College students: Are they a captive audience?

Some strategies could cross the line

To clinical trial coordinators looking for study subjects, a nearby university campus looks like a godsend — large numbers of unemployed young people all in one place for a designated period of time.

But college students are more vulnerable to coercion, in some ways, than people in the general population, and IRBs may take a dim view of researchers who seem to be exploiting them.

"Students are generally unemployed and need money, and they are relatively easy to target with advertising around campus to solicit participation," notes Jon Merz, JD, PhD, MBA, assistant professor at the University of Pennsylvania Center for Bioethics. "But for this group, I would be concerned about how much money is being offered as an incentive to participation and whether the solicitation is forthright about what participation will entail."

Merz cites reports of bad outcomes in human subjects research where participants were paid considerable sums of money and consented to procedures that might seem unthinkable to someone not being paid.

For unemployed students in need of money, the amount that might be coercive could be lower than that for someone able to earn money in the work force, for example.

Good subjects — or, just easy to get?

Ethically, research subjects, to the extent that it is feasible, should be drawn from the population mostly likely to benefit from the results of the research, Merz notes. Therefore, IRBs might legitimately question why students are being considered as subjects for a given trial in the first place.

"If they’re simply available and easily targeted, this might be an area of concern," he continues. "For example, we no longer allow research on prisoners unless it is therapeutic or is related to their status as incarcerated persons. So with students, research on students is more legitimate if it benefits the students themselves."

Frequently, students in health-related areas of study are recruited by their professors or medical leaders to serve as subjects in projects related to their field. However, this has the potential to be extremely coercive.

"Medical, nursing, or students in the related professions might be solicited because of their ready availability, need for cash, and usually, their willingness to participate in clinical activities," Merz notes. "It could also be argued that if they are doing research or will be in their careers, they should also be willing to be subjects. Nonetheless, the potential for coercion by professors or mentors or anyone of authority must assiduously be guarded against."

Many departments have rules that prohibit research on their own staff or residents, he notes. If individuals want to get involved in studies in other departments, they’re free to do so. But persons of authority over the person considering participation should not solicit or otherwise be involved in such studies.

"This isn’t always the case in the real world," he acknowledges. "I know of one case of a cancer researcher who proposed taking control bone marrow biopsies from staff in his department, asserting that the people were quite willing to do it because they do it to patients all the time, and they needed the $75. The IRB approved this."

Local IRB scrutiny

Some universities have policies that off-campus researchers attempting to recruit students must get the approval of the school. In some cases, this also means, getting the local IRB to review the protocol.

Members of the institutional review board at Towson University in Maryland have a policy of asking off-campus researchers to submit their protocols for review before they recruit on campus, says Patricia Alt, PhD, a professor in the department of health science and chair of the university’s IRB.

"We don’t do clinical research trials here but we do have a large, nearby medical center that frequently wants to recruit our students; and we have had people contacting faculty, wanting to use their classes."

University policy prohibits researchers from posting ads in the student newspaper or on university-sponsored bulletin boards without prior approval of the administration, but this policy is frequently flouted, and strict enforcement is difficult, Alt notes.

"The faculty are supposed to come to us if they get a request [to recruit students]. But we frequently find all kinds of things on the bulletin boards recruiting people to participate in studies for large amounts of money," she says. "We call them up and actually say, Has this even been in front of your IRB, much less ours?’"

A recent flier, posted without administration approval, recruited participants for an anthrax vaccine study. The protocol had been in front of the IRB of the sponsoring institution, but no one at Towson was notified.

"I think when you recruit on campus, especially on a campus-sanctioned bulletin board, that implies we are supporting it," she states. "When we spot one of those, we usually call the coordinator and ask them, Are you aware that we’re talking about 18-year-olds here?’ and try to get them to run it by our IRB. They are usually pretty graceful about it. Occasionally, you will find someone who doesn’t see why they should bother — it’s been through their IRB. We just ask as a courtesy. We’d like to see it."

Of course, IRBs have no real authority to restrict research not sponsored at their institution, both Merz and Alt admit, though some feel that solicitation and enrollment of students at their institution should be within their jurisdiction.

"Technically, IRBs have jurisdiction only over researchers at their institutions," Merz says. "I always argue that the IRB has no authority and it is really an institutional question whether solicitation of subjects by off-site researchers should be permitted. But if that institution decides that their IRB should approve any such studies, then, that’s the end of it."

The local IRB may have no knowledge of the off-site investigators, their reputations, etc., and has no institutional hook to assert authority over those researchers, he adds. But the local IRB may know its study population best and can even be helpful in getting the solicitation done in a way that is sensitive to the population’s needs.

It’s a moral issue

Although they have no legal jurisdiction over off-campus researchers, Alt says he believes that university IRBs have a moral responsibility to the students to monitor what types of trials are allowed to recruit students, she says.

"As a parent, I would hope that the colleges would not allow on-campus recruiting for things that might be dangerous," she says. "Obviously, if researchers refuse [to get local approval], I can’t go stand outside their office and watch for Towson students. And if they are 18, in the eyes of the law, they are adults."

In the interest of providing true informed consent and protecting the safety of participants, Alt feels that IRBs and study coordinators should seek the input of review boards at the institutions they propose recruiting from.

"Last year, we had a person who was working on a doctorate at a university in another state but had gotten a job in Baltimore at a local clinical organization," she continues. "She decided on her own that Towson had this great big campus, and she had a friend here; she had her university back home approve her protocol to use some of her friend’s classmates as subjects for her study, but she did not come to us. We were pleasant about it, but it sort of shocked us. If someone were to propose something similar here, we might say it was fine, but only if they got the approval of the other IRB."