Is the use of a “focus group” human subjects research?
We have found that investigators tend to use three separate definitions for “focus group:” • If the proposed studies involve a group of individuals who are consultants and have been chosen for their expertise to improve the research design, the research IS NOT considered human subjects research. • If the studies involve a group of individuals who are brought in to test a new product (e.g. software, equipment, surveys) to identify “bugs” or problems, the research IS NOT considered human subjects research because the data collected is about the product and not about the individuals. This is a Beta -Test of the product. • If the studies involve a group of the eventual target population who is brought in to “pilot test” a new product or intervention before researchers finalize the design of the product or intervention, the research MAY BE considered human subjects research. Pilot tests involve living individuals if the PI conducting research obtains data or individually identifiable privat
Related Questions
- Activities must meet the definition of research and involve human subjects as defined in DHHS regulations, or be research and involve human subjects as defined in FDA regulations to be subject to the IRBs jurisdiction. How do I know if my project meets the definition of human research?
- Do all researchers working with human subjects have to take a responsible conduct in research compliance training?
- What Are the Basic Ethical Principles That Should Underlie the Conduct of Research Involving Human Subjects?
