Informed Consent Template
For this assignment, you will complete an informed consent document. Use this Informed Consent Template (Word) for this assignment. You will edit the Informed Consent template to make it about your proposed research project. The language you use to complete the template should be professional, objective, and clear. It should be grammatically correct and free of spelling and punctuation errors. For the purposes of this assignment, you are the Primary Investigator (PI) in the study.
Informed Consent Template
This informed consent template has been adopted by the Regis IRB to assist researchers in developing easy-to-read consent documents. The format may be expanded, but the consent form must contain all the elements below. The brackets [ ] contain additional instructions and areas for customizing the form according to the purpose and procedure of your study.
For studies involving adult participants (ages 18 and older), you must obtain written informed consent. If your study involves participants ages 7-17, you must obtain written assent from the child and written informed consent from a parent or legal guardian. For participants ages 6 or younger, you must obtain oral assent from the child and written informed consent from a parent or legal guardian.
Consent cannot truly be called “informed” unless the participant understands the terms of his or her participation in the study. It is the researcher’s responsibility to ensure that the consent documents are comprehensible to the participants. The Regis IRB requires researchers to assess the readability of their forms using the Flesch-Kincaid Grade Level score which is calculated based on the average sentence length and the average number of syllables per word. A grade of 7.0 would indicate that a seventh grader would likely understand the document. The Regis IRB also requires that an informed consent document for an adult (age 18 or over) not exceed a score of 7.0. To test your document’s grade level score in Microsoft Word:
