Introduction

This guidance focuses on research conducted in post-secondary schools with individuals 18 and older. For more information on research conducted in elementary and secondary schools, please see the IGS: Research Conducted in Elementary and Secondary Schools.

Federal Research Regulations

Students attending an institution of higher education are not directly mentioned in the federal regulations as a vulnerable population. However, the University of Utah IRB considers students of the research institution to be a vulnerable population because students may be vulnerable to coercion or undue influence. The regulations state:

“When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.”[45 CFR 46.111(b) and 21 CFR 56.111(b)]

If students are involved as research participants, the investigator must include additional safeguards in the study to protect their rights and welfare.

Guidance

Student participation in research is common on university and college campuses. Of particular concern is the possibility that students may feel pressure to participate in research. Students may feel they must volunteer to participate to win favor with faculty (e.g. participating in research may lead to a better grade or a letter of recommendation, etc.). Students may also feel that if they choose not to participate, it will negatively impact their relationship with faculty.

The University of Utah IRB recognizes the importance of students participating in research and does not prohibit students from voluntarily participating in research. The following guidelines have been implemented to protect students and minimize coercion while allowing students to voluntarily participate in research.

Course Credit for Research Participation

Often in behavioral or social science classes, course credit is offered for participation in research. If participation in research is required in a class, students must be given other options for fulfilling the research requirement. Other options must be comparable in terms of time, effort and educational benefit. For example, to fulfill the research requirement, students can choose to participate in two hours of research, read research articles and answer questions, or attend a faculty research symposium. To reduce coercion, the questions about the research articles are not graded, and students who attend the symposium are only required to be in attendance to receive research credit.

Students cannot be required to participate in one particular study to earn course credit. Students must have the freedom to participate in a study of their own choosing.

Students cannot be required to participate in research that is greater than minimal risk (as determined by the IRB) to earn course credit.

Right to Withdraw

If a student agrees to participate in a study, he/she may withdraw from the study at any time without losing credit. The right of the student to withdraw must be presented in the consent process and informed consent document.

Advertisements

An investigator must recruit participants generally rather than from those students enrolled in a course taught by the investigator or others involved in the study. For example, advertisements should be posted in a general area in the school or department. Advertisements must also adhere to the University of Utah IRB policy (see Investigator Guidance Series: Advertisements).

Additional Considerations

Confidentiality

The University setting may provide opportunities to conduct research involving the collection of data on sensitive subjects such as mental health, sexual activity, or the use of illicit drugs or alcohol. This type of research may present confidentiality risks, particularly in the close environment of the university setting. Participants should be made aware of these risks in the consent process and the informed consent document.

Age of Consent

Individuals under the age of 18 are considered children (exceptions are described in the Investigator Guidance Series: Research Involving Children) and are subject to additional regulatory protections. Generally, children are required to have parental permission and provide assent (children age 7 and up) before participating in research. Investigators need to consider that some university students are not 18 years old and cannot provide consent to participate in research without first obtaining parental permission.

Student-Athletes: Compensation for Participation

It has become common for institutions to use student-athletes in studies specifically related to the conditions under which student-athletes participate. Such research is important but must be balanced with protecting the student-athletes’ eligibility to participate in collegiate sports. Providing compensation to student-athletes for participation in research studies is allowed provided the study does not violate any NCAA rules or regulations or jeopardizes a student-athlete’s eligibility. The investigator should consult with the NCAA Faculty Athletics Representative as needed.

Family Educational Rights and Privacy Act (FERPA)

FERPA seeks to ensure student rights in education including student information privacy. However, FERPA regulations permit educational agencies and institutions to disclose personal identifiable information from education records without consent under specific conditions for research studies. If you intend to obtain information from student records, verification of privacy protection signed by a representative of the school or institution must confirm the study’s adherence to FERPA and provide the determination regarding whether written consent to disclose student information is required. The verification should be included with your IRB submission. Please see the IRB website for the Privacy Protection Verification for Research Conducted in Schools form. The verification should be included with your IRB submission.

Student-Employees

In the event that student(s) may also be employed by the University of Utah, the investigator should be aware that there are restrictions on investigators enrolling employees in greater-than minimal risk research. Employees may not enroll in research that is designated “greater-than-minimal risk” by an IRB if 1) they are directly supervised by an investigator (principal or co-investigator) of the research; 2) their direct supervisor reports to an investigator (principal or co-investigator) of the research. If applicable, the application should be clear that student-employees who report directly to an investigator or who reports directly someone who directly reports to an investigator will be excluded from enrollment. For more information, please see IGS: Recruitment and Enrollment of Employees.

Documents and References

Privacy Protection Verification for Research Conducted in Schools: https://irb.utah.edu/informed-consent/forms-templates-cpt/

OHRP Informed Consent FAQs: What constitutes coercion or undue influence when students are involved in research in a college or university setting? https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html

Investigator Guidance Series: Recruitment Methods: https://irb.utah.edu/guidance-series/recruitment-methods/

Investigator Guidance Series: Research Involving Children: https://irb.utah.edu/guidance-series/research-inlvolving-children/

U.S. Department of Education: Protecting Student Privacy https://studentprivacy.ed.gov/

Points to Consider