Examples and Tools
Informed consent documents explain to potential participants the information that a reasonable person would want to have in order to make an informed decision about whether to participate. Using this standard, informed consent remains focused on what information a reasonable person would want to have to make an informed choice about participation; this includes:
- the nature of the research project,
- why they are candidates for the research,
- what risks, benefits, and alternatives are associated with the research, and
- what rights they have as research subjects.
The consent form is one part of the dialogue that investigators have with each subject.
Informed Consent Document Tips
It is recommended that forms for adult subjects be written at a 6th-grade reading level or lower, information should be accurate, precise, in sufficient detail, and organized in a way that facilitates an understanding of why one might, or might not, want to participate.
Moreover, the informed consent should not merely be a list of isolated facts. Many consent forms are not as good as they could be in terms of aiding decision-making. The goal is to help people process the complicated information they’re being given and make it easier for them to make a more informed decision. Ways to facilitate understanding:
- sentences and paragraphs are short,
- terms and concepts are simple,
- technical information is explained in non-technical ways, and
- subjects are directly addressed as “you;” investigators are referred to as “we.”
The consent form should be easy to look at, with:
- a clear layout,
- white-space borders, and
- easy to read fonts.