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Evaluating research risk requires understanding a variety of potential harms and their nuanced impact. IRBs might find it useful to have a matrix to help explore each potential harm.
"In order to evaluate risk, you have to understand that it’s a construction, a conceptual construction that we make where we try to get a sense of the severity of the harm," says Paul Reitemeier, PhD, chair of the human research review committee and associate professor of philosophy at Grand Valley State University in Allendale, MI.
"You have to identify the nature of the harm and its severity, and you have to identify the likelihood of it occurring," he adds.
Federal regulations identify four kinds of harm, so the IRB decided to look at four degrees of severity and four areas of harm. These form the rows and columns of the matrix.
"We decided to put an empirical descriptor in each box," Reitemeier says.
The four columns pertaining to the four levels of risk include potential harms of health/physical, privacy/social/legal, psychological, and financial. (See information on these four potential harms, page 90.)
Researchers find communicating risk to be a delicate dance, Reitemeier notes.
They want to provide adequate information without unnecessarily alarming potential subjects. The matrix with its empirical examples in each of the categories gives them a way to describe risk to participants and to better educate themselves about their study’s risk, he adds.
The matrix doesn’t address frequency because researchers often will not know a potential harm’s frequency until the study is underway.
"You can imagine all kinds of research where the people who are asked to participate have a different understanding of what minimal or moderate or significant risk would mean," he says. "So the matrix is a tool to try to help the researcher figure out how to describe a potential harm based on the type of harm and the severity of it," he explains.
An example of how differently scientists and a study population might view harm is what happened with the Havasupai Indians in Arizona over the past 24 years, Reitemeier says.
Researchers in 1990 obtained permission from the community to draw blood for research. Investigators initially hoped to learn more about the tribe’s high rate of diabetes. But over the years, the blood samples were used for other genetic research, including study into the tribe’s geographical origin.
"When they completed their research, they did a DNA analysis and determined these people came across the Bering Strait from Russia years ago," Reitemeier says. "This was upsetting to Native Americans because their culture said they had originated in the Grand Canyon."
Had the researcher or IRB anticipated this cultural and psychological harm, they could have provided better informed consent and took precautions to minimize the risk, he says.
The four rows of the matrix stipulating the severity of risk are these:
• No more than minimal risk. This is defined in the regulations as the risk you undertake if you are an average, normal, healthy person living in a safe environment, he says.
"It includes routine physical or psychological procedures or tests," he adds.
Blood tests and gathering information about height and weight are examples of no more than minimal risk.
• Minor increase over minimal risk. This one is ambiguously defined as more risk than minimal, but less than moderate, Reitemeier says.
• Moderate risk. "This is more harmful than most people would think about, but the harm has to be temporary," he explains. "It could last more than 24 hours, and it should be reversible with moderate discomfort, bodily function or pain."
Consider the risk associated with getting one’s tooth drilled or if someone’s private information is released with his or her identity attached and it appears to be socially embarrassing, he notes.
Consider psychological harm, defined subjectively, as upsetting, unwanted emotional responses, but not impairing, and they are transient.
"They go away after a while," Reitemeier says. "You might be sad and nervous and have your sleep disrupted, or it could be financial, a temporary or moderate financial cost or loss, a short absence from work where you lose wages, or it might be a waste of time if the research lacks scientific merit."
• High risk and life-threatening risk. "It is permissible for IRBs to review and approve research that carries that level of risk, but it has to have strong justification," Reitemeier says.
The matrix contains a series of examples of types of harm at different levels of risk. IRB reviewers can consult it when they’re trying to make a determination, and IRB staff can use it when trying to decide if a study is exempt or requires an expedited or full board review, he explains.