Principal Investigators Association

Most research projects must receive approval from their institution’s Institutional Review Board (IRB)
before they start. The IRB is a committee within the institution that reviews research proposals to ensure that they maintain the privacy and safety of human subjects involved in the research.

Any study that involves living human subjects needs IRB review, although some types of projects are exempt. The approval process involves filling out an application that describes the projects, its system for informed consent, its methods and goals. The application is then reviewed by the committee, which may request changes in protocols or further justifications to protect human subjects.Depending on the nature of the research and the process at a local IRB, getting IRB approval can be a simple procedure taking several weeks or a long, protracted negotiation that can hold up or alter research projects.

While IRB rules have always exempted some forms of research, increasingly every study needs to at least prove that it protects human subjects through an IRB application. Qualitative studies face particular challenges completing this process because IRBs are generally developed for medical or quantitative research. As a result, IRB staff may be unfamiliar with qualitative research processes. In addition, cumbersome written consent forms and other standardized procedures developed by local IRBs may not work well in qualitative research. Qualitative researchers often find they need to justify alternative procedures to an IRB committee.

This 125-page guide has been designed to provide a general overview of IRB history and process, but focuses on the special needs of qualitative researchers. The guide has the following goals:

  • Provide an overview of the IRB process for qualitative studies
  • Qualitative Research and IRB, a Comprehensive Guide
  • Discuss various forms of informed consent for qualitative methods and ways to present them in an IRB application
  • Describe procedures to protect confidentiality in qualitative research
  • Clarify when a qualitative project is exempt or eligible for expedited review
  • Outline strategies to write a successful IRB application

About the Co-Author:

Dr. Jo Anne Schneider has successfully developed IRB statements for a wide
array of qualitative studies since the mid-1980s. She wrote the guidelines for IRB
approval for students and courses at one university. She has also advised multiple
students about informed consent and IRB statements. A former American Association for the Advancement of Science Policy and Technology Fellow at NIH, she is currently an Associate Research Professor at George Washington University. She also has an international reputation for university/community involvement, serving as a PennServe Community Based Fellow for Service Learning involving community/researcher partnerships. Recent major projects include developing a model to reach at-risk communities for NCI, the Faith and Organizations Project (, and multiple projects related to social welfare and human services (see

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This guide is brought to you as a training tool by the Principal Investigators Association, which is an independent organization. The information presented and its contents are not connected with the National Institutes of Health (NIH) or the National Science Foundation (NSF), nor are they endorsed by these agencies. All views expressed are those personally held by the author and are not official government policies or opinions.