Special Report

Students and research protection: Student recruiting raises issues, concerns for IRBs

Researchers, IRB officials offer advice

College student populations may offer a plentiful and accessible source for human subjects research, but IRB and university research officials say that a variety of issues arise when students are used, and it’s important for IRBs to address these in policies and procedures.

Here are some of the issues that arise when students are recruited for research:

• Selecting an equivalent alternative activity: When universities permit instructors to issue credit for research participation, there must be an alternative way that the student can earn the same credit. IRB members and others say this area is one that IRBs need to carefully review, because what looks like an equivalent alternative to professors may not seem equal to students.

The alternative to research participation cannot be more onerous, and it should be made public to students, says Celia Walker, MA, director of the Regulatory Compliance Office at Colorado State University in Fort Collins.

The IRB at Syracuse (NY) University saw a red flag raised regarding this issue when one protocol called for offering students extra credit for signing up for one of a variety of research projects that each would take about an hour to 1½ hours of student time, says Steven Taylor, PhD, professor of education and IRB chair.

"This department offered students a non-research activity that was a 10-page research paper," he says. "You can see why that reached our attention, because there is no way to write a 10-page research paper in one to 1½ hours."

Offering students such a time-consuming alternative to research participation constitutes undue coercive pressure, Taylor adds. "No student would take the nonresearch alternative, so that’s one issue that has concerned us."

When Taylor questioned the investigator about this unequal alternative, the investigator replied that the 10-page paper would take comparable time and effort. "I said, No, it would not,’" he says.

At Rutgers University in New Brunswick, NJ, students may be given the alternative of writing a two- or four-page paper, depending on the intensity of the research study, says Karen M. Janes, associate director of research integrity and compliance in the Office of Research and Sponsored Programs.

"When you participate in the psychology department as a student, you have a choice of signing up for the subject pool or opting not to and doing an equivalent paper," Janes says.

• Recruitment incentives: For college students, grades and credit are more enticing incentives than cash, so IRBs need to be very careful in reviewing protocols for potentially coercive incentives, IRB members say.

"If you offer a student an extra grade or 20% more credit, then that is enticing them with their gold standard, and it probably is more valuable to them than $50 or $100," says Carol B. Willeke, PhD, associate director of the Office for the Advancement of Research and Scholarship at Miami University in Oxford, OH. The question IRBs need to ask is whether the incentive is coercive.

Mercer University in Macon, GA, has addressed this issue in its written policy on "Selection and Recruitment of Subjects in Research Investigations" with the following statement: "Potential subjects should not feel coerced into participating in research, nor must they fear the loss of some benefit to which they are otherwise entitled if they choose not to participate. A person in authority, such as a teacher recruiting students or a physician recruiting patients, should take precautions to ensure a potential subject’s decision to participate in research is not based on subtle pressures such as grades or a fear of loss of benefits, like medical treatment."

• Handling college students as subjects when students are minors: It’s not uncommon for college students to be under age 18, so an institution and IRB will need to revise policies for how recruitment can take place when student subjects are underage.

About 15% of the incoming freshmen living in residence halls at Colorado State University are younger than age 18, Walker says.

"So if those students are involved in research projects for intro psych or another class, they can only participate with parental permission unless parental permission can be waived," Walker says.

Some institutions may handle this by sending parents at the beginning of the semester a standard parental consent form, asking whether they give approval for their son or daughter to participate in research experiments and to state what is clearly unacceptable, Taylor notes.

But this isn’t adequate for informed consent, Taylor explains. "Parental consent has to be specific to the research study, and parents have to be aware of the benefits or risks."

• Monitoring off-campus research recruitment: Another issue that occasionally will cross an IRB’s desk involves the recruitment of a college’s students for research that is conducted by an organization not affiliated with the college or university.

The IRB at Towson (MD) University was alerted several years ago to a problem involving an outside study, says Patricia M. Alt, PhD, IRB chair and professor of health science.

A flier had been circulating on the campus for a study of how quickly alcohol and antihistamines, when taken together, would clear out of a person’s system, she recalls.

"Someone brought us the flier, and we flipped out," Alt says. "We had mental images of people getting drunk and driving up the expressway, banging into things."

After further investigation, the IRB learned that the study, which was conducted by another university and reviewed by its IRB, would involve having participants spend the night after observation, and it would carefully screen out all students younger than age 21, she says.