Which key elements must be included in an informed consent form?

An informed consent form is a crucial document in research ethics, ensuring that participants are fully aware of what their involvement entails. One of the key elements that must be included in such a form is a clear disclosure of all foreseeable risks and discomforts associated with participation in the research study. This information is vital because it allows potential participants to make an educated decision about whether or not to participate, knowing any potential risks they might face.

Understanding the risks helps in respecting the autonomy of participants, as they should not be placed in a position where they could inadvertently expose themselves to harm without being aware of it. This ethical principle of truthfulness and transparency is central to informed consent.

While the potential benefits, funding sources, and the name of the institution are also important pieces of information, the paramount concern of informed consent is to ensure that individuals are fully aware of any risks they may encounter. Thus, it's essential to include clear and comprehensive descriptions of risks and discomforts involved in the research.