IRB Guidance: Qualitative Research

This page provides guidance to assist qualitative researchers in responding to the questions in the ARROW protocol application.

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.

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 signed 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:

Interviews/Focus Groups/Surveys

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 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 assess 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 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: