IRB Guidance: Qualitative Research
The IRB recognizes that qualitative research includes unique characteristics that are not applicable to other types of research. However, the basic ethical principles, federal regulations, and campus policies that apply remain the same for all research. Outlined below is guidance drafted by IRB staff to assist qualitative researchers in responding to the questions in the ARROW protocol application.
This page provides guidance to assist qualitative researchers in responding to the questions in the ARROW protocol application.
Qualitative researchers often embed themselves in a community or organization in order to collect observational data and/or develop a cultural context for their research. While perfectly acceptable, it is the expectation of the IRB that researchers identify themselves as a UW researcher immediately upon meeting potential research subjects. It is NOT appropriate to “lurk” and collect data. In a scenario such as this, the “recruitment script” used to identify yourself as a researcher might read “Hello, my name is _______, and I am a researcher from the University of Wisconsin-Madison (in the United States), and I am going to be living here for the next six months while I conduct my research.” In addition, the IRB expects a more detailed recruitment plan for focal subjects. This must be included on the recruitment page(s) in the ARROW application and should include details of how additional information will be presented to individual focal participants.
If a researcher plans to use snowball sampling to recruit participants, the subject population should be considered. For example, it is NOT appropriate to use conventional snowball sampling to recruit participants with HIV or participants who are gang members, as just providing a name or contact information to the researcher could present a risk to the potential subject. In these situations, the researcher could instead provide a business card to a participant with the directive “I am looking for others who may be willing to talk with me. If you know of anyone, please ask them to contact me, using this information.”
The requirement to obtain informed consent is no different than any other type of research. Written (signed) consent is the standard.
There are circumstances that make this standard not appropriate (e.g., when conducting informal discussions with community members where only written notes will be taken; when cultural norms conflict with obtaining signatures; when there are literacy issues; and when NOT collecting signatures allows participants to remain anonymous). In these situations, it may be appropriate to utilize an oral consent process and/or the presentation of an information sheet that contains all of the elements of informed consent. The researcher must then request a waiver of documentation of written consent and provide appropriate justification for the waiver in the ARROW application.
A waiver of informed consent - where there is no consent process at all - is seldom appropriate when interacting with subjects. Typically, this is only allowed when data collection is limited to general observations. For example, observing at a Farmer’s Market as part of a larger study, noting only the number of buyers vs sellers, number of vendors who brought their children along, how weather affected attendance. In other words, no personal, identifiable data is collected. If some of the focal participants will also be included in observational data, that information should be included in the general consent process they agree to (e.g., “I may also observe you in public, like at the Friday street dances or other community events.”).
Common issues related to consent in qualitative research must be addressed in the ARROW application:
- If identifiable quotes will be used, documentation of consent may be required and should be detailed;
- Data collection cannot include identifiable data about a 3rd party who has not been consented (e.g., tell me about your neighbor’s experiences with the new rules); If the researcher wants or needs those details, the neighbor must be contacted and consented;
- If direct or indirect identifiers WILL be a part of the research, this must be clearly spelled out to participants on the consent form. It is perfectly acceptable to state “This research will NOT be confidential. I want to use your name and quote you directly." Signed consent will likely be required in such cases.
- Any potential risks associated with being identified must be included on consent documents and in the application;
- As with any other type of research, minors cannot be recruited or included as participants in research without first contacting and consenting a parent or guardian.
Semi-structured interviews, conversational interviews, and community based focus groups are all acceptable methods of collecting qualitative data. However, to satisfy the regulatory requirements, the IRB still needs, at minimum, draft instruments that outline the scope of the questions, the general topics that will be covered, and/or sample questions/conversation starters that the Study Team plans to use. The IRB will also want assurance that, if the scope of the project changes or is expanded, a Change of Protocol will be submitted to the IRB prior to implementation of those changes in order for the IRB to assess whether the changes impact the risk level to the project.
Number of Participants
Qualitative researchers often have no idea how many participants may eventually enroll as subjects. However, to asses risk (it is a lot more likely that a person could be identified if there a 3 participants as opposed to 33), and to meet the regulatory requirements, a number is required in the ARROW protocol. The IRB recommends choosing the maximum number of participants anticipated, as a Change of Protocol will be required in order to enroll more participants than what has been approved.
Site(s) Where Data will be Collected
The following information must be included in the ARROW application so the IRB may determine risk and whether additional organizational approval is required for the site:
- If practical, a private spot in a public meeting space is best;
- If the researcher will be going into homes in Wisconsin, reporting language will be required on consent forms in the event that the researcher must break confidentiality to report abuse or neglect witnessed while in the participant's home;
- Businesses, organizations, schools, and community centers will all require some type of documentation from the site that they are aware of and support the fact that research activity is taking place at their site.