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Research

Where to Publish and Not to Publish in Bioethics

5 May, 16 | by bearp

Guest Post by Stefan Eriksson & Gert Helgesson, Uppsala University

* Note: this is a cross-posting from The Ethics Blog, hosted by the Centre for Research Ethics & Bioethics (CRB) at Uppsala University. The link to the original article is here. Re-posted with permission of the authors.

Introduction

Allegedly, there are over 8,000 so-called predatory journals out there. Instead of supporting readers and science, these journals serve their own economic interests first and at best offer dubious merits for scholars. We believe that scholars working in any academic discipline have a professional interest and a responsibility to keep track of these journals. It is our job to warn the young or inexperienced of journals where a publication or editorship could be detrimental to their career. Even with the best of intent, researchers who publish in these journals inadvertently subject themselves to criticism. We have seen “predatory” publishing take off in a big way and noticed how colleagues start to turn up in the pages of some of these journals. This trend, referred to by some as the dark side of publishing, needs to be reversed.

more…

Circumcision and Sexual Function: Bad Science Reporting Misleads Parents

22 Apr, 16 | by bearp

by Brian D. Earp / (@briandavidearp)

Introduction

Another day, another round of uncritical media coverage of an empirical study about circumcision and sexual function. That’s including from the New York Times, whose Nicholas Bakalar has more or less recycled the content of a university press release without incorporating any skeptical analysis from other scientists. That’s par for the course for Bakalar.[1]

The new study is by Jennifer Bossio and her colleagues from Queen’s University in Ontario, Canada: it looked at penile sensitivity at various locations on the penis, comparing a sample of men who had been circumcised when they were infants (meaning they had their foreskins surgically removed), with a sample of men who remained genitally intact (meaning they kept their foreskins into adulthood).[2]

What did the researchers discover? According to a typical headline from the past few days:

Circumcision does not reduce penis sensitivity.”

But that’s not what the study showed. Before we get into the details of the science, and looking just at this claim from the “headline” conclusion, it might be helpful to review some basic anatomy.

more…

A Tool to Help Address Key Ethical Issues in Research

22 Feb, 16 | by BMJ

Guest post by Rebecca H. Li and Holly Fernandez Lynch

One of the most important responsibilities of a clinical project lead at a biotech company or an academic research team is to generate clinical trial protocols. The protocol dictates how a trial will be conducted and details background information on prior research, scientific objectives, study rationale, research methodology and design, participant eligibility criteria, anticipated risks and benefits, how adverse events will be handled, plans for statistical analysis, and other topics. Many protocol authors use as a starting point a “standardised” protocol template from their funder or institution. These templates often provide standard language, and sections for customisation, sometimes with various “pick-and-choose” options based on the nature of the research. They inevitably cover each of the key topics listed above, but often fail to include ethical principles and considerations beyond the regulatory requirement of informed consent. Indeed, the process of protocol writing has traditionally focused on scientific detail, with ethical analysis often left to institutional review boards (IRBs) and research ethics committees (RECs); unfortunately, robust discussion of specific ethical issues is often absent from clinical trial protocols.

When IRBs and RECs convene to review protocols, they are expected to evaluate whether the study will adequately protect enrolled participants. When the protocol fails to address potential ethical concerns explicitly, reviewers are left to speculate: did the investigator consider the concern, but dismiss it as not relevant in this particular context; did the investigator fail to understand the concern; does the investigator have an appropriate plan in place to resolve the concern, but has left it unstated in the protocol? This uncertainty can contribute to delays as reviewers debate among themselves, and can require lengthy back-and-forth with researchers, including series of protocol revisions and re-reviews until clarity is established. In some cases, it may also be that reviewers with less experience or expertise fail to identify an ethical concern that has not been brought to their attention in a protocol. more…

The Unbearable Asymmetry of Bullshit

16 Feb, 16 | by bearp

By Brian D. Earp (@briandavidearp)

* Note: this article was first published online at Quillette magazine. The official version is forthcoming in the HealthWatch Newsletter; see http://www.healthwatch-uk.org/.

Introduction

Science and medicine have done a lot for the world. Diseases have been eradicated, rockets have been sent to the moon, and convincing, causal explanations have been given for a whole range of formerly inscrutable phenomena. Notwithstanding recent concerns about sloppy research, small sample sizes, and challenges in replicating major findings—concerns I share and which I have written about at length — I still believe that the scientific method is the best available tool for getting at empirical truth. Or to put it a slightly different way (if I may paraphrase Winston Churchill’s famous remark about democracy): it is perhaps the worst tool, except for all the rest.

Scientists are people too

In other words, science is flawed. And scientists are people too. While it is true that most scientists — at least the ones I know and work with — are hell-bent on getting things right, they are not therefore immune from human foibles. If they want to keep their jobs, at least, they must contend with a perverse “publish or perish” incentive structure that tends to reward flashy findings and high-volume “productivity” over painstaking, reliable research. On top of that, they have reputations to defend, egos to protect, and grants to pursue. They get tired. They get overwhelmed. They don’t always check their references, or even read what they cite. They have cognitive and emotional limitations, not to mention biases, like everyone else.

At the same time, as the psychologist Gary Marcus has recently put it, “it is facile to dismiss science itself. The most careful scientists, and the best science journalists, realize that all science is provisional. There will always be things that we haven’t figured out yet, and even some that we get wrong.” But science is not just about conclusions, he argues, which are occasionally (or even frequently) incorrect. Instead, “It’s about a methodology for investigation, which includes, at its core, a relentless drive towards questioning that which came before.” You can both “love science,” he concludes, “and question it.”

I agree with Marcus. In fact, I agree with him so much that I would like to go a step further: if you love science, you had better question it, and question it well, so it can live up to its potential.

And it is with that in mind that I bring up the subject of bullshit.

more…

The Legal and Moral Significance of Implantation

23 Jun, 15 | by BMJ

Guest post by Sally Sheldon

We tend to talk about contraception and abortion as if they were two separate and readily distinguishable practices, the former preventing pregnancy and the latter ending it. This understanding has a very important effect in current British law, where a relatively permissive approach to the availability of contraception stands in stark contrast to the morally grounded, onerous criminal sanctions against abortion. Yet is the distinction between abortion and contraception really so clear cut?  How and why do we make it? And is the line that we have drawn between the two morally defensible?

As a matter of biological fact, the development of human life is not characterised by bright lines. As the eminent lawyer Glanville Williams once put it, “abstract human life does not ‘begin’; it just keeps going.” A seamless biological continuum exists through the production of sperm and egg, their joining together in a process of fertilisation, the gradual development of the new entity thus created throughout pregnancy, birth, subsequent growth, eventual death and ensuing decay of the body. Defining what happens along the way as an ‘embryo’, ‘fetus’, ‘person’, ‘adult’, or ‘corpse’ requires an attempt to draw lines on the basis of criteria selected as holding significance for legal or other purposes. How and where we draw such lines is a tricky business, involving careful moral reflection informed by medical fact.

The “regulatory cliff edge” between the relatively permissive regulation of contraception and the criminal prohibition of abortion relies on a line drawn on the basis of the biological event of implantation, where the fertilised egg physically attaches itself to the wall of the womb some six to twelve days after ovulation. Yet while enormous legal weight has been placed upon it, little consideration seems to have been given as to why implantation matters morally. The voluminous philosophical literature on the ethical status of the human embryo and foetus offers little support for the view that implantation is an important marker.

Further, while it might once have been suggested that implantation offers a conveniently timed moment for a necessary gear change between the appropriate regulation of contraception and abortion, this argument is difficult to sustain in the light of modern medical science. more…

What should Investigators be Doing with Unexpected Findings in Brain Imaging Research?

22 Jun, 15 | by BMJ

Guest Post by Caitlin Cole

Incidental findings in brain imaging research are common. Investigators can discover these unexpected findings of potential medical significance in up to 70% of their research scans. However, there are no standards to guide investigators as to whether they should actively search for these findings or which, if any, they should return to research participants.

This complex ethical issue impacts many groups in brain imaging: participants and parents of child participants who may desire relevant health information, but alternatively may suffer from anxiety and financial burden; investigators who must ethically grant their participants autonomy, but who also may suffer from budget and personnel restrictions to manage the review and report of these findings; Institutional Review Board (IRB) members who must provide ethical oversight to imaging research and help mandate institutional standards; and health providers who must interface with their patients and assist with follow up care when necessary.

Our research study shows these groups share some ideas on the ethics of returning incidental findings – the researcher has an ethical responsibility or obligation to tell a subject that there’s something there, however they do it, but just inform the subject, even though it’s not part of the research” – yet also acknowledge the inherent risk in reporting medical research information. As one of our IRB members commented, I mean [in regards to withholding findings] one reason would be to protect the patient from doing something stupid about them.

When participants are asked about incidental findings, they consistently state that they want to receive all information pertinent to their health. Research participants want to make their own medical decisions and feel investigators have a responsibility to keep them informed.

However, it is clear from our research that participants do not always understand the difference between a brain scan for research purposes and a clinical scan. The incidental finding reports that they receive include personal health information, written in medical jargon, discovered during a clinical procedure that may have immediate or long term medical significance. Because of this crossover between conducting research and sharing health information, participants may overestimate the clinical utility of the reported research information. This is a challenge for investigators whose role is to conduct research, not to diagnose participants or offer findings with clinical certainty. Participant assumptions otherwise have the potential to cause downstream legal complications for the research institution.

It is necessary to understand the impact on all parties involved in the process of disclosing incidental findings to determine appropriate management policy. This challenging task should not be underestimated as these groups think differently about the balance between risk and benefit based on their role in this process, whether they be a research participant, a research investigator, an IRB member or a health provider. Overall there is an ethical demand to manage and report unexpected findings discovered in brain imaging research; finding a way to do this while minimizing negative impact for all involved is important.

Read the full paper here.

Is Age a Determinant Variable in Forgoing Treatment Decisions at the End of Life?

14 May, 15 | by BMJ

Guest post by Sandra Martins Pereira, Roeline Pasman and Bregje Onwuteaka-Philipsen

Decisions to forgo treatment are embedded in clinical, socio-cultural, philosophical, religious, legal and ethical contexts and beliefs, and they cannot be considered as representing good or poor quality care. Particularly for older people, it is sometimes argued that treatment is aggressive, and that there may be a tendency to continue or start treatments in situations where a shift to a focus on quality of life in light of a limited life expectancy might be preferred. Others argue that an attitude of ageism might prevent older people from receiving treatments and care from which they could benefit, thus resulting in some type of harm and compromising the ethical principles of beneficence and non-maleficence.

When the need to make a decision about treatment concerns an older person at the end of life, physicians need to reflect on the following questions: In this situation, for this person, what is the best course of action? Is this person capable of assessing the situation and making a decision about it adequately herself? What are the preferences of the person? Who needs to be involved in the decision-making process? What will be the consequences of starting or withholding this treatment?

Our study shows that decisions to forgo treatment preceded death in a substantial proportion of older people in the Netherlands, and more often than in younger groups. Also, it shows that compared to the younger age groups, in the older age group differences were more significant when deciding on withholding than on withdrawing a treatment. This is interesting because it suggests that Dutch physicians, especially those caring for older people, assume a palliative culture and approach, thus meeting the relatively more frequent preference older people have of receiving comfort care and not aggressive treatments aiming to prolong life. Moreover, it seems that decisions to forgo treatments among the ‘oldest old’ (i.e., older people aged 80 and above), when compared to the youngest age group, were made more frequently due to a wish of the patient, indicating consideration and respect for the patient’s wishes.

However, with regard to patient participation in decision making, we also saw that most of the patients, regardless of their age, did not discuss the forgoing treatment decision with the attending physician. As our findings indicate, this occurred mostly because the patient was not able to assess the situation and make a decision about it in an adequate manner. This result highlights the need to further implement strategies aiming at implementing advance care planning in practice and in an earlier stage of the disease trajectory.

Finally, based on our study, we cannot assume that any age-related differences in forgoing treatment decisions occur due to an attitude of ageism. On the contrary, our study suggests that care for older people in the Netherlands seems to be focused on providing palliative care, also suggesting a better acceptance that these patients are nearing death. This is particularly relevant for the discussion about the meaning of dying well in older ages, having an impact on older people’s experiences and end-of-life care.

Read the full paper here.

Animal Liberation: Sacrificing the Good on the Altar of the Perfect?

24 Apr, 15 | by Iain Brassington

For my money, one of the best papers at the nonhuman animal ethics conference at Birmingham a couple of weeks ago was Steve Cooke’s.*  He was looking at the justifications for direct action in the name of disrupting research on animals, and presented the case – reasonably convincingly – that the main arguments against the permissibility of such direct action simply don’t work.  For him, there’s a decent analogy between rescuing animals from laboratories and rescuing drowning children from ponds: in both cases, if you can do so, you should, subject to the normal constraints about reasonable costs.  The question then becomes one of what is a reasonable cost.  He added to this that the mere illegality of such disruption mightn’t tip the balance away from action.  After all, if a law is unjust (he claims), it’s hard to see how that alone would make an all-else-being-equal permissible action impermissible.  What the law allows to be done to animals in labs is unjust, and so it doesn’t make much sense to say that breaking the law per se is wrong.

Now, I’m paraphrasing the argument, and ignoring a lot of background jurisprudential debate about obligations to follow the law.  (There are those who think that there’s a prima facie obligation to obey the law qua law; but I think that any reasonable version of that account will have a cutoff somewhere should the law be sufficiently unjust.)  But for my purposes, I don’t think that that matters.

It’s also worth noting that, at least formally, Cooke’s argument might be able to accommodate at least some animal research.  If you can claim that a given piece of research is, all things considered, justifiable, then direct action to disrupt it might not have the same moral backing.  Cooke thinks that little, if any, animal research is justified – but, again, that’s another, higher-order, argument.

One consideration in that further argument may be whether you think that there’s a duty to carry out (at least certain kinds of) research. more…

Animals in US Laboratories: Who Counts, Who Matters?

21 Mar, 15 | by BMJ

Guest post by Alka Chandna

How many animals are experimented on in laboratories? It’s a simple question, the answer to which provides a basic parameter to help us wrap our heads around the increasingly controversial and ethically harrowing practice of locking animals in cages and conducting harmful procedures on them that are often scary, painful, and deadly. Yet ascertaining the answer in the United States – the world’s largest user of animals in experiments – is surprisingly difficult.

In the eyes of the US Animal Welfare Act (AWA) – the single federal law that governs the treatment of animals used in experimentation – not all animals are created equal. Mice, rats, and birds bred for experimentation, and all cold-blooded animals – estimated by industry to comprise more than 95 percent of all animals used – are all unscientifically and dumbfoundingly excluded from the AWA’s definition of “animal”. Orwell cheers from his grave while Darwin rolls in his.

Leaving aside the question of whether mice and rats should be categorized as vegetable or mineral, the exclusion of these animals from the AWA also results in a dearth of data on the most widely used species, as the only figures on animal use in US laboratories that are systematically collected, organized, and published by the government are on AWA-regulated species. more…

Growing a Kidney Inside a Pig Using your own DNA: The Ethics of ‘Chimera Organs’

6 Nov, 14 | by Iain Brassington

Guest post by David Shaw

Imagine that you’re in dire need of a new kidney. You’re near the top of the waiting list, but time is running out and you might not be lucky enough to receive a new organ from a deceased or living donor. But another option is now available: scientists could take some of your skin cells, and from them derive stem cells that can then be added to a pig embryo. Once that embryo is implanted and carried to term, the resulting pig will have a kidney that is a perfect genetic match to you, and the organ can be transplanted into your body within a few months without fear of immune rejection. Would you prefer to take the risk of waiting for an organ donated by a human, which would require you to take immunosuppressant drugs for the rest of your life? Or would you rather receive a “chimera organ”?

This scenario might seem far-fetched, but it is quite likely to be a clinical reality within a decade or so. Scientists have already used the same technique to grow rat organs inside mice, and it has also been shown to work in different types of pig. Although clinical trials in humans have not yet taken place, using these techniques to create human organs inside animals could solve the current organ scarcity problem by increasing supply of organs, saving thousands of lives each year in Europe alone. As illustrated in the example, organs created in this way could be tailored to the individual patient’s DNA, allowing transplantation without the risk of immune rejection. However, the prospect of growing organs of human origin within (non-human) animals raises several ethical issues, which we explore in our paper.

Although chimera organs are ‘personalised’ and unlikely to be rejected, one of the major concerns about using organs transplanted from animals is the risk of ‘zoonosis’ – the possibility that an animal virus might be transmitted along with the organ, resulting in a new disease that could cause a pandemic. more…

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