Tips for Writing Consent Forms

• Informed consent is a process, not merely a form. Information must be presented to enable individuals to decide voluntarily whether to participate in research. Informed Consent is a fundamental mechanism to ensure respect for persons through provision of thorough information about the research in which the individual is being invited to participate so that he or she can make an informed decision to participate voluntarily.  
• The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand. Therefore, informed consent language and its documentation must be written in plain language. Plain language is simple and has as few technical terms as possible so that the intended audience can understand it from a single reading.
• The written presentation of information is used to document the basis for consent and for the participant’s future reference.
• The informed consent document should be revised when deficiencies are noted or when additional information will improve the consent process.
• Write directly to the reader, as though you are explaining the facts in person.  Informed consent language should be written in the second person (“you”), not in the first person (“I”).
• Minimize passive voice to the extent possible.  Example of passive voice: “A summary of results will be sent to all study participants.”  Example of active voice: “We will send you a summary of the results.”
• The informed consent documentation should be friendly, straightforward, and conversational.
• Ideally, the adult informed consent documents should be written at or below an 8th grade reading level, with a readability score of more than 50 (the higher the score, the easier your document is to read).  Children’s assent should be age appropriate.  Use Flesch-Kincaid* to test the readability level of your document.
• If enrolling children, make appropriate changes to section headings (e.g., replace “I” with “my child”, etc.).  Also note that parental permission and child assent may be required for research involving children.
• No exculpatory language releasing the participant’s rights should be included in an informed consent document.
• Merely reading the informed consent materials to the prospective subject is not acceptable.  Rather; The informed consent process should be an ongoing and interactive process.  The individual should have an opportunity to read the informed consent document and to ask questions of the researcher regarding the research.  The researcher should ask open-ended questions to stimulate interaction.
• The informed consent process is different for every study, because the study complexity varies.  Similarly, the informed consent process differs for every subject, because individual comprehension varies.  An effective informed consent process is essential for a study’s success, for participant compliance, for study validity, and to avoid unexplained risks to participants.

Considerations in preparing the informed consent document:

• Elements of consent present
• Complete explanations
• Lay language
• Protection of confidentiality
• No unproven claims of effectiveness
• Device studies include a statement that the study includes an evaluation of the safety of the test article
• Consistent with protocol, application, investigator’s brochure, and contract
• Standard of care versus research
• Current template
• Contact information

Considerations in preparing the informed consent process:

• Method of presentation
• Voluntary participation
• Environment
• Compete explanations
• Length of time devoted to the process
• Simple explanations
• Adequate time offered to ask questions
• Promptness of reporting new information

*Flesch-Kincaid – The Flesch/Flesch–Kincaid readability tests are designed to indicate comprehension difficulty when reading a passage of contemporary academic English. There are two tests: the Flesch Reading Ease, and the Flesch–Kincaid Grade Level. Although they use the same core measures (word length and sentence length), they have different weighting factors, so the results of the two tests correlate approximately inversely: a text with a comparatively high score on the Reading Ease test should have a lower score on the Grade Level test. Both systems were devised by Rudolf Flesch.