Consent form guidance
Formatting, readability tips, and requirement checklists
When writing consent, assent, and parent permission forms, use the templates provided by the Institutional Review Board to ensure that you meet informed consent requirements. If you must significantly alter a template to promote participant autonomy, please consult with the IRB office: email@example.com.
Informed consent is a process that occurs throughout a study and is one way that researchers can ensure participant autonomy in research. Your protocol illustrates how the process of consent will take place in a given study design. To facilitate this process, the IRB has constructed templates that comply with federal regulations for your use. We encourage you to use these templates to inform prospective participants and confirm participants’ willingness to engage in research. This webpage focuses specifically on consent templates, rather than the consent process.
When conducting the consent process electronically, if there is a consent form that will be electronically signed, there must be a mechanism to verify that the person signing is the participant (e.g. Multifactor authentication, or MFA) Note: this is to meet the requirements of WA state law for attribution of an electronic signature. Platforms such as WSU REDCap have the ability to obtain consent by utilizing MFA; WSU Qualtrics may require additional consultation to ensure MFA is supported for consent.
When using the consent, assent (ages 7-10, 11-14, and 15-17), and parent permission form templates, adhere to the following formatting guidelines:
- Delete all red italicized instructions.
Do so before finishing your form. Also delete any sections of information that are not relevant to your study.
- Use 12-point font.
Times New Roman or Arial are recommended.
- Bold section headings.
Place them directly above the text to which they refer.
- Do not let headings stand alone at the bottom of a page.
- Use 1” margins.
Keep them at the top, bottom, and each side of the page.
- Write at a 6th to 8th grade reading level.
Use the readability checker in Microsoft Word.
- Number all pages.
Include the version date in the footer in the lower left corner of each page.
- Speak to your reader.
Use “you” to refer to the participant.
- Use words with the fewest number of syllables
For example, you might say “take part” rather than “participate”.
- Use short, simple sentences.
Break long sentences into several shorter ones.
- Express only one idea per sentence.
- Break long paragraphs into several shorter paragraphs.
Express only one major idea per paragraph.
- Use spacing to emphasize important concepts.
- Avoid contractions such as “don’t”.
- Use lay terms for medical and scientific terminology.
- Avoid jargon.
- Outline complex procedures.
Use tables or bulleted lists to present information simply.
The WSU IRB aims to promote participant autonomy through both consent documents and processes; therefore, we recognize that the templates provided may not work in all situations. If you wish to significantly depart from a template for an informed consent document, please contact our office: firstname.lastname@example.org
Regardless of study design and template use, however, no informed consent, whether oral or written, may include any exculpatory language through which the subject is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. (45 CFR 46.116)