IRB: Research Method Class Protocol Policy number: 423 References: Research Method Class Protocol application Human Subject Protection Guide; section 3.6 and 2.5 Date: 04/18/2014 Policy Owner: Executive Director, HRPP Cross references: None Definitions: None 1.0 Reason for Policy This policy describes how the Institutional Review Board (IRB) will document and review research method course assignments. 2.0 Scope of Policy This policy applies to the University of Minnesota community and its healthcare components. 3.0 Policy Statement When the overall objective of a research method course assignment is to learn about the design and conduct of research projects, and if the data collected meets the definition of research with human subjects and will be collected and analyzed for classroom learning only, the faculty member or instructor is responsible for both the submission of a Research Methods Class Protocol (RMCP) application for prospective review by the IRB and the conduct of the course. For example, the faculty member or instructor is responsible for assuring that students have completed the basic level of training for human subject protection. Examples of appropriate research methods include simple anonymous survey, interview with innocuous questions or observation of public behavior. If the data collected does not meet the definition of human subjects’ research, an RMCP is not required. Page 1 of 2 The RMCP method and scope must qualify as no greater than minimal risk research and include no vulnerable populations, no sensitive or incriminating topics, and all subjects must be 18 years of age or older. The IRB will review the RMCP through expedited review. The RMCP approval will be reevaluated annually to ensure that the guidelines are maintained. The RMCP approval may be applied to other courses when multiple sessions of the same course are taught during an academic year. 4.0 Required approvals for this document Title Executive Director, HRPP 5.0 Revision History Revision 04/18/14 09/30/11 01/29/10 Reason for change Update Revision, definition clarification New Policy Development Date of release 09/02/14 09/30/11 02/02/10 To obtain a copy of a historical policy, e-mail IRB at irb@umn.edu or call 612-626-5654 Page 2 of 2