This consent form generator is designed to ask you a series of questions about your human subjects research plans. Based on your answers to these questions, a Microsoft Word document will be generated for you that should incorporate the majority of consent form language that is applicable to your protocol. The document can be edited in Microsoft Word, and additional edits may be needed as required for your specific protocol needs and/or as directed by the IRB before, during, and after the approval process.

To begin, please read through these initial, standard instructions for consent forms. The consent generator is designed to include the below requirements; however, you must ensure these standards continue to be met:

• All forms should be submitted to the IRB in PDF form suitable for reproduction (printing single sided or available electronically) using, at minimum, reasonable 12-point font and 1-inch margins.
• Each page of the consent form should be full without inappropriate divisions: sections can be split (some on one page, some on another page) so that large blank areas do not exist, and the signature block is not on the page by itself.
• All pages, including a 1-page consent form, must include page numbers (e.g., Page 1 of 1) and (if applicable) a blank for the participant's initials at the bottom of each page.
• The informed consent form must be written in the second person (i.e., using the pronouns you, your, and yours). When combined with conditional language, utilization of the second person personalizes the consent form and reflects the existence of voluntary decision making on the part of the prospective subject.
• The informational content of the elements of informed consent should not be mixed or repeated unless necessary. Information presented under any given element should be reasonably complete and restricted to content appropriate to that element. This helps the prospective subject focus on each individual element of consent thereby increasing the validity of the consent process.
• The consent form must be written in simple enough language so that it is readily understood by the least educated of the subjects to be enrolled. Normally, the highest level of language in the consent form should equate to a seventh-grade standard. Scientific terms should be avoided when possible. If scientific terms are included, the lay term or definition should be provided.
• Please remember, the age of majority in Nebraska is 19 years old. Anyone younger than 19 requires parental consent/assent or a waiver of parental consent must be approved by the IRB.

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