Your research objectives, target users, protocols, and timeframes play an essential role in determining which research method(s) you will implement. That, in turn, determines whether the PRA applies. The number of people needed to complete a study for insight generation may be under the PRA threshold or because a technique is not subject to the PRA since it employs direct observation and non-standardized conversation. For example, with human-centered design (HCD), the goal is to understand people (end-users and other stakeholders) and their interactions with everything or a particular product or service during their daily lives. If that is your goal, you may select observational and ethnographic research methods to learn about people to extract valuable insights from the research. The PRA may not apply since exclusions include direct observation and non-standard oral communication, which is the essence of ethnographic research. Ultimately, the number of participants depends on what researchers need to know, the purpose of the inquiry, the business problem, what lends credibility to the study, and available resources. There are best practices you can apply as a rule of thumb to begin research in some instances. Some studies will require more individuals and some fewer. Navigating HCD and PRA Navigating HCD Research and PRA is a summary document that can help you determine if the PRA applies to your study. It includes high-level steps to get started, HCD research methods and PRA quick reference guide, and a decision tree to help you understand if you need clearance. The job aid is a general reference and should not be confused with official guidance from the Office of Strategic Operations and Regulatory Affairs (OSORA). Always follow your group’s guidelines about research and PRA guidelines. |