Informed Consent Part 3: Protecting Participants

In the previous posts in this blog series, we went over the basics of informed consent and the elements of the consent form that serve to explain your study to participants. Here, we will cover the remaining key elements of the informed consent form. This includes discussions of benefits, risks, participants’ rights, and protection of participants. As noted in the previous blog in this series, it is important to be aware of the requirements specific to your school’s Institutional Review Board (IRB), which may require more or less detail than what is covered here.

A necessary element of the informed consent form is a presentation of the benefits and risks of the study. First, participants need to know how the study may benefit them (or others). If you are going to provide any kind of incentive or monetary compensation to participants, this should be clearly stated in the consent form. If you are conducting an intervention study, you need to explain the possible benefits of the intervention. If the participants will not receive any direct benefits, you need to state this and also briefly explain the potential scientific, academic, or social benefits the study may provide to people in general.

Participants also need to be informed of the potential risks they may face by participating in the study. You need to inform participants if their participation could possibly have any negative impact on their physical, mental, or emotional well-being, if the privacy of their personal information could be compromised, or if there are any possible financial costs associated with participation in the study. Even if you are conducting a “minimal risk” study (e.g., having people fill out a survey about their attitudes or opinions), you should provide a statement indicating that the risks associated with the study are expected to be no greater than what the participants would encounter in their everyday lives.

In addition to explaining the benefits and risks of the study, the informed consent form needs to include an explanation of participants’ rights and how participants will be protected. In all human-subjects research, participants should have the right to refuse participation or to stop their participation at any time without consequence. In other words, even if participants agree to be in the study, they have the right to change their mind and quit at any point in time without being punished in any way.

The informed consent also should explain how risks will be minimized and how participants’ privacy will be maintained. If your study involves more than minimal risk, you need to give specific details about how the risks will be minimized. For example, if you are doing a study on a sensitive topic (such as trauma or abuse) and there is a risk of participants having negative emotional reactions during your study, you may want to include information on counseling resources. You also need to outline how participants’ data will be protected. For paper and pencil data, you should specify how and where the data will be stored (e.g., in a locked filing cabinet in the researcher’s office); for electronic data, you should specify how electronic files will be secured (e.g., on a password-protected computer or encrypted cloud storage). If you are not collecting data anonymously, you should indicate how you will protect any personally-identifying information that you collect (e.g., through assignment of ID numbers in quantitative studies or the use of pseudonyms in qualitative studies).

Finally, the closing elements of the informed consent form include contact information and the signature line. It is typical to include the researcher’s contact information so that participants can ask questions about the study, as well as the IRB’s contact information so that participants can ask questions or voice concerns about their research participation. After all of the required elements of the consent form are presented, a signature or endorsement line should be included so that participants can actively indicate their consent to participate. In face-to-face studies, participants usually provide a hand-written signature; in online studies it is usually appropriate to have participants endorse a statement such as “I agree to participate.”

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