Drafting Informed Consent Forms

The key objective of obtaining informed consent from a clinical trial participant is to ensure that the participant fully understands the nature and risks of the clinical trial. The informed consent form, itself, is an important foundational component in the informed consent process. A well-drafted informed consent form addresses both substantive and style issues. 

Substantive Issues

Consider any state-specific requirements for the content of the form, including Power of Attorney or Medical Directives. Additionally, all informed consent forms must comply with Food and Drug Administration (“FDA”) requirements. (See “FDA’s Requirements for Informed Consent Forms” in the Risk Management 101 series.) Consider whether the regulations of any other regulating entities, such as the Department of Health and Human Services, come into play. Finally, remember that the rules imposed by regulating entities serve only to establish the minimum requirements for an informed consent form.

Style Issues

Style issues include but are not limited to the wording, readability, and formatting of the document. Style is important because it can impact whether a potential clinical trial participant fully understands the nature and risk of the clinical trial. Consider the following when drafting an informed consent form:

• Whenever possible, use a conversational and nontechnical tone. If you must use technical or medical terms and jargon, consider defining them in an understandable manner.
• Write in the second person (“you”) if possible rather than first (“I”) or third person (“the participant”). Whatever you do, be consistent and do not switch between first, second, or third person throughout the document.
• Consider the background of those likely to participate in the clinical trial. Is there a need to have the informed consent form available in several languages? 
• Most informed consent forms should be written at a 6th – 8th grade reading level. Consider using readability software to score the informed consent form.
• Avoid conclusive statements, such as “You understand,” as they can draw false conclusions about what the participant actually understands. It may be better to indicate that a particular topic was discussed with the participant without addressing what the participant understood.
• Consider having a focus group read and comment on a draft of the informed consent form prior to actually using it. Did the readers receive the message you intended? Were certain areas unclear? If so, revise the language.
• Use a readable font size and avoid small print. Highlight key points by underlining them or using bold typeface. Write short direct sentences. Try to limit the length of paragraphs and the number of concepts discussed in a paragraph.
• Consider the manner in which the information is presented. Is the format reader-friendly? Use section headings to break the document up into “bite size” pieces.
• If using illustrations, make sure that they are meaningful and likely to be understood by the reader. Tables and graphics are also good tools.

Conclusion

A well-drafted informed consent form is vital to the informed consent process. It aids in making sure that the potential clinical trial participant understands the nature of the consent and can mitigate against potential litigation.