Research Involving Students as Research Participants

Students as Research Participants

Students, including University of Pittsburgh students (e.g., undergraduates, graduate students, medical students, residents, fellows, 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). The University of Pittsburgh has a FERPA policy that is applicable in part for researchers who are conducting research on students at this institution. For researchers conducting research at other institutions, 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.

See Chapter 26 for further information on this topic.

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. Guidance on PPRA requirements can be obtained at http://www.hrpo.pitt.edu/Guidance/.

  • 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.

See Chapter 26 for further information on this topic.

Medical Students as Participants

Given the heavy curriculum burden on Medical students, the School of Medicine specifically developed a policy for the enrollment of University of Pittsburgh Medical Students into research protocols.

For research studies in which medical students are being recruited as subjects, including surveys of medical students, the School of Medicine’s Research on Medical Students (ROMS) Review Committee must review the proposed research plan before it can be submitted to the University of Pittsburgh Institutional Review Board (IRB). This review includes examination of how medical students will be recruited, and be involved, in the study, and how the study will fit within the conduct of the medical school curriculum. The goal of this requirement is to balance the needs of researchers with the interests and availability of the medical students being solicited as research subjects.

For this review, investigators are asked to submit their draft IRB proposal along with any supporting documents that will shed light on what any one medical student would experience as being part of the project. The submission is then reviewed by the ROMS Review Committee. Reviews are typically conducted within 2-3 weeks. The result of an approval from the ROMS Review Committee is a letter to the primary investigator which must be submitted to the IRB together with the other IRB documents in the OSIRIS electronic submission system.

To submit a study for review by the ROMS Review Committee, please e-mail the review request to John Mahoney MD, Associate Dean for Medical Education at mahoney@medschool.pitt.edu. Dr. Mahoney can also be reached at 412-648-8714.

Psychology Subject Pool

University of Pittsburgh students are offered the opportunity to participate in research (as participants) in various ways. Examples include participation for credit as part of a course requirement (e.g., Psychology Subject Pool), for credit in a course, or in exchange for payment. A Pitt student may not be required to participate in research for course credit. In all cases, a comparable non-research alternative must be offered.

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.

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. When payment 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.

Study-specific informed consent is required as described by federal regulations and University of Pittsburgh policies. Parental permission and assent are required for University of Pittsburgh students (including high school students taking Pitt courses) who meet the regulatory definition of children.

Research Involving Employees as Research Participants

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

Employees, including University of Pittsburgh and UPMC employees (e.g., full-time, part-time, temporary, visiting, student employee appointments, 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.

version 3.1.2016