This chapter tries to provide a way by which research participants can assess the risks of being involved in a particular research project. At the heart of the process will be the balance and a judgement made by the individual between the perceived benefits of the research and the possible risks.
Uncertainty is a key word in the assessment of risk. It should also be noted that any potential benefits may not be for the person taking part in the research, but for subsequent patients and/or populations. By definition, carrying out research means that the outcome is not known and thus potential benefits and risks not known. If they were clear, the procedure, treatment, intervention, would be classified as good practice, not research, as the risks would have been already assessed. It is thus difficult to assess the risks of taking part in a research project as much is unknown. This section can only give an indication of the terms and language used and the kinds of issues which might be considered by people before taking part in a research project.
Before considering some of the possible categories of risk, it is worth being clear about what certain terms mean.
(a) A hazard is any set of circumstances that may have harmful consequences.
(b) The risk is the probability of the hazard causing an adverse effect.
Thus a hazard, such as a drug, is not a risk until it is administered. The risk, the probability of an adverse effect occurring, will depend on various factors including the nature of the drug itself, the dose, the condition of the patient, and many others.