Problems involving student research participants are rare, but even the occasional issue can be a major headache for IRBs and research institutions. That’s what one organization discovered when a confidential complaint resulted in an investigation by the Office for Human Research Protections (OHRP) last year.
OHRP recently investigated several studies enrolling students and looked into questions of informed consent and the possibility of enrollment coercion at East Tennessee State University (ETSU) in Johnson City.
A confidential complaint to OHRP alleged that student athletes were tested on physical performance characteristics by doctoral students who used data for research purposes, according to a letter dated Sept. 25, 2014, by OHRP to East Tennessee State University.
“This was a learning experience in trying to do the right thing,” says William R. Duncan, PhD, vice provost for research and sponsored programs at ETSU.
ETSU addressed OHRP’s concerns and made policy changes as part of its corrective action.
“First of all, we started at the level of the IRB and did some educational programs for IRB members, raising their awareness and to make sure they had a thorough review of circumstances in research involving students,” Duncan explains. “We’ve developed a brochure for students who are considering participation in research studies and posted this at every site.”
OHRP’s attention on the issue raises a question for IRBs: How up to date are your policies and procedures (P&Ps) about enrolling students and employees in studies?
Proactive policies and procedures are one way IRBs and research institutions can prevent problems that lead to OHRP investigation, according to a regulatory services specialist.
“We have considered students as a kind of vulnerable population, even though they’re not vulnerable by the regulations,” says Alyson Stearns, regulatory services specialist at the University of Texas at Arlington.
“Students are here to be educated, and we want to make sure they receive the best education possible without any coercion or undue influence,” Stearns adds.
The institution has published on its website detailed guidance for enrolling university students as research subjects. The guidance clearly states, “Care should be taken to eliminate or reduce the risk that undue influence of faculty or coercion affects student participation in research.”
The complaint to OHRP raised questions about student participants who were under age 18 and did not have parental consent and about studies conducted by team coaches whose participation could have a coercive impact on student athletes.
“The complainant also alleged that the same doctoral students are often team coaches, so the student athletes believe that if they do not agree to have the test results used for research purposes they will not be able to play and will lose their athletic scholarships,” OHRP stated in its letter to ETSU. “There was also concern that, if students are taking a course being taught by the doctoral student, they will get a poorer grade if they don’t participate in the research.”
Since the OHRP investigation began, ETSU instituted corrective actions that include audits of studies involving students and requiring further human research protection training for the researchers named in the complaint, the letter states.
Corrective actions, as named in OHRP’s letter, include:
• The principal investigator strengthened the informed consent language to say that refusal to participate in the study would not affect students’ grades.
• IRB members will observe the IC process for the study at three random times in the next year.
• The organization would develop a standard checklist for individuals obtaining consent to ensure that assents and parental permissions were obtained when necessary.
• There would be further educational programs for IRB members to ensure a thorough review of circumstances related to the consent process in studies involving students.
• The organization would develop a new brochure for students considering research participation.1
OHRP’s four-page letter concludes by saying ETSU made corrective actions, addressing all concerns and determinations, and there would be no need for further OHRP involvement.1
IRBs should always be alert to the possibility of undue influence when studies enroll students, notes Mary-Collette Lybrand, MS, CCRP, regulatory services manager at the University of Texas at Arlington.
“There are at least 30,000 students here, and if you’re doing a research project with students, that’s a whole lot of people right at your fingertips,” Lybrand says. “We can’t talk to all 30,000 students one on one, but having guidance online can be very helpful so everyone can be on the same page when recruiting students.”
The ETSU IRB will learn more about students’ perceptions of research enrollment by interviewing students who are participating in studies to understand their perception of the consent process and whether they felt coerced, Duncan says.
“I’ve been here six years, and we’ve not had any students complain to us about the consent process or that they felt coerced,” he notes.
If students have any concerns about a study, they can contact ETSU’s research office and IRB to express their concerns confidentially, Duncan says.
But no one came forward to the IRB with the complaints that were sent to OHRP, he adds.
Having policies and procedures that address enrollment of university employees, as well as students, is a good way to prevent problems, says Martha Jones, executive director of the human research protection office at Washington University in St. Louis.
“Faculty members teaching or running a lab have a lot of authority over the people working for them or over students,” Jones says.
At a different institution, Jones once heard a complaint made by a lab employee who had worked for one research scientist for many years. “The employee was leaving the job after many years in the lab, and he said, ‘One thing I wanted to share is I always felt pressure whenever my faculty member had a study that just needed blood. I always felt I had to volunteer,’” Jones recalls.
The IRB wasn’t aware that coercion was occurring because no one had complained earlier, she notes.
A good policy for an IRB is to say that where there is a study that could enroll anyone, then it shouldn’t directly recruit students or staff simply because they’re the most convenient to recruit, Jones says.
“They should post fliers, and if one lab employee sees the flier and wants to participate, then that’s fine,” she suggests. “But they should not feel obligated to participate because they work in the lab.”
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Office of Human Research Protections. Re: Human Research Subject Protections Under Federalwide Assurance FWA-2703. September 25, 2014. http://1.usa.gov/1L32iZe
