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

[Mrsdavidcaruso]

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

[Mrsdavidcaruso]

hi zeezak yes a new baby and a new puppy am keeping up her spirits by sending her pug and baby pics

thanks for your support

[raltheraffe]

I used to work as a medical doctor and have done some research in neuroscience.
The issue here is whether or not the patient has the capacity to consent to treatment/research. Unfortunately this is a complex and subjective judgement to make. If the patient did not have the capacity to understand that this was a research procedure then I would think they legally did not have the ability to consent.
I have NEVER heard of a "best interests of the patient" clause ever. Also it was NOT in the patient's best interests. Exactly how has the patient benefited? They haven't. The researcher has benefited only.
I really think you need to make a formal complaint to the GMC. It has to be very serious to go to Fitness To Practice panel, but I honestly think this is a case that may well meet the threshold for FtoP proceedings. Make a full complaint ASAP, this is very serious indeed.

[zeezeek]

Mrsdavidcaruso - that would work ;-)

[nocheeseinhouse]

Ignore me if you like, but I'm not 'talking crap'. Even in research, no adult can consent for another adult.

The story is odd. Perhaps because an assault has been committed. Perhaps because the OP (was OP actually party to any of the discussions with consultant, or GP?) has been told an odd story.

[Minerves]

i think for research you could also find out who is in charge of th e project and report it to the institutional review board, they're supposed to approve studies after seeing informed consent and if there was none they will prob want to hear about it unless the study is not required to have the informed consent, but even then theres other regulations that stll might require informed consent even if its not a study under the IRB

[Chocolatefudgebrownieicecream]

Agree with nocheese. Story is very odd. This doesn't necessarily mean anyone is lying, but maybe there is a misunderstanding. For one thing, my goodness it is hard to get a CT scan with out a good reason on a request card.... And if they lied on the request card!?!?! Well, then I don't know what to say to that, it would be disgraceful... You could start there... Ask for the records and the request card for the scan? And an unecessary ct is never in 'best interest'.... Radiation is dangerous.

[nocheeseinhouse]

Exactly. I'm not saying anyone is lying, but it sounds like there are some high emotions here, and communication can be a problem.

And I wish to quickly try and spread the knowledge that 'next of kin' don't have consent 'rights', as there appears to be a popular misconception about that. (Not including the Mental Health Act 'Nearest Relative' rights, which are different and complex, mind.)

[Mrsdavidcaruso]

Then tell me nocheese why my friends GP asked her to put it in WRITING that she did not consent to her DH being used for research if there is no requirement for consent to be sought in the first place.

As for high emotions and misunderstandings my friend is not someone who is ruled by emotion or misunderstands things, she is an intelligent articulate woman who was a psychologist before she had to abandon her career to care for her DH.

I didn't need to be there for me to believe and support my friend, after all her GP wasn't there was she? yet her GP immediately made the complaint to the GMC, I have met her GP she is a very experienced lady who has been the families GP for a number of years and knows friend and friends DH very well

[FoxgloveFairy]

Research like this surely has to be approved by an ethics committee within the institution backing it, doesn't it? Certainly seems a fundamental breach of ethics to me. I would have thought that as a part of the research proposal, there would be a consent form for all participants, or in this case, carers, to sign, and would not be approved without one.

[Toooldtobearsed]

You are correct Foxglove.

Participant information must be written in plain English and be understandable and consent forms must be signed. It is not enough to simply ask a participant or their consultee to sign, it is the responsibility of the researcher to ensure that they understand what they are signing.
If the participant lacks mental capacity, a personal consultee may consent for them
The consultee may be a partner, carer or a nominated health professional who is independent of the research.

Those who are saying that no one may consent on behalf of another adult are wrong. If this was so, then no research could ever be carried out with anyone lacking mental capacity, which would be a tragedy.

OP, your friend needs to ask for sight of the participant information sheet and the signed consent form

[3bunnies]

They should also have been offered the right to withdraw from the study, this includes withdrawing the data after it has been collected. Your friend may not wish to do this, what is done is done, but it is an option which they might consider.

Some researchers can be very arrogant (I've worked for some - although not as clearly damaging to the participants as this) and they feel that ethics gets in the way but the stress your friend is experiencing shows how important it is. As a psychologist she will no doubt realise the importance of research but also the ethical responsibility. If they had sent adequate information with the invitation letter she would know what the purpose of the research was. Depending on her dh he might also have some more lucid moments when she might have mentioned it to him and gained his views even if he wasn't able to fully understand and consent. This is the procedure with children who are not old enough to consent. Consent is obtained from the parents but it is also important to explain to the child and get them to consent to the extent that they can understand. Even children as young as preschoolers should be given a clear explanation.

She should definitely contact the ethics committee at the hospital as it sounds as if either the researcher isn't following the protocol or the ethics committee have failed to adequately ensure that the consent process is adequate.

[Dawndonnaagain]

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


Ignore me if you like, but I'm not 'talking crap'. Even in research, no adult can consent for another adult.

Sorry, you are completely wrong. I give informed consent on a regular basis. That's what it's called, informed consent. I do this on behalf of my dh and on occasion on behalf of my adult children. I have taken legal advice on this and have undertaken a considerable amount of research (as a historian, research is my field) regarding this. An adult is, under some circumstances legally able to give informed consent on behalf of another adult.

OP I can fully understand your anger and distress and sincerely hope you get this sorted.

[olympicsrock]

I am horrified at this case as It seems that a vulnerable person underwent a dangerous test involving radiation with a no benefit to themselves directly.

I take consent for surgery frequently in the nhs often involving pts with dementia so am aware of the consent rules for treatment . I wonder if the rules for research may be slightly different.

Re consent to treatment an individual can only give consent for another adult if they have power of attorney. If the patient is an adult with learning difficulties or a disability the doctor seeking consent has to try as best as they can to make it possible for the patient to understand and give informed consent themselves and this means involving family or carers using pictures leaflets simple language etc.
If the patient can definitely not give informed consent then the doctor must sign the form in the best interests of the patient BUT unless this is an emergency they must involve family or significant carers in a discussion to find out what the patients beliefs attitudes and wishes were be for they lost capacity. The doctor makes the final decision and is the one who gives consent. This is important as sometimes relatives feel that decisions such as putting someone through an operation or deciding not to attempt resuscitation are a burden.

In this case I believe that the doctor should not have signed the consent forms for the study without a discussion with the next of kin. They should be reported.

[nocheeseinhouse]

I can't explain anything about this case- it sounds very odd and unusual.

The only time you could possibly consent on the behalf of someone else is if they set up a Lasting Power of Attorney for health and welfare, while they had capacity, and even so, you couldn't do anything not considered to be in their best interests. It's a complicated area of the law.

This case sounds so odd, I cannot comment on it, and find it significant that it's a 'friend' of the OP, rather than it happening to the OP, and wonder if things are as it sounds.

[Dayshiftdoris]

Ok NoCheese

Let's put it another way... No consent was gained from either the gentleman or his wife.

Given the status of this research (involving scans, testing, etc) there should have been a number of steps to ensure the correct consents were gained.
None of them happened... It is IRRELEVANT what consent could have been gained and from who because no consent was gained.

That us an incredibly serious breach of ethics and professional practice.

[MammaTJ]

MammaTJ - Google Join Dementia Research.

I just did, thank you. I'm all signed up. Now to discuss with DP and eldest DD.

[MammaTJ]

Oh my, a study has popped up that I fit the criteria for. They need 100 people and 33 are signed up for it.

I am quite excited by the thought.

It is a study about alzheimers and how early it can be detected.

It is quite a distance, but manageable and they pay for travel.

[Dayshiftdoris]

Mamma TJ

I will have a look too and see if I can do it.

Wouldn't it be great if the OP could tell her friend something good came out of it with genuine, reputable research.

[MammaTJ]

Dayshiftdoris indeed it would. All because of her posting on here about
the negative experience they had had.



I will even provide a link. www.crn.nihr.ac.uk/dementia/about-dementia-research/join-dementia-research/

[Mrsdavidcaruso]

Nocheese I am counting to ten and trying not to be rude to you

The reason why I am posting for my friend is because she is NOT on mumsnet ( in fact she had never heard of it) and as zeezak will confirm I have posted on mumsnet on a regular basis including a thread about research so I knew that there would be people on here able and willing to give help and opinions and apart from you people have been supportive and have given me good advise and some excellent information all of which I have passed on to her by email and on FB messaging and I assure you she is very grateful for the input from posters on here.

so please take your doubts and stick them where the monkey sticks its nuts oh dear was that rude I am so sorry (only got up to 9)

[Mrsdavidcaruso]

oh just seen this on the link
To contribute to achieving the Prime Minister’s Dementia Challenge ambition for 10% of dementia patients to be involved in research

I wonder if that's why the neurologist has done this, would there be extra funding for her if she meets this goal for her Department

[GnTcupcake]

This all sounds a little odd. Did the letter inviting your friend and her partner for the tests not mention anything about research? As other have said there are normally quite a lot of communication regarding patients entering research projects. If it was a funded research project there should be a lead on it and it would be worthwhile contacting them. The hospital's research approval board should be aware of any registered projects. If it hasn't been registered, then it is a maverick consultant doing it and that is unethical. However, it would be very hard for a consultant to do that kind of research without anyone else noticing. Getting a CT scan is difficult and the radiology department don't just send out phishing appointments - you said the scan appointment came out of the blue. If the consultant was ordering lots of CT scans that may or may not be attended it would be picked up by the department.
Could it be that your friend didn't fully realise it was for research, heard CT scan and further tests and focused on that thinking as you said she would be getting some information on what the future might hold, and it wasn't until she wasn't getting these answers that she fully realised it was for research only purposes? Again that is failing of the research team that she was not fully informed of the processes.
The GMC would take a very dim view and take the allegations very seriously if the events are as you describe. It's not an 'old boys' club and the consultant would certainly be up in front of a panel which is mostly made up of lay people.

[Mrsdavidcaruso]

Gn if the latter has mentioned research and training she wouldn't have put her DH through it nothing was mentioned throughout the visit until the Doctor said 'the data will be invaluable' and also seemed pleased her DH failed the dexterity test

When she got the letter she assumed her GP had arranged tests as it was only a couple of weeks before that that her DH had a fall and hit his head and she had been trying to get her Hospital to do an Xray (which they didn't do at A&E at the time) and had spoken to her GP about it she thought these tests were to do with that and to see if his meds needed to be changed.

I don't know protocol I only know what happened and as I have said my friend is intelligent and articulate she doesn't lie or make mistakes

Her GP was not at the appointment and only had the same information that my friend gave me yet she made the complaint to the GMC, would a GP report a fellow professional to the GMC only on information given to them by a patient without further checks especially a highly experienced one who knows the full history of both my friend and her DH, would that experienced GP have told my friend that her DH does not have to attend any appointment at the Hospital unless she herself had arranged the referral if she didn't believe her account.