High schoolers getting schooled in protections

Through science fairs, special schools and summer programs, they get experience with IRBs

As high school students get exposed to more sophisticated science and health programs, some are also having their first encounters with human subjects protection issues.

In science fair projects, in special science and health schools and through outreach programs from research institutions, they're doing social and behavioral studies and being taken on to help established scientists with medical research.

While the number is not necessarily large, observers say aspiring investigators already are interacting with IRBs.

Rebecca Dahl, PhD, CIP, manager of the human subjects protection program at Children's Hospital Los Angeles, says she recently was approached about allowing a high school student who was participating in a summer research program to be added to a protocol.

"They wanted to have the student assist them," Dahl says. "And people were wondering what to do and how to go about the proper process."

Dahl says that she would be very cautious about what type of assistance a high school student would be able to provide.

"I would have to determine if what the student is doing is really at the level of knowledge and understanding so that they can perform things where they can feel successful," she says.

Those tasks might actually include interaction with subjects — handing out surveys or answering simple questions — as long as they were closely supervised by an investigator. And she says they would require the same type of training required of older research staff.

"But remember, most of these kids, although they're screened very carefully to even be involved in the summer programs, they're not screened for research knowledge and they don't get that, necessarily, in the high schools."

High school IRB

At some specialty high schools, however, human research ethics is actually part of the curriculum.

Judith Scheppler, PhD, is coordinator of student inquiry and research for the Illinois Mathematics and Science Academy in Aurora. Her students conduct their own research projects, as well as working off-site with established researchers at area institutions such as the University of Chicago, Northwestern University and Fermilab.

The school requires that students working off-site be written into investigators' IRBs proposals and that the school receive a copy of the outside IRB's approval letter.

"We don't want our kids to be used in the wrong way to do data collection," she says. "And we also use it as an educational tool for our students. By getting that (approval), we hope that they understand that you can't just go out and do research with human subjects without oversight."

IMSA also has its own IRB, chaired by Scheppler, in part to deal with student-generated research (It also fields requests from adult investigators wishing to recruit IMSA students for studies). Although the school does not handle federally funded research, Scheppler says the board's policies require that it follow federal guidelines.

"If your students are doing research, one can make the case that they are doing it as an educational endeavor and therefore they don't actually need IRB approval," Scheppler says.

"But for a number of students, it really becomes a gray area. I will have some of my students present at places such as the Illinois Gifted Conference. At that point, they are subject to IRB guidelines, because they are participating in a public venue, contributing to generalizable knowledge."

Scheppler says that about five years ago, the school added a core course for sophomores called "Methods of Scientific Inquiry," part of which deals with human subjects protection issues.

When students submit research proposals, they must provide an ethical overview of their research, and, if it involves humans, must detail how they plan to handle such questions as voluntary participation, confidentiality and informed consent.

Scheppler says some of her students have done observational research in classrooms at other schools, and have quizzed students to gauge the effectiveness of different teaching styles.

"We're really not going to do anything that's more than minimal risk, because our students just aren't skilled enough to take on anything more than that," she says. "And we're dealing with, at least on the campus, non-biomedical research."

But she says students have studied topics such as teasing, where there was some concern about psychological risk.

"What we do is make sure they're working with one of the counselors when they do those surveys, so the counselors are aware if any student becomes stressed because of the nature of the questions."

Science fairs

For many high school scientists across the country, the school science fair can be their introduction to some form of an IRB.

The world's largest international high-school science competition, the Intel International Science and Engineering Fair (ISEF) has requirements for human subjects research that follow federal regulations.

Each participating school that allows human research must establish its own IRB, made up of at least three members including a science teacher, a school administrator and someone who can assess physical and/or psychological risk (a doctor, social worker, psychologist or school nurse can fulfill this requirement).

Nancy Aiello, PhD, chairwoman of Intel ISEF's scientific review committee (SRC), says some schools in larger metropolitan areas can tap local research institutions for IRB members. Students working off-site with an established researcher must have that project approved by the outside institution's IRB.

Local and regional SRCs, as well as her own SRC, which oversees the entire fair, can review decisions of school IRBs. If an SRC believes subjects were not adequately protected, a finished project can be declared ineligible for competition.

The most common concern, Aiello says, are surveys that ask high school students inappropriate questions.

"Kids are always trying to find out information about other kids," she says. "Asking about drug use, about their sexual habits, things like that. In cases like that, you have to make sure that there's been proper review and approval, that parental permission has been obtained and that the parent has seen the copy of whatever instrument was used."

Elaine Labrocca is on the SRC for schools on Long Island, NY, an area well-populated with research institutions and parents who work at them. So she sees a lot of fairly ambitious research projects from students.

"You'd be surprised what some high school kids do," she says.

She says her SRC is conservative about what it will allow. Recently, she notes, it required that surveys and other research being conducted with students not be done in a classroom during class hours. The SRC was concerned about issues of voluntariness.

"The high school population is very prone to pressures from peers," Labrocca says. "And we didn't want it where there was a grade being given. We want (participants) to go where they have to go voluntarily."

The Long Island SRC also does not allow students to ask other students about illegal activity.

"On a cell phone study, there was a question this year that seemed innocuous. They asked, 'Have you ever used your cell phone while you're driving?' Well that's an illegal behavior in New York," Labrocca says. "That project was deemed minimal risk and so there was no qualified scientist, although I believe they did have consents.

"We allowed it to go through, but we used the opportunity to educate them and we required a letter from their IRB that they are aware that any question that implies an illegal behavior is inappropriate."

Teachers on the front lines

Labrocca says that while some school IRBs have become well-educated about human subjects protection issues, other schools still struggle with it. She has investigated the possibility of requiring one member of each local school IRB to have online human subjects protection training.

Meanwhile, she says, the importance of educating students about these issues lies with their teachers.

Scheppler notes that students are very interested in the types of ethical questions that have historically been raised by human subjects research.

"Talking to students about things like the Tuskegee syphilis study, (Stanley) Milgram's (obedience) studies — kids like that sort of stuff," she says. "They like that human element, that dilemma, that thing that went wrong. I think that's one place where you can bring some of these things to light for them and have a discussion."

Dahl believes there may be a role for IRBs in promoting awareness of human subjects protection issues among high school students.

Before coming to Children's Hospital Los Angeles, she was director of human subjects protection at the University of Arizona, where she began to explore the idea of engaging with high school students in order to interest them in human subjects research.

"My goal was to reach out to high school seniors because they are the ones who may progress to a career in research," she says. "I wanted to go out and do workshops, brown bags, lunch seminars."

When she was recruited to CHLA, the idea was dropped. But Dahl still hopes to pursue it someday.