Challenges and Strategies of Applying Biomedically-focused Regulations to Qualitative Methods
All non-exempt research involving human subjects must have advance IRB approval. The University of Washington runs its own Institutional Review Board (IRB) at the UW Human Subjects Division (HSD). This Spring, Assistant Director for Research Support Adrienne Meyer shared with the QUAL community the criteria researchers must review to determine whether they need IRB review.
Qualitative research often does not need IRB, Meyer said. But when it does, there are some considerations particular to qualitative research that she highlighted. Lastly, there are a set of impending changes to IRB regulations and Meyer discussed how these may impact qualitative researchers.
Does my research require IRB review?
There are four questions graduate students and other researchers must ask themselves to determine whether their project requires IRB. The first question is whether a project is considered research. Meyer shared the regulatory definition of “research” which has key features such as generalizability. She gave an example of how one type of qualitative project may or may not fit this particular component – oral histories could be considered research or not depending on the intent of the data collected to be used for generalizable knowledge or not.
The second test in determining if a research project requires IRB is whether it involves human subjects. When qualitative researchers interview “key informants” – experts who are questioned about their area of expertise; or when they analyze published, public information such as Twitter online content, they are not considered to be involving human subjects in their research. In her presentation slides, Meyer includes links to HSD website tools that can help researchers self-determine whether their projects are considered “research” for IRB purposes.
Even if the answer to the first two questions is yes (Is it “research”? and Does it involve human subjects?), a project may still qualify for an exemption. Meyer said determining whether one’s research qualifies for exemption must be done by the UW HSD office. There are several common exemptions that many qualitative research designs may qualify for. For example, if a researcher is using a colleague’s already collected interview data to extract some non-identifiable information for a new project, this approach would qualify for an exemption. Many educational research projects, including some interview and observation approaches, would also qualify for an exemption.
Lastly, if indeed a qualitative project does require IRB, the fourth question to consider is what type of review is required. This, Meyer says, will be determined by the HSD office, but researchers can use online resources such as a worksheet for expedited review eligibility to help anticipate what their projects may be required to undergo: an expedited IRB review for minimal risk projects vs. a full board review for greater than minimal risk research.
Timeline to plan for IRB:
- Exemptions – 2 days median, but budget 2 weeks;
- Expedited review – 14 business days, but budget for 1 month;
- Full IRB review – 30 business days, but budget for 2 months.
Common issues for qualitative research undergoing the IRB process
The IRB reviewers are concerned with potential harm to research subjects, including reputational harm. Thus, Meyer advised, a researcher can tailor creative protections to the risk of their study. One recent example she gave featured a researcher who used an audio recording device for their interviews that masked interviewees’ voices during the recording process itself.
“Anticipate when and where you may need to build flexibility into your review application,” Meyer said.
This advice translates into strategies in the IRB application such as describing interview topics and the most sensitive questions planned, rather than providing a fixed transcript of all questions.
Future changes to federal IRB regulations
For more than seven years, changes to Federal regulations for IRB review have been in the works. They are planned for implementation in January 2018 and aim to reduce some regulations and simplify the process for researchers. These changes are currently on hold by the Trump administration. If implemented as planned, they will include:
- No more continuing review for minimal risk research;
- Federally-funded studies will qualify for an exemption they are currently ineligible for; and
- A small change to the information that must be provided to subjects as consent.
More from Meyer’s presentation
For more details from Meyer’s talk, please click on the presentation slides, which include common mistakes when submitting research for IRB review, an overview of HSD’s new e-IRB tool, Zipline, and links to other helpful resources.