蜜柚视频

Purpose: This guidance aims to inform 蜜柚视频 faculty and students about considerations pertaining to potential IRB review for class projects involving interaction with and/or data collection from living people.  

Scope: This guidance applies to projects undertaken for all 蜜柚视频 courses offered through all 蜜柚视频 campuses and online programs. 

Class Projects and Definitions of 鈥淩esearch鈥� and 鈥淗uman Subjects鈥� 

Class projects meeting both the definitions of research and human subjects by the federal definitions of those terms require IRB review. First, instructors should consider whether projects they assign to their students could meet the federal definition of research: a systematic investigation designed to develop or contribute to generalizable knowledge.  

If a project is solely designed and intended for educational purposes (for example, to teach students how to design a survey or conduct an interview), it is not considered to be a systematic investigation designed to develop or contribute to generalizable knowledge and therefore would not require IRB review.  

Projects that meet the federal definition of research may or may not involve human subjects. A project involves human subjects whenever the investigator will interact with humans to obtain information about the individual or use data that includes potentially identifiable information that can be linked to specific living individuals. Projects, including class projects, that meet both the federal definition of research and the federal definition of human subjects do require IRB review and approval.  

Types of Interactions with Individuals 

Instructors should consider that online surveys -- a type of project commonly assigned for coursework -- do constitute an interaction with humans even though the investigator and the participants may never engage in direct communication, and even though the investigator may not know the identity of the participants.  

In some cases, interaction with an individual may not be intended to collect information about the individual. For example, interviewing an employee to obtain information only about an organization or a policy of the organization would not place that employee in the position of a human subject by the federal definition.   

In other cases, an investigator may interact with an individual and collect information about them, but the intended purpose may not be to conduct a systematic investigation designed to develop or contribute to generalizable knowledge. Oral history interviews with or about single individuals that are not part of a larger project to draw generalizable conclusions about a group, for example, would not meet the federal definition of research. As another example, surveys conducted for the sole purpose of a program evaluation for a single organization and that an investigator will not use to generate data with the intention of extrapolating to generalizable conclusions would not meet the federal definition of research.  

Not Human Subjects Research Determinations and Class Projects 

The Office of Research Compliance (ORC) does not require investigators to submit for a formal determination of not human subjects research in the Cayuse system. Applying this guidance, instructors can prospectively determine if class projects they assign do not meet the federal definition of human subjects research and will thus not require students to submit in Cayuse.  

Internal Documentation for Class Projects that are Not Human Subjects Research 

Instructors who prospectively determine that their class projects do not constitute human subjects research are advised to document this in their own records with the following information: 

Class Title and Semester: 

Is the Class Project Research? 

• No, it is not a systematic investigation 

And/or 

• No, it is not intended to contribute to generalizable knowledge 

Does the Class Project Involve Human Subjects? 

• Data and/or biospecimens are not being obtained or analyzed from living individuals 

• Data is not 鈥渁bout鈥� a living individual 

• Data is not private information and is publicly available 

At least one of these three conditions must be met to determine that a project does not involve 鈥渉uman subjects.鈥� 

Formal Documentation for Class Projects that are Not Human Subjects Research 

Instructors who foresee the need for formal documentation that their class project does not meet the federal definition of human subjects research are welcome to submit this information in Cayuse. The ORC will review the submission. If the information provided sufficiently demonstrates that the class project is not federally defined human subjects research, a formal determination of not human subjects research (NHSR) will be issued.  

However, the ORC cannot issue an NHSR determination retrospectively. Any holistic NHSR determination for a class project must be granted before any project activities, including recruitment or data collection, begin. 

In some cases, the ORC can work with faculty to devise alternative processes if they anticipate a need to document not human subjects research determinations for some students in a class and to have other students submit protocols for IRB review that meet the federal definition of human subjects research. Please contact compliance@ohio.edu for more information. 

Don鈥檛s for Instructors 

• Do not set writing exercises instructing students to create submissions in Cayuse for projects that the students will not actually be undertaking. The ORC cannot process such submissions. 

• Do not instruct an entire class of students to submit individually in Cayuse before contacting the ORC. Large submission influxes extend turnaround time for all researchers at 蜜柚视频. The ORC appreciates advance notice from instructors in this situation so we can advise students and their faculty advisors if a protocol submission is actually required and so that we can allocate staff time accordingly. 

• Do not construct class projects that would constitute greater than minimal risk to individuals if these were being conducted in a research setting. 

• Do not include the following terms in consent forms used for class projects not requiring IRB review: Institutional Review Board/IRB; Research Compliance or the Director of Research Compliance; The Office of Human Research Protections/OHRP 

• Do not require students to do classroom-based projects involving interaction with living individuals and/or their identifiable data without also providing guidance about minimizing harm to individuals and about ethical standards in your discipline. 

• Do not require students to do classroom-based projects involving interaction with living individuals and/or their identifiable data without being prepared to accept responsibility for the conduct of those projects and to assure that the guidelines outlined here are upheld.