You don't need to be signed in to read BMJ Blogs, but you can register here to receive updates about other BMJ products and services via our Group site.

clinical ethics

Paper Preview: Implementation of a Consent for Chart Review and Contact

23 Sep, 14 | by BMJ

Guest post by 
Our article “Implementation of a Consent for Chart Review and Contact and its Impact in one Clinical Centre” focuses on issues regarding patient health information privacy and recruitment for medical research studies.  Research studies are an integral part of the advancement of medical therapies; however, recruitment into research studies can be challenging.  In Canada, the use of health information is governed by Personal Health Information Protection Act and at our institution a policy is in place that allows only those health professionals directly in the circle of care access to patient information to further protect patient’s privacy.  This policy could have a potential negative effect on recruitment rates into research studies.  Physicians and other clinical personnel often do not have the time to discuss ongoing research projects with patients as time is spent focusing on the patient’s medical issues.  In addition, there is concern that if  physicians use the information that they gather in a clinical encounter to recruit for research studies, it is equivalent to that physician sharing medical information  with someone who does not have a right to it.
In light of these challenges, the Division of Metabolism and Endocrinology at the University of Ottawa implemented a consent for chart review and contact (CCRC).  The CCRC is a document presented to a patient on their first meeting a new physician.  The CCRC gives permission for the patient’s medical file to be reviewed by research personnel to determine whether a patient is eligible for a research study.  If the patient meets the study criteria, the CCRC also grants permission for the patient to be contacted by research personnel to be provided with the details of the research study so they can decide if they wish to participate.
It has been proposed that patients may feel pressured to agree if a  CCRC is presented on their first meeting a new health professional.   Patients may feel that refusing the CCRC would affect the future care they receive.  Our  paper discusses how we have addressed this possible pitfalls with our CCRC document.
In addition, we performed an analysis to assess the impact the CCRC was having at our institution.  We compared the basic demographics of the patients who did and did not agree to the CCRC.  Furthermore, we analysed our centre’s recruitment rate into a known, ongoing, multi-centre, international trial.  Of the participating centres, we found that our institution had some of the highest recruitment rates into the trial, and that the majority of our patients were being recruited via our novel approach of the CCRC.  It is not certain that the use of a CCRC would consistently translate into higher recruitment, but certainly our experience has been encouraging.  Data suggest that participation in research trials has been decreasing in recent years.  Any measure to preserve recruitment may be beneficial, especially a measure which allows for the conduction of research, without having to sacrifice any patient rights with regards to privacy and confidentiality.
Read the paper here.

 

Adrenaline, Information Provision and the Benefits of a Non-Randomised Methodology

17 Aug, 14 | by Iain Brassington

Guest Post by Ruth Stirton and Lindsay Stirton, University of Sheffield

One of us – Ruth – was on Newsnight on Wednesday the 13th August talking about the PARAMEDIC2 trial.  The trial is a double blind, individually randomised, placebo controlled trial of adrenaline v. normal saline injections in cardiac arrest patients treated outside hospital.  In simpler terms, if a person were to have a cardiac arrest and was treated by paramedics, they would usually get an injection of adrenaline prior to shocks to start the heart.  If that same person was enrolled in this study they would still receive an injection but neither the person nor the paramedic giving the injection would know whether it was adrenaline or normal saline.  The research team is proposing to consent only the survivors for the collection of additional information after recovery from the cardiac arrest.  This study is responding to evidence coming from other jurisdictions that indicates that there might be some significant long term damage caused by adrenaline – specifically that adrenaline saves the heart at the expense of the brain.  It is seeking to challenge the accepted practice of giving adrenaline to cardiac arrest patients.

Our starting position is that we do not disagree with the research team.  These sorts of questions need to be asked and investigated.  The development of healthcare depends on building an evidence base for accepted interventions, and where that evidence base is not forthcoming from the research, the treatment protocols need changing.  This going to be tricky in the context of emergency healthcare, but that must not be a barrier to research.

There are two major ethical concerns that could bring this project to a grinding halt.  One is the opt-out consent arrangements, and the other is the choice of methodology.

Consent, then. more…

Advance Directives, Critical Interests, and Dementia Research

14 Aug, 14 | by BMJ

Guest post by Tom Buller, Illinois State University

In my paper, “Advance Directives, Critical Interests, and Dementia Research”, I investigate whether advance directives can be applied in the context of dementia research. Consider, for the sake of argument, the following fictional case. William, a 77-year-old man who has moderate to severe dementia. When he was first diagnosed and while still competent he declared on many occasions that he wished to do all he could to help future sufferers of the disease and find a cure for Alzheimer’s, and he repeatedly said that he very much wanted to participate in any clinical trials, even those that might involve hardship and risk. With the full agreement of his family William was enrolled in a five-year clinical trial testing a new treatment for Alzheimer’s that involves.

I think it can be legitimately argued that William has the right to make a future-binding decision to participate in the above trial, for the reasons that justify the use of a decision in the treatment context also apply in the present research context. First, William’s beneficent desire to help future sufferers of Alzheimer’s is part and parcel of his character and what gives his life value. Second, the principle of precedent autonomy is not invalidated by the fact the person is encouraging, rather than, refusing intervention, and that the chosen course of action requires the assistance of others. Third, William’s decision is not invalidated by the fact that it is motivated by beneficence rather than self-interest.

If this analysis is correct, then it would seem that there are good reasons to think that a competent person has the right to decide to participate in future research once competence has been lost, even research that is (significantly) greater than minimal risk.

 

Read the full paper online first here.

Paternalism up a Mountain

12 Aug, 14 | by Iain Brassington

“Paternalism” is one of those words that has a hell of a lot of power.  On several occasions, I’ve seen it used as a trump to shut down an argument: saying “But that’s paternalism” is, at least sometimes, treated as a way of showing that anyone arguing in favour of the allegedly paternalistic action is an imbecile, and has therefore lost the argument by default.  I suspect that this is due to a bastardisation of the (already iffy) “Georgetown Mantra”; but it does seem to be a position horribly common in medical schools.  It’s also very unsophisticated.  Whether or not something is paternalistic seems to me to be less important than whether it’s justified.  Something might be unjustified, and the reason for that might be because it’s paternalistic; but it doesn’t follow from that that no paternalism could be justified.  In just the same way, too much bleach or bleach in the wrong place is something you’d want to avoid; but it doesn’t follow that you should avoid bleach at all times and at all costs.

I want here to tell you a story based on something that happened just over a week ago. more…

Intentionally Exposing Patients to HIV: When Might it be Ethical?

7 Jun, 14 | by BMJ

Guest Post by Bram Wispelwey, Ari Zivotofsky, and Alan Jotkowitz

Much has been made of the fact that over the last two decades HIV has transformed from an inevitable, agonising killer into a controllable chronic disease.  But have we reached a point where infecting someone with HIV in order to avoid other, potentially worse health outcomes might be justified?  In the realm of organ transplantation we found that if we are not yet there, perhaps we should be.

Our paper was in part inspired by what many considered a shocking ruling by former Israeli Chief Rabbi Eliyahu Bakshi-Doron, who decreed that it was consistent with Jewish religious law for HIV-negative individuals to receive HIV-positive organ transplants, even if the evidence indicates a possibility for the recipient to contract the disease.  Many considered this opinion premature because only recently had HIV-positive individuals been found to be good candidates for solid organ transplantation, and doctors in South Africa were still in the early research stages of examining kidney transplantation between HIV-positive individuals.  But in examining the ethical considerations of autonomy, beneficence, non-maleficence, and justice, we argue in our paper that Rabbi Bakshi-Doron’s opinion is ethically sound.

Focusing on the history of HIV in transplantation and using a comparison to current practice with regard to another infectious disease, cytomegalovirus, we demonstrate that disallowing HIV-negative candidates from receiving HIV-positive organs would be a significant limit on patient autonomy.  The elimination of the ban on this type of potentially life-saving (and improving) donation may also represent a more socially just option, as it would expand the donor pool and engender cost savings. HIV-positive to HIV-positive donation will soon be a reality in several countries; it’s time to think about going one step further.

 

Read the full paper here.

Oh, and while we’re talking about media hype…

1 Apr, 14 | by Iain Brassington

… there’s this, from last week’s Independent:

Thousands of unborn foetuses incinerated to heat UK hospitals

The bodies of more than 15,000 unborn foetuses have been incinerated in the UK, an investigation has found, with some treated as “clinical waste” and others burned to heat hospitals.

The practice was carried out by 27 NHS trusts, with at least 15,500 bodies burned over the last two years alone.

Ten of those trusts admitted to burning more than 1,000 sets of remains along with other hospital rubbish, while two said they were incinerated in “waste-to-energy” furnaces that generate energy used to power and heat hospitals.

Gasp!  One kind of human tissue is disposed of in the same way as other kinds of human tissue!

From the tone of the reporting, one would only be mildly surprised to find people employed to encourage abortions in order that hospitals can save money on fuel.

Except that that’s nonsense.  If clinical waste is incinerated in waste-to-heat plants, it doesn’t follow that it’s being incinerated to provide heating; rather, it’s that the heat from the incinerator is captured and put to use, rather than being wasted.  For sure, the physics is the same; but the emphasis makes a heck of a difference.  (And, as PZ points out, for abortus* to be an effective fuel would require them to be “the most energy-dense substance in the world”.)  So what we actually have is a situation in which an abortus is incinerated.

And the problem with that is…?

Um…

Well, I’m sure there must be one, because health minister Dan Poulter is reported as describing the practice as “totally unacceptable”, and Poulter is an honourable man.

Actually, there is a few things that might strike us as questionable – though as we’ll see, the fact that something prompts a question doesn’t really tell us much, since some questions can be answered easily.   more…

What should we Think about Belgium’s Child Euthanasia Law?

15 Feb, 14 | by Iain Brassington

With any luck, the nuts real-world work schedule of the past few months* will begin to ease in a few days, so I should be able to start blogging more frequently soon; but I thought I’d take a moment out from writing jurisprudence lectures to do some thinking out loud about Belgium’s recent change to its euthanasia law, which legalises it for children.  This is partly because it’s interesting in its own right, and partly because I’m debating it on Radio 4’s Sunday programme this week.  I’ve drafted this post before the interview’s recorded, but I’m not publishing it until after (though before the broadcast); let’s see how my thoughts here pan out on air…**

For reference, the text of the law is available here in French, and here in Dutch – thank goodness for A/S levels.  A decent précis provided by AP is hosted here; and Christian Munthe has an unofficial translation here.

OK: so, what should we think about it? more…

Medical Information for Sale?

21 Jan, 14 | by Iain Brassington

Reader Keith emailed me a week or so ago to tip me off about the government’s plans to allow private firms to access medical information.  It’s a story that has subsequently been picked up by  – inter alia – The Guardian.

As with the last post I made here, I’m going to have to cry off from saying much in my own right – I’ve got lectures that need to be written, and I need at least to go through the motions of being competent – but I would draw your attention the Christian Munthe’s take on the matter.

Touch wood, I’ll be able to get back to more frequent blogging soon.

Aintree University Hospital NHS Foundation Trust v James: Best Interests and Futility under the Judicial Microscope

14 Nov, 13 | by BMJ

Guest post by Daniel Sokol, barrister at 12 King’s Bench Walk / King’s College London.

Eight years after coming into force, the Mental Capacity Act 2005 has finally reached the scrutiny of the Supreme Court in Aintree University Hospital NHS Foundation Trust v James [2013] UKSC 67.

David James was a professional musician, and a family man.  He had three children, three grandchildren, and many friends.  In May 2012, he acquired an infection in hospital which resulted in his admission to the critical care unit.  He was put on a ventilator.  In the following months, his condition fluctuated.  At one point, his heart stopped and he required 6 minutes of CPR.  He later underwent a tracheostomy, and received artificial nutrition and hydration.  Two months after his admission in hospital, he lost the capacity to make decisions about his medical treatment.  In spite of this, Mr James was able to recognise his wife and son, to kiss them, to follow their movements with his eyes, and, on occasion, to smile.  His prospects of leaving the hospital were nonetheless slim.

In September 2012, the hospital sought a number of declarations from the Court of Protection, one of which was that it would be in Mr James’ best interests not to receive certain treatments, including CPR, in the event of his deterioration.  The family disagreed.  They felt he still enjoyed life and that, each time he contracted an infection, he managed to pull through.

The judge at first instance refused to make the declarations.  He did not consider the treatments to be futile or unduly burdensome.

The hospital trust appealed to the Court of Appeal.  By then, Mr James’s condition had deteriorated dramatically.  He was comatose, or semi-comatose, and completely ventilator-dependent.  The Court allowed the appeal and made the declarations.  On 31st December 2012, Mr James suffered a cardiac arrest and died.

Mr James’s widow appealed to the Supreme Court. more…

Biases in Clinical Ethics Consultation

19 Sep, 13 | by Iain Brassington

Guest post by Morten Magelssen, Reidar Pedersen, and Reidun Førde

Read the full paper here.

A difficult case involving a patient in an intensive care unit is brought to a clinical ethics consultant.  The ethics consultant argues that intensive care is futile and should be withdrawn.  The clinicians are grateful for the advice, and, with the assent of the patient’s relatives, decide to withdraw intensive care accordingly.

Clinical ethics consultation – by committees or individual consultants – involves reflection upon ethically and medically challenging cases.  When reflection is carried out in a systematic manner, then ideally the ethically salient points are brought out and discussed in a comprehensive and unbiased way.

But what if the consultation itself introduces new biases and implicit value judgments?  We won’t take a stand on how often this in fact happens, but rather draw attention to how easily it may occur and the dangers involved.  In our JME article we identify six sources of bias – or conflicts of interest – in clinical ethics consultation. For instance, in the case above, the ethics consultant could be biased towards the interests of health-care professions, or towards the hospital’s interests in keeping costs down and maintaining an unblemished public image.  In general, we argue, the potential for harmful biases is greater when the consultation is performed by an individual consultant rather than by a committee.

The introduction of new, harmful biases through ethics consultation, a process intended to reduce biases, would be problematic (and somewhat ironic).  Especially considering that, in the eyes of clinicians, the conclusion and advice of ethics consultation may appear to bear a stamp of ”ethically approved”.

We are fundamentally optimistic about the positive role clinical ethics consultation can play in aiding clinicians in the management of ethically complex cases.  However, ensuring the quality of clinical ethics case deliberations is vital.  Although biases can never be completely eradicated, the identification of potentially significant biases is an important part of quality improvement.

JME blog homepage

Journal of Medical Ethics

Analysis and discussion of developments in the medical ethics field. Visit site

Latest from JME

Latest from JME

Blogs linking here

Blogs linking here