University Students as Research Subjects

Human subjects research in which students will be asked to serve as research subjects is governed not only by fundamental regulations under 45 CFR 46, and 21 CFR 50 and 812 (for FDA regulated studies) but also the Family Educational Rights and Privacy Act (FERPA) and the Department of Education’s 34 CFR Part 97.

FERPA is a federal law that protects the privacy of personally identifiable information contained within a student’s educational record. FERPA applies to all schools (K-12 including postsecondary institutions) that receive funds under various programs from the U.S. Department of Education. Where applicable, researchers may choose to apply principles of professional societies and organizations, when they provide protections above and beyond those of federal regulations.

The purpose of this policy is to provide guidance on conducting research studies in which students will be asked to be research participants within their educational setting.

In some research situations, use of students is integral to a research protocol. This is particularly true of research into teaching methods, curricula and other areas related to the scholarship of teaching and learning.

An underlying principle of the regulations governing use of human subjects in research is that the subject’s participation is voluntary and based upon full and accurate information. The student-educator relationship raises the issue of volunteer participation. For example, students may volunteer to participate in the belief that doing so will place them in a favorable situation with an instructor (e.g., better grade, good recommendation, employment possibilities), or that failure to participate will negatively affect their relationship with them (e.g. lower grade, less favorable recommendation, being "uncooperative and not part of the scientific community).

Instructors cannot mandate or require student participation and care should be taken to eliminate or reduce the risk that they may unduly influence or coerce student participation in research. Instructors are strongly discouraged from recruiting students they directly supervise or selecting subjects on such basis.

Students must be of the age of majority (legal threshold when a minor officially becomes an adult) in order to consent for themselves. Research involving minors less than age of majority (including college students) in most instances requires signed parental permission, as well as assent from the student.

Researchers generally may not access classroom performance evaluations, grades, and information in a student’s records without prior written permission from the student, regardless of the access a researcher may have in their academic role.

If the instructor is also the researcher, they should arrange to have the consents and/or data collected by an independent third party when not present, so they do not know who participated and do not have access to the identifiable data or identity of participants for any purpose until grades have been assigned and entered. A teaching assistant in the class in which the student is enrolled does not qualify as a ‘third party’ for collecting the data on behalf of the researcher if they have a role in teaching and grading as well.

Unless the research is directly related to class material, or the study process is being used as a teaching opportunity, the IRB discourages the use of class time to recruit subjects or class time used to complete study instruments. The use of class time for research purposes must be justified.

When course credit or extra credit is given to students who participate in research, non-research alternative assignments should be provided to students who do not wish to participate in the research to ensure students are not unduly influenced into participating in the research study. The credit and alternative must be fully detailed in the consent/ assent, including duration and amount. The amount of course credit or extra credit should not be so great as to coerce a student into participation if they would otherwise choose not to participate.

To avoid undue influence, student subjects should be recruited by a general announcement, central posting or announcement mechanism that should include a clearly written description of the project and a statement of the proposed student participation.

Since there are special risks of confidentiality in the close environment of a learning environment, special attention should be given to full disclosure of these risks when obtaining the student’s consent/ assent to participate. The plan for handling research data should be designed to minimize the risk that confidentiality will be breached.

Researcher seeking to enroll students outside of the Florida Atlantic System (FAU, FAU High School, A.D. Henderson University School) must seek approval from the school and/ or district in which they wish to enroll students. FAU IRB will defer to the requirements of the local institutions. It is strongly advised that researchers contact the school and/ or district in which they wish to conduct research to understand requirements prior to submitting to the FAU IRB for review. https://www.fau.edu/research-admin/research-integrity/human-subjects-irb/toolkit/

The Principal Investigator (PI) will be responsible for:

• Ensuring that the points addressed in this policy are taken into consideration when designing a research protocol that proposes to enroll students as subjects.
• Ensuring that co-investigators or any other person (including faculty, staff, students or agents) involved in the design, conduct, evaluation, participant care, and/or reporting for the proposed study adhere to the responsibilities included in or referred to in this policy, as well as those outlined in their study protocol.
• When completing the IRB application, the PI should note on the IRB application whether the types of subjects will include either ‘students of PI or study staff’ and/or ‘students to be recruited in their educational setting.’
• Ensuring that the student’s participation is truly voluntary.

45 CFR 46, Subpart D

34 CFR 97

Family Educational Rights and Privacy Act (FERPA)