The use of focus groups to obtain data generates unique ethical challenges regarding recruitment, consent, confidentiality and anonymity, and risk of harm. The Principal Investigator must take specific steps to ensure compliance with the ethical standards for the protection of human research participants.
Informing Potential Participants – Recruitment and Consent
Many potential participants may have never been part of a focus group and may not understand what it entails. All recruitment materials should clearly identify that a focus group will be used to collect data and should explain what a focus group is, how many people will be involved, and about the potential benefits and risks of participating, in addition to other details about the research. (For example, include if the focus group be audio or video recorded.)
The consent document must provide information regarding what a focus group is, the topic that will be discussed during the focus group session, who the other participants may be, where the group will meet, and how long the session will last. It is particularly important to inform participants ahead of time when sensitive topics will be discussed (e.g., sexuality, substance abuse). Keep in mind that information in the consent document must match the information provided in the recruitment document to potential participants.
In the consent document and during the consent discussion, participants should be informed that the information shared in the focus group session should not be shared with anyone outside of the group, and that the confidentiality of anything they choose to say during the session cannot be guaranteed. If the focus group is being recorded (audio or video), participants should be instructed to maintain their privacy and confidentiality, and that of the people they talk about, they should not use names. An additional consent form is required for video-recording of participants. No additional consent form is required for audio-recording.
Risks and Confidentiality
The nature of a focus group is such that confidentiality cannot be guaranteed. The researchers must explain to participants the procedures in place to maintain confidentiality of the research data and they must inform participants not to repeat what is said in the focus group to others. For research that is minimal risk adding a paragraph to the informed consent detailing issues of confidentiality for focus groups will suffice.
Example paragraph that may be included in a focus group consent document:
Although the researchers will take every precaution to maintain confidentiality of the data, the nature of focus groups prevents the researchers from guaranteeing confidentiality. The researchers would like to remind participants to respect the privacy of your fellow participants and not repeat what is said in the focus group to others.
For studies presenting greater than minimal risk to participants, please contact the IRB at irb@sandiego.edu before proceeding with a research design that requires the use of focus groups under these circumstances.
Audio- or Video-recording
In cases where the focus group session will be audio- or video-recorded, the researchers must disclose use of recording devices in the recruitment and consent forms. USD IRB also requires a separate Video Consent Form (found under “Forms” on the USD IRB website).
When the focus group meets, the PI should again disclose that the focus group will be recorded and reaffirm participant consent.
If a participant of the focus group objects to being audio and/or video recorded, the PI can excuse the participant from the group, or agree not to record the session. Video editing tools that blur or block individual participants may also be used, but must be described in the study application and disclosed in the consent form and agreed to by participants.
Participants must be informed that they can withdraw from the study at any time and receive any compensation if it was offered during recruitment.
Special Considerations
Researchers must use special care in conducting focus group sessions with vulnerable populations (e.g., 45 CFR § 46.111(b)) or in international contexts. Please contact the IRB at irb@sandiego.edu.