Guidelines for Student Work with Human Subjects
Evergreen supports student engagement in research. Projects involving human participants are a frequent part of academic programs and independent learning contracts at the college. There are three primary considerations for the protection of human participants in student-led projects at Evergreen.
1. Student projects should present no more than minimal risk to human participants.
2. Student projects require human subjects review if the project meets the definition of human subjects research.
3. Subjects in most research projects about human beings must give voluntary, informed consent, even if the project does not require human subjects review.
Read on for more information about each of these items.
1. Student projects should present minimal risk
Evergreen requires that students not engage in collecting data or information about human beings if doing so presents more than minimal risk to their subjects. This standard holds whether a student project requires human subjects review or not.
Minimal risk "means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR 46.102(i)). The federal Office for Human Research Protections offers detailed descriptions of minimal risk research activities. Also see the page, Understanding Risk.
Minimal risk can be exceeded in research projects in two ways--through the potential loss of confidentiality about a subject's private information, and through the actual research procedures.
Protection of private, sensitive information. Faculty and students must take great care in projects where the identification of the subjects and/or their responses would reasonably place those subjects at risk of criminal or civil liability, or be damaging to their financial standing, employability, insurability, reputation, or cause them loss of status in society or their personal relationships.
Student researchers should not collect sensitive identifiable information about human subjects unless:
- The potential benefits of the research justifies the risk of the loss of subject confidentiality; and
- Adequate protections are implemented to prevent invasion of privacy and breach of confidentiality (source: Federal Register, 63 FR 60364-60367). Recordings (audio or video) of human beings providing this kind of information is typically not justified.
Minimal risk protocols and procedures. Most often, students working with human participants on projects: 1) collect biological specimens or physiological data; and/or 2) collect information through interactions, such as surveys, interviews, tests, personal records, and other methods.
Students collecting biological specimens or physiological data must adhere to the Office for Human Research Protections guidance about minimal risk research activities. Such activities may also require review by the Science Operations Manager and the Campus Safety Officer.
Students collecting information through interaction with subjects must carefully consider the possible impact that those interactions might have on subjects, and the risk of harm that could result. Students are not permitted to conduct projects, in particular, where an interview, survey, focus group or other research interaction has the potential to evoke or reintroduce emotional harm to participants. Examples of projects to be avoided by students include but are not limited to:
- Any exploration of topics that could reasonably remind subjects of harm they suffered as a result of sexual assault, violent crime, war violence, domestic violence, state violence, terrorism, natural disaster, or other traumatic experiences.
- Tests or examinations that could bring to light personal information that could be troubling to subjects, such as IQ or some kinds of behavioral tests.
- Projects that ask for participant responses to potentially disturbing images, events, or reenactments of events, such as pornography, violence, verbal abuse.
- Projects that involve deception of participants.
2. Some student projects require human subjects review
If a student is conducting a project that meets the definition of human subjects research, that project must be reviewed and approved by the IRB. Before proceeding, please be sure you have read and are familiar with the guidance at Who Must Apply for Human Subjects Review?
Student projects that meet the federal definition of human subjects research require IRB review and approval. Any project conducted under the auspices of the college that meets the federal definition of research (systematic investigations leading to generalizable results) about human subjects (living people whose personal data or private information are the subject of the investigation) requires review and approval by the Institutional Review Board (IRB). This includes student projects offered for academic credit.
Examples of class projects that require IRB review include systematic investigations with human subjects that will result in:
- Publication (e.g., journals, books, electronic media, web sites, and student theses or dissertations that become part of the library’s collection) or public presentation (i.e., outside the classroom) of findings.
- Preservation of data or information that may be included in a longer-term generalizable research project by the faculty or another researcher.
For information about how to apply for human subjects review, visit the human subjects review application page.
Student projects that do not meet the federal definition of human subjects research, and involve no more than minimal risk to human participants, do not require IRB review and approval. Projects embedded within academic programs and independent learning contracts are frequently designed to help students develop their understanding of the principles of sound research and practice research methods, but they are not intended to produce generalizable results. These projects may involve human participants, and they may employ systematic protocols for gathering information (surveys, interviews, behavioral observations in controlled environments, etc.) If the results of the activity, however, will be used only for classroom instruction or for the student’s own personal academic development (that is, it will not be published or presented beyond the specific class or academic program), it does not require human subjects review. (No classroom-based project should present more than minimal risk to subjects. See the page Understanding Risk.)
Examples of class projects that do not require IRB review include:
- Interviews or surveys that will be summarized in class presentations or papers, but not published more broadly.
- Documentary or journalistic projects that may be published, but that only investigate small numbers of individuals in specific contexts and do not lead to generalizable research findings.
3. Most projects involving human participants require informed consent
Most projects involving human participants should have a process for achieving informed consent, whether or not the project itself requires human subjects review. For more information, visit the page Informed Consent. There is an exception in cases where the researcher is not collecting any identifying information and is merely observing subjects in places where individuals have no reasonable expectation of privacy.