Institute's checklist helps IRBs with informed consent
January 1, 2010
Institute's checklist helps IRBs with informed consent
The National Cancer Institute (NCI) working group created a checklist for easy-to-read informed consent documents.
The checklist includes examples of words and graphics that could be used to simplify the IC document, as well as advice on how to discuss a study with potential participants and how to assess their understanding.
Here is a sample of what's in the checklist:
Words are:
- Words are familiar to the reader. Any scientific, medical, or legal words are defined clearly.
- Words and terminology are consistent throughout the document.
- Sentences are short, simple, and direct.
- Line length is limited to 30-50 characters and spaces.
- Paragraphs are short. Convey one idea per paragraph.
- Verbs are in active voice (i.e., the subject is the doer of the act).
- Personal pronouns are used to increase personal identification.
- Each idea is clear and logically sequenced (according to audience logic).
- Important points are highlighted.
- Study purpose is presented early in the text.
Graphics are:
- Helpful in explaining the text.
- Easy to understand.
- Meaningful to the audience.
- Appropriately located. Text and graphics go together.
- Simple and uncluttered.
- Images reflect cultural context.
- Visuals have captions.
- Each visual is directly related to one message.
- Cues, such as circles or arrows, point out key information.
- Colors, when used, are appealing to the audience.
- Avoid graphics that won't reproduce well.
Time to Read and Discuss the Form:
Researchers should encourage the potential research participant to thoroughly read and re-read the consent form and supplemental materials, if provided, and to discuss the proposed research with others before signing the consent form. This may require a delay between the describing of the study and the signing of the consent document.
Assess Understanding:
It may be helpful for the researcher to ask the potential research participant short questions, after the research has been described and the consent form read, in order to assess that the potential research participant has at least a basic understanding of what the research involves. Example questions include:
- Tell me in your own words what this study is all about.
- Tell me what you think will happen to you in this study.
- What do you expect to gain by taking part in this research?
- What risks might you experience by participating in the research?
- What are your alternatives (other choices or options to participating in this research)?
Source: The entire checklist is available on the National Cancer Institute's Web site at this address: http://www.cancer.gov/clinicaltrials.