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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.


The Ebola Outbreak in Western Africa: Ethical Obligations for Care

11 Sep, 14 | by BMJ

Guest post by Aminu Yakubu, Morenike Oluwatoyin FolayanNasir Sani-Gwarzo, Patrick Nguku, Kristin Peterson, and Brandon Brown

In our article “The Ebola Outbreak in Western Africa: Ethical Obligations for Care” we focus on the health care system’s ability to combat the recent epidemic of Ebola in Western Africa.  This is a timely and urgent issue.  Many medical ethicists – including those called upon by the WHO – are focusing on availability of experimental drugs, but little is being discussed about on-the-ground care and human rights.  By the time this article was written, in August 2014, there were 1145 deaths from Ebola.  In the news, Ebola treatment facilities were being taken over by armed civilians who stole medicines to protect themselves, resulting in Ebola patients fleeing for their lives and further spreading the virus.  This action has taken a toll on an already limited infrastructure.

The unspoken heroes of the Ebola epidemic are the healthcare workers who brave potential infection to save the lives of those infected.   In Nigeria, nine health care workers were infected, and three health care workers had already died by the time this blog was written.  With this news, willingness of medical staff to provide care for patients with Ebola virus is limited, as the danger to their own life is great.  Moral obligations of healthcare staff to provide care should have limited sanctions for non-compliance so as not to infringe on the healthcare workers right to life.  Workers who do care for Ebola patients must be provided with adequate protective equipment and a safe working environment, as well as compensated if they become infected in the course of duty.  Traditional public health ethics has paid little attention to the protection of the rights of healthcare workers, but the Ebola epidemic has brought this issue to the forefront.  Its time those who are responsible for saving our lives have a voice.


Read the full paper here.

UPDATE:  Brandon Brown emails:
I just received a nice on the ground photo (Ebola decontamination) from my collaborators in Nigeria if we can attach to the blog entry.  [Click image for bigger.]





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.

On Conflicts of Interest

28 Jul, 14 | by Iain Brassington

It’s only a few days since Richie’s paper on providing IVF in the context of global warming was published, but already there’s been a couple of lines of objection to it that have been fairly widespread; I thought it might be worth nodding to one, and perhaps offering an attempt of a defence against the other.

The first objection is that there’s no justification for the claim about same-sex couples in Richie’s paper – that she shouldn’t have treated homosexuality as a lifestyle choice and as “non-biological” infertility.  I think that there’s significant merit to this objection to the paper; and though neither Dominic nor I mentioned the objection explicitly, I think that it’s there between the lines of each of our commentaries.  (It’s certainly an aspect of the paper that’s picked up by the Telegraph‘s coverage of the paper, and it’s been mentioned a couple of times on Twitter and Facebook by people I know and follow.  (I note that the Telegraph also gave a highly bastardised version of my post here.  Ho hum.))  I think that Richie’s argument would have been at least as strong if she’d talked about providing IVF to anyone whatsoever – the qualifications about different “sorts” of infertility and lifestyle, I suspect, weakened the paper, inasmuch as that a paper with unnecessary and argumentatively weak aspects is more vulnerable to objections generally than one in which those aspects have been left out.  So, yeah: I think that that might count as having been – at best – a strategic error on Richie’s part.

Here’s the other claim that I’ve seen a few times about the paper: that it’s weakened by a conflict of interest because of the author’s affiliation.  This isn’t directly a claim about the quality of the argument in the same way that the previous objection is.  Rather, it’s a claim that there’s something unreliable about the very fact of the argument’s having been put.  (I’m not articulating the distinction very well, but I think you can see what I mean.)  In essence, the worry is this: Richie works for a Jesuit Institution; this isn’t clear from her affiliation in the paper; there’s something iffy about this; this iffiness is some form of conflict of interest and her argument is likely to be biased.

I’m not sure what to make of this. more…

Gaia Doesn’t Care where your Baby Comes From

25 Jul, 14 | by Iain Brassington

Guest Post by Dominic Wilkinson, Associate Editor, Journal of Medical Ethics

In a provocative paper published today in the Journal of Medical Ethics, US theologian Cristina Richie argues that the carbon cost and environmental impact of population growth in the West should lead to restrictions on artificial reproduction.  She points to the substantial carbon emissions that result from birth in developed countries like North America.  Seven percent of the world’s population contribute fifty percent of the world’s CO2 emissions, and children born by in vitro fertilization are likely to be in this seven percent.  Richie argues in favour of a carbon cap on artificial reproduction and argues that IVF should not be funded for women who are “biologically fertile”.

Richie is correct to point to the enormous carbon cost of additional human population. One of the most significant ways that individuals in Western countries can reduce global carbon emissions is by having fewer children. However, her focus on artificial reproduction and on the “biologically fertile” is not justified.

Richie ignores questions about the moral implications of climate change and climate cost for natural reproduction.  She sets to one side “the larger realm of sexual ethics and procreation”.  Yet there are two reasons for thinking that this is a mistake.  First, as Richie notes, “Reproduction-related CO2 is primarily due to choices of those who have children naturally: a huge majority of all births.”  Only 2% of all children born in the UK are conceived by IVF.[1]  Therefore interventions to reduce the number of children naturally conceived will potentially have a fifty fold higher impact on carbon emissions.  Secondly, it is profoundly unjust to apply restrictions to reproduction only on those who are unable to conceive by natural means.  It could be justified to limit the reproductive choices of women because of concern for the environment.  However, if this were justified, it would be equally justified to try to limit the reproduction of the naturally fertile and the naturally infertile.  It is ad hoc and unfair to confine our attention to those who must reproduce artificially.

Second, Richie proposes that public funding for IVF be confined to those who are “biologically infertile”, excluding same sex couples and single women.  However, she provides no reason at all for restricting the availability of IVF for these women.  Put simply, the carbon cost of artificial reproduction is exactly the same for a woman who is infertile because of endometriosis or polycystic ovary syndrome or because she does not have a male partner.  The only possible reason for making a distinction between biologically infertile and biologically fertile women is because Richie believes that lesbian and single women are less deserving of public funding because of their lifestyle choices.  However, that argument, as problematic and contentious as it is, is completely independent of the question of environmental impact.  The carbon cost of children born to gay couples is likely to be exactly the same as the carbon cost of children born to women with endometriosis.

The carbon cost of additional births might well be sufficiently important for the state to justify limiting reproductive freedom.  However, if the state is going to interfere in couples’ decisions about whether to have children or the number of children that they have, it should do so fairly and equally.  Carbon caps should be applied equally to those who conceive naturally and those who require artificial reproductive treatment.  They should not be used as a way to discriminate against those who are single or gay, or have some other ‘undesirable’ characteristic.



ARTs in a Warming World

25 Jul, 14 | by Iain Brassington

There are some people who disagree, but we can take some things as read: there is such a thing as global climate change, it is at least substantially anthropogenic, and there are moral reasons to try to minimise it.

With that in mind, how should we think about reproductive technologies?  These are techniques whose intent is to create humans, and – presumably – those humans will have an environmental impact.  This is a question that Christina Richie confronts in her paper in the JME:

The use of ART to produce more human-consumers in a time of climate change needs to be addressed.  Policymakers should ask carbon-emitting countries to change their habits to align with conservation.  And though all areas of life – from transportation, to food, to planned technological obsolescence – must be analysed for ecological impact, the offerings of the medical industry, especially reproductive technologies, must be considered as well.

One of her suggestions is of carbon-capping for the fertility industry; she’s more reluctant to suggest a moratorium on the use of ARTs.  But she does suggest thinking quite seriously about who should get access to fertility treatment.  After all, she points out, fertility treatment is unlike other medical treatments in a number of ways.  Not the least of these is that someone whose life is saved by medicine will go on to have a carbon footprint bigger than it might have been – but that’s not the intention.  The whole point of fertility treatment is to create new humans, though – and therefore the treatment has not just a footprint, but a long-lasting carbon legacy.

I wonder, actually, whether the argument could be radicalised. more…

Are FIGO’s Regulations Risking the Lives of Pregnant Women?

10 Jul, 14 | by Iain Brassington

Guest post by Douwe Verkuyl

The International Federation of Gynecology and Obstetrics (FIGO) Committee for the Ethical Aspects of Human Reproduction and Women’s Health believes that there is never an indication for a tubal occlusion (TO) to be performed at the time of caesarean section or following a vaginal delivery in cases where this sterilisation has not been discussed with the woman in an earlier phase of her pregnancy.  This applies even if there is a uterus rupture.

But what if a mother of 5 children, living in rural Africa near a Catholic clinic, unexpectedly needs referral to a government hospital because of arrested labour, and faces a journey of at least 4 hours over a dirt road?  Does the Committee’s recommendation against belated TO counselling still apply if referring establishments have deliberately ignored its advice to counsel pregnant women early in pregnancy about the option of a concurrent sterilisation in the event that a caesarean section is needed?  Catholic institutions – which are often the only health facility for miles around – not only ignore this advice, but also fail to assist a woman with “sinful” modern contraception after she has returned with a scarred uterus.  In many Western, developed countries, Catholic contraception doctrines are mostly inconvenient, guilt-provoking and expensive.  In rural Africa, Latin America and the Philippines, they often kill.

Imagine a 37-year-old woman in labour in a well-equipped and staffed Doctors Without Borders (DWB) emergency hospital which happened to be located near her home.  She has previously given birth, with some difficulty, six times at home, and now there is a full civil war.  The doctors detect foetal distress.  They think there might be a 10%-30% chance her child will be damaged or die before it is born.  On the other hand, with the uncertain political situation – consider that on 17 June a DWB hospital was bombed in Sudan – and poor infrastructure, it might be the case that her chance of dying from a uterine scar during a subsequent labour is around 30%, and the probability that she has continuous access to reliable reversible contraception for the next 13 years is zero.  If she would choose to have a TO with a caesarean section that would solve the quandary.  Is it really unethical to ask her, or unethical not to give her that choice?

Read the full paper in the latest edition of the JME here.

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.

Rescuing the Duty to Rescue

1 May, 14 | by BMJ

Guest post by Tina Rulli and Joseph Millum

It is commonly thought that individuals have a moral duty to rescue others in peril. Bioethicists have leveraged this duty to rescue for a variety of purposes—including to criticize the use of placebo controls in trials in developing countries; to defend duties of researchers to return urgent incidental findings and provide ancillary care; to argue for a duty to become an organ donor; to defend allocating resources to develop drugs for rare diseases and to fund costly end of life care.

Despite their widespread use, there are serious problems with the two most cited duties to rescue: the individual duty of easy rescue and the institutional rule of rescue. The latter—the psychological tendency to support allocation of large amounts of money to rescuing identifiable victims at the opportunity cost of helping anonymous others—is indefensible.  (See Peter Singer’s opinion piece in the Washington Post criticizing donations to Make-a-Wish). The former can be defended, but has its own problems. One concerns its force: does it really apply only to very low-cost rescues? Consideration of physicians’ duties to warn suggests otherwise. Another problem concerns its scope: whom do I have to rescue? If it applies to everyone who needs rescue, even low-cost rescues may place enormous demands on individuals (cf Peter Singer’s famous essay: “Famine, Affluence, and Morality”).

We identify two further conceptions of the duty to rescue that have received less attention. An institutional duty of easy rescue would justify spending institutional dollars on rescue cases that are not too costly, while leaving room for institutions to fulfill lesser, but still important needs of others. A professional duty to rescue recognizes the more demanding duties certain medical professionals have. Both provide traction in answering some outstanding rescue dilemmas. We conclude our paper by proposing research priorities for bioethicists to help researchers and doctors sort through the obligations they have to people in need of medical rescue.

Read the full paper in the JME here.

Multiplex Parenting: in vitro Gametogenesis and the Generations to Come

24 Mar, 14 | by BMJ

Guest Post by César Palacios-González, John Harris and Giuseppe Testa; for the full paper, click here.

Recent biotechnology breakthroughs suggest that functional human gametes could soon be created in vitro.  While the ethical debate on the uses of in vitro generated gametes (IVG) was originally constrained by the fact that they could be derived only from embryonic stem cell lines, the advent of induced Pluripotent Stem Cells (hiPSC) creates the possibility that somatic cells may be used to generate gametes.  This means that in the future it might be possible to generate human sperm and oocytes from male cells, and oocytes from female cells.  (So far it has not been possible to derive sperm from female cells.)

Among the different applications that have been explored in the academic literature, like the creation of embryos for genetic research and what has been called “in vitro eugenics”, we think that the most dramatic application of IVG will be in the field of human reproduction.  In a recent article in the Journal of Medical Ethics, Robert Sparrow rightly notices that IVG could allow post-puberty males who are unable to produce viable sperm, women who have undergone premature menopause, and those who have lost their gonads due to injury or had them removed in the course of cancer treatment to have genetically related kin.  To this list we add (and explore in our paper) a fourth use that has been overlooked until now: that IVG would allow the reparation of some of the harms done to people by means of biological involuntary sterilization. more…

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