Student Research Policy

Student research projects that meet all of these conditions may be conducted under the supervision of the faculty member without submitting a protocol to the IRB. Projects that do not meet all of these conditions must be submitted to the IRB for review.

1. The project must meet the definition of classroom research/student research. This is defined as a project that:
   1. is a normal part of the student's coursework,
   2. is supervised by a faculty member,
   3. has as its primary purpose the development of the student's research skills,
   4. does not present more than minimal risk to participants or to the student investigator,
   5. does not include any persons as research subjects under the age of 18,
   6. does not include any persons as research subjects who are classified as protected populations or sensitive subjects according to Federal regulations,
   7. is not genuine research and will not result in a degree culminating product (e.g., thesis, dissertation), publication or some other form of public dissemination (e.g., presentation at conferences including the undergraduate/graduate scholars forum);
   8. does not involve sensitive, personal, or incriminating topics,
   9. would be eligible for review at the Exempt or Expedited level.
       
2. Student research projects must meet all the criteria for an Exempt or Expedited Review as defined in the IRB Guidelines. If the faculty member has concerns or doubts, he/she should consult with the chair of the IRB. The faculty member or student researcher may also request a formal review by the IRB of any student research project prior to beginning the research project.
    
3. Projects considered "classroom research" are viewed as being outside of the federal definition for human subjects research. As such, these projects do not have formal IRB approval and thus may not be presented at local, state, national or international conferences, published, or used for thesis/dissertation projects. If a student believes they may wish to present or publish their work at a future point, the student must submit a regular IRB protocol and have it reviewed accordingly. Please note, we do not provide IRB approval for projects after the fact.
    
4. Faculty teaching research methods and overseeing student research projects are expected to understand the philosophy, ethics, and practice of protecting human subjects in research; to adhere to these principles during the conduct and supervision of classroom research projects; and to teach these practices and principles to students. Faculty will be responsible for ensuring that all student research projects are conducted in accordance with federal regulations and principles regarding protection of human subjects in research.
    
5. Faculty who want to supervise classroom research projects must complete ethics training via CITI, a Computer-Based Training module located CITI - Collaborative Institutional Training Initiative
    
6. Members of the IRB are available to provide advice and consultation about the protection of human subjects to faculty, staff and students as questions arise. Contact the IRB at irb@stmarys-ca.edu.

All student researchers must have a faculty supervisor for the project. All IRB applications for student projects must be pre-approved by the faculty supervisor.

Generally, student research involving human subjects falls into one of two categories: (1) research practica, and (2) directed or independent research projects.

Research practica are class projects designed to provide students an opportunity to practice various research methods such as interview, observation and survey techniques, as well as data analysis. Such projects typically do not lead to generalizable knowledge, and thus they are typically excluded from IRB oversight. However, results obtained from research practica cannot be shared outside of the classroom context.

Research practica do not require IRB review unless the project falls into one of the following categories:

1. Studies involving participants who belong to vulnerable populations (such as children, pregnant women, racial or ethnic minorities, etc.), or participants who may have difficulty making an informed decision about participating in the study.
2. Studies investigating illegal activities. (Including shoplifting, underage drinking, etc.)
3. Studies in which a breach of confidentiality poses a risk to participants, such as those that ask about socially stigmatized behaviors and attitudes.
4. Studies that place participants at risk due to emotionally charged subject matter.
5. Studies involving deception.

If you are a faculty member designing a research practicum or intending to incorporate data gathering activities into your course, please review the section entitled Data Gathering Activities within Courses on this site.

Any student-led human subjects research, as defined by the Code of Federal Regulations (CFR), that does not meet the criteria for research practica outlined above is subject to IRB review. This includes, but is not limited to, independent undergraduate research projects and honors theses, as well as master's theses and dissertations.

Graduate and undergraduate students often have no experience preparing research protocols for submission to the Institutional Review Board. This lack of experience can lead to multiple protocol revisions and significant delays in the review and approval process. It is the responsibility of the faculty supervisor to ensure that research pratica are conducted according to the ethical standards of the relevant discipline, and to determine when an undergraduate student project does not meet the definition of a practicum and must be reviewed by the IRB.

The faculty supervisor will assume the role of the responsible investigator on all research involving human subjects designed and carried out by students.  The responsible investigator will advise students throughout the process of protocol development, submission, and review, as well as in the implementation of the research project. The faculty supervisor must ensure student researchers are aware of their responsibilities as investigators, and that the content, quality, and timing of submitted research protocols meet all IRB requirements. The faculty supervisor is also accountable for ensuring that the IRB is notified immediately in the event of research-related, unanticipated events or findings during the study that would affect the risks or benefits of participation.