We are asking our customers to complete a survey on their experience with products they bought from our company. We will then share the customer feedback on our website so that other people can be more informed when making decisions about the product. Are these individuals “human subjects”? Is IRB approval required to conduct these surveys?
In deciding whether a project is human subject research under the US federal regulations (the Common Rule), the first question you should ask is whether the activity meets the regulatory definition of research.
The Common Rule defines research as: “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” According to the Office of Human Research, a “systematic investigation” would likely involve a hypothesis, research question, and a plan to systematically collect and analyze data. “Generalizable knowledge” is information that can be broadly applied to field of study, a population, or a discipline.
It may also be useful to consider the definition of research described in the Belmont Report, “…the term ‘research’ designates an activity designed to test a hypothesis [and] permit conclusions to be drawn…” Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective.”
Gathering information about a customer’s satisfaction or experience with a product would not likely meet the regulatory definition of research requiring IRB review when those activities are intended to guide a customers’ decision about purchasing a product rather than to add or contribute to generalizable knowledge. Therefore, the “about whom” question that helps decide if the project is regulated as human subjects research doesn’t need to be considered, since this isn’t the type of “research” to which those regulations apply.
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