IRB Application Instructions - Subject Population, Number

Help Information

D. Number of Subjects

  • Sample size is the total number of human subjects to be included in your research, including controls. If using pre-existing data, indicate the number of cases. Approximations are acceptable and encouraged to allow flexibility when a specific number is difficult to project.

E. Sample Size Explanation

  • Every discipline has established guidelines for the number of research subjects appropriate for the research design, whether it is an oral history, focus group, clinical trial or a survey involving thousands of subjects. In some cases, there are qualitative guidelines and in some cases sample size can be statistically determined (power analysis). How did you arrive at the sample size? For example, if you are doing one interview, is this an acceptable number based on your field of study?

Helpful HRPP Manual Sections

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Question Number

  • Initial Application (Exempt) - Question 9D

  • Initial Application (Expedited and Full Board) - Question 20D and 20E