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IRB role at small colleges sometimes a little murky
Informal review processes are on way out
Small colleges and undergraduate departments at universities are finding it increasingly important to formalize their human subject protection programs while making certain IRBs are reviewing what they should and not filling agendas with a lot of unnecessary reviews, several experts say.
"A lot of the focus in IRB review has been on large institutions and, particularly, those with academic medical centers," says Julie Pedroni, PhD, a visiting assistant professor of philosophy at Williams College in Williamstown, MA. She spoke about IRB reviews at smaller and undergraduate institutions at the PRIM&R 2003 annual IRB conference.
"It’s been shifting slowly, but surely, to concern about undergraduate institutions, and they have very special concepts and IRB needs," Pedroni adds.
Traditionally, undergraduate and smaller institutions may have had an informal process of research review, such as a secretary or administrator who handled the paperwork or an IRB that has a chairman who makes informal decisions or an IRB that meets infrequently, she says.
"Even if they don’t have assurances with the Office for Human Research Protections, I think they realize OHRP is setting the standards, and they face some liability," Pedroni says. "And there are new PhDs taking up faculty positions, and they received research ethics training while graduate students, and they say, We need a functional IRB here,’ and that may be part of the trend, too."
More training needed
Once the IRB process becomes official, it’s often necessary to educate faculty, staff, and students about what an IRB does and when research should be submitted for review, she says.
"The truth is that faculty at undergraduate or liberal arts institutions, at least, tend to focus on teaching rather than research and they may not be all that up on human experimentation ethics in their fields," Pedroni notes. "Also at small institutions you may get fairly spotty or narrow expertise on your IRB."
This means there could be problems, at least initially. For instance, Pedroni recalls speaking with a professor at a college she was visiting who had been doing human subjects research, but didn’t realize it would be considered research and therefore possibly subject to federal regulations governing human subject studies until he spoke with Pedroni.
Likewise, she encountered a student who was conducting a survey about sexual experiences and HIV exposure. Her project was for a classroom exercise, but its nature would have required an IRB review, Pedroni says.
"I did send an e-mail to that instructor," she says. "And I had a good long talk with the student."
This examples highlights one of the key issues for IRBs at undergraduate or small institutions, and that is determining when a project is research and when it’s only an educational activity, says Lori Bross, assistant to the vice president for research at the Office of Research Compliance at Northern Illinois University in DeKalb. She spoke at the PRIM&R conference on this topic.
"You train a student to think like a researcher and learn techniques that a researcher would use, but they’re not really doing research, and that’s a fuzzy line that IRBs have to tread," she says.
State law also may govern how an IRB handles student research and educational research activities. Some states require all research to be reviewed by an IRB, Bross says.
"Then some larger cities may have ordinances on the books that govern research conducted within city limits, and that’s another example of local regulations that you might need to know about," she says.
IRBs might take the stand that all theses and dissertations that involve research would be required to have an IRB review, but there are other projects that still may trigger some sort of IRB scrutiny, Bross adds.
For instance, any time a person is asked to review personal information for a research or educational project by a student, professor or someone else, then an IRB might want to consider the impact of that interview on the subject, she says.
"It doesn’t matter whether it’s for a class project or a thesis or a study because the impact is the same on the subject," Bross notes.
On the other hand, institutions would be inundated with paperwork, if IRBs had every student submit his or her projects.
"You need to find a way to balance issues of subject protection and ethically conscientious research with practical issues like workload," Bross says.
A creative solution might include having an IRB comprised of students and faculty who look only at student projects, she suggests.
Another issue that IRBs at small or undergraduate institutions might face is opposition to having an IRB review all socio-behavioral research and expecting such research to meet some of the same rigorous standards as biomedical research.
"While we all understand that research participants can be hurt by being involved in socio-behavioral research, the likelihood of their being hurt in any significant way is dramatically smaller than for biomedical research," says Stuart Plattner, program officer for cultural anthropology at the National Science Foundation in Arlington, VA.
Socio-behavioral research fell under the federal regulatory umbrella after the fact, he notes.
"They didn’t want to draft any new regulations, so they included social-behavioral research in the biomedical research regulations," Plattner says.
"The problem is not that people are being harmed or that they’re not giving informed consent, but that the researcher is being stymied by a reviewer for biomedical concerns," he says. "It’s very difficult for a sociologist or anthropologist to fit his or her research project into something defined for biomedical research."
For one thing, the power structure between researcher and subject is quite different in socio-behavioral research, where a researcher may go to a person’s home and ask them a few questions in a setting where they are very comfortable and free to say "No," Plattner explains.
By contrast, a person who seeks medical treatment from a doctor, who then suggests a treatment that is under study and asks the patient whether he or she would be interested in participating in the study, is in a position of lesser power than the physician, who may hold a key to that person’s health and well-being.
Plattner says that in his experience IRBs are being too cautious about socio-behavioral research.
"My advice to IRBs is they should spend time worrying about these projects where people can really be harmed," he says.
"But if a socio-linguist wants to review the grammatical structure of language, then there is no issue — don’t waste time on this," Plattner says.