Informed Consent Part 1: What is it and when do you need it?

Posted April 11, 2018

If you are conducting research with human participants, your school’s Institutional Review Board (IRB) will likely require you to obtain informed consent from each of your participants. If you have conducted (or participated) in a research study before, you may already be familiar with informed consent and the role it plays in research ethics. However, if this is your first time conducting a research study, this may be a part of the research process that you have never even thought about until now. Here we discuss the very basics of informed consent to help get your feet wet.

So, what is informed consent? Put simply, informed consent is the process of educating potential participants about your study so that they can properly decide if they want to be in your study or not. It is your responsibility as a researcher to give participants what they need to make an informed decision. Typically, participants should be informed about the general purpose of the study, what they will be asked to do, what the potential risks and benefits of the study are, how they will be protected against potential risks, and what their rights are as participants. This information is given to participants in a document called an informed consent form. In face-to-face research settings, participants are usually given a physical copy of the informed consent form; in online survey studies, the informed consent form is commonly presented on the first page of the survey before any study questions are presented. Participants should be encouraged to read the entire informed consent form and ask the researcher questions if they do not fully understand it. Once participants have read and fully understand the information, they should indicate their willingness to participate by signing the document (in face-to-face studies) or endorsing a statement such as “I agree to participate” (in online studies). You should not allow anyone to proceed with the study unless they sign the informed consent form.

In almost all studies with human participants, having an informed consent procedure is mandatory. However, there are some exceptions to this. For example, if you are conducting a study using archival data (i.e., data that has already been collected), informed consent is generally not needed; instead you need to obtain permission from the data administrator to use the data. There are some other cases in which an IRB may allow a study to proceed without documented informed consent or with some elements of the informed consent process waived. Examples include experiments that involve deception, studies in which prior knowledge about the nature of the study would invalidate participants’ responses, studies in which participants’ privacy or welfare may be compromised by documenting consent, or studies that would be impractical or impossible to conduct without waiving documented informed consent. In all of these cases, the IRB normally requires the study to involve no more than minimal risk in order for informed consent to be waived.

In the next part of this blog series, we will discuss the elements of the informed consent form in more detail.

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