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111.7 Organization Policy on Sample Size

August 2013

The Organization requires that applications for human subject research specify a number of participants to be enrolled in a research study. The Organization authorizes the JHM IRBs to require modification to the proposed sample size.  A new application submitted for IRB review must state the number of participants to be enrolled. When approval is issued, approval is granted to enroll only the number of participants listed in the application. This number is defined as the number of participants who sign the informed consent document, are enrolled using an oral consent process or are enrolled with a waiver of consent. If this number is reached, enrollment must cease. Enrollment of participants beyond the initial approved number is considered non-compliance with terms of the project approval. In order to increase the sample size above the number approved, a change in research must be submitted to the IRB for review. Enrollment may not continue above the approved sample size until the IRB approves the change in research. A change in research concerning sample size may be eligible for an expedited review by the JHM IRB.