Student researchers are held to the same standards as all other researchers. Below you will find information that will help you during the life cycle of a study.
- How to Apply for IRB Review
- Types of IRB Review
- Student Handbook: Making Sense of Human Subjects Research
- About iStar- IRB Application System
- Training Required for Human Subjects Research
- Model IRB Applications
- Doing Research Online
For questions or assistance with an IRB application contact the IRB Student Mentor
USC recognizes that some student projects are conducted to fulfill course requirements, and involve activities that might appear to be human subjects research. Classroom assignments do not require IRB approval. These projects typically fulfill a course requirements, are often completed in one semester, and are designed to teach research methods. Faculty members design these assignments to engage students in interaction with individuals, gather data about individuals, and/or illustrate concepts covered in the course.
If students or faculty are uncertain if a classroom project must be reviewed by the IRB, they should contact the IRB.
Is Your Project Human Subjects Research, Or Not?
The first question a researcher should consider with respect to IRB review is whether the research project fits the definition of “human subjects and research”.
Human Subjects Defined
A human subject is defined by Federal Regulations as
“a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable information”.
Living individual-The specimen(s)/data/information must be collected from live subjects. Cadavers, autopsy specimens or specimens/information from subjects now deceased is not human subjects.
“About whom”-a human subject research project requires the data received from the living individual to be about the person.
Intervention includes physical procedures, manipulations of the subject, or manipulations of the subject’s environment for research purposes. Interaction includes communication between the investigator and the subject. Interaction also includes face-to-face, mail, and the phone interaction as well as other modes of communication.
Research is defined by federal regulations as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”.
Identifying Human Research Studies
Certain studies may have the characteristics of human subjects research but may not meet the regulatory definition. Studies which meet the definition require IRB review. There are three categories to consider:
- Studies that are human subjects research
- Studies that may be considered human subjects research (gray area)
- Studies that do not qualify as human subjects research
Any investigator who is unsure of whether his/her proposal constitutes “human subjects research” should contact the IRB office or submit an online “Request for Human Subjects Research Determination” through iStar. The IRB staff, Chair and/or designee will determine if the study is human subjects research. Federal regulation do not recommend investigators to make this determination themselves.
Studies that ARE Human Subjects Research
- Studies that utilize test subjects for new devices, products, drugs, or materials.
- Studies that collect data through intervention or interaction with individuals. Examples of this type of research include drug trials, internet surveys about alcohol consumption, studies that involve deception, research involving risky behaviors or attitudes, and open-ended interviews with minors that contribute to generalizable knowledge.
- Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.
- Studies that use bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if one did not collect these materials for the study.
- Studies that reproduce generalizable knowledge about categories or classes of subjects from individually identifiable information.
- Studies that use human beings to evaluate environmental alterations, for example, weatherization options or habitat modification to their living or working space or test chamber.
Studies that ARE NOT human subjects research
Studies that fit any of the categories below do not need an IRB review.
- Data Collection
- Service Surveys
- Information-gathering Interviews
- Course-related Activities
- Biography or Oral History Research
- Independent Contract for Procedures
- Research Involving Cadavers
- Innovative Therapies
- Quality Improvement
- Case Histories
- Publicly Available Data
- Coded Private Information or Biological Specimens
At USC, faculty who supervise student research are called Faculty Advisors (FAs). FAs play an important role in human subjects protections. The FA bears ultimate responsibility for the ethical conduct of research carried out by the student. The time and effort FAs dedicate to their students has considerable impact on student projects, quality data, and the time required for IRB approval.
Faculty Advisors Must:
- Take an active role in mentoring
- Assume responsibility for students’ research: both planning and conduct
- Validate study design and methodology
- Allocate adequate time for each student
- Assure scientific merit in student projects
- Know if an informed consent or waiver is needed
- Help students determine the level of risk: Is the project less than or greater than minimal risk?
- Know the levels of IRB review: Exempt, Expedited, Full Board, or “NHSR”
- Anticipate time required for students to secure IRB approval and conduct the research
- Complete mandatory Human Subjects training (CITI)
Student Investigators Must:
- Work with the advisor to develop a study design with merit
- Meet regularly with the advisor to report their progress
- Take online human subjects education training (CITI)
- After the FA approves, submit an application to the IRB
- Obtain IRB approval before initiating any research activities
- Inform the IRB of all proposed changes or additions to the previously approved study before implementing them