Informed Consent Part 2: Explaining your study


Posted May 10, 2018

In the first part of this blog series, we covered the basics of informed consent, including what the informed consent process is and when informed consent is necessary. In this blog, we begin to discuss the components of the informed consent form. First, however, it is worth noting that every study is unique and Institutional Review Board (IRB) requirements will be different across schools. The items covered in this blog series are the most commonly required components of informed consent forms, but your school’s IRB may require more or less information for your specific study.

The informed consent form usually begins with an introduction and information about the purpose of the study. It is common to include a statement explaining who the researcher is (e.g., a doctoral student at ____ University), why the research is being conducted (e.g., to complete the requirements for a doctoral degree), and what the general topic and purpose of the study is. It is important to give participants enough information to generally understand the nature and purpose of the study; but at the same time, you want to avoid giving them details that might unduly influence their responses (e.g., specific research hypotheses). If you tip off participants about your hypotheses or expected results, the participants may respond in a biased way.

Next, the informed consent typically explains who is eligible for the study, what participants will be asked to do if they agree to be in the study, and how long it will take to complete the study. It is often acceptable to list your eligibility criteria and the tasks that participants will be asked to complete in bullet point form. For example, if you are conducting a survey study using the MLQ, you might explain that participants will be asked to “answer questions about your supervisor’s leadership qualities.” Some IRBs may require you to present example survey questions in your consent form. You should also provide an estimate for how long it will take participants to complete the study. This is especially important in studies with multiple data collection periods (i.e., a longitudinal or repeated-measures study); the time commitment required for the study needs to be clearly explained.

When drafting your consent form with all of the above information, it is important to consider factors such as the age, reading ability, and English language proficiency of your participants. In other words, the consent form needs to be written so that the participants can fully understand it. So, if you are studying young children, the language in your consent or assent form needs to be simplified so that the children can read and understand it. In some cases, the IRB may require you to produce a readability report for your consent form to prove that the writing level is appropriate for your participants’ reading level.

In the next blog in this series, we will discuss the remaining components of the consent form, including benefits, risks, participants’ rights, and protection of participants.


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