Student Researchers

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 Defined

Research is defined by federal regulations as “a systematic investigation, including development, testing, and evaluation, designed to develop  or contribute to generalizable knowledge”.

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

1. Studies that utilize test subjects for new devices, products, drugs, or materials.
2. 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.
3. Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.
4. 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.
5. Studies that reproduce generalizable knowledge about categories or classes of subjects from individually identifiable information.
6. 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

Cohort—a single group of students who are all addressing the same research question in the same way.

Submit as a single protocol if all the following are true:

• Targeting the exact same sample (with minor differences such as different schooling levels or different districts)
• Engaging in the exact same data collection methods (I.e., using the exact same survey or interview protocol)
• Undertaking the exact same approach to analysis

In this instance one student would be listed as the principal investigator and the other students would be identified as co-investigators or other study personnel.

Submit individual protocols if any of the following are true:

• Student has defended their proposal before others in cohort
• Research question, the sample, the data collection activities or instruments, or the analysis approach differ from others in cohort

Student researchers must submit their application using the correct review (risk) determination category (e.g., exempt, expedited, etc.). It is the faculty advisor’s responsibility to verify that the correct review category has been selected prior to submitting the application to the IRB. Exempt applications submitted as expedited or Full Board will be returned to the PI, which will delay the review/approval process.

If you, or your faculty advisor, have questions regarding the review type, please reach out to the IRB Office or schedule virtual office hours.

Faculty Advisors

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
  process.
• 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
  HRPP and/or IRB Offices may require additional training/education for those
  Faculty Advisors.
• 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 completed form must be submitted to the IRB
as a part of the iStar application. The request form can be found on Forms and Templates page.