Non-maleficence: the second ethical principle

Posted on Feb 11, 2015 by Leslie Gelling in Ethics, Non-maleficence, Research, Research ethics

In my blog last week I wrote about ‘beneficence’, the principle that all research should have the potential to benefit someone, and this week I am going to write about non-maleficence. Non-Maleficence, the second ethical principle, and one closely linked to the first, is the principle dictating that harm should not come to individuals as a result of their participation in a research project. This principle also forms the basis for professional codes of practice, including the Nursing and Midwifery Council’s ‘Code‘ and medicine’s Hippocratic Oath. The challenge for researchers is that harm can take many forms and is not always easy to predict. Without some element of uncertainty about the impact of an innovative intervention or new drug treatment there would be less need for research.

Possible harm can include physical, emotional, social and financial harm. Whilst it might be relatively straightforward to identify or even predict physical harm, for example the momentary discomfort of the needle prick when giving a blood sample, it can be more challenging to predict other types of harm. This is further complicated because participants might experience harm without researchers being aware. For example, the the upset that might occur as a result of participating in a qualitative interview study might go undetected but could have a significant impact on a participant’s emotional well-being.

No research is without risk so in an attempt to help researchers identify, predict and prepare for the possible side-effects of research, all research can be placed into one of five categories:

No anticipated effects. No research is without risk. Even research where there is no contact with patients can risk causing harm if there is a breach of confidentiality.
Temporary discomfort. This level of harm involves a momentary discomfort that will normally be no more than would be encountered in everyday life. For example, when a skilled practitioner takes a blood sample.
Unusual levels of temporary discomfort. This level of harm occurs when a research participant continues to experience discomfort when the research procedure has ended. For example, when a participant is interviewed about a sensitive topic they might experience distress for some time after the interview and might need to seek further support.
Risk of permanent damage. This level of harm is associated with research projects where there might be a higher degree of uncertainty about the short or long-term effects of an intervention. The most obvious example is the uncertainty associated with the possible side-effects of new drug treatments.
Certainty of permanent damage. Any research falling into this category would be highly questionable and it would be extremely unlikely that any research ethics committee would permit research with this level of harm.

No research is without risk and research where there might be the possibility of permanent damage would not be permitted, so all research projects with fall into categories 2 to 4. The primary function of research ethics committees is to consider the possible risks to research participants, to balance these against the possible benefits (beneficence) and to ensure, as far as possible, that researchers minimise the possible harm. Research ethics committees know that risk cannot be eliminated but they do want to be reassured that researchers have given due regard to the possible risks of participating in their research and the above framework might prove useful.