A. Scope of Review
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.
B. Whose Research Is Reviewed?
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.
C. Funded Research
Federal, state, local, and private funding agencies may require documentation of IRB approval for research that involves human participants. UNF requires IRB approval prior to the release of funds to support any research involving human participants, regardless of the review category. IRB approval must remain current in order for subsequent funds to be released.
D. Class Research Projects
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.
Activity is described as a class project rather than as research to prospective participants, other students, university faculty, and university staff. To the extent that these projects involve practicing and honing skills (e.g., interview techniques, observational methods, and data analysis), projects should be described as exercises in developing and practicing such skills.
No dissemination of findings and conclusions in ways that contribute to generalizable knowledge. Data collected by instructors and students in class projects cannot be used by them or anyone else for publication or presentation outside of the course for which the projects were conducted. The only exception to this provision involves community-based projects (e.g., program evaluation). For community-based projects, dissemination of project information is limited to reports to community agencies for which project information was collected.
Participants from vulnerable groups cannot be included. Class projects cannot involve the use of vulnerable populations, as defined in federal regulations and University of North Florida IRB Standard Operating Procedures. Additionally, individuals potentially vulnerable to coercion or undue influence (e.g., individuals with whom students in a research methods course have a supervisory relationship) should not be included.
The project involves no more than minimal risk to participants. Class projects cannot involve topics that involve physical, social, psychological, and/or legal harm to the participants.
Provision for informed consent. Participants in a class project must be fully informed about the nature of the project (including but not limited to its risks and benefits) and must voluntarily consent to participate in the class project. The only exceptions to this requirement for informed consent are projects that only involve (a) the observation of public behavior or (b) the use of archival data (i.e., existing data, records, or documents), provided these data are recorded by students in such a way that the participants cannot be identified.
Adequate Provision for Data Monitoring and Storage. Any data collected as part of class projects must be collected and stored in such a way that the identity of participants cannot be compromised. All information collected from participants in class projects (e.g., surveys, observation notes, and interview transcriptions) must be destroyed at the end of the semester. This requirement does not apply to course-related products such as student papers that may need to be retained by instructors as part of the course records.
Instructor Responsibility for Student Training. Given that students in research methods classes are inexperienced with respect to ethical issues in conducting research with human participants, instructors agree to complete the certification required for principal investigators and to train their students with respect to ethical principles and issues that may arise in interactions with human participants.
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.
E. Institutional Quality Assurance, Quality Control, and Program Evaluation
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.