Guidance on Research Involving Focus Groups
Focus group research can often qualify for exemption from IRB Review as defined in the federal Common Rule 45 CFR 46.101 (b)(2):
Version Date: July 10, 2014
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
a. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
b. any disclosure of the human subjects' responses outside the research could reasonably place the subjects risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
NOTE: The exemption for survey and interview research does not apply to research in which the subjects are children, except for research involving observation of public behavior if the investigator does not participate in the activities being observed.
Under this definition, focus groups are considered to be in the same category as surveys and interviews and are reviewed in much the same way. The following elements apply to survey, interview, focus group research:
- Research involving focus groups, interviews, and surveys cannot qualify for exemption if minors are included in the subject population.
- There is an institutional requirement that there be some kind of consent process for category 2 research, including focus groups. In virtually all circumstances, the study team must provide consent information either orally via a script or in some written format, but signatures are not required from the subjects. This consent information must address the required elements of informed consent [Informed Consent ] but need not be in the full consent template format. For focus groups, the study team may either read a consent script at the beginning of the focus group or provide a consent information sheet at the time of recruitment or at the beginning of the focus group.
- In order to qualify for exemption under 45 CFR 46.101 (b)(2), or "category 2," data cannot be both sensitive (as described in point b above) and identifiable. Focus group research cannot qualify for exemption if the discussion involves the subjects revealing sensitive information about themselves (e.g. substance abuse, HIV status, domestic violence, etc.), even if the study team does not link subject identifiers to the data. This is because the study team cannot guarantee that the focus group members themselves will keep the information confidential. Focus group research of this nature must be submitted as a full initial review application. It is possible that focus groups that involve professional subjects discussing sensitive topics (e.g. approaches to treating domestic abuse survivors) may qualify for exemption, but the professional subjects may not reveal identifiable patient information.
- All focus group studies must include a reminder to the group to keep the discussion confidential. This should be included in the consent information and in the facilitator's introduction to the group.