A focus group can be a good way to gather data from several participants in a short amount of time. Depending on the topics discussed, the information gathered about the participants, and the methods of recording data, Focus Groups may often qualify for an exempt review. 

Informing Participants:  Participants should be informed about the topics that will be discussed and who will participate in the focus group so that they may make an informed decision to participate beforehand. Subjects should be informed of any anticipated risks that might be associated with participation. Depending on the topic and data collection method, a minimal risk focus group may qualify for a waiver of documented consent, allowing a verbal consent process. If you ask for a waiver of signed consent, you should prepare an information sheet with much of the same information that you would have included in a consent form requiring a signature.

Audio and Video Recordings: Participants should be informed before the focus group if the session will be audio or video recorded. Participants should also be informed about what will be done with these recordings. If audio or video from the focus groups will be used for something other than data analysis for the approved protocol (i.e. – future research studies, educational purposes, conference presentations, etc.) then participants must explicitly agree to this in the form of a checked box agreeing to or not agreeing to have their video/audio used for the above purposes in the consent form.

Risks and Confidentiality: The nature of a focus group is such that there can be no expectation of confidentiality. The researchers should provide participants with the procedures in place to maintain confidentiality of the research data and they should ask participants not to repeat what is said in the focus group to others especially if the topic is sensitive. For research that is minimal risk adding a paragraph to the informed consent detailing issues of confidentiality for focus groups will suffice. For sensitive topics, you may want to include a statement of non-disclosure in the consent document.