Adrenaline or salt water. Changes to the way heart attack patients are treated.

[Darkesteyes]

Just seen a report on Newsnight. Instead of injecting with adrenaline some patients (but we wont know which ones until afterwards) will be injected with saltwater as a placebo. It is to see if adrenaline causes more harm than good.
DH has heart disease. He called this an experiment. And i certainly see his point. He says its obviously to "kill some people off" He got quite upset. What do MNers think of this?

Gold - read the Redfern report into the Alder Hey scandel. That suggests people should be asked for consent in those circumstances. Also, it is the issue of personal data being included, and being tracked that is the issue. That is why consent needs to be sought.

NCIS - I would have every faith in my NoK making decisions on my behalf. I have absolutely no faith in Ethics Committtes making them on my bahalf.

Your nok does not have the right to withhold or insist on medical treatment for an adult.

How do you know? You can give them that right. That us why we have Power of Attorneys, so the someone is not at the mercy of the self-governing decision making powers of the NHS when they lack capacity.

Also you might have that faith in your nok but Ms Bloggs down the road with no partner only a distant relative may not have that faith. You do not speak for everyone nor are you always right.

But very few people give power of attorney.

Gold - read the Redfern report into the Alder Hey scandel. I did, albeit not in great detail.

It doesn't change the fact that it isn't necessarily possible to carry out this particular piece of research effectively and ethically if consent is required.

POA doesn't necessarily give the person the right to withhold / decline specific medical treatments though.

Pseudonym99

Data is collected all the time without consent, and not just for medical research. Yesterday there was a report of the most common names given to babies last year, I bet not one of those babies or there parents gave 'consent' for their child's name to be counted.

As for consent from NoK when someone is dead... Well 'Mrs Smith is it OK if we check in 3 months to see if your father is still dead?" yep that's going to be useful

sash - but with medical trials, doctors, nurses and other NHS staff have professional codes of conduct, which say they must always act in the best interests of the patient, always seek consent, respect confidentiality etc etc. Performing clinical trials without consent, involves breaching confidentiality and goes against the NHS constitution, which includes such things as dignity, respect etc.
Your remark about still checking someone is dead 3 months after they've died trivialises the argument - of course someone will still be dead three months after they've died. My point is, the researches should inform relatives that their loved one has been involved in a trial, and seek consent to include that data in the trial. Likewise, if a survivor withholds consent, the data already gathered from them before they've been able to be asked for their consent should not be included in the trial.

Researchers being scared of upsetting relatives is not a good enough excuse not to seek consent, and fears of skewing the results should not be a good enough excuse to ignore patient preferences regarding consent about data already gathered.

People have died in wars to protect individual freedoms, and if people have to die to protect patient freedoms and autonomy from researchers, doctors, nurses and other unscrupulous NHS staff, then so be it. All for the simple discourtesy of not asking for permission to use your data.

Not in my name, I do not and will never consent to die to protect your patient freedom. How does that fit in with your ideas?

pseudonym99 I am a philosopher and have trained RECs for years. Some of the things you say are factually wrong, some are unsupportable and some are downright offensive to people who sit on RECs.

Research governance is not a result of people like you but has a long history back to the lessons learnt from the Nuremberg trials and the development of the Declaration of Helsinki. It is as much the product of concerned doctors, health care professionals, lawyers, law makers and philosophers as it is the product of concerned patients and lay people.

Valid consent is not necessary for all trials, RECs are there to determine exceptions.

REC members are extremely overworked professionals and laypeople who nonetheless volunteer their time and expertise to deal with these extremely complicated issues to their best of their abilities. They are not out to get you and have nothing to gain from it.

There is no perspective from which you can ask "are they working for ME?". You as what? A patient desperate for a treatment? A doctor committed to improving care? An academic invested in promoting knowledge? A vulnerable person in need of protection? A society attempting to prioritise costs? RECs try to balance myriad of considerations in a very technical environment with diverse specialist knowledge.

Btw you are also missing the point about consent and confidentiality. Consent is action specific. The specific action here is participation in a RCT and as has been clearly pointed out consent for this specific action cannot be obtained in advance. There is no such thing as retrospective consent as there is no option to withhold consent thus making the whole thing pointless. Consent is not required in order to use anonymised data for research, audit or educational purposes. This is not a breach of confidentiality because there is no connection between you as an individual and the information.

But data can be withheld from the study until consent can be obtained. The data is not anonymised, as it has to be linked with outcomes. The ambulance service has to link the data with the hospital data and back again, to be included in the trial, therefore by its very nature it has to be indentifiable. Even if the patient's name is replaced by a number unique to the study, it is pseudo-anonymised, not anonymous, and data about you is being linked and following you around. This data about you should not be added to the study until consent has been gained.

You will not get me to change my stance on this issue - although I agree the study needs to be done, it is the system of consent I take issue with. Consent can be obtained - retrospectively, yes - so hiding behind not wanting to upset people should not be an acceptable defense to not gaining that consent.

Data is anonymised. It doesn't follow you around. I've done clinical research. Each participant is given a number. That is kept secret and separate from their medical/hospital notes. Their study notes only have their number on them, so only very, very few people can find out who is who from the study.

Data about you is collected EVERY time you go to hospital and you don't give explicit consent for it, because it is anonymised.

You don't understand this, and that's okay. It is a complex issue but you are coming out with some ridiculous statements about clinical research and those who conduct clinical research.

You've said you are not going to change your stance on this, so you have decided already, based on your incorrect assumptions and extrapolation, that it is wrong. As so many of us have explained, consent CAN NOT be gained retrospectively. Consent for further involvement in the study WILL BE gained from survivors. Consent from those who didn't survive is not required because they are dead and no further data will be collected.

Data is not anonymised. This is half the problem - it is claimed it is anonymised, but it is not. It is pseudo-anonymised, hence the secret number you refer to. If it were anonymised, there would be no secret number. People are told it is anonymised, when it is not. If it were truly anonymised, then nobody would know who the data relates to - not even the very, very few people you say know. If it were truly anonymised, then you would not be able to link it when further information becomes available.

Dino - I do not think you understand my argument. The data does follow you around, because it is not anonymised, even though you claim it is. Consent from those who did not survive should be required - from their next of kin. As per the duty of confidentiality required by those employed by the NHS, which still stands, even after death. They are not even bothering to seek retrospective consent from those who do survive for the information already gathered. It is outrageous, and should not be allowed. And anyone involved in such a study should be ashamed of themselves, and are not worthy of the work they do, and brings down the reputation of those hard-working doctors, nurses and others employed in the sector who do have respect for their patients.

Dino - please explain to me why consent cannot be gained retrospectively. It is simple - a person is treated with a kit from the trial. The data on whether that patient survives or dies is withheld from the study until consent can be gained or refused. Why is that so difficult?

Data is anonymised when patient identities are turned into numbers and a chain of people may be involved in the process so that no one individual has access to the whole chain. You don't wan't to accept that, that's fine.

Consent cannot be retrospective because it cannot be withheld retrospectively. Once data has been collected it exists and once it is stored people have access to it. If it is not anonymised but instead we wait to obtain consent it is much more likely that identifiable information will be passed on from one person to another, e.g. The person who collected the data, the person trying to obtain retrospective consent, the person who open the non-anonymised folder by accident. Again you do not seem to be aware of how these processes actually work.

As for obtaining consent from relatives, which relatives? What if they disagree? Would you seriously expect the courts to give their time to deciding such questions in cases of disagreements between relatives or between relatives and doctors?

Oh of course you would need to find the funds to pay for the billions needed to obtain consent for all these bits of information that are currently available in an anonymised fashion.

Or a non-anonymised, publically accessible fashion - e.g. death certificates...

Or even publicly. Stupid phone nonsense words.

This debate was on the Wright show, apparently the statistic of people surviving a myopic infarction outside of hospital is less than 6%. Scary figure.

The NHS have decided to do this without testing on animals so I am guessing that they have taken data on board from other countries?

There already exist small scale studies indicating that adrenaline is harmful. Approval of large scale studies follows protocols that require that appropriate earlier steps have been positive. What is appropriate will differ, it may be laboratory studies, animal studies , simulations, etc.

Booboo - my argument is not about anonymity. It is about consent. Yes, the data when originally collected is obviously identifiable. It can stay that way in hospital systems, like it would be anyway, until consent can be obtained. It does not enter the trial unless consent has been obtained. Simples. But you don't want to see that, do you, as it would make life hard for researchers if they had to treat people like people, whether they were dead or alive.

There is an established pecking order for consent from relatives, for such situations as deemed organ consent in Wales. And yes, if they cannot agree, I would expect the courts to decide such questions - this is why such organisations as the Court of Protection exist. Or in the case of disagreements, then consent is deemed not to be given. Simples. Or I do not see why we cannot just microchip people (with their agreement), and on there it can state your identity, your consent preferences for treatment in emergency, whether you would want to participate in research in an emergency, and your next of kin who you would like to be asked to make decisions if you weren't able to be asked.

I'm sure life would be a lots easier if the world were as black and white as you seem to think it is and decisions were so easy to make.

In reality there are countless angles and complicating factors to consider and ethics committees have the unenviable job of trying to navigate through them to find an outcome that serves the greater good.

The decisions aren't ever made to make the lives of researchers easier. The considerations are about making sure the least/no harm is done while acknowledging that inaction can also be harmful.

Why not volunteer to join a ethics committee yourself rather than judging them from a position of ignorance?