Decision making by Research Ethics Committees (Part 1) – Freely given informed consent
Much has been written about decision making by Research Ethics Committees (RECs) and factors that most influence how RECs reach an opinion on an application for research ethics approval. Decision making has been linked to focusing on the underpinning ethical principles (considered in a series of earlier blogs), to balancing potential risks and benefits or to meeting expectations set for the REC by those with authority over the REC. In my 10 years as the Chair of a National Health Service (NHS) REC I have come to the conclusion that there are just four key issues that REC members need to satisfied about if they are to be able to offer a favourable opinion:
- Freely given informed consent
- Risks to research participants
- Risks to researchers
- The Science
In this series of four blogs I will consider each of these factors and how I believe they influence REC decision making.
Freely given informed consent
The need for informed consent is the primary principle of the Nuremberg Code, of the Declaration of Helsinki and of all more recent research codes so it is perhaps not surprising that I have highlighted this as the first factor influencing REC decision making. What might be more surprising, however, is that RECs still spend so much time considering issues around freely given informed consent and invariably need to seek clarification and/or amendment on proposed recruitment strategies. Questions frequently asked of researchers might include:
How and when will potential research participants first be approached?
Many patients will not be surprised if they are approached to participate in research because there is now much improved public understanding of research and greater public engagement in research. Patients do, however, often form a dependent relationship with those responsible for their clinical care. This could mean that when a patient is approached to participate in research, the invite might be misinterpreted as a recommendation that they participate. For this reason, RECs are often keen, when possible, to distance recruitment to research from the clinical context. Whilst it might be reasonable for a clinician to introduce a research study to a patient, the risk of inadvertent coercion is much reduced if recruitment if then followed up by members of the research team, possibly by research nurses. RECs will, therefore, consider how potential participants are approached and recruited when forming an opinion.
How much information does a potential participant need to make an informed decision?
There has been considerable debate about how much information someone needs to be able to make an informed decision about participating in research. The main means of providing information is through a participant information sheet (PIS) but the challenge for researchers is to make each PIS as easy as possible to read, as comprehensive as possible and as short as possible. Combining these three criteria is not an easy task and there will frequently be differences of opinion about what should and what shouldn’t be included in a PIS. One very useful way to ensure that a PIS includes these criteria is by involving users or patient groups in writing them. It is noticeable that a PIS written with Patient and Public Involvement (PPI) input is considerably better than those written only by researchers. The REC will want to be reassured that each of the above criteria has been met within each PIS and it is easier for researchers to reassure RECs if there has been PPI involvement.
How long will potential participants have to make a decision?
In most instances, the answer to this question should be that participants will get as much time as they need to make a decision. There will, of course, be times when it might not be possible to give potential participants as much time as one would like, especially in emergency research. It is quite common, however, for researchers to state that they will give potential participants ‘at least 24 hours’ to make a decision but it is unclear where the 24 hour time limit has come from. RECs will want to be reassured that potential research participants will be given as much time as possible to consider their participation in research.
Will potential research participants be able to say ‘yes’ or feel able to say ‘no’?
Any discussion about freely given informed consent for research will include consideration of the potential participant’s capacity to make a decision. RECs will also want to be reassured that anyone approached and invited to participate in a research study feels able to say ‘no’ if they don’t want to participate. This isn’t always straightforward because in many instances patients are approached and invited to participate in research at a time when they have many other concerns. As noted above, patients might also be in a dependent relationship with their clinical team, who might also be part of the research team, making it difficult for them to say ‘no’. The REC will want to be reassured that every effort is made to allow potential participants to make a free decision.
Ensuring that consent is freely given and informed is key to REC decision making and will dominate REC deliberations. In this blog I have touched on just some of the factors that RECs might consider when reviewing issues around recruitment in an application for ethical approval. In my next blog I’ll share some thoughts on REC thinking around risks to research participants and how this influences decision making.