Title
Office of Human Research Ethics SOP 4601: Trainee or Student Research and Course Projects Involving Human Subjects
1. Purpose
Federal regulations and University of North Carolina at Chapel Hill (UNC-Chapel Hill) policies require Institutional Review Board (IRB) approval for research with human subjects. This applies whether the research is conducted by faculty or students, by individuals, or a group. Failure to obtain proper approval in advance may jeopardize your data, prevent you from publishing the results, and place you and UNC-Chapel Hill in violation of federal regulations. The IRB does not have the option of granting “retroactive” approval after research is done; you should err on the side of submitting an application to the IRB if there is any doubt.
2. Policy
2.1 - Student or Course Projects that Qualify as Human Subjects Research
When class projects and student or trainee research projects in the form of directed or independent research, including projects that result in undergraduate honors theses, Masters theses, or doctoral dissertations qualify as human subjects’ research as defined by 45 CFR 46.102(l), submission to the UNC-Chapel Hill IRB is required.
Student researchers should submit an application to the IRB through IRBIS. In order to serve as Principal Investigator (PI), student researchers must have a UNC-Chapel Hill Faculty advisor listed in their IRB application. Please see the UNC-Chapel Hill Office of Human Research Ethics (OHRE) SOP 1501: Investigator Responsibilities for more information on who may serve as the PI on trainee research projects.
Please make special note that under 45 CFR 46.102(l) the following activities (including but not limited to) are deemed not to be research under the purview of Human Subjects’ research regulation, or the IRB:
Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
2.2 - Training of Student Researchers
Student researchers engaged in human subjects’ research must complete the human research education training required for all research team members as outlined in OHRE SOP 1501: Investigator Responsibilities. Instructors should actively instruct the students in the application of ethical principles and regulations as they apply to the class project, including, but not limited to: respect for persons as it translates into informed consent, courtesy, avoidance of unnecessary discomfort, and protection of privacy.
All submissions to the UNC-Chapel Hill IRB with as student named as the Principal Investigator to require a UNC-Chapel Hill faculty advisor as outlined in OHRE SOP 1501: Investigator Responsibilities. Students and advisors should contact the IRB Office with any questions.
2.3 - Student and Course Projects, Not Human Subjects Research
Class projects are generally conducted for educational purposes and are not designed to develop or add to generalizable knowledge. Learning how to conduct ethical research is an important part of a student’s educational experience. To receive a formal, written determination from the UNC-Chapel Hill IRB that a class project is not human subjects research, investigators must submit a Non-Human Subjects Research application via IRBIS. See also OHRE SOP 501: Human Subject Research Determination.
Instructors and departments are encouraged to contact the relevant IRB for guidance about ways to handle topics such as privacy, confidentiality, informed consent for participation, and professional ethics when class projects are part of the course syllabus. These issues may still remain even when IRB approval is not required, in which case instructors, advisors, departments, and schools play an even greater role in providing the appropriate guidance and oversight.
When student or course projects do not qualify as Human Subjects Research under 45 CFR 46.102(l), the IRB recommends the following parameters as best practices for student projects:
- Results of the project are used only by the course instructor for teaching purposes and discussed within the classroom for teaching and learning purposes;
- Activities are no more than minimal risk;
- Vulnerable populations are not targeted (e.g., children under age 18, prisoners, persons who are cognitively impaired, etc.);
- Data collected are recorded in such a manner that the subjects are not identifiable (images in videotapes and photographs and voices on audiotape are identifiable); and
- When appropriate, there is a process in place for participants to be informed about and consider participation in the project
2.4 - Responsibility of the Course Instructor
The course instructor is responsible for communicating to the students the ethics of human subjects research, ensuring the protection of human subjects (including a process is in place for obtaining voluntary informed consent from research subjects when appropriate), and for monitoring the students’ progress.
When designing a project, students should be instructed on the ethical conduct of research and on how to complete an IRB application when one is required. In particular, instructors and students should:
- Understand the elements of informed consent;
- Understand how to develop appropriate consent documents;
- Plan appropriate strategies for recruiting participants;
- Identify and minimize potential risks to participants;
- Assess the risk-benefit ratio for the project;
- Establish and maintain strict guidelines for protecting privacy and confidentiality, and
- Allow sufficient time for IRB review process (if necessary) and completion of the project.
When considering whether or not a class research project requires IRB review, the instructor or student, as applicable, is encouraged to contact the IRB office for assistance.
Contact Information
Policy Contact
Name: Kimberly Brownley
Title: Associate Director of Policy and Initiative
Unit: Office of Human Research Ethics (OHRE)
Email: kim_brownley@med.unc.edu