Student Projects that Satisfy a Course Requirement Designing a research protocol that is both scientifically sound and ethically permissible is a learned skill-set that requires practice. The New School offers various courses to teach students these skills (such as "Research Methods," “Methods of Inquiry,” and others). Students in these classes learn how to design protocols and data collection instruments; students then develop skills by practice in conducting projects with human subjects, and collect data that they can use to practice data analysis methods. When these activities and the resulting projects are part of pedagogy, they rarely meet the federal definition of regulated research that requires HRPP/IRB review. For example, these projects often are not investigating new phenomena with the purpose of drawing conclusions, so that the knowledge can be brought into general use or can be applied to a wider or different range of circumstances. Please refer to the section "Considerations for RESEARCH determinations" in the HRPP Policies and Procedures, "Determining Research involving Human Subjects at The New School." In general, activities designed for educational purposes that teach research methods or demonstrate course concepts are not activities intended to create new knowledge, and therefore do not meet the federal regulatory definition of "research." It is important to not conflate a desired outcome with the designed purpose of the activity; if the purpose (or deliverables) of the study are to produce scholarly knowledge for a particular field, only then would the project be regulated ‘research’. When this is the case, then a student is required to submit the research protocol materials in accordance with HRPP Policies.38 Students, like faculty and staff, must still uphold the highest ethical and professional standards of their field while conducting projects, even if the project is not subject to HRPP/IRB review. It is also important to note that the possible publication/presenting of a student project does not change the purpose of this activity; many non-research projects conducted by investigators are regularly published, such as quality improvement/assessment projects, case reports, etc. The Office for Human Research Protections (OHRP) has published guidance in the form of FAQs stating that the intent to publish is an insufficient criterion for determining whether an activity involves "research" that is subject to review. Therefore, if a student is merely presenting/publishing their coursework and not conducting new/different analyses from what was completed for their course, then the student can provide a copy of this HRPP Policies and Procedures Manual to an editor, and refer to the relevant sections. 38

Student researchers must have a faculty advisor (FA) who has agreed to serve as an active mentor to the student; the FA shares responsibility for the ethical design and conduct of the research as well as ensuring compliance with applicable regulations, laws, and institutional policies. The FA is also responsible for monitoring the student researcher’s progress to avoid non-compliance, adverse events, or problems, and for promptly reporting these events if they occur. (Please refer to the "Roles and Responsibilities" section for more information).

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However, it is common for a project to grow and change, such that the initial activity may have been for one purpose (to fulfill a course requirement), but afterwards, the collected data could be used for a new/different purpose (new analyses). If the student wants to use the collected data for a new/different purpose, then it is possible that the student at that point may be conducting regulated "research" with existing data (collected during the course). Please see the section titled "Secondary use of Existing data" for more information.

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