Have you read the draft guidance posted by FDA on Facilitating Understanding in Informed Consent?
The key takeaway is that important information that would impact a participant’s decision on whether to participate in a trial should be presented at the beginning of the ICF process.
FDA encourages the use of ‘bubbles’ to highlight key information, bullet points and white space for this summary of key information with reference (links or page numbers) to where additional information is located in the ICF document. An example of a Key Information Section is provided as an Appendix to the guidance.
They also recommend use of plain language principles for the entire consent form. Plain language is clear, concise, organized, and appropriate for the intended audience.
The 10 Top Principles for Plain Language as per the National Archives are:
- Write for your reader, not yourself.
- State your major points first before going into details.
- Stick to the topic. Limit each paragraph to one ide and keep it short.
- Write in an active voice. Use the passive voice only in rare cases.
- Use short sentences as much as possible.
- Use everyday words. If you must use technical terms, explain them on the first reference.
- Omit unneeded words.
- Keep the subject and verb close together.
- Use headings, list and table to make reading easier,
- Proofread your work and have a colleague proof it as well.
I think the draft guidance is a step in the right direction.
It would be helpful if FDA elaborated on plain language principles in the guidance.
IRBs and Investigators also need to be more proactive about holding sponsors accountable for consent content, on paper or electronically, that is easily understood and reduces the reader’s cognitive load.
