Chapter 15: Student Research

In accordance with federal regulations, the IRB requires that all human subjects’ research be reviewed by an IRB including master’s theses, doctoral dissertations, and all student research projects involving human subjects prior to recruitment and data collection. Under IRB policy, no USC student research will be approved with a study design that includes administration of medications. For unique situations, this prohibition may be discussed with the HRPP.

Classroom assignments or projects that typically fulfill a course requirement, 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. For the most part, they are not intended to create new knowledge or to lead to scholarly publication.

If a student develops a project with intention to use collected data for future research, create new knowledge, or contribute to scholarly publication, the project must be submitted to IRB for review and approval prior to conducting the research.

Students planning to complete classroom projects that will be reviewed and approved by the IRB must complete the Human Subjects Training course prior to iStar submission. Required courses are online at the Collaborative IRB Training Initiative (CITI).

At USC, students involved in classroom assignments must follow the University’s Code of Ethics and the USC Human Subjects Protection Program Policies and Procedures when designing and conducting projects with human volunteers.

Faculty members assigning projects in research methods classes are expected to help students understand the requirements for IRB review and the ethical obligations toward anyone with whom they interact to complete their assignments.

If students or faculty are uncertain if a classroom project must be reviewed by the IRB, they should contact the HRPP.. They should also review the guidance on what is Not Human Subjects Research as this may address questions for classroom projects. All Senior Thesis, Master’s Thesis and Dissertation research must be submitted to the IRB. In addition, any and all class research activities that will result in publication.

Faculty should determine whether an assigned project involving human subjects is defined as a course-related student project. Faculty should carefully review the Not Human Subjects Research guidance prior to contacting the HRPP office.  Next, if there are additional questions, faculty are strongly encouraged to contact the HRPP  office for assistance in making this determination.   Faculty should discuss general principles of research ethics with the class prior to the initiation of any project involving human subjects.  It may be possible to bundle similar studies conducted under one faculty advisor, decreasing the number of submissions that need to be submitted to the IRB (please contact the HRPP for further information).  Please review the information regarding to human subjects research in a cohort. If there is any intent to publish the classroom research, an IRB application must be submitted. No IRB approval may be given after a classroom-assigned study is begun or completed.

Faculty Responsibilities for the Protection of Human Subjects

Faculty who supervise student research are responsible for the protection of human subjects and are required to:

• • 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 fulfill 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.

• • 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 (refer to Section 18.2 – Unanticipated Problems Involving Risks to Subjects or Others).

Generally a Faculty Advisor is a member of the USC faculty, has an academic appointment,  and has a USC email address.  However, there may be circumstances when individuals who do not have an academic appointment may be the best person to oversee a student’s research.  In such cases, a Faculty Advisor Approval Form  must be submitted with the students IRB application in iStar section 40. The request form is available on the HRPP website: Forms and Templates, Other Forms. Please refer to specific guidance in Chapter 12.7 – Faculty Advisor’s Mentoring Students through Human Subjects Research .

The following approval is required:

1. The faculty advisor is qualified to oversee the proposed research and mentor the student.
2. The faculty advisor appointment extends for long enough to allow the student to complete this project.
3. The faculty advisor will complete the requisite Human Subject Protection training before the student begins his or her research involving human subjects and follow all policies and procedures of USC’s Human Research Protection Program.

The following policy is specific to international research conducted by USC students and is not applicable to funded clinical trials.

International research involves projects that are conducted outside of the United States. Federal regulations acknowledge that local customs, norms, and laws where the research will take place may differ from U.S. regulations governing research. Funded student research is required to meet U.S. standards wherever it is conducted. For unfunded student research, USC IRBs may accept equivalent protections depending on the risk level. It is the expectation that there will be a local contact and/or consultant for the student researcher who will provide information on local laws and cultural norms.

IRB Considerations

If an unfunded study involves minimal risk to participants, domestic IRB approval may be sufficient. Examples include surveys that compare use of social media in U.S. adults versus adults in another country or other questionnaires that do not collect sensitive information. Students and/or faculty should contact the IRB for additional information.

If a study involves more than minimal risk to participants, USC requires protocol review and permission from an IRB/Ethical Review Committee (EC), or equivalent organization in the country where the research will occur (refer to 6.9 – International Research). Examples of these studies include surveys about high-risk behavior or questionnaires that ask questions about HIV status.

International studies will follow the same criteria for IRB review and approval as domestic studies. For example, minimal risk study can receive an expedited review, whether the study is conducted within the US or abroad.

Research policies for studies conducted within the U.S. apply to international research wherever possible. In addition, international research protocols may include:

• • • Explanations of cultural differences that influenced the study design and the consent process.

• • • Rationale for conducting the study with an international population.

• • • Information regarding the host country’s IRB, Ethical Review Committee or equivalent organization and documentation of its approval of the research, if applicable.

• • • Permissions from local host Institution(s), and from government officials, as necessary, to cooperate in the proposed research.

• • • A copy of the informed consent form, if used, in English, and a copy in the appropriate language(s) of the participants.

• • • Information regarding the literacy level of the expected subjects and how this may affect the informed consent process.

• • • A description of the informed consent process, including methods for minimizing the possibility of coercion or undue influence in seeking consent and safeguards to protect the rights and welfare of vulnerable subjects.

• • • A description of the processes for assuring securing all data, and a description of the methods of transport and security of data to the United States, if applicable.

• • • If data will be collected by someone other than the researcher, submit their resume/ curriculum vitae and determine if human subjects training will be needed.

• • • If compensation is to be given to subjects, justification for the amount of money or goods should be provided with an explanation.

Faculty Advisor Responsibilities

Faculty Advisors are expected to remain in contact with students conducting research at any international site to ensure safety and welfare of the participants and student. Faculty must also prepare students for cultural differences they will encounter in an international setting. Faculty who supervise student researchers must be aware of their responsibilities and their role in the protection of human subjects. Refer to Section 15.3 – Requirements of Faculty Who Supervise Student Research for more information.

Consistent with an overall concern that no research subject should be coerced, researchers must take precautions to avoid the coercion that can occur when potential research subjects are also students. For this reason, researchers should avoid using their own students as research subjects. Researchers who wish to use their own students must be able to provide a good scientific reason, rather than convenience, for selecting their own students as research subjects.

In instances where investigators can provide justification for using their own students in their research, the IRB generally requires that someone other than the investigator (instructor) obtain informed consent and collect the data. When this is not possible, the IRB will consider other methods for obtaining consent and collecting data that would not reveal to the instructor, whether or not a student participated in the research project until after final grades have been determined. The students should be informed of these procedures in the informed consent form. In addition, it is generally recommended that the investigator/professor provide a recruitment flyer or letter to the students, so that the students may be the initiators and contact the investigator/professor regarding the research study.

Mandated reporters are individuals who are obligated by law to report suspected cases of child and/or elder abuse and neglect. In general, any person who has contact with children or the elderly in a professional capacity is a mandated reporter, although laws vary from state to state, as does the legal entity to which reports must be made. For the California Penal Code definition of mandated reporter see Elder Abuse and Dependent Adult Civil Protection Act Section 15630 (a) and Child Abuse and Neglect Reporting Act Section 11165.7. USC policies and procedures covering “mandated reporter” and the reporting of abuse/neglect can be found at the following site:
http://policy.usc.edu/mandated-reporters/.

Student Researchers’ Abuse Reporting Obligations

Although child or elder abuse may be disclosed or suspected in many research disciplines, research conducted in certain schools or departments (gerontology, psychology and social work) often provide situations in which evidence or disclosure of such abuse is more likely to be encountered. In the event that a student researcher becomes aware of, or reasonably suspects, that a study subject has been the victim of child or elder abuse, the student should follow these procedures:

If student researcher’s faculty advisor is a mandated reporter, the student researcher should notify that mandated reporter of the suspected abuse. A mandated reporter is legally obligated to follow up.

Even when the student’s faculty advisor is not a mandated reporter, the student researcher should notify the faculty advisor and/or the department of their concerns.

If one is not a mandated reporter, he or she need not make a mandated report however, students have an ethical obligation to report their suspicion to a faculty member for further action.

Abuse Disclosure Notification in Consent Documents

Disclosing the obligation to report certain types of neglect and abuse in the informed consent process is required for research projects involving mandated reporters. However, even though the requirement to report only applies to mandated reporters, Section 11166.05 broadens the scope of possible reporting beyond the mandated areas by allowing (not requiring) mandated reporters to make reports regarding children suffering from “serious emotional damage or… at a substantial risk of suffering serious emotional damage, evidenced by states of being or behavior, including, but not limited to, severe anxiety, depression, withdrawal, or untoward aggressive behavior toward self or others”. This should be addressed in the informed consent process.

A Subject Pool is a research resource used by some departments and schools in academic settings to enroll a large number of “available” subjects as potential volunteers. These volunteers are used in studies for that school or department. Subject Pools serve several roles: to provide researchers a pool from which to recruit primarily student participants for their studies and to familiarize students with the research process as subjects and researchers.

Participants in subject pools may be compensated for their time through course credit, extra credit or other means. These uses make subject pools commonplace in Social and Behavioral Studies.

Note: students must be provided an alternative to participation in the subject pool. The alternative assignment must not coerce subjects to participate in the subject pool. To prevent undue influence, the assignment should require approximately the same commitment of time and effort to complete as would participation in the subject pool.

Extra Credit

The IRB can approve projects that give extra credit to student subjects for participating in a research project only when alternative means of obtaining equivalent extra credit with an equivalent effort is available for students who decide not to participate in the research. The IRB carefully reviews the alternatives to participation to ensure that students are not being coerced.

The informed consent form should detail the consequences of withdrawing from a project prior to completing the research activities (extra credit should be given despite withdrawal). In general, the IRB favors giving extra credit even if a subject withdraws, unless the student withdraws immediately or there is clear evidence of bad faith on the part of the student.

Marshall School of Business Subject Pools

The Marshall School of Business has an unpaid student subject pool conducted by the Department of Management and Organization and a paid subject pool open to the general public conducted by the Department of Marketing. Links to the Marshall School subject pools and to additional information from Marshall are listed below.

• • • Policy for Researchers at Marshall School of Business

• • • Marshall Behavioral Lab

Department of Psychology Subject Pool

The Department of Psychology subject pool is only open to USC students. To access the Psychology Subject Pool webpage, click on link below.

• • • Department of Psychology – Subject Pool Webpage

Recent Federal Guidance on Subject Pool and Penalties for
“No Shows”

Penalties for no-shows may not be assessed in subject pools

The Office for Human Research Protections (OHRP) posted on its website a letter stating that imposing penalty credits on students who fail to show up for scheduled appointments with investigators without canceling by a specified deadline violates the requirement of Department of Health and Human Services (DHHS) regulation 45 CFR part 46.116(a)(8). The letter can be viewed by clicking here. At USC, the OHRP position is upheld for all research and no such penalty credits may be imposed on subject pool participants.

Correspondence with OHRP has indicated that in subject pool policies, penalties may be assessed when students:

• • • Sign up for a study for which they are not eligible

• • • Sign up for the same study for multiple different times

• • • Sign up for a study in which they have already participated