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February 25, 2005

When Bad Things Happen to Good Investigators

Question: What do the following scenarios have in common?

Answer: The people in these situations have crossed the line into human-subjects research. By submitting her thesis for publication and by collecting data for some future publication, the student and the team of workers have both entered into the human-subject research arena—without the necessary approvals of the Committee on Human Research (CHR). And they may have already jeopardized their ability to publish or disseminate their data as human-subjects research.

"One of the knottiest problems here at the School is the distinction between public health service and public health research," says Pat German, director of the CHR. "Researchers out in the field often start out doing public health projects, or service, but then see things that may be valuable in other regions of the world or in other similar projects elsewhere, and so they seek to generalize it beyond the particular situation." In short, many projects start out as practice, but become research.

Nate Pierce, MD, professor of International Health and the institutional official for the CHR, agrees: "It's not the activity itself that's a problem, it's the context: The same activity can be either service or research, depending on your intent."

CHR Wants to Be of Service
German and Pierce are working hard these days to get the word out to faculty and students about the Center for Human Research. They first explain that the CHR serves as the Bloomberg School's Institutional Review Board (IRB), and is staffed and supported by the Office for Research Subjects (ORS).

"CHR is on your side," explains German. "If you give us the chance, we can apprize you of any preventable pitfalls ahead of time, before they have a chance to develop."

"Too often," says Pierce, "we're seen as an obstacle investigators have to get past, rather than a partner and resource that can help them avoid a passel of headaches later on."

German and Pierce know that investigators don't get into these situations because of deviousness—after all, scientists are well aware that the Institutional Review Board must be involved every step of the way. "Public health researchers are particularly vulnerable to these troubles, however, because the line between public health service and research is often blurred," says German.

"Ideally," she says, "we want researchers to recognize pitfalls as soon as possible so that the most that's lost is the time CHR spends approving it. But if they get ahead of the process, they may lose the use of all the data they've collected."

Student and Overseas Projects Need Careful Supervision
Students are another group vulnerable to this problem because, although student projects are not considered research, if they should wish to distribute any information they've gathered—through abstracts, posters, meetings, publications—that suddenly becomes research.

“Faculty need to keep in mind that they must supply adequate supervision and monitoring of student projects," says German. "We are required to require that there's always a faculty principal investigator for every student project. Faculty must understand that, when they are the P.I. for student work, they have all the responsibilities they'd have as regular P.I.s."

Likewise, principal investigators at the School must also keep close tabs on the work being done in their name overseas or through international collaborations, to make sure their far-flung colleagues don’t get ahead of themselves.

Another source of trouble, says Pierce, is that researchers sometimes start revising or changing the content of a study without first getting prior approval from CHR. "It may start out as public health practice but then gradually become research—and we can't retroactively  approve such work as research, and it can't be published as research."

Thus, as long as a student is working on a project for her PhD thesis, that work will never be considered research. But should she later go to a conference with the intention of sharing and disseminating her data, that intention automatically transmogrifies her efforts into research and, unfortunately, she loses the right to use that data because she did not get clearance from CHR before she started the project.

Can This Research Be Saved?
Are such situations salvageable? "Often they are," says German, "but repairs may be lengthy and may involve going back to a large cohort of uninformed participants, explaining in an interview what went wrong, and getting written permission to proceed." The investigators must even provide proof that each of these interviews took place. Meanwhile, CHR is working to determine the level of compliance, or lack thereof.

When CHR does enter the picture, they determine exactly what happened and then determine what has been done without approval that may have changed the risk/benefit ratio for the subjects. Actions then taken by CHR could be anything from requiring you to get permission forms from subjects, or stopping the research altogether and not allowing you to use any of your hard-won data. "It depends on the sense we get of how it came about—it's innocent, usually," says Pierce. "They aren't trying to get away with anything. At that point, they need to get clearance for formal prospective studies."

So, what to do if you stumble into trouble? "Part of it is recognizing at the earliest possible point and asking questions," says German. "Call CHR as soon as you realize you've gotten ahead of yourself. The situation may be very fixable, but it becomes less so the longer you wait."

This past year, CHR saw several examples of insufficient monitoring, interaction, and supervision of international collaborations and student projects. All were salvageable but in some cases rather major repairs were necessary, which placed a very substantial burden on investigators. —Rod Graham