When research involves the use of focus groups to obtain data, the participants should be given information before the focus group takes place regarding what a focus group is, what the topic is, who the other participants / stakeholders 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).
Purpose of the Focus Group
Many individuals have never been part of a focus group and may have no idea what it entails. During the recruitment process, the PI should explain what a focus group is, how many people will be involved, and about the potential benefits and risks of participating. This recruitment script must be approved by the IRB before recruitment can begin.
Other Participants
In the consent form and during the consent discussion, participants should be informed of who may participate in the focus group. Ideally this would be done during the recruitment phase, throughout the consent discussion and in the consent form. A participant may decide that he/she does not want to participate.
Example
A focus group to discuss substance abuse and availability of drugs might possibly include participants who are current and former drugs users and members of law enforcement. Because of the sensitivity of the topic, participants should be told that it is possible that law enforcement officers may take part in the group. This must also be clearly stated in the consent form. However, until the focus group actually takes place, it is not possible to know whether members of law enforcement will actually be present. Therefore, before the discussion takes place, members should be informed who is present in the focus group and given a choice as to whether they would still like to participate.
Confidentiality of the Information Shared
In the consent form 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 audiotaped, participants should be instructed to maintain their privacy and confidentiality, and that of the people they talk about, they should not use names.
The Focus Group Topic
In the consent form and during the consent discussion, participants should be informed of the topic that will be discussed during the focus group session. The IRB expects the PI to fully disclose the exact nature of the focus group topic area in the consent form and as part of the consent discussion. However, the cultural context must be taken into consideration when addressing this issue. The PI must provide a justification for not fully disclosing the topic in the protocol application. (See additional guidance for the use of deception in research.)
Audio or Videotaping
In cases where the focus group session will be audio or videotaped, the PI must disclose use of recording devices in the consent form and as part of the consent discussion. When the focus group meets, the PI should again disclose this to each member of the focus group, and ask if they agree to be audio or videotaped. If being taped is a requirement of participation in the focus group, this must be stated in the consent form. If a member of the focus group objects to being taped, the PI can excuse the participant from the group, or agree not to audio or videotape the session. Video editing tools that blur or block individual participants may also be used, and described in the protocol application. Participants should be given the opportunity to withdraw their consent AFTER the focus group session has ended. All of these specifics regarding videotaping must be clearly stated in the consent form.
Focus Groups Conducted in Developing/Traditional Societies
PIs must use special care in conducting focus group sessions in developing countries and in vulnerable communities. It is crucial that the PI thoroughly understand the structure of local governments and local communities in order to gain permission from a representative of the community to conduct research. As a first step, the IRB suggests that the PI obtain permission from the mayor, a tribal elder, or from a tribal council. In some cultures, it is inappropriate for men and women to be invited to discuss some or all topics in one group. Sensitivity to and knowledge of local culture must be demonstrated by the PI in the IRB application.