Helena - Interview 35

Brief Outline:

Helena says that communication is key to her role as Senior Research Nurse. Helena explains how her role helps to support parents and children when they participate in a clinical trial, from beginning to end and after the trial has finished.

Background:

Helena is a Senior Research Nurse for the Medicines for Children Research Network. She has been in research for nine years and involved with the various stages of consenting patients and families.

More about me...

 “I’m a senior research nurse for the Medicines of Children’s Research Network at the moment. I’ve been working in research for about nine years now involved in various stages of consenting patients and families. I’ve worked with children and adults in research so I’ve been involved in parent consent and adolescent and children consent and assent as well.” 

 

Helena ensures that parents understand the information they have been given about a trial. “Especially for a clinical trial of a drug and I think some typical questions that people ask is “Am I the first one to have the drug?” which is what people will ask. Has it been tested on other people and we would always say if it has yes obviously, you know we would tell the truth and say yes it has. It may be that the trial that we’re doing is the first time it’s been tested in children, but there’s been adult trials before. So you would say it’s the first trial on children but it has been tested on adults and that’s where the information that we give comes from. It comes from previous studies so the potential side effects or adverse events comes from previous studies.”

 

Helena talks about her role in giving support to families when they have given consent for their child to take part in a trial. She explains how it is important for parents and their children to understand what is involved in the trial and who they are likely to meet. This can vary depending on the type of trial. She ensures that parents and children are aware that they can stop the trial at any time without giving a reason. 

 

Helena sums up her role' “I’ve been a research nurse for nine years and my role generally includes consenting and recruiting families to research has been giving information out. Discussing with families, letting them ask questions and answering them about the practical side of research about the, yes where do I park when I come, what time of day are the visits. And anything medical I’ve then referred on to the medical team and fed that back or got them to contact them back. And we’re also involved in recruiting patients in a slightly different way because I do a lot of training and education to researchers in our area. So I’m trying to help, make sure that people know there are guidance and regulations and make the consent and communication a positive thing for families. I’m also involved with patients that are on studies, once they’ve consented that’s not just the end of it, it’s important to make sure throughout the study that they’re happy to continue and if they’ve got any worries we can allay those or if necessary withdraw them from the study. So it’s not just the consent at the beginning it’s an ongoing process right to the very end and even beyond the end of the study like we’ve discussed about getting them information as well.”

 

As Helena says, information given to families about a trial should include an explanation of all the relevant terms used, including randomisation, control, blind and placebo.

Yes some terms that we use are blinded which means that you don’t know what treatment is, the patients having. There is single blinded where just the family don’t know, double blinded where the family and the researchers at site don’t know. Randomised means where a patient is randomly allocated one arm of the treatment of the study or another. And there can be two arms to the treatment, there can be three arms and they are randomly allocated. There are lots of different ways that they do like and how they’ll be done electronically or it can be done by sending a fax and someone not related to the study, here at site, randomises them and picks the next consecutive envelope, as simple as that or enters it onto a spreadsheet and it randomly allocates them.

Placebo, there’s some studies what we call placebo controlled and some patients get a placebo. A lot of families like it explained as a dummy drug so it’s a drug that isn’t a drug. It can be a lactose tablet or something else. And it will always be made to look exactly the same as the actual active drug so that people don’t know. So if we had a girl and a boy both on the study they couldn’t look at the drug and say “Oh well you’re on different than me”. They would always look the same and the tablets would look the same as each other, liquid would look the same as each other and everything would look the same as each other. And the idea of a placebo is, is it that the active ingredient is helping the patient and the symptoms and the quality of life or is the fact that they feel that having something is helping them and that’s, it’s very interesting to see the placebo effect.
 

Helena, a health professional, explains what happens when English is not the first language.

And what do you do when maybe as you said it isn’t their first language?

It depends really, for some studies the patient information leaflets are translated into different languages. But for example here in [hospital], I can’t remember the number, but I think there’s something like 150 different written and spoken languages. So which language do you choose is always the question? For diseases and studies where it, certain languages are spoken, or for certain ethnic minorities you could sort of pick one or two. And for some of the bigger commercial sponsors, so drug companies, they would if you had a potential patient who spoke a certain language they would pay for that information to be translated but it is quite an expensive thing to do. And apparently they, it has to be back translated so the information sheet has to go to translation services to translate it and then send it on to somebody else who back translates it and it has to be identical. And then the ethics committee obviously don’t necessarily speak the language so they give approval on a sort of certificate of approval. We would try and use, always try and use translation services within the hospital link workers which most hospitals have. But it’s generally not appropriate to get a family member to translate because we can’t, not that we don’t believe them, but we can’t be sure of what they’ve actually told them and that they’ve covered all the key points unless we understand that language ourselves. So generally we wouldn’t take family members translating for us, we would chose to pay for a translator within the trust.
 

Helena explains the age at which children can give assent and consent and what may happen when there is a difference of opinion between young people and their parents.

At what age can, what age do children assent to take part?

For some studies information sheets produced from children from three which are three to five which are basically pictures. And if you’ve given information sheet there’s a lot of the sponsors who are running the studies like the children to give their assent. So they like them to say yes okay I’ll do this. It’s debatable at what age is appropriate and that’s something that varies from people to people and from researchers to researchers. But obviously fifteen year old knows their mind and as long as they’re given the right information you will always get assent from them but because it’s a clinical trial you wouldn’t be able to give consent you would still need to speak to the parents. And then if there’s a difference of opinion that’s something that needs to be discussed locally and decided on whether you’re going to put that patient in the study or not.

So sort of aged sixteen and over, under sixteen they still have to have, even if they agree, they’ve still got to have parental consent?

Yes, until the child's sixteenth birthday, if it’s a clinical trial of a drug, the clinical trials regulations state that parents give consent and if the child is aware enough about the study and are able to we would take assent from them, once they’ve been given all the information as well.
 

Helena says that one of her roles is to ensure families understand and that we do not know for sure if the new treatment in a trial actually works.

Yes I think when families do say that they want to take part in the study it’s a two way thing really. We’re obviously offering them the chance of potentially better treatment or not and that’s what the study is about. And at the end of the day that’s something that we, we always explain the fact it is a trial means that it’s never been proven which of the drugs, say for example is better. Because if it had been proven it wouldn’t still be a trial so we, you know, we don’t know for sure. We, sometimes people can say, “Oh I think, you know I’ve used this for years and I’m sure it’s better and I’ve done my own bit of, or sometimes I give this and sometimes I give that and certain children do better.” But the fact that it’s had to go to a clinical trial means that it’s never been proven which is a key point that families need to, you know, be aware of really.

Helena, a health professional has a lot of experience of clinical trials and explains what some of these terms mean.

Yes some terms that we use are blinded which means that you don’t know what treatment is, the patient’s having. There is single blinded where just the family don’t know, double blinded where the family and the researchers at site don’t know. Randomised means where a patient is randomly allocated one arm of the treatment of the study or another. And there can be two arms to the treatment, there can be three arms and they are randomly allocated. There are lots of different ways that they do like and how they’ll be done electronically or it can be done by sending a fax and someone not related to the study, here at site, randomises them and picks the next consecutive envelope, as simple as that or enters it onto a spreadsheet and it randomly allocates them.

Placebo, there’s some studies what we call placebo controlled and some patients get a placebo. A lot of families like it explained as a dummy drug so it’s a drug that isn’t a drug. It can be a lactose tablet or something else. And it will always be made to look exactly the same as the actual active drug so that people don’t know. So if we had a girl and a boy both on the study they couldn’t look at the drug and say, “Oh well you’re on different than me”. They would always look the same and the tablets would look the same as each other, liquid would look the same as each other and everything would look the same as each other. And the idea of a placebo is it that the active ingredient is helping the patient and the symptoms and the quality of life or is the fact that they feel that having something is helping them and that’s, it’s very interesting to see the placebo effect.