomplete disclosure
- Participants are informed about the purpose of the study in vague, general terms. While these are true, participants are not informed about the specific focus and therefore the actual objective of the study.
- Participants are asked to complete a quiz without being told that the research question is how background noise affects their ability to concentrate.
- Participants are asked to read a list of words or look at a series of pictures without being told that their memory is being tested.
Examples of deception
- Participants complete a quiz and are falsely told that they did very poorly, regardless of their actual performance.
- There is an "ally" of the researcher among the participants who pretends to be a participant themself, although their behaviour is part of the experimental intervention.
Requirements
If deception or incomplete disclosure are necessary means of a study, the following requirements apply:
- Deception and partial disclosure in research should only be used when alternate study designs would be inadequate to answer the research question. The application to the Ethics Commission should thus explain why the study objective cannot be achieved without these means.
- The use of deception or partial disclosure must be justified by an anticipated major scientific or societal benefit of the research project.
- Whenever possible, participants should be informed of the withheld or false information once participation is finished. The application to the Ethics Commission should include the intended text for such a debriefing, which (a) informs participants that incomplete information was provided, or that they were deceived; (b) indicates what information was withheld or falsified; (c) explains why it was necessary to disclose only partially, or to deceive; (d) gives participants the opportunity to ask questions; and (e) allows them to have their data deleted.
The applicability of these requirements is limited in the case of observational studies without any researcher-participant interaction and collection of personal data (e.g., in public spaces or social networks).
This guideline has been published by the Ethics Commission on May 2022.