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Student Rights as Research Participants

Approved: Chaminade University IRB, April 2016

1.  Human Subjects Research at Chaminade

Research that involves human subjects is regulated at Chaminade by the Institutional Review Board (IRB). The IRB is composed of faculty, staff and community members. The IRB’s role is to protect the rights, safety and well-being of humans involved in research projects at Chaminade. Students may find themselves being offered the opportunity to participate in research projects being conducted by faculty as research subjects (also known as participants). Students should be aware of their rights associated with such requests from faculty. These principles are derived from federal guidance provided by the Department of Health and Human Services (DHHS), who note that “the involvement of students, employees, and normal volunteers in research may present special concern”(DHHS, IRB Guidebook).

Guiding principles of student participation in faculty research projects at Chaminade are that coercion or undue influence are to be avoided (45 CFR 46.116). Applicable references to the Code of Federal Regulations (CFR) are noted below. An overview of DHHS guidance may be found at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/index.html.

  1. Faculty are required to have IRB approval (45 CFR 46) for any human subject’s research at Chaminade, and students should ask for documentation of this approval.

  2. Students should be of the age of majority in Hawaii (18 years old) in order to be recruited as research subjects/participants. Research involving minors (under 18 years of age) as subjects (even 17-year-old college students) in most instances requires a signed parental consent, as well as the consent of the student.

  3. Students must be provided with the opportunity for informed consent, wherein they are fully notified of the risks and benefits of participating in the research study, unless there is a Waiver of Informed Consent approved by the IRB for a specific study (45 CFR 46.116).

  4. Student participation must always be voluntary, and students must be free to withdraw at any time without negative effects on the student’s grade or academic progress (45 CFR 46.116).

2.  Recruitment and Avoidance of Coercion

Students may feel that they do not have a choice when a faculty member asks them to participate in a research study. Students should understand that participation is always voluntary.

  1. In any proposed study that involves recruiting for research through classrooms, student listservs, or other student groups, clear explanation or justification should be provided as to why those students are the most appropriate participants for the study.

  2. A CUH student may not be required to participate in research for course credit. In all cases, a comparable non- research alternative must be offered.

  3. Students may be recruited for research participation; however, a student may not be required to participate in research (without a comparable non-research alternative offered) as a course requirement.

  4. To minimize the potential for coercion, alternatives to participating in research for course credit that are offered must be comparable in terms of time, effort, and fulfillment of course requirements.

  5. All research participants, including students, must be free to withdraw from participation at any point in a study without penalty. Students who withdraw from a research study for course credit must receive full course credit for participation.

  6. If a nominal incentive or reimbursement for costs associated with participation is offered, credit for payment accrues as the study progresses (as appropriate to the research) and is not contingent upon the student completing the entire study.

3.  Informed Consent

You are likely to be presented with an informed consent form indicating approval by the IRB. This document is intended to provide you with relevant information necessary to decide whether or not you want to participate. This form itself should be coupled with a discussion of the research.

Generally, informed consent will involve a description of the following:

  1. An explanation of the purpose of the research.

  2. A description of what you will be asked to do and how long it will take should you participate and whether or not you will be compensated for your time.

  3. A description of any risks involved in participating. These risks could be physical, psychological, social or criminal. The steps taken to minimize these risks should also be described.

  4. A description of any benefits to you or to society as a whole.

  5. The degree to which the information will be kept confidential and how your privacy will be protected.

  6. Whom to contact should you have questions about the research or about your rights as a participant.

  7. A statement that you are free to not participate and can stop participating at any time.

You should not sign the form agreeing to the research until all of your questions have been answered to your satisfaction. Signing this form does not waive any of your legal rights or alter your ability to stop participating at a later time. You should be given a copy of the form to take with you in case you have questions later.

4.  Voluntary Participation

Any participation in a research study is completely voluntary. You are free to decline to participate for any reason. You may also stop participating at any time or refuse to answer any individual questions. Even after you sign the consent form, you can stop. Should you decide to decline or stop participating, this decision will in no way influence any services to which you are otherwise entitled. For example, if you are a student, your teacher or professor cannot hold this against you when determining your grade.

5.  Safeguards for Privacy

Additional safeguards may be needed to protect the privacy interests of research participants when the participants are students. Classroom conditions may make it difficult for faculty to keep an individual’s participation confidential, which could pose risks to participants, e.g., when stigma is associated with the condition or question under study or when peer pressure is a component of the research. In such situations, consideration should be given to whether conducting the research off-site and/or outside of regular school hours may minimize potential risks. Protecting the confidentiality of research participants’ personal information when the participants are students may also present additional challenges. The extent to which personal information and/or research data may be accessible to parents, teachers, or others not directly involved in the research must be considered and disclosed to potential participants and their parents/guardians (if applicable) in the informed consent process.

In cases where regular classroom activities are also the topic of research, investigators must clarify for potential research participants (and/or their parents, as applicable) those activities that are optional and distinct from required classroom activities that would take place even without the research. When access to students or educational records is needed for recruitment and/or research activities, a letter of support from an individual authorized to speak on behalf of the institution (e.g., department chair, dean, etc.) may be required.

6.  Family Educational and Rights Privacy Act (FERPA)

Certain additional protections for students and parents are provided by federal regulations. The proposed use of student education records for research must comply with the requirements of the Family Educational and Rights Privacy Act (FERPA). See: www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html.

7.  Reporting Concerns

If at any time during or after participating in a study you have any questions or concerns, you can contact either the researcher, using the contact information on the consent form ,or the CUH IRB at irb@chaminade.edu.