Risk - Part 2

In addition to identifying risks, IRBs must ensure that the risks are minimized, that the risks are reasonable in relation to the anticipated benefits, and that subjects are informed about reasonably foreseeable risks.

Minimizing risks does not mean eliminating risks. There is nothing in the Belmont Principles or the regulations that requires that research be risk free. Research sometimes involves risk to subjects. Research ethics demands, however, that the risks be the minimum necessary to obtain valid results. No researcher wants to subject people to unnecessary risks. Researchers, though, need to actively consider whether the risks in their research are actually minimized. How do we minimize risks? One way is to explore alternatives – is there another way to do this research that would be less risky? A second way to minimize risk is to add precautions to the research. These are procedures that reduce the likelihood that the harm will occur, such as additional screening or subject preparation prior to the research. Sometimes, however, the risk in the research is unavoidable. In this case, researchers need to build in contingencies that will reduce the impact of the harm when it occurs, such as increased monitoring.

Analyzing the risk/benefit relationship is one of the key components of research ethics. It is not ethical under any circumstances to inflict risk on subjects unless those risks are justified by the benefits that are expected to accrue from the research. Even the most zealous scientist would not engage in research that might harm subjects unless there was some good which could come from the research. The more risky the research, the more benefit it takes to justify that risk. Not all research, however, must involve direct benefits to subjects. Although the regulations talk about risk to subjects, benefits may be to subjects or others. Advancing scientific knowledge or improve social welfare are benefits; even training students is a benefit. Direct benefits to subjects, however, are stronger benefits than benefits to others and, therefore, more risks are justified.

Finally, it is required that subjects be informed about the risks and benefits of the research. These need to be described to subjects in a way that they can understand and make an informed decision as to whether these are risks they are willing to take. As I said in my first post on risk, simply listing the possible harms in a research study is not informing subjects about the risks.

To sum up, risk is a very misunderstood and misapplied term. We must make sure not to confuse risk and harm and remember that simply listing possible harms is not informing subjects about the risks in research. We must also make sure that the research involves the least amount of risk necessary to obtain valid results, that the risks are justified by the benefits of the research and that subjects are clearly informed about the risks and benefits of the research. Only then will we, researchers and IRBs, be fulfilling our ethical responsibility to the subjects of the research.