STUDENTS, EMPLOYEES, AND NORMAL VOLUNTEERS

INTRODUCTION

The involvement of students, employees, and normal volunteers in research may present special concerns with which IRBs should be familiar. The federal regulations do not provide explicit protections for subjects in these categories

IRB CONSIDERATIONS

Normal Volunteers. Strange as it may seem at first, special concerns surround the involvement of normal (i.e., healthy) persons who volunteer to participate in research. Primarily, the principles involved are beneficence and respect for persons. In the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research stated the two general rules that describe beneficent actions as: (1) do not harm; and (2) maximize possible benefits and minimize possible harms. Volunteers for whom no therapeutic benefit can result from participation in research should, therefore, be exposed to risks that are minimized to the greatest extent possible. While the minimization of risks is an important requisite for any research involving human participants, the altruistic motivation of the normal volunteer's agreement to participate (i.e., of contributing to scientific knowledge for the benefit of society) heightens the concern for the risks to which such participants should ethically be exposed.

The principle of respect for persons requires that research participants are, where capable of doing so, allowed to act autonomously and to express their right of self-determination. These principles are effectuated through the process of informed consent, which involves providing subjects with all relevant information about the study, including the risks and benefits involved, in clear and simple language, and ensuring that the information is understood and appreciated. Furthermore, the agreement to participate must be voluntary; the consent negotiations must be free from elements of coercion or undue inducement to participate. In research involving normal volunteers, particularly where the research involves more than minimal risk, IRBs must ensure that any monetary payments to subjects are not so great as to constitute an undue inducement. This issue may be particularly difficult for IRBs to deal with. Since subjects who volunteer to participate in such studies are usually compensated for their time and discomfort, IRBs should seriously scrutinize the payment schedules to ensure that any compensation offered is commensurate with the time, discomfort, and risk involved. Even so, where a research procedure involves serious discomfort and/or the real, though slight, possibility of serious harm (e.g., studies that involve the insertion and positioning of catheters in veins or the heart), one can easily imagine that the motivation of persons who volunteer to participate may be monetary. IRBs should pay particular attention to the proposed study population and whether it may comprise persons who are likely to be vulnerable to coercion or undue influence, such as persons who are educationally or economically disadvantaged. The federal regulations require that IRBs employ special safeguards under such circumstances [Federal Policy §___.111(b); 45 CFR 46.111(b)].

One area where normal volunteers are employed in research is in Phase 1 drug trials. The justification for the involvement of normal, healthy subjects is the need for volunteers whose experience with the trial materials is more easily analyzed because of the existence of fewer confounding factors. While Phase 1 trials are the first use of experimental drugs and devices in humans, preliminary studies involving animals provide investigators with data indicating a high likelihood of safe use in humans. Studies have indicated that the risk of injury from participating in Phase 1 studies is small, about the same as the risk of being injured while working as an office secretary [Levine (1982)]. The likelihood of risk, including the availability of animal data, should be scrutinized by IRBs.

Normal volunteers, like students and employees, should be recruited through general announcements or advertisements, rather than through individual solicitations. Personal solicitations increase the likelihood that participation will be the result of undue influence, either because of the relationship between the recruiter and the prospective subject, or methods of communication employed by the recruiter that may act to persuade prospective subjects to participate, thus compromising the voluntariness of the agreement to participate.

Investigators and IRBs should carefully consider what will happen if and when a normal volunteer should become sick or be injured during the research. As with any research involving human subjects, such issues should be clearly spelled out in the informed consent document, and should be reviewed carefully with the prospective subject. For example, subjects should be told: whether any medical treatments will be made available should injury occur and, if so, what they consist of; whom to contact should a research-related injury occur; and that they may discontinue participation at any time without penalty or loss of benefits to which they would otherwise be entitled [Federal Policy §___.116(a)(6-8); 45 CFR 46.116(a)(6-8)]. In addition, where appropriate subjects should be told whether they will be dropped from the study in the event of injury or illness, and whether they will be required to pay for treatment of research-related injuries or illness [Federal Policy §___.116(b)(2-3); 45 CFR 46(b)(2-3)]. Where illness in healthy volunteers does occur, particularly during a drug study, investigation by an independent physician may be warranted. [See Fazackerley, Randall, and Pleuvry (1987).]

The issues raised by the involvement of healthy subjects in genetic research is discussed in Guidebook Chapter 5, Section H, "Human Genetic Research."

Students. Universities, and the association of investigators with them, provide investigators with a ready pool of research subjects: students. Many IRBs have faced the question of whether and in what way students may participate in research. Two questions that have been posed are whether students - medical students, in particular - should be allowed to participate in biomedical research (and whether special protections should be adopted to restrict their participation), and whether participation in research can appropriately be included as a course component for course credit. The latter practice is commonly employed in psychology departments.

The problem with student participation in research conducted at the university is the possibility that their agreement to participate will not be freely given. Students may volunteer to participate out of a belief that doing so will place them in good favor with faculty (e.g., that participating will result in receiving better grades, recommendations, employment, or the like), or that failure to participate will negatively affect their relationship with the investigator or faculty generally (i.e., by seeming "uncooperative," not part of the scientific community). Prohibiting all student participation in research, however, may be an over protective reaction. An alternative way to protect against coercion is to require that faculty-investigators advertise for subjects generally (e.g., through notices posted in the school or department) rather than recruit individual students directly. As with any research involving a potentially vulnerable subject population, IRBs should pay special attention to the potential for coercion or undue influence and consider ways in which the possibility of exploitation can be reduced or eliminated.

Whether medical students in particular require special protections has been hotly debated. Some universities have either prohibited their participation or severely restricted it to, for instance, research involving minimal risk and minimal interruption of time. Strong arguments have been made against such protections, including claims that as future physicians (and possibly researchers) they may be obliged to participate. Angoff has argued that protecting medical students to a greater degree than protecting other normal volunteers smacks of elitism. Angoff (1985) states, "One may wonder why it is acceptable to ask the masses to accept risk in the name of science but not the very people whose futures are linked to the successful perpetuation of biomedical research" [p. 10]. Nolan (1979), Levine (1984), Angoff (1985), and others have argued that medical students are in a particularly good position to participate in some biomedical research because of their ability to comprehend the procedures involved in studies and evaluate the risks involved, which may not be possible to achieve with other normal volunteers. Angoff and others have also argued that it is acceptable to pay medical students as one would any research participant.

Requiring participation in research for course credit (or extra credit) is also controversial, though common in the social and behavioral sciences. The justification offered for requiring student participation is educational benefit [Gamble (1982); Cohen (1982)]. Clearly, however, participation of students is seen by faculty-investigators as necessary to the conduct of their research. Grant budgets often do not allow investigators to pay subjects; giving course credit or extra credit is a means of obtaining sufficient participation rates. Again, the issue for IRBs is whether such arrangements for selecting subjects is fair and noncoercive.

Participation in studies might be mandatory or for extra credit. Students in beginning psychology courses, for instance, might be required to serve as subjects for a given number of hours of research or in a given number of research projects. Or they might be given the option of participating for additional grade credit. Several mechanisms have been suggested for diminishing or eliminating the coercive aspect of student participation for course credit that IRBs might find useful. Gamble (1982) describes a departmental guideline for research involving students where extra credit is offered for participation. Students are to be given other options for fulfilling the research component that were comparable in terms of time, effort, and educational benefit: "for example, short papers, special projects, book reports, and brief quizzes on additional readings" [p. 7]. He raises concerns about the comparability of such alternatives with participating in research (e.g., that if they participate in studies, all they have to do is show up and spend the time, but if they choose to write a paper, it gets graded, and if they do extra readings, they have to be tested on them), and concludes that paying student subjects as researchers would any other subject is the only way to protect students' freedom of choice to participate. Cohen (1982) describes a similar policy that seems to meet these concerns. To fulfill the research component, students can either participate in five hours of research, write a brief research paper, or attend faculty research colloquia. The paper is not graded, and students who attend the colloquia have only to show up. If students do choose to participate in studies, the policy seeks to increase the likelihood that participation is freely chosen by requiring: that students be given several studies to choose from and may not be required to volunteer for any particular study; that the studies must not involve more than minimal risk; that students can withdraw from the study at any time without losing the extra credit [p. 11].

Another concern raised by the involvement of students as subjects is confidentiality. As with research involving human subjects generally, IRBs should be aware that research involving the collection of data on sensitive subjects such as mental health, sexual activity, or the use of illicit drugs or alcohol presents risks to subjects of which they should be made aware and from which they should be protected, to the greatest extent possible. The close environment of the university amplifies this problem.

Where students are likely to be participating in research, IRBs should consider including a student member or consulting with students where appropriate.

Employees. The issues with respect to employees as research subjects are essentially identical to those involving students as research subjects: coercion or undue influence, and confidentiality. As medical students have seemed ideal subjects by biomedical researchers, employees of drug companies have been seen by investigators as ideal subjects in some ways, because of their ability to comprehend the protocol and to understand the importance of the research and compliance with the protocol. Meyers (1979) provides a good summary of the structure of employee volunteer research programs. As student participation raises questions of the ability to exercise free choice because of the possibility that grades or other important factors will be affected by decisions to participate, employee research programs raise the possibility that the decision will affect performance evaluations or job advancement. It may also be difficult to maintain the confidentiality of personal medical information or research data when the subjects are also employees, particularly when the employer is also a medical institution [Meyers (1979)].