Office of Human Research Ethics SOP 4601: Trainee or Student Projects Involving Human Subjects Research

Title

Office of Human Research Ethics SOP 4601: Trainee or Student Projects Involving Human Subjects Research

1. Student Research

1.1 Human Subject Research and Course Projects

Learning how to conduct ethical human subject research is an important part of a student’s educational experience. Research activities that are designed as part of a course requirement for purposes of learning experience only and are not “designed to develop or contribute to generalizable knowledge” may not require IRB review and approval if all of the following conditions are true:

  • Results of the research are viewed only by the course instructor for teaching purposes and discussed within the classroom for teaching and learning purposes.
  • Results of the research are not made public through presentation (outside of the classroom) and are not published in paper or electronic format (e.g., cannot be made available on the internet, cannot be published in a journal, etc.).
  • Research procedures 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).
  • When appropriate, an informed consent process is in place.

1.2 Responsibility of the Course Instructor

The course instructor is responsible for communicating to the students the ethics of human subject research, for 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 the preparation of the IRB application when such is required. In particular, instructors and students should:

  • Understand the elements of informed consent;
  • Develop appropriate consent documents;
  • Plan appropriate strategies for recruiting subjects;
  • Identify and minimize potential risks to subjects;
  • 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 (if necessary) and completion of the project.

In making a determination of whether or not a class research project requires IRB review, the instructor is encouraged to contact the IRB office for assistance.

1.3 Individual Research Projects Conducted by Students

Independent study projects, senior theses, undergraduate research projects, Masters and advanced degree research, and similar exercises must be independently submitted for IRB review. It is important to keep in mind that any human subject research activity that will ultimately contribute to part or all of a thesis, dissertation, or other type of publication or presentation must go through the IRB review process prior to enrolling subjects and collecting data. IRB review/approval cannot occur after a study has begun.

1.4 Student or Trainee Honors Projects, Theses and Dissertations

Student or trainee research projects in the form of directed or independent research, such as theses, dissertations and honors research projects, are generally research intended to contribute to generalizable knowledge. When they involve human subjects, these projects require IRB review, as with any human subject research.

1.5 Student or Trainee Human Subjects Projects (Class Projects)

Class human subject research projects (not for thesis or dissertation) are often designed primarily to educate students in research techniques or issues, without an expectation of contributing to generalizable knowledge. However, since the lines between educational goals and research are sometimes difficult to demarcate, and class projects may still (either directly or through data about them) involve living persons, class projects may expose individual subjects to the same risks as research intended for broader purposes. Furthermore, since a major goal of a class project should be to educate students in the process of human subjects research, instructors should make every effort to make the research process as realistic as possible.

1.6 Training of Student Researchers

Trainees must complete the human research education training required for all University research team members, or a tailored package deemed appropriate by the IRB, in consultation with the instructor. 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.

Students and advisors should contact the IRB Office with any questions.

1.7 Independent Study, Theses and Dissertations

These research activities are considered to meet the federal definition of human subject research and must be independently submitted to the IRB by the student-investigator. However, when students conduct research as part of a course of study, a faculty member ultimately is responsible for the protection of the subjects, even if the student is the primary investigator and actually directs the project. Advisers assume the responsibility for students engaged in independent research, and instructors are responsible for research that is conducted as part of a course.

Students may not serve as principle investigators. They must have a faculty sponsor who fulfills the principle investigator eligibility criteria and who will serve as principle investigator and faculty advisor on the study.

2. Self-Experimentation

Generally, researchers should not enroll themselves as subjects in a study that they are supervising. Such a practice presents obvious conflict of interest issues and a variety of other ethical and practical issues.

3. Family Members in Research

While there is no absolute prohibition on an investigator enrolling family members in a study, due to the possibility of undue influence and a conflict of interest, in most cases, this should be avoided.

Contact Information

Policy Contact

Office of Human Research Ethics
CB 7097
720 Martin Luther King Jr. Blvd.
Bldg # 385, Second Floor
Chapel Hill, NC 27599-7097

Ph: 919-966-3113
Fax: 919-966-7879

Details

Article ID: 132264
Created
Thu 4/8/21 9:27 PM
Modified
Fri 3/18/22 4:58 PM
Effective Date
If the date on which this document became/becomes enforceable differs from the Origination or Last Revision, this attribute reflects the date on which it is/was enforcable.
06/02/2017 12:00 AM
Issuing Officer
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Issuing Officer Title
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Vice Chancellor
Last Review
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06/02/2017 12:00 AM
Last Revised
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06/02/2017 12:00 AM
Next Review
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06/02/2019 12:00 AM
Origination
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06/02/2017 12:00 AM
Responsible Unit
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Research-IRB and Human Research Ethics