Author: Jennifer L. Harrison, Ph.D., LP  Solutions IRB Reviewer and Board Member

Considerations for Design of Virtual Focus Group

• Consider:
  • Do the risks outweigh the benefits?
  • Can taking notes suffice instead of recording? And then discard the notes immediately after analysis is complete?
  • If you prefer to record, can you agree to delete the recordings immediately after analysis? Can you ensure that participants’ names will not be used on the recordings and instead ask that they use a pseudonym?
  • Can you obtain a certificate of confidentiality from the NIH (depending upon the type of information that is collected in the study)?
  • Video recording is more identifiable than audio recording, though audio recording is still identifiable by voice. Can you use audio recording in lieu of video and audio recording in instances where the participants’ identity should be protected?

Checklist for Consent Form

• Ensure that risks for a breach of confidentiality – specifically related to focus groups and the researcher’s inability to guarantee confidentiality of information discussed – is addressed in the risks section and how this will be mitigated to the extent possible.
• Include a statement that asks for consent to audio and/or video record prior to asking for consent to participate (e.g., “I provide consent to be audio recorded.”).
• Include a statement that indicates whether or not the participant can still participate if they decline to be recorded (e.g., “I understand that if I decide not to be recorded, I cannot participate in this study.” OR “I understand that if I decide not to be recorded, I can still participate in this study.”).
• Include a statement that asks for consent to participate.
• If a waiver of documentation of consent was requested, ensure that either a box to be checked is used or some other way for the researcher to document that consent was obtained is included on the form – instead of a signature line – as names should not be collected in this instance for protecting participant identities – if there could be potential harm to the participant in the event of a breach of confidentiality.

Checklist for Obtaining Informed Consent and Consent to Record for Virtual Focus Group

• Gather informed consent to participate on an individual basis.
• Gather consent to audio and/or video record on an individual basis, at the same time as informed consent.
• Within the focus group script, ensure that verbalizations are added to denote when the recording will begin and end so that participants are aware.
• Do not ask for consent to participate in the focus group again at the time of the focus group – this has already been obtained at the time of informed consent.
• Do not ask for consent to audio and/or video record again at the time of the focus group – this has already been obtained at the time of informed consent.

Author: Jennifer L. Harrison, Ph.D., LP  Solutions IRB Reviewer and Board Member

Given that focus groups can increase the risk for participants, researchers should carefully consider whether this is an appropriate research method for the information that will be obtained from them. One such risk is that the researcher does not have the ability to ensure confidentiality of the information that is discussed within the group. This is primarily because once participants leave the group and the study, they are on their own and they can share any information they so choose with anyone. For this reason, researchers must inform participants of this risk, and attempt to mitigate this to the extent possible by asking participants to respect others’ privacy by keeping information discussed within the group confidential.

Focus Group Consent

Obtaining informed consent to participate in a virtual focus group should occur on an individualized basis so that the individual can take the appropriate time to review the information, ask any questions they may have, and ultimately provide consent after making an informed decision. Consent cannot be obtained in a group setting as this does not provide each individual with the appropriate attention needed to ensure they individually understand the information that has been presented to them, they are less likely to ask questions in a group setting, they are essentially put “on the spot” to provide their answer in front of others, they may be rushed to make a decision, and they are more likely to engage in groupthink – meaning, a desire for agreement or harmony in a group setting results in individuals disregarding their own judgment and critical thinking from pressure to conform. Such a group setting can actually be considered coercive in nature for obtaining consent for these aforementioned reasons. To obtain consent, it is possible to ask participants to click a box in an online form where they agree to a statement, such as, “By clicking this box, I agree that I have read and understand the above information and I agree to participate in the study.”

Recording a Focus Group

Recording a focus group, whether audio and/or video, can present even more risks to participants depending on the data that will be collected. For example, if a researcher is interested in understanding substance use behaviors and patterns in more detail, information obtained will in essence be an identifiable, recorded admission of guilt that could be used against them and potentially have negative consequences for the participant (e.g., loss of employment, criminal charges from law enforcement) – as many substances remain illegal in the US. For these reasons, careful consideration should be afforded to the design process to determine if recording can be avoided in order to better protect participants. If the information collected is sensitive in nature, such as the above example, researchers should consider obtaining a certificate of confidentiality from the National Institutes of Health (NIH). If a recording can be avoided and the researcher can instead take notes, this is preferable given the risks of the potential for a breach of confidentiality of the information. In addition, it is also possible to request a waiver of documentation of consent if there is a possibility of harm to a participant due to a breach of confidentiality – so that participants’ names are not identified on consent forms in order to further protect their identity.

Seeking consent to record a focus group also needs to occur on an individualized basis and during the informed consent process. Participants should be clearly informed in the informed consent process that they will be recorded, via the specific method (i.e., audio and/or video recording), and if the participant chooses to decline to be recorded – whether or not they can still participate in the study. Just prior to notating consent for participation in the study at the bottom of the form, participants should be asked to provide their consent for recording – and this is the only occasion that this information needs to be covered – in other words, permission to record should not be asked again at the commencement of the focus group. Doing so can actually be considered coercive – because if a participant declines to be recorded and is asked again at the start of the focus group – they may be pressured to say yes when they have already declined.