Under the provisions of 45 CFR 46, research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” [45 CFR 46.102(d)]. The term human subject is defined as “a living individual about whom an investigator…conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” [45 CFR 46.102(f) (1 and 2)].
By UNF policy, all research involving human participants should be conducted under equivalent levels of protection regardless of funding source. All research that uses human participants, tissues/specimens from humans, data/records from human participants, or surveys of human participants requires review and may require approval from the IRB.
Classroom experiences designed to develop knowledge and skills in research methodologies and inquiries designed to inform internal university decision making and program improvement may not be subject to IRB review.
The requirement for IRB review extends to human subject research conducted by any UNF faculty, staff, or student. All UNF faculty members, staff, and students must submit protocols for their research involving human participants to the UNF IRB. Student research includes, but is not limited to, all honors theses, master’s theses, and doctoral dissertations.
Each research study submitted for review can list only one principal investigator. A principal investigator may be a UNF faculty member or a collaborator at another institution. Co-investigators may be faculty members, community faculty, residents, students, collaborators at other institutions, and others who are adequately trained to play a significant role in the research project. For student research other than theses and dissertations, the principal investigator shall be the faculty member supervising the research.
Class projects at UNF are those in which students’ involvement is limited to developing the knowledge and skills needed for conducting research with human participants. Class projects might involve interviews in person or by telephone, observations, written or electronic surveys, or analysis of archival data. Given the pedagogical nature of class projects and the inexperience of students conducting class projects, the subject matter of such projects cannot involve more than minimal risk or include vulnerable participants. Designation as a class project does not apply to courses labeled (a) directed independent study, (b) supervised research, (c) honors theses, (d) masters theses, or (e) dissertations if these courses involve research with human participants (as defined in 45 CFR 46).
In order to obtain a determination from the IRB administrators that student activity in classrooms qualifies as a class project rather than research, class projects must meet the following criteria.
Instructors who believe that student activities in a course should be classified as class projects should submit the “Instructor Checklist for Class Projects,” with attachments to the IRB administrators, Office of Research and Sponsored Programs. As is the case with all research conducted by UNF faculty, staff, and students, determination of the student activity as a class project rather than research must be made by the Chair of the IRB in consultation with the IRB administrators.
Whether studies conducted for the purposes of quality assurance, quality control, or program evaluation constitute research with human subjects is not always a simple matter. If such studies are intended solely for use in internal program planning and development or to monitor processes within the organization and are not designed to have application beyond the organization or program that is the target or source of the study, these studies may not be subject to IRB review. The data collection and analysis activities from these studies are not be intended to contribute to generalizable scientific knowledge but are rather used to improve the provision of services to a specific population, organization or program, the studies are not by definition research involving human participants and are not subject to IRB review. If, on the other hand, such studies are intended to inform the field of study and lead to dissemination of the results outside the institution, they are considered research involving human participants and are, therefore, subject to IRB review.
Typically, the following UNF internal quality assurance activities do not require IRB review: teaching, faculty, and staff evaluations (but research on such evaluations would require IRB review); performance evaluations; institutional program review; classroom assessment, program assessment, curriculum review; and strategic planning.
By contrast, some quality control studies, needs assessments, or program evaluations may also be designed as research involving human subjects. For example, the study results may be intended to inform the field of study and, thus, may lead to publication of the results in scholarly journals, presentations at professional conferences, and books or monographs that report the findings in a way that impacts the replication of programs or services or the development of public policy. Such studies should be reviewed by the IRB prior to commencing the study. Principal investigators who are unsure about how the results from a study may be used and who may want to publish results in a scholarly venue because the findings are important and the results warrant dissemination should seek IRB review prior to beginning the study. The IRB will not grant retroactive approval for researchers to publish data that were not collected through an IRB-approved project.
Principal investigators who are planning studies that may not meet the federal guidelines for research involving human participants should submit the appropriate documentation for IRB review. After review of this form, IRB administrative staff will provide official written notification stating whether a project requires IRB approval. Even when the project does not fall under the purview of the IRB, projects must be conducted in compliance with the highest ethical standards and principles.
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