Blog – Why Some people Say No to Research And How We Can Respond

Clinical trial recruitment in dementia is essential. Without participants, even the most promising treatments never leave the lab. It’s the difference between an idea and something that can actually help people. Every person who takes part makes progress possible.

Recruitment in healthcare settings starts well before anyone speaks to a patient. It begins at the desk, reviewing notes, understanding histories, and quietly weighing up who might be eligible, who might be interested, and who it is fair to ask. This may be by using services like Join Dementia Research, or from our own system and volunteer register… or people recently seen in clinic. This early thinking shapes the entire approach. It is where ethical, sensitive recruitment really begins.

So… we have done our due diligence to ensure that ‘may’ be suitable for the trial. Its now time to talk to the patient.  Talk to them about the study… and they say no. What do we do now?

Everyone has the right to say no. Taking part in research is always a choice, and that choice must be respected.

There should never be any pressure, even if we believe the study could benefit them or others in the future. Our role is to provide clear information and create space for a genuine decision — not to persuade.

But, it is also important to understand why someone doesn’t want to take part. To understand if there is something about the study (and potentially something we need to change), something about the patient and their circumstances or something else. There are many possible reasons, and sometimes, by exploring those concerns, a person might change their mind. In the next section, I’ll look at some of the common reasons people choose not to join a trial, and what we can learn from them.

If a partner is required is there an issue with this? Does the person have a partner who is willing and able to take part? If not, is there someone who has contact with that person for 12 hours, per day, per week or whatever the protocol stipulates.

Are they worried that the partner is not able to commit to the number of visits required? This can be explored with the potential participant and their partner.

Is the partner putting pressure on the person to not participate? It may be that speaking to the partner will ease any issues which can be addressed. Are any other members of the family putting pressure on them not to be part of research, despite their wish to do so? Again, this can be further explored with the person or people who are not happy about their loved one being a research participant.

Are they worried about the financial implications? You can go over that with them: any travel will be reimbursed; that if required overnight stays, they too will be reimbursed. Any reasonable out of pocket expenses will be reimbursed; food and drink will be provided as most clinical research companies have budget for this. Sometimes visits can be conducted to suit a person’s work life or other commitments. Some visits may even be able to be done at the participants own home.

Do they understand what the research is about? Have they had a look at the patient information leaflet and if so do they understand what it says? Would talking them through it help with their understanding and make them more amenable to taking part. Can the team allay any fears about the consequences of taking part. There can be some dire warnings about the health and safety implications which are a requirement of the study protocol but things like ‘risk of infection due to blood sample being taken’ can be explained as the risk of every single procedure has to be looked at, even though the risk are minimal. Are they afraid of some of the procedures specified? This can be in relation to a simple (to us) task like taking blood to more complex procedures such as having a lumbar puncture or a CT scan. By explaining what this means and how this would actually affect a person can help to reduce anxiety around some of these procedures. Also having some further literature available about some of the more complex procedures can help people to understand what will happen to them, during them.

You may want to explore with them, why they have put themselves on a register to be approached but then do not want to be part of research. Perhaps they only want to be part of research which involves interviews, or questionnaires. In this case their preferences should be noted.

If it’s still a hard no, then discussion around what they would want to do and are there any alternatives to them being involved in research without actually being part of a clinical trial. Would they be willing to go onto a patient or expert panel and become part of a patient and public expert group, informing research? Would they be willing to have a look at papers and proposals for research to give their views on suitability or relevance of these proposals, giving the researchers valuable feedback from a different perspective?

They may be happy to donate brain tissue after death although this suggestion needs to be handled sensitively.

Finally, you need to ascertain whether they want to be removed from any research lists. Or do they need a break from being contacted by researchers but would be willing to be approached after a period of time has elapsed. If they wish to not be contacted again then one has to respect this and remove them for any databases they are on, such as Join Dementia Research.

I hope this has given you some strategies to think about if someone refuses to be part of a trial. It may just be the wrong one for them or they may decide they no longer want to be contacted or be part of research in any way. But ultimately it comes down to the wishes of that person.

Dr Emma Law

Author

Dr Emma Law is Strategic Manager for the The Neuroprogressive and Dementia Network in Scotland. Emma has 13 years experience as a Clinical Trails Network Manager and over 35 years experience as a Nurse, many of which were spent in the delivery of Clinical Research Trials. Emma completed her PhD and is passionate about giving people living with dementia and their carers access to participate in research.