Well-written consent forms ease IRB process

A pen lies on a piece of paper next to the printed words, "I Agree," and a checkbox.

Consent forms are an ethical requirement for conducting human subjects research. Knowing what to do and what not to do when creating a consent form will help prevent delays in IRB review and approval.

Do

  • Be concise. Briefly worded forms are more likely to be read
  • Use vocabulary and grammar appropriate for the subject population. Doing so makes it more likely for participants to understand the form. Most forms should be written at an 8th grade level. Reading level can be assessed using Microsoft Word for Mac or Windows, or an online tool such as Expresso or Readability Calculator.
  • Include the following elements of consent:
    • Brief introduction of the researcher(s) and their affiliation with Miami University;
    • Brief description of the research;
    • Duration of participation;
    • Brief description of procedures, distinguishing normal activities from research activities;
    • Statement of risks;
    • Benefits to society;
    • Extent of confidentiality;
    • Statement of voluntariness and explanation of withdrawal procedures;
    • Contact information for researchers, faculty advisor, and the Research Ethics & Integrity office;
    • IRB/exemption approval reference ID.

Don’t

  • Don’t imply the subject is committing to participation. A consent form is not a legal document and should not have the appearance of of a contract.
  • Don’t overuse the word “understand,” which has certain legal implications. A consent form is not a liability waiver or other legal document. “I understand the risks associated with this research,” is a statement commonly included in consent forms submitted to the IRB. But how can a subject know they understand the risks, let alone sign a document stating they do?
  • Don’t word a consent form in the first person from the viewpoint of the subject. In other words, avoid statements such as, “I will take part in an interview with the researcher where I will be asked questions . . . “
  • Don’t make a form overly long and/or redundant.
  • Don’t create a form that is coercive.
  • Don’t use a template without customizing it for your specific project. The Research Ethics & Integrity office has sample consent form templates available on its website. Any Miami researcher who uses these — or any other — templates should take care to edit them to provide specific information about their project. For instance, blanks in statements such as, “The purpose of this research is to ___________,” should be filled in.

Written by Jennifer Sutton, Associate Director of Research Ethics & Integrity, Miami University.

Raised hand image by Genusfotografen (Tomas Gunnarsson) via Wikimedia Sverige. “I Agree” image by Pixabay via Pexels. Both used under Creative Commons license.

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