One of the simpler ways to prevent regulatory problems with student or employee research recruitment is to have clear, well-outlined policies and procedures (P&Ps) or guidance available for all to see.
Here are some points that should be included in an IRB’s policies regarding students and research, according to experts.
• Include guidelines to avoid undue influence and coercion. The guidelines for Washington University in St. Louis list coercion under the first heading. The policy states that teacher-researchers should not use as research subjects any students or employees they currently supervise in a teaching or work situation. But when it is justified to enroll these students or employees, the students/employees should be treated as a vulnerable population.
The institution’s guidelines also address having an alternative to research available for students who might volunteer for a study so they can earn academic credit.
“If they don’t want to participate in research, they should be able to do something else that takes equivalent time and effort and gets class credit,” says Martha Jones, executive director of the human research protection office at Washington University in St. Louis.
“If the requirement is that you do three research experiences of one hour each, then the alternative might be to write three reviews or to go to three one-hour talks on campus,” Jones adds.
Similarly, university employees, including graduate and lab assistants, could be influenced without the investigator being aware that it’s happening, Jones says.
“Especially in a laboratory setting where they’re working so closely together, it doesn’t always occur to people that the employee-employer relationship could have some ramifications when you’re talking about research,” she explains.
The University of Texas at Arlington’s guidance states that all solicitation of volunteer student subjects for research must be done in a non-coercive manner. “To avoid undue influence, subjects should be recruited by a general announcement, central posting or announcement mechanism,” the guidance says.
“Instructors are aware there are clear boundaries if this is a research project, and there can be an opt-out situation,” says Alyson Stearns, regulatory services specialist at UT Arlington.
Students should be offered alternatives to enrolling in research, such as participation in another classroom activity, says Mary-Collette Lybrand, MS, CCRP, regulatory services manager at UT Arlington.
• Provide policies and procedures (P&Ps) as well as education to students, faculty, and others. Often, problems arise simply because a researcher hasn’t thought of a situation the same way that an ethics board or a volunteer might see it, Jones notes.
Education and easily accessible P&Ps are potential solutions.
“We have different reach-out methods to the student population,” Lybrand says. “We go to the classroom and speak directly to nursing students, engineering students, or psychology students, and twice a year we have mini conferences for faculty and staff with all-day discussions and panels.”
Those conferences always include the topic of using university students as research subjects, she adds.
Also, an institution can establish a potential subject pool in which students can register as possible volunteers. There can be rules and guidelines for using the pool.
For instance, UT Arlington’s guidance on enrolling university students is open to the public on its website and includes an outline for departmental considerations when using student subject pools.
The outline addresses the definition and purpose of a subject pool, issues concerning the use of subject pools, documentation, IRB responsibilities, the main risks, obtaining parental consent and child assent, requirements for use of the subject pool, recruitment vs. informed consent, and special issues in prescreening and database management.
For example, under requirements for the use of the subject pool, the following items are listed:
- only exempt or minimal risk research will be permitted;
- parental consent for those under 18, if the data is intended for research use;
- students fully informed of their rights as participants;
- documentation of participation to receive credit remains separate from documentation for participation in the research;
- studies must have IRB approval prior to initiation;
- must provide comparable alternatives;
- decrease presence of coercion.
• Address recruitment techniques. The Washington University guidelines explicitly state that students, employees, and normal volunteers should be recruited through general announcements or advertisements rather than individual solicitations.
The guidelines also say that if a researcher requests consideration of recruitment of students or employees whose evaluation is at risk of being influenced as a result of research participation or non-participation, then the human research protection office may suggest use of a disinterested third party to recruit participants.
“We have faculty who do socio-behavioral science type of research, and they might want to look at different types of teaching methods in the classroom,” Jones says. “Often they want to look at methods they’re familiar with and using, and so there is some rationale for using their own classroom studies for doing this.”
In these cases, the IRB will have them bring in a third party to do recruitment and informed consent so that the researcher doesn’t know who consented until after the grades are complete, she adds.
“Or we have them not approach students until evaluation or the term is over,” she adds. “This has worked quite well; I cannot think of a time when we have not worked with a researcher and allowed research to go forward without putting in some protections.”