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To think that vunerable dementia patients should not be used for research and training aids by the NHS without full informed consent by the patients carers

(80 Posts)
Mrsdavidcaruso Thu 06-Nov-14 20:29:50

My best friends husband is 59 and has frontal lobe dementia she has terrible trouble getting him the help and support they BOTH need, so when she got an appointment out of the blue for him to have a CAT scan and a dexterity test she was over the moon thinking at last she would have the answers she needs about his condition, how far it's progressed and the likely outcome, she knows it cant be reversed but no-one else had given her any info on just what the future will hold for her and her DH - not an unreasonable assumption.

She was a bit concerned when the Neurologist seem PLEASED when he failed the dexterity tests, but was driven almost to tears when she asked when she would have the results of the scan, only to be told the tests were for training and research only and the results of his scan would be used for a training graph.

When she protested saying she hadn't given consent for this she was told they have a 'best interest of the patient' clause for people who cant consent themselves therefore HER consent was not needed.

When she said she wasn't having her husband used as a lab rat the Doc said 'now now it's not like that' to which she replied its exactly like that and we are leaving now.

She phoned her GP who was furious and is actually going to report the Neurologist to the GMC and has told her she does NOT have to attend anymore appointments at the hospital unless the GP herself has arranged them
know we need research I know medical staff need to be trained, but is it ethically and morally acceptable for a man in his condition to be left scared and confused after tests that are not even for his benefit and his wife still does not know what the future is going to hold for them both.

I am very angry on her behalf

BackOnlyBriefly Thu 06-Nov-14 21:10:24

That is terrible and I'm glad the GP is taking it further.

Of course we should all cooperate with training when we can, but that is a choice and if I were called in just for that without being told there'd be hell to pay.

I'm pretty certain she made up the 'best interest of the patient' clause and in fact there is a small health risk with CAT scans that you should never be exposed to without good reason.

zeezeek Thu 06-Nov-14 21:14:41

I work in research and I would like to assure you that this is NOT usual practice. Anyone recruiting a patient into the trial must first be trained in Good Clinical Practice (GCP) and that training includes going through various bits of legislation and, most importantly, how to obtain informed consent.

Obviously I do not know what happened in this situation, but I can tell you what should happen.

A GP or consultant who wishes to recruit a patient into a study must first discuss the study with the patient. They must give the patient information about the trial - this is in the form of a patient information leaflet. Patients are entitled to take this away with them and think about whether or not they wish to take part. They should then, if they do wish to take part, give consent.

At every single follow up visit the patient has to be asked if they wish to continue in the trial.

Generally, where a patient lacks mental capacity - in the form of dementia, eg - they are classed as not being able to give informed consent and so can't take part. However, dementia research is very important and high profile, so it is not unreasonable to find a way around these patients giving informed consent. One way is for a register of interested patients - they sign up when they still have mental capacity. Another way is to seek consent from a carer. It is still an ethically difficult situation in my opinion and I'm not an expert because I don't do dementia research.

There are times when it is not possible to get the consent of a patient. This may happen in emergency situations, or if the patient is unconscious. These need to be approved. It is not always wrong to recruit a patient in these circumstances and must be justified. Again, I'm not an expert in this.

However, what seems to have happened here is that the consultant did not seek informed consent or even attempt to do so. In fact neither the patient nor the carer knew that the patient was being recruited into a trial. This is a very serious matter. That consultant needs to be reported to the GMC definitely, but your friend should also contact the R&D department of the hospital where her husband was treated and tell them. I can honestly say that in over 20 years of research I have never encountered this situation before, so I can't tell you what the outcome will be. But it needs reporting.

You may be interested in visiting the Health Research Authority website: or the MHRA website. Both of these will give further information and guidance.

I hope that this works out well for you all. I would like to re-assure you that the vast majority of researchers treat their patients with respect and dignity.

itiswhatitiswhatitis Thu 06-Nov-14 21:22:10

That is disgraceful and I think the consultant was using a little artistic license by quoting best interest of the patient. this is quite interesting and does state that wherever possible care givers should be consulted

offtoseethewizard64 Thu 06-Nov-14 21:25:02

I don't know about the legality of this situation but it sounds very wrong to me. Whenever I have been asked for information about my DD to be used in research or for training purposes, we have always been given full information about how the information will be used and I have had to sign a consent form. My DD has a severe learning disability (amongst other conditions) so would never be able to consent - although I don't think we have been asked to take part in anything since she turned 18, so the 'capacity' issue probably didn't apply then. But I too would be furious if someone 'tricked' me into letting DD take part in something now on the basis that she couldn't consent so they just assumed consent on her behalf without my approval. I would be even more furious if tests were carried out and the findings were not disclosed to me.
I'm glad your GP sounds supportive and hope you can take this further as it doesn't sound morally right to me (even if it is legal).

jezzapaxmanslovechild Thu 06-Nov-14 21:30:08

Like zeezeek said - I work in research and also have GCP.

zeezeek Thu 06-Nov-14 21:35:55

offtoseethewizard64 - as her parents you were able to give permission and you were given full information, asked for your consent and had everything explained to you. As an adult with reduced capacity, if you legally have power of attorney over your DD then the process should be the same.

Research is in the best interests of the patient - and future patients. It is a the cornerstone to innovations in the health service and vital to improving lives, preventing illnesses etc. What it is not is an ego trip for arrogant consultants/researchers/others who are merely thinking of their own careers.

nocheeseinhouse Thu 06-Nov-14 22:17:17

YABU in that no adult can consent for another adult, and decisions are made on a 'best interests' basis.

The story you tell is very odd, and IME nothing like this has ever happened in any of the hospitals I have worked in. Unless you know exactly what's going on, i.e. were at the appointment, and know for certain nothing was miscommunicated/understood, I'm afraid I have my doubts about the situation being as you described.

Mrsdavidcaruso Thu 06-Nov-14 22:45:33

Message deleted by MNHQ. Here's a link to our Talk Guidelines.

GuiltyAsAGirlCanBe Thu 06-Nov-14 22:53:41

As doctors we are allowed to make best interest decisions with regard to TREATMENT, but this is absolutely not the case for research, which needs consent and ethical approval.

This research sounds highly unethical and I am glad a complaint has been made.

Your friend ought to complain directly to the hospital trust - they ought to have an ethics committee so she should try and talk to them in the first instance.

Mrsdavidcaruso Thu 06-Nov-14 23:37:55


This is what she told me and I have cause to think she is lying

'I thought the tests were a precursor to changing or upping his meds. It was after that she innocently said the data collected will be invaluable that I blew my top and said I haven't consented to his data being used for research.

Her GP BTW totally agreed with her that she should have been told before hand and has written to the hospital and the GMC

Her MP is also involved now

Toooldtobearsed Fri 07-Nov-14 05:40:29

I work in research ethics and this is very, very wrong.
Informed consent must be sought. If the participant lacks mental capacity and is unable to give informed consent, then the carer, or nominated person may consent on their behalf.
This is a serious breech of protocol and must be reported to the R&D department. Any research has to be approved by a research ethics committee and the first thing they look for is how consent will be sought and particularly hot on the patient participation information.



Rosa Fri 07-Nov-14 06:11:46

I would also be asking the question who gave out his medical info so that he was 'contacted for this scan. '
He must be ' in the system' for treatment etc requested by the GP but for a CAT to be provided then someone along the line must have ticked the boxes.
I hope that he gets seen soon by someone who can provide some help , advice and support its a horrible horrible disease.

Mrsdavidcaruso Fri 07-Nov-14 07:15:49

sorry my last post should have been I have NO CAUSE to think she is lying

DamnBamboo Fri 07-Nov-14 07:23:32

OP this is not allowed at all.
The consultant will be in very serious trouble if you report this.
You must report this

DamnBamboo Fri 07-Nov-14 07:25:57

YABU in that no adult can consent for another adult, and decisions are made on a 'best interests' basis

What a load of cobblers.

Ignore nocheese OP. From her post she clearly has no understanding about research ethics. I clearly note the box about seeking consent for those unable to do so on my own applications (even though it doesn't apply to me)

fridayfreedom Fri 07-Nov-14 07:33:07

Totally agree that what happened was unethical.
However, if it helps, if he already has a diagnosis of FT dementia then having a CAT scan would not help with getting support etc.
Is he known to the local memory clinic? In our area we are part of the older persons service but take people under 65 who have dementia.
There is also a very useful website with message forums etc, think its under Picks disease which is a form of FT dementia.

zeezeek Fri 07-Nov-14 18:41:12

OP please let us know how this progresses.

Mrsdavidcaruso Fri 07-Nov-14 19:25:03

Thanks zeezak will do

MammaTJ Fri 07-Nov-14 19:35:59

I care for people with dementia and have seen how they are totally disregarded. This is shocking and disgusting! Even getting the gentleman to the appointment would have caused difficulty, as if they don't have enough on their plate without that!

To build her hopes up of a good outcome is just awful, then to let her down, there are no words!

zeezeek Fri 07-Nov-14 19:43:24

MammaTJ - it is a minefield, ethically. We need to be able to do research on dementia, and yet it is unethical to do that research on someone without mental capacity. There is also the issue that even if you do follow the (vague) rules on this - then you still run the risk that you might not be following the patient's wishes.

However, in this case, it is clear cut. The consultant is in the wrong. The research may well be a good, useful and ethical study BUT the patient/carer were not informed and therefore the results from the tests that patient underwent cannot be used. This is a serious matter and this consultant needs to be prevented from continuing to recruit to this study.

It makes me angry because those of us who do research know that nothing is possible without the good will of the patients agreeing to take part.

Sorry for ranting again.

I know we've disagreed in the past MrsDavid, but I am with you 100% on this.

Booboostoo Fri 07-Nov-14 19:49:21

What Toooold said.

All research on human subjects must get approval from a Research Ethics Committee which will cover issues such as consent, confidentiality, use and dissemination of the information gathered, purpose of research, etc. In general where patients are incapable of consent the study has to specify who will consent on their behalf, e..g. legal guardians and it is generally good practice to keep careers/family informed even if they are not legally responsible for consenting. In general it is easier to get approval for trials involving competent adults than incompetents because in the latter case the patient cannot express their wishes about participation and the risks involved. In general it is easier getting approval for a therapeutic rather than a non-therapeutic trial as the former is of direct benefit to the participants. A non-therapeutic trial on incompetent patients would not be impossible to run (would have to show low risks and great potential benefits) but it would be subject to quite stringent stipulations. It is also good practice to share trial results with trial participants as a general point.

Your friend's DH was grossly mistreated by this doctor, she is right to complain and I would expect this to be taken further and perhaps have disciplinary repercussions for the neurologist. Your friend may also want to look into the legalities of her taking over medical decision making on behalf of her DH if she has not already done so.

MammaTJ Fri 07-Nov-14 19:49:27

Of course research needs to be done! Where can I give my consent now for just in case?

That is a serious question!

I am passionate about dementia care!

Mrsdavidcaruso Fri 07-Nov-14 20:06:01

Oh thank you MammaTJ at least someone who understands I have been with my friend when she is trying to get her DH ready to go out and it is incredibly hard to watch what she has to do just to get him dressed and into her car.

She lives in a different part of the country, so I cant support her as much as I would like. I know from phone calls and texts in the last couple of days how agitated he is at the moment and how scared and confused he was after the appointment.

But the thing that makes me fucking furious is how she now feels that she didn't protect him and has let him down as she should have known what the appointment was for before subjecting him to the tests.

That's the disgusting and totally disgraceful aspect of this she feels guilty and feels personally responsible for her DH's pain and confusion, just because some arrogant Doctor decided that a dementia patient has no rights and because they are an NHS patient who is getting the benefit of her expertise for 'free' she can bloody well do what she likes and screw his dignity and privacy.

She wont be having another appointment with that Dr her GP has told her so, its a shame actually as I would have loved to have gone with her and give that Dr a very large set down

I hope the GMC will do something but sadly I would suspect not and she will be free to do the same to another vulnerable patient

zeezeek Fri 07-Nov-14 20:32:06

MammaTJ - Google Join Dementia Research.

Mrsdavidcaruso - I'm sure you are helping her as much as possible and you are being a good friend. Don't you have a new baby DD as well at the moment?

It does sound like she has a good supportive GP. It might also help her to see if there is any further support that she can get from Social Services or the Alzheimer's Society to help him calm down and feel more secure.

It is a cruel disease at any age, but somehow it feels worse when someone is so young. Hope your friend and her DH find some peace and keep the calls and texts because I'm sure you are helping....I know it would if it was me.

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