Qualitative Research is a branch of research equal to but different from Quantitative Research. It depends on observer descriptions of events rather than counting them. As such, instead of many interventions and randomization, Qualitative methods of research observe, watch, and interpret. Common procedures used in qualitative research include, but are not limited to:
- Focus Group Discussions
- Case Study
- Oral History
- Internet Survey
IS IRB REVIEW NEEDED FOR QUALITATIVE RESEARCH?
Most qualitative research gathers data from people who are directly, or indirectly identifiable. A “human subject” is a person about whom the investigator obtains “identifiable private information.”
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Within the qualitative research community concerns have been expressed that the IRB system may at times "over-reach" also referred to as “mission creep”. One contributing factor has been the practice of some institutions to require submission of studies that do not always meet the definition of human subjects research. Oral historians, for instance, use the procedure in history collections. They, of course, gain the permission of the interviewee. Doing that does not make it research. The question of whether something is “research” precedes the question of whether the tools are the correct ones to employ.
E&I reviews a significant amount of qualitative research, both required and voluntary. Our team can assist you in determining if review of your project is required, or if there is benefit to choosing to undergo review voluntarily.
WHAT ARE THE MAJOR ISSUES IN IRB REVIEW OF RESEARCH?
The review criteria used to evaluate qualitative and quantitative studies is the same. The reviewing IRB must be able to understand and apply those criteria appropriately. The applicant needs to understand that the review criteria must be addressed. Some of the areas that have caused difficulty in the past include:
- Ensuring a purpose and a clear means of achieving the end exists.
- Typically there is little to no subject benefit so all of the potential for benefit lies in there being a well-constructed study capable of yielding an answer.
- Subject privacy should be considered. (For example, instructing a room full of people that you need not take the survey if you have HIV would put a person with HIV in a difficult position.)
- Subject confidentiality (use of codes, transfer of information) and data security (encryption and passwords) are incompletely described.
- Subjects have the right to receive sufficient information to give informed consent. This may not translate to a full consent document so waivers of some elements of consent and of documentation might be appropriate.
- All risks must be disclosed.
- Subjects must have the right to refuse without risk of negative consequences which includes refusing to answer individual questions. Their pre-screen phone data should not be retained without consent.
E&I chooses to include individuals with qualitative research experience on our boards as well as our staff. This perspective helps ensure a better pre-submission advice and better understanding of the projects being reviewed, as well as the regulatory requirements for exemptions, review and approval.
If you have questions about the design of your project or the need for IRB review, please contact us for more information.