Decision making by Research Ethics Committees (Part 2) – Risks to research participants

Posted on Nov 16, 2016 by Leslie Gelling in Ethics, informed consent, Research, Research ethics, Research ethics committee, respect for autonomy

In last week’s blog, the first of four in this series, I introduced the idea that decision making by Research Ethics Committees (RECs) is predominantly influenced by four considerations; the need for freely given informed consent, the risk to research participants, the risk to researchers and the science. Having previously considered REC thinking around informed consent, in this week’s blog I will offer an insight into REC thinking on risks to research participants.

Identifying and minimising the possible risks to potential research participants is undoubtedly one of the main reasons why RECs have become such an important part of the research process. As highlighted in a previous blog, the history of research ethics is littered with examples of unethical research that resulted in harm to those ‘participating’ in the research, even when that harm might have been predicted.

It is important to remember that it is never possible to eliminate all risk from any research involving human participants, regardless of whether the research is a international multi-centre clinical trial or an undergraduate student research project. I have taught ‘research ethics’ to many students over a long period of time and one of my favourite exercises is to ask the students, usually in groups, to think up a research project in which they believe there to be absolutely no risk to those who might participate in the research. Sometimes they have got close, but I have always been able to identify a potential risk in their proposed research. So a good starting point, when contemplating risk, is that it can’t be avoided. Therefore researchers need to demonstrate to the REC that possible risks have been identified and, when possible, minimised and the protocol should be clear about what action will be taken should someone be harmed during the research.

Next the REC will want to know what the degree of risk might be and all risks falls into one of five categories (see below). As we have already established, research where there is ‘no risk of harm’ doesn’t exist and no REC would offer a favourable opinion for research where there is ‘certainty of permanent damage’. This means that all research falls into one of the three remaining categories.

Research where there is a risk of ‘temporary discomfort’ might be research that only involves taking a single blood sample (as long as the person taking the sample is appropriately trained). There might be momentary discomfort as the needle pierces the skin but recovery is almost immediate and there are usually no long-term consequences. Research where there is a risk of ‘unusual levels of temporary discomfort’ might include qualitative research where participants are invited to recall and describe a personal, and possibly upsetting, experience. These participants might feel distressed during and for a period after the interview and might even need follow-up support. In all these situations the participant will usually make a full recovery.

Research where there is a ‘risk of permanent harm’ will include all clinical trials of investigational medicinal products (CTIMPs). While most possible risks or side-effects are known and, therefore, predictable as a result of previous or ongoing studies, there will always remain some element of uncertainty. To turn this around, the researchers are unable to guarantee that participants will not experience a serious or potentially life-threatening side-effect that has not been reported previously.

So the REC will want to be reassured that the researchers have acknowledged all possible risks, how these might be minimised and what action will be taken should someone experience harm. They will also want to ensure that this information is shared with potential participants so they can make an informed decision about participating in the research.

It is also important to remember that potential harm is not limited to physical harm but can also include emotional harm, social harm and economic harm. The above example of the possible upset caused by qualitative research is an example of emotional harm. The risk of social harm might become important in situations where the research risks creating social conflict within families or within communities. For example, research that requires samples from a child and both parents could create significant conflict if it transpires that one of the parents is unknowingly not one of the blood parents (seemingly not as uncommon as one might think).

Participants in CTIMPs frequently need to make repeated visits to the research centre for assessments but if travel costs aren’t being reimbursed then those participants could be described as being economically harmed. This is why RECs are so keen for travel expenses to be reimbursed whenever possible. This is also why participants who are of working age may need to have salaries reimbursed, especially if they are self-employed and might be financially harmed by participating in the research.

Consideration of the possible risks to research participants is undoubtedly an important factor influencing REC decision making. Whilst most researcher will give due consideration to relevant risks in their application for research ethical approval, it remains the case that some research still do not place sufficient emphasis on acknowledging and seeking to minimise risk.

In next week’s blog, the third in this series, I will share some insight into REC deliberations around the possible risks to the researchers undertaking the research.