Students as Research Participants

Students, including University of North Alabama students (e.g., undergraduates, graduate students, doctoral students, etc.) 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. Students (individuals or groups) should not be selected solely on the basis of convenience when they would not otherwise be appropriate for inclusion.

Recruitment

Recruitment of students as research participants must be designed to minimize the possibility of undue influence. In general, potential participants should be solicited from a “broad base” of individuals meeting the conditions for study, rather than by personal solicitation of specific students. Strategies to minimize the potential influence of an investigator when recruiting his/her own students include recruitment by general announcements, postings or sign-up sheets, or other methods that require a student interested in participation to initiate contact with the investigator(s).

Investigators and IRBs must consider strategies to ensure voluntary participation when the subjects of research include students who receive instruction directly from the investigator(s). Young students, particularly, may volunteer to participate in research in an effort to please a teacher (e.g., as when credit is given for participation in class) or because they fear that failure to participate will negatively affect their relationship with the teacher-investigator or faculty in general (i.e., by seeming uncooperative or unaware of scholarly research). Students’ cultural or religious backgrounds (e.g., requiring deference to authority figures) may also influence their choices. A student’s decision about research participation may not affect (favorably or unfavorably) grades, potential letters of recommendation, or other opportunities or decisions made by teacher-investigators.

Except in unusual circumstances, investigators should not enroll students from their own classes when the research involves greater than minimal risk without the prospect of direct benefit. Such studies should proceed only where the IRB determines that adequate provisions have been made to minimize the possibility of coercion, and the research is of significant importance and cannot be conducted without the enrollment of these students.

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 investigators 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 (as applicable) in the informed consent and assent processes.

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.

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). Please note that FERPA restricts researchers’ access to student records without written permission from parents of minor children, or permission of students over the age of 18. While some exceptions to FERPA may be available in a particular case, investigators must contact each institution in which they will be conducting research and follow that institution’s FERPA policy, in addition to the requirements of the IRB.

Protection of Pupil Rights Amendment (PPRA)

Research involving surveys with students in elementary and secondary schools that receive funding from the Department of Education must also comply with the Protection of Pupil Rights Amendment (PPRA) http://www2.ed.gov/policy/gen/guid/fpco/ppra/index.html..

• Per the Department of Education, research or experimental program or project means any program or project in any research that is designed to explore or develop new or unproven teaching methods or techniques.

Research Involving Employees as Research Participants

University of North Alabama employees may enroll in research protocols approved by the IRB. However, additional considerations and safeguards should be considered.

UNA employees (e.g., full-time, part-time, temporary, visiting, student employee, etc.) may be recruited for research participation. However, an employee may not be required to participate in research as a condition of employment. Employees (individuals or groups) should not be selected solely on the basis of convenience when they would not otherwise be appropriate for inclusion.

Recruitment of potential participants who are employees must be designed to minimize the possibility of coercion or undue influence. In general, potential participants should be solicited from a “broad base” of individuals meeting the conditions for study, rather than from individuals who report directly to the investigator(s). Strategies to minimize the potential influence of an investigator when recruiting his/her own employees include recruitment through a third party unassociated in a supervisory relationship with the employee, postings or sign-up sheets, or other methods that require an employee interested in participation to initiate contact with the investigator(s).

Investigators and IRBs must consider strategies to ensure voluntary participation when the subjects of research include employees who are directly supervised by the investigator(s). An employee’s decision about research participation may not affect (favorably or unfavorably) performance evaluations, career advancement, or other employment-related decisions made by peers or supervisors. Investigators may act as participants in their own studies if they meet the inclusion/exclusion criteria and all procedures including consent are completed by a Co-Investigator or Coordinator.

Except in unusual circumstances, investigators should not enroll employees under their direct supervision into research studies that involve greater than minimal risk without the prospect of direct benefit. Such studies should proceed only where the IRB determines that adequate provisions have been made to minimize the possibility of coercion, and the research is of significant importance and cannot be conducted without the enrollment of these employees.

Additional safeguards may be needed to protect the privacy interests of employees who are also research participants. Workplace conditions may make it difficult for investigators 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, research should be conducted off-site and/or outside of regular work hours when possible to minimize potential risks.

Protecting the confidentiality of research participants’ personal information when the participants are employees may also present additional challenges. The extent to which medical information and/or research data may be accessible to supervisors or others not directly involved in the research must be considered and disclosed to potential participants in the informed consent process.

In cases where regular workplace activities are also the topic of research, investigators must clarify for potential research participants those activities that are optional and distinct from any mandatory workplace activities that would take place even without the research. When access to individuals or the facilities of the site is needed for recruitment and/or research activities, a letter of support from someone authorized to speak on behalf of the employees/site may be required.

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