The trusted source for
healthcare information and
Special Report: Students and research protection
Should IRBs review public school studies?
In some cases, yes
(Editor’s note: In this issue of IRB Advisor is the second part of a special report on how IRBs are dealing with evolving policies on students and human subject research.)
Monitoring student research isn’t always a top priority for an IRB, and often the job may be partly handled by the student’s department and graduate advisor. However, in the cases where the student research involves human subjects who are children, the issue becomes far more complicated.
Student researchers at Colorado State University in Fort Collins often need to conduct research in the fields of education, occupational therapy, and music therapy, using local public school students, says Celia Walker, MA, director of the regulatory compliance office.
The university’s IRB shoulders a lot of responsibility for these projects because there are no IRBs in the public schools, and for most of the people who approve the research at the school level, the concept of human subjects protection is foreign, she says.
"If the school’s involvement meets the federal definition of engaged research, they technically should be reviewing it for IRB-type issues, but they don’t know how to do that and they don’t know what the regulations say," Walker explains. "So how can we get assurance from them that their students are being protected when they don’t know what the regulations say?"
The ideal solution would be for the school district to have one person who is knowledgeable about IRBs and research ethics, who can make informed decisions about whether a school’s students should be recruited for a particular investigation, she says.
"The more sensitive the research — such as drug and alcohol surveys — the more valuable that information is to the school and the greater the incentive for the school to approve it without thinking whether their students are adequately protected," Walker says. "That’s where the pressure comes in to do passive consent."
Passive consent used to slide under the IRB radar screen, but it’s no longer easy for investigators to bypass parents in obtaining informed consent, she adds.
For example, a proposed research project involves a nutrition curriculum with small children. As part of the project, they’ll be fed new and interesting foods, Walker says.
There are some safety considerations that may not occur to the investigator or school staff, such as how to find out whether a particular student has food allergies, she says.
"The project staff will say, We’ll just pull the kids’ records and look at that,’" Walker adds. "Our IRB will say, You shouldn’t have access to those records.’"
The problem is that it is too tempting for investigators to take the easy route to obtaining information because they recognize that teachers are overworked and don’t have time to pull this information for the researchers, Walker explains.
The solution to this dilemma is for the IRB to require that investigators design a procedure that would have teachers scanning academic files to get the necessary information, she says.
"They had to receive verification from the local school district and had to have parental consent, also," Walker says.
Investigators were hesitant to call parents and explain the study and inquire about allergic reactions because they didn’t want to scare parents away from having their children participate, she says.
Should I or shouldn’t I?
So much of what occurs in educational research is questionable about whether it was intended to be subject to the human research regulations, Walker notes. "If you are a teacher, and you want to try a new math book for year, do you evaluate it and make your own decision, or do you tell parents that you are evaluating a new math book?"
Likewise, if a graduate student is writing a new math program that uses environmental measurements, and it’s directed at third-graders, there isn’t any way to decide whether this new program will work without testing it in third-graders, she says.
Whether an aspect of education is research depends on how one defines the type of research that is contributing to general knowledge, Walker says.
"Demonstration projects, evaluations, where do you draw the line?" she asks.
The American Institutes for Research in Washington, DC, involves students in state department of education studies of standardized tests, says Douglas B. Gibson, PhD, a senior research scientist and IRB administrator.
"We have done that for school districts in Pennsylvania, Ohio, South Carolina, and California," he says. "Some of this involves obtaining student records, and that’s where people sometimes run into problems."
Such research must follow regulations under the Pupil Protection Rights Act, and this includes rules about sharing information with parents about instructional methods and obtaining informed consent from parents when there are sensitive medical or other questions being asked, Gibson explains.
For instance, the student survey questions that receive the most scrutiny are the ones that ask children about their psychological feelings and attitudes, he notes.
"If there are questions that are intrusive, or we feel like they might be psychologically damaging to the children, then we take those issues to the full IRB and don’t do expedited reviews," Gibson adds. "We try to make sure there are sufficient protections in place, and we send protocols back to researchers over and over again until they’re safe for students."
Occasionally, the IRB places so many burdens on researchers that they’ll back away from a project, Gibson says.
When research involves a large database of student information, the IRB makes certain the protocol doesn’t require informed consent, because obtaining it would be impractical, he notes.
While IRBs may not be able to decide all of the gray areas, they can at least make certain that student and faculty researchers are well educated about human subjects protections and regulations.
"If you can do anything to improve human subjects protection it would be to get more people informed about human subjects issues," Gibson says. "Education drives the whole process."
At Towson (MD) University, members of the IRB routinely speak with graduate students about human subjects research in an effort to make them aware of ethical issues they may not have considered as they prepare to begin master’s degree projects, says Patricia M. Alt, PhD, professor of health science and IRB chair for the Towson University IRB and the Maryland Department of Health and Mental Hygiene IRB in Baltimore.
"This university historically was a teachers’ college, and we still have a lot of education research, psychology, mass communications, and other things, but it’s the education research that is particularly tricky," she reports.
The problem is the rules were written for medical research with considerations involving the possibility of life-threatening medical interventions. Instead, the most common studies conducted by students would involve social science, behavioral, and other areas where a human subject could be harmed, but not physically, Alt explains.
"Our biggest interest is in making certain students learn something in the process about how to do research," she says. "We do require the faculty advisor to sign the form, and if the advisor signs it, it means the advisor has made certain the study is scientifically valid."
"We occasionally get complaints about things like grad students in education who are classroom teachers distributing surveys to their own students or to other students in the school," Alt says. "Once in a while, a parent will call up and complain that they were pushed to return the survey or whatever."
However, the extensive research education the graduate students are given has resulted in the process working quite well most of the time, she adds.
Another consideration IRBs should make in reviewing research protocols that will involve minors in schools involves studies that use passive consent, Walker says.
While an IRB may allow researchers to obtain passive consent, meaning that parents are asked to inform the school if they do not want their children to participate in a study, this sort of consent must be done carefully, she says.
"Our committee may put additional requirements on the process," Walker says.
For example, if the researcher doesn’t present information about the study to parents in a timely fashion, then parents may not have enough time to make an informed decision, Walker states.
Also, investigators need to communicate the purpose of the study in a variety of ways to parents. For example, at a Native American boarding school, investigators wrote parents about the study and placed public service announcements (PSAs) on the radio in various communities, Walker recalls.
One IRB member asked the investigator what time the PSAs were aired, because often these are run when it’s convenient to the radio stations and not necessarily at a time that the parents might be expected to hear them, she says.
"We expect investigators to use two to three ways of notifying parents that the study is on and how they can obtain information," Walker says. "It may be a creative and expensive process to reach the parents."