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
- About iStar- IRB Application System
- Training Required for Human Subjects Research
- Doing Research Online
- Best Practices in Clinical Research Protocol Writing
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:
- Determine whether projects require IRB review and assist students with the
- Discuss research ethics with the students.
- Familiarize themselves and students with ethical and regulatory mandates for
human subjects research.
- Complete Human Subjects Training – online at CITI and maintain certification.
- Ensure student iStar applications are complete and describe all study procedures
to be conducted; all sections are accurate and all relevant materials (e.g.,
instruments, consent documents, recruitment materials, etc.) are uploaded. The
IRB Office will return incomplete/inadequate applications to students and require
Faculty Advisors to assist them with the contingency responses requested. Faculty
Advisors who repeatedly allow their students to submit incomplete/inadequate
applications will have applications returned to their students without an IRB
review in order to allow the Faculty Advisors to fulfil their responsibilities. The
OPRS and/or IRB Offices may require additional training/education for those
- Approving the student’s IRB application and signing a Faculty Advisor Assurance
outlining their responsibilities.
- Monitor student projects focusing on maintaining confidentiality, privacy, the
level of risk, voluntary participation and withdrawal, and informed consent.
- Assure prompt reporting to the IRB of any event that requires reporting in
accordance with the IRB policies and procedures for Unanticipated Problems
Involving Risks to Subjects or Others and Adverse Events.
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
Waiver of Full-Time Faculty Status to Serve as Advisor for Research
Generally, only those who have a full-time academic appointment may serve as Faculty Advisor. However, there may be circumstances when individuals who do not have an academic appointment or full-time status may be the best person to oversee a student’s research. In such cases, a Waiver of Full-Time Faculty Status to Serve as Advisor for Research Proposal must be requested. The waiver is limited to studies that are no greater than minimal risk; any studies that are greater than minimal risk, and require Full Board Review, will require a full-time academic appointment at USC.
All personnel listed in the iStar application must adhere to USC requirements for iStar accounts and educational certificates (Human Subjects, Good Clinical Practice and HIPAA). Please see chapter 12 of the USC Policies and Procedures.
If the candidates FA does not have a full-time academic appointment with USC, the candidates FA must request an iStar account and submit the fully executed waiver to the iStar tech support (email@example.com) with the request to assign the FA role in iStar.
Once the function has been activated, and all current certificates have been uploaded into their iStar profile, the candidates FA can be listed in Section 2.1.
The candidate is required to upload the fully executed waiver into Section 40.1 of the iStar application, prior to submitting the application to the IRB. The OPRS Director, in consultation with the IRB, will review the request on a case-by-case basis and may reject the FA request if the IRB determines that the FA is not qualified to serve.
The waiver form can be found on the Forms and Templates page.