Student or Medical Resident Researchers
Research conducted as part of an in-class assignment generally does not require IRB review. The purpose of an IRB is to review research conducted using human subjects. For the purposes of UCD’s IRB, research is defined as:
- A Systematic investigation, including research development, testing, and evaluation, designed to create generalizable knowledge.
- Generalizable knowledge means new information that has relevance beyond the population or program from which it was collected, or information that is added to the scientific literature.
Knowledge that can be generalized is collected under systematic procedures that reduce bias, allowing the knowledge to be applied to populations and settings different from the ones from which it was collected. Most in-class projects where research is conducted using human subjects is not systematic or generalizable. In general, if the project is meant to complete an assignment for a class and has no relevance beyond the class, it does not require IRB review.
In This Section
- What is a Class Project?
- Instructor Responsibilities
- Student Responsibilities
- Student Research Involving Human Subjects
- Graduate Student Research Requiring an IRB
- Faculty Advisor Responsibilities for Student Researchers
A class project is an academic project or student assignment that may involve collection of data from human subjects when the data is used solely for the purpose of teaching course content and is not intended to be used to develop or contribute to generalizable knowledge.
Once something is classified as a class project, it is always a class project. In other words, retroactive approval for data collected during or after a class cannot be added to ongoing data collection or for previously collected data.
All projects where human subjects may be involved must have the explicit approval of the course instructor. Course instructors who require such assignments are encouraged to complete CITI training in research ethics to ensure that their assignments and the work their students do conforms to federal rules and guidelines.
For an in-class assignment that does NOT require an IRB review, instructors have an obligation to ensure that students understand their ethical obligations in carrying out their assignments. Instructors should provide guidance to students collecting information so as to minimize any unwitting or unintentional harm to other students or individuals, especially if students will interact with or collect private information about vulnerable individuals.
Faculty members may pursue some of the following options:
- Review students’ plans for classroom or group projects and suggest improvements in design and protections for confidentiality.
- Suggest students take the CITI online training on human subject protection before collecting information from others.
- Explain ways in which students should be attentive to the welfare of individuals in vulnerable situations, such as young children, prisoners, or the cognitively impaired, or when there is any possibility of physical harm.
- Explain ways in which students should be attentive to the welfare of individuals in situations in which students will pose sensitive questions, including topics related to sexual activity, victimization, use of alcohol or illegal drugs, or involvement in illegal activity.
- When written questionnaires are to be used, suggest that information be printed on them explaining the use of the data for coursework and including the name and contact number of the instructor.
- Suggest, whenever possible, anonymous data collection so that the data are not linked to individuals.
- Suggest that information identifying individuals be kept separately from the information collected from those individuals.
- Suggest destruction of non-research data at the end of the course or within a short time afterward.
- Instruct students about the privacy and security vulnerabilities associated with networked computers.
Data procured for the purposes of ‘course work’ may not under any circumstances be used for research without consulting the IRB. If students (or faculty on their behalf) think the data may be used for research purposes beyond the classroom assignment, then an IRB application should be filled out prior to data collection.
Students who publish their research projects via any vehicle, e.g., blogs, must have submitted an IRB application for review prior to conducting the research. No retroactive determination is available.
Research projects conducted by students, such as theses, dissertations, honors projects, capstone projects, and independent study projects, that collect data through interactions with living people or access to private information fall under the jurisdiction of the IRB. As with other in-class projects, these research projects must be approved by the student’s Faculty Advisor before coming to the IRB. Visit our Does My Project Need Review by the IRB? webpage for more information about research requiring IRB review.
Because most graduate level projects are very time sensitive, graduate students are encouraged to begin their discussions with their professor about the nature of their intended research and its potential IRB review as soon as possible. Students should expect the IRB process to take at least one month, review times vary based on complexity of the research. All IRB initial review applications MUST have instructor approval, see requirements for student principal investigators. All IRB applicants are required to complete CITI IRB training prior to submitting their applications. Research will not be approved until the training requirements are met. Visit our Does My Project Need Review by the IRB? webpage for more information about research requiring IRB review.
Responsibilities apply to faculty supervising students/medical residents as a Principal Investigator (PI). The IRB holds the faculty advisor responsible for the overall management of an approved research protocol in conjunction with the student PI. Management of the research encompasses the ethical, administrative, fiscal, and applied elements of a project. More information, and a list of responsibilities, can be found here.