IRBs often have questions about dealing with student research

When should it be reviewed, how to educate

Student research sometimes falls between the IRB cracks usually because faculty and physicians may not be aware of the importance for an IRB review of all research involving human subjects. As IRBs face increasing scrutiny and research institutions are finding that all research conducted by their faculty, staff, and students can be at risk for legal and regulatory problems, IRBs are beginning to take a closer look at student research.

"The regulations that IRBs are expected to follow are silent on making a distinction on what happens in school settings and pedagogy and student research," says Moira Keane, MA, director of research subjects protection program at the University of Minnesota in Minneapolis.

So it’s left to individual institutions and IRBs to decide the answer to the question: What constitutes real student research? "The question is whether or not it’s really being done for research purposes or training purposes," says John M. Cavendish, EdD, JD, CRA, an associate professor of occupational therapy at the Shenandoah University in Winchester, VA. Cavendish is a member of the university’s human subjects review board. "Say you have a research class, and they’ll administer each other surveys and the process is to learn how to construct a survey and analyze results," Cavendish says. "Then you have something different from if you have a graduate student doing a thesis and who is surveying middle school students and analyzing their attitudes about drugs and alcohol."

That type of pedagogical research will never be published, only involves fellow students in a common setting, and is not intended for any purpose other than to help students learn the process. That would appear to be a place where an IRB could draw a line and say that such projects do not require IRB review. Yet, not all IRBs would agree. "Other colleagues will say that students’ research does not contribute to generalizable knowledge, and therefore, IRB rules don’t apply, but we take the opposite stand," Keane says. "We believe that we are training the next generation of research scientists; these students should be fully versed in the requirements for conducting research, and one of those requirements is IRB review."

One way to handle IRB reviews involving student pedagogical research would be to have the faculty advisor/instructor submit a research proposal for approval and then use that very same project for all students, so the one review will suffice, Keane suggests. "If students do an independent project as part of a master’s thesis or undergraduate senior thesis or graduate project, then it should be handled separately," Keane adds.

Decide where to draw the line

Student research is a gray area that each IRB should consider, says Miguel Roig, PhD, associate professor of psychology at the Notre Dame division of St. John’s College in Staten Island, NY. "Technically, as I understand the regulations, if the activity is not for research purposes, then it should not be sent to an IRB," Roig says.

However, unpublished student research that was conducted for research purposes should be reviewed by an IRB, Roig adds. For example, at St. John’s University, there are some master’s-level research projects that conceivably could be testing novel hypotheses, although they most likely will end up in a professor’s slush pile, Roig explains. "But if they are implemented as if they are research, actual research, then in those cases the projects ought to be reviewed by an IRB, in my opinion," Roig says.

IRBs should decide where it draws the line in defining research that requires an IRB review, whether it’s at the dissertation, master’s thesis, or undergraduate level, and then it could set a policy so that faculty and students will have some idea of what will be required. Otherwise, there often is some confusion and varying interpretations. For instance, Cavendish recently asked members of IRBs on an IRB Internet list service whether they thought this particular scenario constitutes research and whether it should require an IRB review: "A class data set consisting of blood pressure, resting pulse, height, weight, and a few similar variables is collected at the beginning of the term from students in a research course. These data will be used in class to demonstrate how to conduct various statistical analyses. No further use will be made of the data, and results will not be published."

While some IRB members wrote Cavendish to say that this scenario should not result in an IRB review, others said the opposite. Keane and Roig note that this particular pedagogical exercise should not be conducted as written, and therefore it might require an IRB review. "You can do all kinds of things inside the classroom that represent experiment studies that are pedagogical exercises that perhaps should not be done in class," Roig says. "What occurred to me about that scenario is the question of whether we should have students ask peers personal information about their weight and blood pressure."

Faculty should be sensitive to these types of issues because weight, height, and other personal physical information can be highly sensitive to certain individuals and therefore are unsuitable data to be collected in a classroom setting, Roig says.

"Weight is not a low-risk question among young women particularly," Keane says in agreement. "Body image and weight and all encumbrances of those issues can have an effect on developing eating disorders." Keane says her IRB would have approved part of the research, but not the collection of data on weight and height.

From an alternative perspective, students who conduct research often believe that the IRB creates unnecessary burdens and road blocks in their efforts to complete projects, says Deana Katz, MBe, research ethics outreach coordinator at the Center for Bioethics at the University of Pennsylvania in Philadelphia. It particularly grows complicated when the student research is in the social sciences area, such as a project that involves obtaining oral histories or having a student become immersed in another culture, as in ethnography, Katz says. "These students won’t collect research in the same way, and the IRB may not understand their methods at all," Katz says. "So what the IRB will wind up doing is focusing on what they do understand, and they may pick apart things."

Safety issues are different in the social science area, and students may have a legitimate complaint that an IRB designed from a biomedical model doesn’t understand their issues, Katz adds.

This is why balance should always be a consideration, Cavendish suggests. "The role of the IRB is not to thwart research, but to protect human subjects," he says. "We don’t want to set up unreasonable barriers." For instance, at another university where Cavendish worked, there was an IRB policy to review every single funding proposal that went out, even if it was only to buy a couple of computers. All were subject to quorum review, leading to an environment in which the faculty was discouraged and research was stagnated.

Don’t get stymied by bureaucracy

Once the policy was changed so that items reviewed were those that were required by federal regulations, the research volume — in terms of funding — was increased fourfold, Cavendish says. "My guess is that 90% or better of the research that had previously been reviewed by the IRB now was exempt from review," he explains. "So you can see in a case like that, it’s not just erring on the side of caution — it’s really throwing up barriers." These are all reasons why it’s important for IRBs to offer education and training about human subjects’ protection to students, faculty, and others, so that they’ll know when research should be submitted to the IRB for approval. (See "Education is key ingredient in successful recipe" in this issue.)

"One thing that would be undesirable would be for IRBs to start looking at all sorts of projects that don’t have anything to do with actual research," Roig says. "But that leaves us with situations where we have student assignments that ought to have some sort of ethical component and ought to be reviewed by someone." Another issue involves faculty advisors, physician researchers and advisors, and research instructors.

Demystify the medical myth

"Some faculty advisors, and I’m sure it’s not just at this institution, say, I’m not sending the research through the IRB,’" Cavendish says. In other situations, faculty advisors might not be aware of the IRB process or they are unaware that student research can require an IRB review.

"We have to change the culture of understanding of what requires an IRB review and what doesn’t," Keane says. "And sometimes it’s working with historic myths that only faculty research or funded research requires IRB review." These myths can create misunderstandings, particularly in social and behavioral sciences departments where faculty may feel the IRB process has a medical bias and so their work doesn’t fit into the IRB review process.

Some universities and IRBs have established a checks-and-balance system that is designed to identify university-generated research that involves human subjects and was submitted to the IRB for review. This system could be done informally, such as IRB members hearing of an instructor who has graduate students who are involved in research that hasn’t been submitted, or by having someone check faculty course offerings against IRB reviews to see whether there are some instructors who teach research or are advisors to graduate thesis projects and who haven’t submitted proposals for approval.

In a more formal scenario, some universities and IRBs have collected information on published studies that generated from a particular university’s staff and students and then compared this information with proposals submitted to the IRB. When cases are identified that did not use the IRB process as required, then someone is assigned to contact and educate those professors, Katz says. "I know of a major research institution that is monitoring things this way, and I think it’s a great idea," Katz adds.

When an IRB coordinator learns of a faculty member who is not instructing students to submit research for IRB review, it’s best to take a diplomatic approach in dealing with the instructor, Cavendish says. "The first step is an informal call and meeting with the chair of the IRB," Cavendish suggests. "The chair would meet with the person and explain the IRB requirements, and I think probably a majority of faculty at that point would say, OK, I don’t like it, and I don’t agree with it, but I’ll at least do it.’"

A good, nonthreatening approach would be to tell the faculty member: "This is something you probably never thought about, and it’s new to all of us, but things have changed generally and at this institution, and here’s how it affects you," Cavendish says. It also might not hurt to mention that if the university is sued over a student’s research project, then the faculty member likely will be named in the lawsuit, as well, he adds. "There have been lawsuits where, for example, a student took a survey in a public school that was offensive to parents and the parents had not given permission," Cavendish notes.

Some universities and IRBs might take the whole process a step further and require all faculty advisors to students conducting research to be named the principal investigator, but this is not necessary.