The consent process in research shouldn’t be treated as a one-off extraction of permission, writes Andrew George
The need to get fully informed consent from participants in health and social care research is vital. It not only protects participants, it is also the fair and respectful way to behave to patients and other volunteers who have given their time and energy to contribute to research.
All too often, however, we focus on a single moment in the process: right at the very start of the research project. Long patient information sheets are prepared and approved by research ethics committees. The researcher gives the sheets to the individual, who may read them, and then the consent form is signed. Everyone can now breathe a sigh of relief—it is over. The process is complete, consent has been taken. We can get on with the research. The box has been ticked.
Except, of course, it has not. Consent is not a singular event, which happens once and then endures forever. You couldn’t, for example, take a blood sample based on a consent form signed six months previously. Consent is an ongoing process; and in research, the researcher will naturally continue to give participants information about what is going to happen, and check that they are still okay with it.
The reality is that the consent process is a relationship. The researcher shares information with the participant, and in complex studies that will often be well before the study is initiated. They will keep the participant up to date with progress and any changes in the project.
One of the most important aspects of the recent strategy for research transparency Make It Public, published by the Health Research Authority, is its emphasis on informing participants of the outcome of the study they took part in. This should be a natural part of the information-consent relationship between the researcher and the participant, but too often it is neglected.
The formal consent process that takes place at the beginning is important. It is an opportunity to make sure that the information provided is complete and understood by the participant. It ensures that there is no ambiguity in the individual’s agreement to take part. It also gives research ethics committees the opportunity to scrutinise the information provided. However, we have overemphasised this moment in the consent process, possibly to the detriment of the ongoing information-consent dialogue. Even the language we use of “taking consent” suggests a one-off, transactional extraction of permission rather than a relationship.
Naturally, the nature of the dialogue and relationship between researchers and participants will vary depending on the type of study, the condition that the patient has, and the length of the project. A project that involves a 10 minute questionnaire is unlikely to result in (or need) a long term interaction between the researcher and participant. However, many studies will span across years or even decades.
Most researchers understand the importance of an ongoing relationship with the participant in studies that go on for a long time. They will often produce newsletters or websites to provide ongoing information and they will engage with patient groups, as well as individuals, to ensure that the communication is two-way.
We need to build on this good practice and ensure that the training and support that researchers get, and the ethical scrutiny of their proposals, emphasises this relationship aspect to the ongoing consent that people give for research. This will have several benefits. It will encourage good behaviour. It will also reduce the temptation to fill the patient information sheet with detail that might be better given elsewhere in the process; do I really need to know, for example, that my clinic visit in three years’ time will involve a 20 ml blood sample? It will also foster a real dialogue between researchers and participants—something that can improve the quality of research as well as its conduct.
So, let us move away from our current emphasis on consent happening at a single moment in time, and instead think of it as an ongoing dialogue that goes from initial discussions through to letting people know what the research project found. This reframing of consent requires several shifts in how research is approached and carried out. Research ethics committees will need to think about how to judge the quality of a less well defined process, and how they might develop trust in the researcher. Researchers will also need to adapt their approach to being more open with patients. And research participants may need to be more involved in the research. However, all this can lead to a more productive relationship, in which informed consent means more than just a signature on a document.
Andrew George has been an academic at Imperial College London and Brunel University London. He is an executive coach and consultant; chair of Imperial College Health Partners; and non-executive director of the Health Research Authority, Health Education England, and Surrey & Borders Partnership NHS Foundation Trust. He chaired the Research Strategy Transparency Group for the HRA. He writes in a private capacity. Twitter @ProfAGeorge
Competing Interests: I have read and understood BMJ policy on declaration of interests and declare the following interests:
I am a non-executive director of the Health Research Authority, which has responsibility for the NHS research ethics service in England (and works in close cooperation with the devolved nations). I chaired the Research Strategy Transparency Group for the Health Research Authority. This article was written in a private capacity