Risk - Part 1

Risk is one of the central concepts in human research protection and is one of the most misunderstood and misapplied terms in the field. Many IRBs and investigators treat risk as if it were the same as harm to subjects, which is why the IRB Forum had a recent discussion about the use of the phrase “possible risk” in consent forms. Risk is not harm; risk is an estimate of the magnitude and probability of the harm to subjects that might happen in research. “Your hair might fall out” or “you might go blind” are not risks, they are possible harms. Simply telling subjects that one or both of these might occur is not informing them of the risks.

In order to determine the risk of these events, you need to evaluate both the severity of the possible harm and the likelihood that the harm with occur. A very severe harm that is extremely unlikely to occur may be a minimal risk, while a less severe harm that is very likely to occur may be more than minimal risk. Clearly, the possibility of going blind is a very serious harm, but if the chances that it will happen are one in five million, then it may be a minimal risk that subjects are willing to take. Losing hair, for most people, is not a very serious risk, but if it is a sure thing, I might have second thoughts about it.

To inform subjects about risks, IRB and investigators must evaluate the risks and make sure that subjects are informed about the reasonably foreseeable risks in the research. This means that IRBs must identify the possible harms in the research, evaluate both the magnitude and probability of those harms, and make sure that subjects are given adequate information about what harms might occur and the likelihood that they will occur. Again, simply listing possible harms is not informing subjects about the risks in the research.

In fact, just providing subjects with a long list of possible harms not only doesn’t inform them about the risks, it is “disinformation”. When subjects see that list of harms, which in some cases goes on for pages, they tend to discount all of it and don’t pay attention to the real risks in the research that they need to focus on to decide whether to participate in the research. Consent forms that include such a “laundry list” of harms without indicating which are likely to occur and which are less likely, are not in compliance with the regulations and should not be approved by IRBs. If sponsors insist on using such consent forms, IRBs should require other mechanisms to explain the real risks to subjects, such as oral presentations and information sheets.

Informing subjects about risks is not the only responsibility with regard to risk that IRBs have; they must also ensure that the risks are minimized and that the risks are reasonable in relation to the anticipated benefits of the research. I’m going to discuss those two responsibilities in another posting.