Students and research protection: IRB monitoring varies for student researchers
Special Report
Students and research protection: IRB monitoring varies for student researchers
Proposals may fall under radar
IRBs located in universities might find themselves inundated with low-risk protocols if they reviewed every single study proposed by college students working on their graduate papers. On the other hand, it would be poor policy and possibly provide risk to human subjects if these studies were routinely ignored.
One way to look at the situation is to see the monitoring of protocols submitted by student researchers as an opportunity to continue educating fledgling investigators about research ethics and the protection of human subjects.
"Our biggest interest is in making certain students learn something in the process about how to do research," says Patricia M. Alt, PhD, IRB chair and professor of health sciences at Towson (MD) University.
"Sometimes we have students who are overeager and submitted protocols to the IRB that they didn’t need to submit because it wasn’t really research," she says. "Sometimes a new faculty person has everyone submit an IRB application because they were going to collect information from friends on their statistics of height, eye color, etc. — not generalizable knowledge, not research."
In these cases the IRB will tell the teacher that while it’s good that they want to teach their students about the IRB process, this type of application should not be submitted because it’s not for research, Alt adds.
While the IRB does not require every student working on a master’s thesis to submit a protocol, the IRB does review any research done by a student for the purpose of collecting data from human subjects that will make a generalizable contribution to science and which will be published in the university’s library.
Other IRBs take an even more stringent stand on research conducted by students.
"Graduate students as investigators are supposed to follow the same standards [as principal investigators]," says Karen M. Janes, associate director of research integrity and compliance in the Office of Research and Sponsored Programs at Rutgers University in New Brunswick, NJ.
"Their advisor signs off on the protocol, as well, and the advisor takes the human certification test," she says. "We carry it a step further here at Rutgers."
Even when students are conducting the type of surveys that fall short of federally defined human subjects research, Rutgers requires the student investigators to submit the proposed protocol to the IRB, Janes adds. "We want to make sure they follow the standards when they’re gathering information and representing Rutgers."
At Towson University, graduate student researchers are given a packet of information that details the types of research that must be approved by the IRB, and a faculty advisor must sign the student’s protocol application, ensuring that it is scientifically valid, Alt says.
"Also, members of the IRB talk to graduate classes about human subjects research, including groups doing master’s projects," she says. "We have workshops about human subjects research several times a year for students and faculty."
Student researchers at the New England School of Acupuncture in Watertown, MA, must have a faculty member monitoring their project, says Barbara Marcel, RN, PhD, research advisor.
Also, she oversees student projects and works with students on their academic research, and everyone involved in research must take an on-line research ethics course and quiz. "So they get more monitoring than what a principle investigator would get," she says.
This sometimes means that a student’s initial ideas for a research project are shot down.
"I have had students call me, saying, I have a friend who’s a nurse doing a project with attention-deficit, hyperactivity disorder, and I want to do that for my research,’" Marcel recalls. "But when the student sent me documents about the research, I could see it did not have an IRB’s approval, and so I said, No, you can’t do that project.’"
Before the school had its own IRB, students were permitted to work in collaboration with another institution that had IRB approval and followed federal guidelines for a particular research project, she says. "Now we wouldn’t do that because everything has to go through our IRB as well."
IRBs located in universities might find themselves inundated with low-risk protocols if they reviewed every single study proposed by college students working on their graduate papers. On the other hand, it would be poor policy and possibly provide risk to human subjects if these studies were routinely ignored.Subscribe Now for Access
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