Clinical Researcher—September 2019 (Volume 33, Issue 8)
RECRUITMENT & RETENTION
Gary W. Cramer
During Phase I studies, a drug is tested for the first time in small numbers (20 to 100) of healthy volunteers—often college students. – Clinical Trials Transformation Initiative’s “Learn More About Clinical Trials” webpage
The stereotypical scenario of the cash-strapped college student who is reduced to selling his or her plasma to make a quick buck has perhaps hung on in good economic times and bad because just enough people see it happening for real to fuel the notion that it’s happening all the time, everywhere. Slightly less pervasive, but carrying with it the same whiff of a practice that is somehow potentially unseemly, is the scenario of those same poor students enrolling in clinical trials to earn their financial infusions.
If the need (or simply the desire) to earn money is the principal goal of trial participation, does this somehow classify the volunteer as vulnerable? Perhaps not in the same manner that research ethicists usually think of certain other categories of subjects—pregnant women, prisoners, children, the developmentally disabled, etc.—being vulnerable to coercion, but perhaps so if the economically distressed volunteer is a student and the researcher has some real or perceived authority over him or her at the institution hosting the study.
When this issue was raised in the ACRP Online Community earlier this year, some of the comments it generated indicated the respondent’s surprise at the idea that students could ever be considered vulnerable. Others, however, pointed to policies in place at their institutions to address the concern and avoid the appearance of coercion.
A Sampling of Student-Focused Recruitment Policies
Although it is not limited to the realm of clinical trials at Johns Hopkins University (JHU), the institution’s “Policy Concerning the Recruitment and Enrollment of Students in Research Involving Human Subjects” from 2005 notes the following:
There has been increasing concern in recent years in the academic community about protecting the rights and welfare of potential human subjects, particularly those who may not be well positioned to protect their own interests. …There have been…concerns expressed about students participating in research conducted at the institution in which they are enrolled.
The primary concern with respect to students is the possibility that, under certain circumstances, they may not feel free to refuse to participate…in research that is under the direction of people who have some control over their academic success and academic future. An additional issue is posed by the granting of extra credit or academic credit for participation in research projects.
Later in the policy, the topic of compensation comes up in this manner:
The use of monetary incentives for soliciting JHU student participation in research is permissible but must be guided by the same considerations and constraints as those applicable to all human subjects.
The use of extra credit as an incentive for JHU student research participation is acceptable if such participation offers educational benefits to the students in question, and the students are offered non-research alternatives by which they may earn an equivalent amount of extra credit.
Edward Fuchs, PA-C, MBA, associate director of the Drug Development Unit at Johns Hopkins School of Medicine, says, “My group does Phase I healthy volunteer studies at Johns Hopkins. For recruitment of college students who do not attend JHU, we have no particular restrictions on recruiting…and they receive the same remuneration as any other healthy volunteer. We do not actively recruit on college campuses.”
Policies at other universities also focus on the practice of recruiting students into studies, though not all the examples below refer directly to clinical research as opposed to surveys, observational studies, psychological assessments, or other research designs:
- At the University of Pittsburgh, a policies and procedures resource from the Human Research Protection Office states that “[r]ecruitment of students as research participants must be designed to minimize the possibility of undue influence. In general, potential participants should be solicited from a ‘broad base’ of individuals meeting the conditions for study, rather than by personal solicitation of specific students. …For research studies in which medical students are being recruited as subjects, including surveys of medical students, the School of Medicine’s Research on Medical Students (ROMS) Review Committee must review the proposed research plan before it can be submitted to the University of Pittsburgh Institutional Review Board (IRB).”
- Syracuse University’s Office of Research Integrity and Protections, meanwhile, notes on its “Students as Research Participants” webpage that “[r]esearch with one’s own students presents unique considerations with regard to human subjects protections. At the center of the issue is the inherent power difference between student and instructor. Regardless how well a faculty member presents the recruitment and option not to participate, students may feel as though they have to participate or risk having their non-participation impact their grade or relationship with the professor. In addition, the idea of ongoing voluntary participation is a potential issue if a student decides they want to discontinue their participation after initially consenting. Real coercion is rare is research, but the perception of coercion can be just as problematic in obtaining voluntary informed consent.”
- The University of Waterloo, on its webpage for “Conducting Research in Classes or With Students as Participants,” explains that “[t]he Office of Research Ethics and the two Research Ethics Committees at the University…recognize that participating in research can have educational value for students by exposing them to the methods used in their discipline or engaging them in the analysis of their own data.” In cases of researchers recruiting their own students, “a third party, who is not connected with the research, nor has any power or authority over the students, must be part of the consent process. …As the instructor and researcher you must wait until the end of the professor-student relationship before accessing the consent forms collected by the third party…[to] mitigate any real, or perceived, influence that you may have toward the student’s grades. Identifiable data must be analyzed only after grades have been submitted to the Registrar’s Office so that any real, or perceived, influence on the student’s grades no longer exists.”
Experts Eye the Ethical and Pragmatic Concerns
Various researchers have weighed in on the ethics and logistics of recruiting students into trials through peer-reviewed articles. For example, in a 2007 issue of The Journal of Chiropractic Education, Goldenberg, et al. note how “[c]ollege research departments have often recruited students at their schools to participate in research trials. Commonly, students are perfect candidates for these trials because many are young and asymptomatic.” However, “[d]isputes have arisen about the appropriateness of financial incentives for study recruits. Most commonly noted is that financial reimbursement could be coercive or serve as an unnecessary stimulus to encourage participation. Conversely, there are those who report that there is justification for reimbursing participants for time and expenses.” The overall article describes methods of recruitment of students for one study at Palmer Center for Chiropractic Research, and includes comments from two other schools about how those institutions recruit volunteers.
A 2004 article by Ferguson, et al. in the International Journal of Qualitative Methods concludes that “failure to address ethical issues in research projects can result in the impairment of the [faculty-student] trust relationship in both the research relationship and the preexisting fiduciary relationship. Because research involving these vulnerable and dependent participants is essential for the development of disciplinary knowledge, researchers must address issues threatening the trust relationship. In all instances, these dependent participants must be protected by ethically and methodologically sound research. As such, faculty researchers using student participants must attain high standards of ethical actions in their studies. Student participants would expect nothing less of faculty researchers.”
The Online Community Has its Say
Respondents in a thread on the ACRP Online Community devoted to considerations about college students as trial subjects touched on some of the same factors as the policies cited above.
“We have done [a study] where we reached out to healthy volunteers and, being a university, we did have a large response from the student body,” wrote Laurie Pearsall, LPN, CCRC, a research coordinator at University of South Florida. “Under our guidelines, students were not to be in any of our [principal investigator’s] lectures or classes. …[W]e did have a few that were only interested in the money and not the science behind the work and were unwilling to invest the time. …[W]e did have some compliance issues [in terms of students] not taking the drug, not refraining from alcohol, and not following through with washout once the study was completed for Part 1. Even with continued education at every visit concerning the importance of compliance—especially to wash out the drug—the students had the mentality of nothing will happen to them, as most young people have.”
Another concern raised by Janine Bennett, ACRP-CP, a regulatory associate with the University of North Carolina’s Lineberger Comprehensive Cancer Center, is that “[f]or research conducted by a peer, [a student] may want to participate to try and benefit the peer if they have a positive relationship, or they may want to participate as a means of sabotaging a peer with whom they have a poor relationship.”
In a private response to this author, an ACRP-certified study coordinator with a university-based medical center in Ohio indicated that her institution has “been doing healthy human subject research” in simulation-based medical education. “Our research participants are residents, medical students, nursing students, and [students from] other disciplines…. We have recruited volunteers from the [main campus’s] undergraduate population…as well. We follow the guidance from our IRB. They do consider these individuals to be vulnerable….”
Finally, in another piece of private feedback resulting from the Online Community thread, an ACRP-certified research coordinator for a nonprofit healthcare system in Virginia noted she has used college students as participants in her site’s industry-sponsored, multisite trials. “There’s no ‘relationship’ to give us any ethical concerns about vulnerability,” she wrote. “A plus [is that] they tend to be more tech-savvy than the elderly participants, making some processes easier to teach…. [On the other hand] if they’re from out of town, I don’t have good access to their other medical records, and they might be unavailable for summer visits.”
Johnson RA, Rid A, Emanuel E, Wendler D. 2016. Risks of phase I research with healthy participants: a systematic review. Clin Trials 13(2):149–60. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4783291/
Tasker R. 2017. Students share why they take part in clinical trials. Daily Collegian. https://www.collegian.psu.edu/news/campus/article_4b9527b2-d10a-11e5-9840-0f27804abe19.html
Gary W. Cramer (firstname.lastname@example.org) is Managing Editor for ACRP.