What should be included in an informed consent document?

The inclusion of the risks and benefits of participation in an informed consent document is essential for several reasons. Informed consent is anchored in the ethical principle of respect for persons, which emphasizes the importance of allowing individuals to make autonomous decisions about their involvement in research. Providing clear information about the risks enables potential participants to weigh the potential for harm against the possible benefits of joining the study.

Understanding the benefits helps participants to evaluate what they might gain from participating, whether it's contributing to scientific knowledge, receiving new treatments, or other advantages. This transparency ensures that prospective participants can make an informed choice about whether or not to participate, aligning with ethical standards expected in human research.

While it is important for informed consent documents to include other elements, such as the purpose of the study, funding sources, and contact information for researchers, the detail about risks and benefits is particularly critical. This information directly impacts a participant's decision-making process, making it foundational to the integrity of the consent process.