Spelling and grammar Spelling and grammar must be correct before it is submitted for review.
Use lay language. The consent form is to be written in language understandable to the participants or their representatives. Remember, it is the responsibility of the investigator to provide “key information” about a study. This is essential to decision making that must appear at the beginning of the consent form and presented first in the consent discussion. Investigators must also present informed consent information in sufficient detail and in a way that helps with participant comprehension, not just running down a list of risks and procedures.
Use gender-neutral language, avoiding gendered terms (e.g., mailman, chairman) and gendered pronouns (he, she, he/she). Gendered terms should be replaced with non-gendered versions (e.g., mail carrier instead of mailman or chairperson instead of chairman). Sentences using gendered pronouns should either use gender-neutral pronouns (e.g., singular they as in “Each subject will receive their gift card upon completing the study.”) or be reworded entirely to avoid such pronoun use (e.g., “Subjects will receive their gift card upon completing the study.”). Consent templates currently use non-gendered pronouns.
Always keep in mind that informed consent is a process; the face-to-face discussion the most important part. The consent form is only a documentation of that process. If you write the consent form to be the same as the information you will give verbally, you will more likely use simple, direct language that anticipates and answers the prospective participant’s needs for information.
Try to achieve a readability score at the grade 8 level. For the typical participant population use of language at a 6th-8th grade level of schooling is recommended. The Flesch-Kincaid tool in Microsoft Word can assist you by scanning your document and assigning a readability score (see instructions below on how to access this tool). If the score is greater than 8.9 (for adults), revise the consent document. Try using simpler words and shorter sentences, and writing in the active voice (For instance, say “You will be asked to do…” instead of “participation in the study will entail…”) If you do not have Microsoft Word, you can also use a SMOG readability calculator instead. One example is found here.
Use three syllable or shorter words. Words longer than three syllables will increase the reading level of the consent. Avoid the temptation to use longer fancy words when short simple words will suffice. Examples: Visualize vs. sees; utilize vs. use; administer vs. give, discomfort vs. pain.
Avoid sentences longer than 20 words. Limit sentences to a single thought or idea. Avoid run-on sentences that contain too many commas, ands and ors. Use bulleted lists if needed.
Avoid paragraphs longer than ten sentences. Paragraphs that become too long increase the reading (grade) level of the consent and decrease the overall readability.
Use first or second person consistently. Throughout the document, to refer to the participant (“I” or “you,” but not both in the same consent form). Always refer to the investigators in the third person (i.e., “the investigators” or “the doctors,” not “we”). If you are using “you” to refer to the participant rather than “I” as in the standard consent form, modify the wording of the required statements to consistently refer to the participant as “you.”
Use factual statements. Use (“I have been informed…”) rather than interpretive statements (“I understand…”).
Avoid language may confuse or intimidate. Use language and set the tone in the consent form/information sheet that is understandable and does not intimidate or confuse participants.
Exculpatory language. Do not use exculpatory language through which the participant or representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
Do not include excessive detail. While some detail is important, a balance between all inclusive information and minimal information must be attained. It is important not to minimize significant risks and procedures by having them “diluted” in a mass of insignificant material. Use concise language and descriptions and avoid repetition.
Use section headings as described in the sample format. Using bolded section headings that clearly identify new sections make it much easier for the reader to follow the consent and be clear about what they are reading. It also makes it easier to refer to specific sections for both the participant and investigative team.
Adequately describe the study. Make sure the project description adequately describes the study. Include 1-2 sentences of rationale for why the investigators think the study is a good idea.
Use white space effectively. White space can be used to break up large blocks of text. The white space makes it easier for the eyes to focus and find your place if distracted.
Use sufficiently large and readable fonts. The UMBC IRB recommends the use of twelve point fonts such as Times New Roman that has the “little tails” on the ends of the character lines. This makes wording easier to read in long documents than block type letters (e.g. Arial, Century Gothic, Helvetica). Use larger fonts (fourteen point or larger) if the potential participants are elderly or likely to be sight impaired. Investigators may also want to use the Accessibility Checker in Word to make documents accessible to people with disabilities.
Use of Minors/Assent Research involving minors requires documentation of child assent. Consent forms for research protocols involving participants less than age 18 must contain documentation of children’s assent. A separate parental consent form is required for these participants providing parental permission to participate. Also, when minors under the age of 7 years are enrolled in a study, the assent form as well as the parental consent should be completed by the parent regarding the child.
Resources:
PROTECTING HUMAN RESEARCH SUBJECTS: Institutional Review Board Guidebook,” 1993,http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
“Model Volunteer Consent Documents for the Indian Health Service” – 2nd Ed William L. Freeman, MD, MPH Chair, National IHS IRB, OCT 1, 2000 http://www.npaihb.org/images/epicenter_docs/irb/docs/consents2.pdf