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Jan2014

On October 24, 2013, PRIM&R hosted a webinar titled Protecting Human Subjects in Qualitative Research: Ethical Considerations for IRBs and Researchers. Julie Simpson, PhD, director of research integrity services at the University of New Hampshire led the webinar while Elisa A. Hurley, PhD, education director at PRIM&R, served as the moderator.

simpson_julieFollowing the webinar, we connected with Dr. Simpson, and she kindly answered a few more questions that came in from webinar participants, exclusively for Ampersand.

Alexandra Shlimovich (AS): Would you consider interviews with vulnerable populations on a sensitive topic to be greater than minimal risk?
Julie Simpson (JS): It is difficult to respond without knowing more about the particular study in question, but, in general, I think it is prudent to work with the presumption that interviews with vulnerable populations on a sensitive topic are greater than minimal risk. Populations are designated vulnerable by an IRB for a reason; that often means that participation in research presents more risk to these individuals than to others, and asking members of these groups sensitive questions adds another reason for concern. A detailed review may find that the study doesn’t present greater than minimal risk, but I consider starting from this position a sensible precaution.

AS: Under what circumstances might qualitative research not require IRB review?
JS: None come to mind at this time. If the activity is research and it involves human subjects, then it needs IRB review.* The nature of data collected (qualitative vs. quantitative) should not make any difference vis-à-vis the requirement for IRB review.

AS: If a researcher plans to conduct a mixed methods study, should they obtain informed consent separately for each method?
JS: It really depends on the study, particularly with regard to the qualitative and quantitative activities and their timing, as well as which participants are involved in what activities. Our IRB reviews mixed methods studies, and for many, researchers propose one consent document. In some cases, though, separate consent documents may be more appropriate. For example, if the initial activity involves a (quantitative) web-based survey of 100 people followed by (qualitative) interviews of several (approximately 10) individuals selected according to their responses to specific questions in the survey, two consent documents for the different activities would make more sense as not everyone who takes the survey will be interviewed. The information pertaining to the interviews (e.g., where, when, how long, recorded, etc.) would be unnecessary for survey participants but imperative for interviewees.

AS: You mentioned that it's important for IRBs to be flexible in working with qualitative researchers. Since research projects are constantly changing, what are some guidelines for when the IRB must re-review or re-approve a particular protocol? 
JS: Particularly for novice researchers, outlining events and/or milestones that trigger communication with the IRB (whether it is for the researcher to check in, to formally request a modification, etc.) can be helpful. If the study was reviewed and approved initially at the expedited or full board level, the researcher will need to communicate with the IRB at least annually through the continuing review process, so periodic reporting of ongoing progress should occur annually at that time. Other events that would likely require IRB review include:

  • The addition of any new data collection methods (e.g., videorecording, interviews via email when the IRB has already approved in-person interviews, collecting basic demographic data) 
  • The addition of new populations (e.g., children, individuals with cognitive impairments)
  • The addition of sites (e.g., a new/different school or nursing home) 
  • The addition of research questions that introduce a new topic or line of inquiry not previously approved by the IRB, (e.g., adding a series of questions about topic Y when the questions approved by the IRB are only about topic X) 
  • The addition of, or changes in, compensation 
  • Changes to recruitment methods, consent forms, or how data will be reported
  • Adverse events

This list is not exhaustive, but these are some of the key events that come to mind for which my IRB would expect a researcher to request a modification.

AS: When is it acceptable to identify sites in a publication?
JS: That’s an interesting question that again, I think transcends the nature of the research. A key issue is whether identification of sites was part of the IRB approval initially, or if it represents a change that the researcher or some other individual connected with the study introduces in the middle or at the conclusion of the study. If an IRB approved the identification of sites in publications, any issues should have been worked out as part of the initial review and approval process, and participants should have agreed to this condition as part of the consent process. Changing the reporting of results to identify sites after initial IRB approval, however, is more complicated and will likely depend a lot on the risk that such identification of sites may present to participants. Here are some factors to consider:

  • Has the person responsible for a site (e.g., principal, owner, CEO) given permission for a site to be identified?
  • Might identifying a site make certain participants identifiable?  Will doing so counter any of the information in the consent document approved for the study and upon which participation was agreed to by subjects?
  • Might identifying a site present issues for the site, such as categorizing it as a facility that does not meet certain standards or is noncompliant with specific regulations?  What impact might this have on the site and on individuals at the site, both participants and non-participants?

Again, this list is neither exhaustive nor all-inclusive.

If you’re interested in learning more about protecting human subjects in qualitative research and did not have a chance to participate in the webinar with Dr. Simpson, the archive is available for purchase. PRIM&R members can also access additional readings related to this topic on our Knowledge Center.

*Editor's note: Federal regulations at 45 CFR 46.101(b) list several categories of research activities involving human subjects that may be eligible for an exemption  from IRB review. The process for determining whether a research activity is exempt varies from institution to institution. At Dr. Simpson's institution, exempt research is subject to review. Please consult your IRB directly to learn how exempt research is handled at your institution. 

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4 thoughts on “Keys to Protecting Subjects in Qualitative Research

  1. Zachary M. Schrag

    Dr. Simpson claims that "If the activity is research and it involves human subjects, then it needs IRB review."

    Of course, 45 CFR 46.101 lists several circumstances in which human subjects research does not require IRB review, some of them (particularly (b)(2) and (b)(3) of enormous importance to qualitative researchers.

    To be sure, OHRP is primarily responsible for discouraging institutions from recognizing the exemptions. But it is a pity to see PRIM&R spread such misinformation.

    Reply
    1. Julie Simpson

      My apologies. Thank you, Dr Schrag, for pointing that out. My perspective comes from an institution that reviews all levels of research; Exempt is a level of review at the University of New Hampshire. So, I amend my response to the question to reflect qualitative research that falls into any categories of research at an institution where they are exempt from IRB review would therefore not require such a review. Again, I apologize; that was my error (or narrow perspective), not PRIM&R's.

      Julie Simpson

      Reply
  2. Erica Heath

    I was interested in the response to question 2:

    "AS: Under what circumstances might qualitative research not require IRB review?
    JS: None come to mind at this time. If the activity is research and it involves human subjects, then it needs IRB review. The nature of data collected (qualitative vs. quantitative) should not make any difference vis-à-vis the requirement for IRB review."

    I don't think that the nature of the data make a difference but the procedures might. There are many qualitative studies that fit exemption #2. "Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:" there are linked identifiers and disclosure might cause a harm. The studies might fit into several other exemptions as well.

    It may depend, of course, upon how exemptions are treated within the particular institution. But my understanding is that, in the decision tree, exemptions are in between the determination of human subjects research and IRB review. They are HSR but are exempt from IRB review.

    Erica

    Reply
    1. Julie Simpson

      Again, Erica, thank you for correcting me and pointing that out. My perspective comes from an institution that reviews all levels of research; Exempt is a level of review at the University of New Hampshire. So, I amend my response to the question to reflect qualitative research that falls into any categories of research at an institution where they are exempt from IRB review would therefore not require such a review. Again, I apologize; that was my error.

      Julie

      Julie

      Reply