2013 Webinar: Protecting Human Subjects in Qualitative Research

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On October 24, 2013, Julie Simpson, PhD , director of research integrity services at the University of New Hampshire,  provided an introduction to qualitative research; discussed ethical challenges inherent in conducting and reviewing this type of research; and offered strategies to address them.

In qualitative inquiry, researchers study phenomena in their natural settings, where the purpose is contextualization, interpretation, and/or understanding the perspectives of others. The role of qualitative researchers in a study is characterized by personal involvement and empathetic understanding. The challenges specific to this research domain, for both researchers and institutional review boards (IRBs), include the emergent nature of qualitative research, a researcher’s relationships with research subjects, obtaining informed consent, and confidentiality and privacy.

Additionally, IRB members’ gaps in understanding qualitative inquiry may stand in the way of correctly identifying problematic aspects of a proposed study, or result in what is often viewed as inappropriate changes to the study design. Qualitative researchers are often frustrated by this perceived lack of understanding of qualitative inquiry. These gaps in understanding may also result in IRBs not correctly identifying problematic aspects of a proposed study. Further, qualitative researchers may not fully grasp the ethical concerns that their studies raise vis-à-vis human subjects protections, such as the potential effects of a researcher’s dual roles in a setting, or that informed consent is a process. They may also not understand how to mitigate such concerns and/or to communicate effectively with IRBs about how to address these challenges within the regulatory framework.

The goal of this webinar was to provide IRB members with a better understanding of the issues that qualitative researchers face and to introduce strategies to address these issues while recognizing the unique characteristics of the qualitative research process. Topics for discussion included:

  • Differences between qualitative and quantitative research paradigms.
  • Ethical issues that qualitative research methodologies may present to study participants.
  • Strategies for IRB members and qualitative researchers to minimize harm to study participants.


This webinar was of interest to researchers involved in qualitative studies, and to IRB members, directors, and staff that review qualitative research protocols. 


Julie Simpson, PhD, is the director of research integrity services and affiliate assistant professor of college teaching at the University of New Hampshire (UNH). Julie oversees UNH’s human subject protections program and IRB operations. Additionally, she administers the institutional animal care and use committee (IACUC) and manages the responsible conduct of research (RCR) and scholarly activity programs at UHN. Julie staffs UNH’s disclosure review committee which oversees the financial conflict of interest in research program, which she co-administers. She co-teaches a cross-disciplinary graduate research ethics course at UNH. Julie previously served as the project director for UNH for an Office of Research Integrity (ORI) grant to develop web-based RCR educational materials and administered UNH’s ORI/Council of Graduate School’s RCR grant. Julie’s interest in ethical issues in qualitative research resulted in her dissertation, More than simply “hanging out”: The nature of participant observation and research relationships. In this study, she interviewed researchers about their experiences conducting ethnographic research, focusing on their relationships with study participants.

Certificates of Attendance

Certificates of attendance for the Protecting Human Subjects in Qualitative Research: Ethical Considerations for IRBs and Researchers webinar were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

If you would like to receive a certificate of attendance for a previous PRIM&R educational program, please email info@primr.org or call 617.423.4112, ext.0.

CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP credential who wish to apply credits from Protecting Human Subjects in Qualitative Research: Ethical Considerations for IRBs and Researchers toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 60-minute webinar counts as 1.0 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP recertification can be found here.