Mission Creep: Is it leading IRBs astray?

Are marginal research activities clogging IRBs?

Expert discusses worst-case scenarios

Mission creep among IRB work occurs when research institutions and IRBs permit fear of missing something to rule their decisions, an expert says.

"It’s because of not understanding and also because the language is so general in the definitions of human subjects and research that so many things can be included or excluded depending on all the interpretations," says Susan L. Rose, PhD, executive director of the office for the protection of research subjects at the University of Southern California in Los Angeles.

"The important thing is that people have overreacted out of fear of missing something," Rose says.

IRBs across the country are finding their agendas clogged with reviews of projects that could marginally be considered research, Rose notes.

"First, IRBs are overworked, and then they add this stuff that should be subtracted," she says. "The work load is humongous."

The answer is better education and more clarity in the regulations. To this aim the University of Southern California has a booklet with guidelines that is available on the university’s Web site at www.usc.edu, Rose says. (See sample excerpts from the booklet, p. 40.)

The booklet, titled "Is Your Project Human Subjects Research?" includes these definitions of research from the federal regulations 45CFR46:

• "A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

• A human subject is "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."

The USC booklet underlines the words "about whom," because those two words are a very important concept in determining what is human subjects research, Rose says.

For instance, one IRB had not given serious consideration to these two words when it decided to review the proposal of a man who wanted to consult with architects and engineers to look at the soundness of buildings and their ability to withstand an earthquake, Rose says. The man had to seek IRB approval for a project that was not about human subjects, but was about buildings and the professional assessment of those buildings, she explains.

The person in charge of the building project was not able to interview the buildings, obviously, so there had to be people involved as experts, and just because there were people involved doesn’t mean this was human subjects research, Rose says.

"Is the intent to test the architects to see if they are worthy of being architects, or is the intent to use their training and knowledge to identify the buildings with problems?" Rose says. It’s not research just because you asked questions to establish a person’s qualifications, Rose says. The architects’ credentials were the criteria for establishing who they were, she says.

"For example, what if there’s a physics experiment about Bunsen burner height of flame and/or radioactivity in flames, and you have physics students whom you have to ask whether they have been trained to work with Bunsen burners or whether they’re approved to work with radiation," Rose says. "These questions get the students over the threshold to be your experts, but it doesn’t turn the focus of the research on them."

Another issue is the generalizability of research and what this means, she says.

"That has been broadened to mean that something you’re doing becomes research if you publish it or even have a poster session at a meeting," Rose says. "Generalizable really means the intent to show it has validity beyond your particular experiment or condition or population."

Alternately, if a campus finds that certain buildings with certain types of ventilation are the ones in which students receive better grades, and so the university publishes this correlation, it doesn’t mean that what is conveyed is generalizable and research, Rose offers as an example.

Likewise, quality improvement projects sometimes are misinterpreted, she says.

For example, a parks recreation entity wanted to find out if a particular park had good traffic, so staff questioned park users about their behavior in the park, focusing on what they ate and how they spent their money in the park, Rose explains.

This type of activity would not be considered human subjects research once an IRB focuses on the question of What is the point of the research?’ Rose says.

In this example, the mission is to direct resources toward improving park usage, so it’s a quality improvement project and not true research, she says.

It shouldn’t be assumed that a project’s findings are generalizable just because the findings are published or made public, Rose says.

"Generalizable means you’re proposing or hoping or presuming the conditions of what you did are useful or valid in all similar situations," she explains. "That’s why oral histories are not human subjects research a lot of times, because if you write about your next-door neighbor, you’re not proposing that everybody is a next door neighbor."

Another step towards showing that something meets the definition of human subjects research is the concept of validating a process or equipment, Rose says.

"Quality improvement falls into this category," Rose says.

If an institution develops new software and then has staff or others validate the new software, the research doesn’t automatically become human subjects research just because humans are doing the validating, Rose explains.

Likewise, if someone asks curators at art galleries to report what kinds of exhibits draw-in the public, this inquiry is not human subjects research, Rose says.

If the institution were to ask curators questions about their relationship to their employer, or what it is about their jobs that is horrible, then it would enter the realm of human subjects research, she notes.

Defining what is human subjects research and legitimately subject to IRB review will continue to be confusing, so it’s important for IRBs and institutions to offer decision trees or guidelines for making this determination, Rose says.

The USC booklet offers guidance for investigators who have questions about their studies, and it provides examples of what types of projects are not human subjects research. "If someone goes through the decision tree and still doesn’t know the answer or if there aren’t clear answers, then we encourage the person to go to the IRB," Rose says.