Participant Consent Information

Consent and Assent Instructions and Sample Language

 Consent is a Process

• Step One: The Investigator should explain the study to the potential participants verbally, providing all pertinent information (purpose, procedures, risks, benefits, etc.), and must allow the potential subject ample opportunity to ask questions.
• Step Two: Following this verbal explanation, the potential participant should be provided with a written consent form and afforded sufficient time to consider whether or not to participate in the research. "Sufficient time" can range from hours to days, depending on how long it reasonably takes to evaluate the procedures, risks, potential benefits, etc.
• Step Three: After allowing the potential subject time to read the consent form, an Investigator listed on the consent form should ask the potential participants if there are  any additional questions s/he may have.

Suggestions for Preparing Consent Forms

1. After you have completed your consent form, please proofread for:
   • Accuracy
   • Completeness using the consent form checklist
   • Spelling and readability You may wish to use FREE Readability Scoring site: https://readabilityformulas.com 
2. The following was taken in 2017 from  http://www.irb.cornell.edu/forms/consent.htm 

(a) Use common, ordinary language instead of technical, academic terms. Ideally, we would like consent forms to be written in an 8th-grade reading level. A helpful gage is to consider if one’s 13-year-old cousin would be able to understand the research after reading the consent form.

(b) Try to keep the sentences as short and simple as possible.

(c) Write in the second person using you/your pronouns. For example: "You are being asked to participate in a research project…," "If you have questions later, you may contact…," or "You will be given a copy of this form to keep for your records."

(d) Do not use assumptive statements such as "You understand that ..." or "You have been told that...."

(e) Use adequate white space so that the form is easy to read, and avoid using small fonts to squeeze all the text onto one page.

(f) Headings for paragraphs are helpful and make the form easier to read and understand.

Consent and Assent Form Samples

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Getting Documented Consent with Qualtrics

You will need these documents:

• Consent Instructions,
• Downloading Documented Consent Forms from Qualtrics, 
• IRB Consent Form Template for Qualtrics. Click the title of this section to access the documents

Template of Institutional Permission Letter

Sample institutional permission letter If you are conducting your research at a non-Minnesota State University, Mankato site you must obtain permission from the appropriate authority to conduct the research at their site. This permission must be obtained only after IRB has approved your research.