- Sheriff Muideen added an answer:27Is it necessary to have consent when conducting a retrospective study? If yes, from whom?From ethical point of view, Is it necessary to have consent when conducting a retrospective study?
For a retrospective study, i dont think there is need for further consent with secondary data aside the IRB and ethical committee approval. Nonetheless, i have heard of editors requesting for renew consent in field study where secondary data was employed. It was an study involving cancer patient. Thus, i think the type of research determine as well as the decision of the ethical committee.Following
- Alvaro Sanz Rubiales added an answer:3Non-treatment of skin cancer for severely mentally ill man with delusionsI am an emergency medical guardian/attorney.
The challenge is the tendency to try to "cure death" among some medical professionals. The resultant pain to the patient and their reaction to it, i.e. pulling out a breathing tube, should be taken into account in the treatment plan. Thoughts?
I do not understand.
What do you mean when you say "skin cancer": melanoma, squamous, basaloid, Merkel, advanced, relapsed...?
And, what is the problem? To be severely mentally ill, the delusion...?
And what will be not treated: the tumour, the mental problem?Following
- Paul H Mason added an answer:5What ethical dimensions should be considered in isolating an immigrant with multidrug resistant tuberculosis?
Submit a response (500-800 words) to the Journal of Bioethical Inquiry (JBI) for inclusion in the 13(1) issue to be published in March 2016:
Thank you for these wonderful responses. Just to let you know, that the Journal of Bioethical Inquiry is accepting responses of 500-800 words for possible inclusion in a special issue on TB and ethics next year. If you would like to write a response to this case study, you might like to copy and paste this link for further information on how to submit:
Responses need to be received by mid November to fit with the peer-review and publication schedule.Following
- Jakub Zawiła-Niedźwiecki added an answer:3Is there a medical ethics infraction (Helsinki) imposing mixed strains of medical cannabis on patients ?
The Israel Medical Cannabis Authority plans to create mixed material sorted by chemical composition (CBD and THC) and impose this material on patients in place of the natural strains. Since this move is based upon a. very incomplete knowledge of the entire chemical composition of the natural strains and b. based on an untested hypothesis that only the measurable THC and CBD are relevant and c. based on considerations external to the welfare of the patients who are satisfied with the natural strains and used to them and d. therefore this constitutes a breach in continuity of care, I believe that imposing such untested matreial on patients constitues human experimentation without consent. Anyone out there with an opinion or literature to cite?
You would need to specify more on the proposed legislation to say for sure, but medical marihuana is doubtful in itself in clinical setting, as there is very little evidence of efficacy for any condition. I presume the move is an attempt at shifting the public from herbalist formulation to something of pharmaceutical quality. The only thing I can say here is that any intervention should be judged on available evidence of safety and efficacy. So far cannabis-derived products are mostly based on pre-scientific faith in "the natural" remedies. I don't think this is acceptable as it is not acceptable with other medical interventions. As commenters above said if we are talking of research protocol it needs to be judged on it's merits.Following
- Ron Iphofen added an answer:16Should bioethicists 'get out of the way'?
Steven Pinker recently wrote an op-ed arguing bioethicists should 'get out of the way' of biomedical progress. (https://www.bostonglobe.com/opinion/2015/07/31/the-moral-imperative-for-bioethics/JmEkoyzlTAu9oQV76JrK9N/story.html) He seems to be worried that the research ethics pendulum has swung too far in the 'protectionism' direction, delaying the development of numerous life-saving and life-improving interventions. But is he right? Pinker is light on the details, but are there topics or subfields where his criticisms are particularly apt?
There is really only one good thing to say about this piece by Pinker - it generates debate about ethics! Otherwise he has certainly lowered the esteem I held for him by such spurious correlations, emotional dredging, idealistic forecasting, over-extended trends, and straw man arguments. Of course consideration must be given to the ethical risks associated with biomedical developments. The real issue is how to do that - and do it well. It must be transparent, based on agreed sound ethical principles, facilitative and supportive of robust research. Necessarily forcing people to 'stop and think' is sound ethical practice - to think about the impact both of research findings and research practice is the sign of high quality research practice. Sadly that might impose some minor delays on research progress, but it is in the longer term interests of us all. The variations in experience of more formal ethical review is very much dependent on the location of the ethics committee. So one can understand the frustrations experienced in the US when IRBs are more concerned with corporate image and institutional protection. It is not the case elsewhere - in the European Commission, for example, ethics committees are composed of multidisciplinary experts who operate in an independent capacity to advise the Commission's research funding and protect the interests of those who might be harmed (humans and animals of course).Following
- G. Owen Schaefer added an answer:3Does anyone have some insight on the role Methodological Naturalism plays in relativizing biomedical ethics?
Eric Racine, a bioethicist, notes: “Naturalism is a controversial stance [in bioethics] because it is customary to view ethics and bioethics as normative and prescriptive fields and therefore different from empirical sciences, which are descriptive and explicative. The reluctance to acknowledge naturalistic commitments, however, can impede methodological and empirical progress in bioethics” (2008, 98). Addendum to that:
"His [Seedhouse’s] belief that no distinction can be drawn between the ethical and empirical aspect of medicine is both wrong and dangerous Whether or not there is a fundamental metaphysical distinction between facts and values, in clinical practice one can and must distinguish the two dimensions…Failure to do so results in muddled thinking. Hume´s naturalistic fallacy is rife in medicine…[he] encourages the powerful body of opinion, which believes that medical ethics is just a matter of opinion…"(Toon 1995, 47).
I know Strong Naturalism, or bioethics as developed by Potter in 1970 doesn't have a good way to counteract a highly relativized medical ethic. Pragmatic Naturalism offers a slightly better model for medical ethics. But also falls short as it will marginalize weaker societal voices. “Thus, as Bellantoni notes, religious experience must, for pragmatic bioethics be at least discounted, if not fully discredited (2003).” (Tollefsen, Cherry, 2003, 541). Then finally, “[I]n the absence of something authoritative to guide moral choices, the phenomenon of moral assertion and argument becomes rather ominous. If moral assertion and argument are understood as oriented towards some standard by which it is to be measured as successful or deviant, then participants in the practice of moral assertion and argument can understand themselves in a common undertaking, aimed at resolving itself into the correct, or right answer. Where there is no such standard, by contrast, assertion and argument become more and more the mere expression of will, and the attempt to manipulate others into accepting one’s own personal dictates.” (540).
If I understand the question - I would say, methodological naturalism (understood as exclusion of the supernatural from consideration) has done very little to relativize bioethics. One might think that, by abandoning talk of God in bioethical work, one cannot ground universal, objective moral claims. But secular ethics has developed a plethora of resources in an attempt do just that. Consider, for example, Rawlsian demands for publically-accessible reasons justifying (basic) laws, which exclude supernatural claims that some will reject. Rawlsians hardly end up being relativists at the normative level (whatever their metaethical commitments) - they ground universal moral claims using the entirely natural procedure of reflective equilibrium. And principalism, which for better or worse is dominant in practical bioethics, is also entirely naturalistic while eschewing relativism. Secular bioethics is very interested indeed in justifying objective moral claims without appeal to God.Following
- Nguyen Phuoc Long added an answer:11Any advice on an ethical issue for case reports?
As far as I'm concerned, case report doesn't require ethical approval and/or informed consent if researchers can protect the right to anonymity and confidentiality of the patient.
I searched and found that the authors usually don't need any informed consent or/and ethical approval for publishing their article(s) (or they didn't state that information?). Nevertheless, I also found some "outside" ones, they mentioned about informed consent in their article.
This is an example: http://www.jogc.com/abstracts/full/201309_CaseReport_2.pdf (The woman whose story is told in this case report has provided written consent for its publication.).
Do I miss something? Could you please give me a big picture about this?
One useful article to read:
- Julian Cockbain added an answer:7Are current bioethics a masquerade of religious movements?
Today is disturbing to note the increase in IRBs built mostly by non-scientists members and with an obscene tendency to base its decisions on religious concepts mainly in the Judeo-Christian tradition (there is a paucity in biology, physics, medicine, sociology, mathematics and philosophy experts) . The curriculum of education as bioethicists do not contemplate quantum physics, physiology or evolution, but creationism is on the table. Then, how these professionals can review and offer an opinion about issues that they don’t really know? and more importantly, their "philosophical" considerations are so innocuous that cannot being published in a serious Journal of Philosophy. We must demand reforms to incorporate real science in the curriculum of training in bioethics. Finally, the religious vision must be out of debate or incorporate all mystic versions of life in equal proportions.
religious views have a valid claim to be put forth in IRB discussions, as do those of other lay people. such views do not however automatically have to be followed - it is the function of the IRB to weigh the arguments put forth and to come to a conclusion which is rationally supportable. Occasionally, that will be a view proposed by the religious. Consider the action by the Vatican this week in arguing that action to combat climate change is required. In this regard, required by God, I do not accept, but required for humanity I do, in either case it is still required.
Alternatively put, it may be a brilliant scientific experiment to create a black hole in your laboratory, but the rest of us should be able to stop you from doing so.Following
- prof V.S Muralidharan added an answer:50How to measure authorship?How select order of authors in case where one person designs experiment (aim, goals, materials and methods), order chemicals/kits, select statistical tests to perform and prepare manuscript while the other run assays and statistical analysis. Is there a quantitative method/model to show what is the value of selecting kit versus running experiment with this kit?
it is a sensitive issue .Following
- Maria Susana Ciruzzi added an answer:4Can Physicians practice common crime, when they do not obey Lex Artis procedure and Ethics, or is this only malpractice ?
Physicians most of the time take risk and plead innocence when something goes wrong during a medical act, in criminal discipline they say they have a "dolus bonus", is that truth ? Never a physicians will practice a crime during a procedure. How we can explain the great amount of deaths by iatrogenic diseases and medical errors ?
I think that Law is never going to get at the same pace as Medicine.......and that's a good thing, in my own point of view. I always tell my students that Medicine is like a Ferrari, and Law is a bike........The duty of law is to provide a common ground that assures the most important principles that a society thinks are so relevant that MUST be protected by law (eg: human rights). But Law -understood as formal law, the one approved by Congress- is not called to regulate medical knowlodge and scientific development, these issues should be regulated by protocols and ethical norms, "material laws". Law has to go along the path with Medicine, guaranteeing the conditions for doctors to exercise Medicine and to gain scientific knowledge, stand by its side, but never impose what Medicine is called to decide in science, applying scientific principles.Following
- Alok Arya added an answer:14When is an ethical clarification needed in research experiments?
I've submitted a research article that deals with new biomarkers, and is based on samples received from cancer patients. The patients didn't give the blood for this project, however they consented to use the samples for research purposes. The journal asked me an ethical clarification, because I'm working with human material. Can anyone help me with this? If there is any document for exception of ethical clarifications please send it to me.
I am sure you must have been able to resolve the situation.
For future, it is always advisable to submit your research proposal (involving human subjects/specimens) to your IRB/IEC and seek their opinion in written document. The IRB/IEC must have mentioned in their SOPs about their review procedures.
All the best.Following
- Brendan P Minogue added an answer:3How do we best address the moral issues about medical rationing?Given the various kinds of health care problems we face as a result of an aging and growing population, is it possible to address medical rationing concerns without, at some point, necessarily reducing such considerations to economic (i.e. basic supply and demand) questions? That is, given the reality that we live on a finite planet with finite resources, must basic economic considerations always be present when we make decisions that directly affect human life and human well-being within the context of our health care systems?
John Rawls' Theory of Justice is a masterpiece of liberal theory regarding distribution and there are literally hundreds of articles about his theory. Start there! Relative to bioethics Beauchamp and Childdress' Bioethics is a great text for getting you up to speed on this big issue. A more conservative approach can be found in Englehardt's Foundations of Bioethics. These three will give you a great sense of how large the problem is .
Most hospital emergency rooms deal with this on a triage basis and tend toward taking care of seriously ill patients on a "first come first served basis" This is basically a lottery approach to distribution but looks really bad if you do not adequately fund the ER or if your patient population is so large and so ill that the concept of "minimally decent" becomes totally unworkable.
Try to narrow your focus to a question like "how do you define minimally decent funding for an ER" in a poor part of a city. You will find that defining "minimally decent" is brutally difficult.
Try taking a look at a technological approach to distribution. In this arena you eliminate the human providers and replace them with data gatherers connected to IBM's Watson. Watson can diagnose better than most docs and he can monitor ongoing care better than most nurses and he can manage millions of patients at one time. It feels a little inhumane but inhumane care is better than no care and subsequent death. This might meet our budget requirements.
- Julian Cockbain added an answer:3How simple or complex is it to remove introns to create cDNA?After reading the Supreme Court's decision on the Myriad case, I am wondering how easily cDNA can be made patentable.
OK, the Supreme Court said native DNA was unpatentable under 35 USC 101, but that cDNA was. Simple as that. Except that Prometheus v Mayo hinted that subject matter that was obvious over the unpatentable product of nature might also be unpatentable, e.g. cDNA. The story is not yet closed. The attorneys for AMP missed the boat.Following
- Singh Shivakumar added an answer:33Does signing a consent form in clinical trials guarantee achievement of research ethics?In other words, are clinical trials ethical? Bio-availability studies depend on humans, and some people agree to participate in such studies for money. How ethical is it to conduct such studies?
I would like to know whether there are studies on subjects as to why they participate in research projects & the reason for signing the informed consent . It is essential for subjects to participate in research projects for development of science & IC is given after detailed discussion with them . It is probable that this can be misused . What is the alternative if IC is unethical . It is the job of the independent ethical committee to protect them , by strictly monitoring the adverse events of the study . Informed consent & ethics committee are the two pillars of research ethics & I consider the latter to be more important .Following
- Risa Mandell added an answer:3Experimental animal models in scientific research: ethical problems and predictability?Are animal models still needed in biomedical research to understand normal and abnormal function, from gene to phenotype, and to provide a basis for preventive or therapeutic intervention in human diseases?
http://www.ncbi.nlm.nih.gov/pubmed/19519367Please view the website, pcrm.org for their section on replacing animals in research, http://www.pcrm.org/research/.Following
- M. Chaitanya Varma added an answer:6What are the unique features of nanomedicine compared to other nanotechnology-based application?Nanomedicine is one of the many applications of nanotechnology for monitoring or treating physiological conditions using nano-scale designed devices, particles, materials, drug delivery systems etc. Since nanomedicine implies dealing with how these tools and devices interact with complex biological systems, one could anticipate there are many issues to consider during their design, manufacturing, and delivery.
I would like to hear your opinion about this and have some input on why nanomedicine can be considered unique.magnetic nanoparticles like iron oxide are best suited for targeted drug delivery since they can be monitored and can be controlled with the help of MRI or by applying magnetic field. when the iron oxide particle reaches the targeted site, by applying ac magnetic field the drug can be released.
for enhancing the contrast at tumor or some other region, one can use semiconducting nanoparticles (quantum dots) and get more details.
like wise there are so many applications and these will increase once scientists understand about how to fully control the properties of the materials at nanoscaleFollowing
- Filippo Salustri added an answer:12Scientific experiments: solving peripheral mysteries or a search for dogmatic validation of the scientist’s beliefs?Scientists are responsible for solving and understanding physical mysteries.
The scientific method outlines the steps in scientific inquiry where the meeting of reality and scientific vision occur at the level of the experiment. The solving of physical puzzles requires experiments for obtaining proof from the physical world and as validation of the scientist’s hypothesis. Results from scientific experiments orient scientific understanding into the direction of current dogmas or novel perceptions. This brings up interesting questions:
Are most scientists really interested in searching for the truth when conducting experiments or validating what they believe to be true? How does the competitiveness of science interfere with this process?
What does a scientist do when an experiment confers results that differ from the dogma they have been taught or are trying to establish?Following
- Francesca Cansani added an answer:19Is there really a 'Wisdom of Repugnance?'In 1997, former chairman of the President's council on bioethics, advanced the idea that “in crucial cases…repugnance is the emotional expression of deep wisdom, beyond reason’s power to fully articulate…” (The New Republic).
I suspect that few ethicists working today take this position at face value. Still, there do appear to be tangible concepts that are commonly defended on the basis of intuition alone - human dignity is one such example.
Do those who would reject any role for emotion and intuition in moral judgment throw the metaphorical baby out with the repugnant bathwater (cf. Jones, The depths of disgust, Nature, 2007)?Following
- Dick Sobsey added an answer:5Where can we set the ethical limits for genetic manipulation of human embryos?There is ethical dilemma toward genetic manipulation of human embryo for correction of genetic disorder and replacement of unwanted gene and defects. When and where can we set-off the limits?X-linked disorders make a strong case for replacing one or a small group of genes. In some cases a single-gene defect means passing on a problem to 50% of offspring, with females having a 50-50 chance of being carriers and males having a 50-50 chance of having a devastating disability. Without this technology women carried these disorders must roll the dice for their future babies, simply forgo having children, or risk repeated pregnancies that end in abortion if the defect is found. So in these cases, it is difficult to argue that replacing a single defective gene would be unethical. The problem is that if this technology is allowed, it might be used for a much broader group of less compelling cases. However, most technologies can be used for unethical purposes and it is difficult to deny legitimate uses simply because there is a potential for misuse.Following
- Ziad O. Abu-Faraj added an answer:3What do you think the benefits or drawbacks of integrated circuits in babies are?http://bit.ly/1fn0LYj
Doctors predict that in 5-10 years, babies will be tattooed with integrated circuits that push medical data to the cloud.There is no doubt Chandra that progressive thought and act should prevail, but the ethical challenges are getting more and more difficult and the research community should be ready for it.Following
- Ivo Van Hilvoorde added an answer:3Is there any way of analysing class room discussion on bioethical issues? Is there any research technique such as 'ethical discourse analysis'?These bioethical issues raise diverse opinions as well as arguments that need to be analysed from an ethical perspective so that right kind of decision making ensues.And these as well
- Marco Huesch added an answer:1Cost and availability of cytostatic drugs?In Indonesia some generic drugs on the essential drugs list of both WHO and Indonesia should be available, but in practice they are not and have to be procured by unusual routes. Does anybody have any experience with similar situations in other countries?
The last few years, 6-mercaptopurine as well as Methotrexate were sometimes unavailable, causing interruption of maintenance treatment for children with leukemia. It has been proven that such interruptions cause increased relapse rates. What can and should we do about this situation?My personal view is that stockouts of generic drugs are unfortunately to be expected, and happen in the US (http://www.nytimes.com/2012/02/11/health/policy/supply-of-methotrexate-a-cancer-drug-may-run-out-soon.html?_r=2&) as well as Indonesia.
Original manufacturer firm exit upon brand expiration and generic firm entry can reduce supply capacity, low profit margins in the eventual generic production & distribution business are insufficient to sustain adequately stocked supply chains and inventories (and sometimes inadequate to sustain good manufacturing practices), and longer supply chains are also common.
This is, as always, reducible to a trade-off between greater investment pre-expiry versus less post-expiry, between more expensive, more restricted but more reliable access before versus after expiry, and ultimately between welfare gains among the current generation of patients benefiting from generics versus welfare losses among future generations from lower innovation in the present.
Practical solutions for Indonesia might be to think about some investments by Indonesia in home-grown generic manufacturing, a regional cooperative to share capacity and overcome local stockouts, having the government look at purchasing excess EU stock (or US http://www.goodrx.com/methotrexate) perhaps under foreign aid programs, or using charitable foundations to fund this very worthwhile and affordable investment in a sick child's future...Following
- Dhastagir Sheriff added an answer:6Does a sperm donor have a moral duty to pay for the subsistence of the resulting children by virtue of being their "biological father"?The British newspaper "The Guardian" reported a couple of weeks ago (27 October 2012) that a gay man who several years ago had donated his sperm to a lesbian couple was now held accountable and told to pay up for the two children that he helped to be conceived. Apparently, if he did the same today, he would not be liable. What happened is that the lesbian couple separated. The children now live with one of them, presumably the biological mother, and the other visits them from time to time, but does not support them financially. In that situation, the mother sued the sperm donor, and he was sentenced to pay. Now, the question is of course whether that is morally justied. Never mind what the law says, can we really believe that he is morally responsible for the children, in the sense that he has a moral duty to contribute to their subsistence?
At first glance, this seems to be case of gross ingratitude. The donor was friends with the two women. They wanted to have children and asked the man for help. That's what he did. He did them a favour. As a friend. It was never intended that he have any part in bringing up the children or contributing financially. The only thing that was expected of him, as a gift to his friends, was to hand over some of his sperm.
However, not everyone sees it this way, as the letters of Guardian readers prove that were published a week after the original article. One reader wrote: "They are his biological children. He helped bring them into the world. He has a duty to cover their costs. He should have been less cavalier with his sperm." Another commented: "This isn't a question of gay rights, it's a question of responsibility for another human being / is a donor really any different to a man who has a one-night stand, which ends in pregnancy (wanted or not)? To reduce the conception of a child to 'doing someone a favour' is an appallingly cavalier attitude. Of course he should pay for the upkeep of his children. If he wasn't prepared to, he should have done us all a favour and kept his sperm to himself." Not much sympathy here.
So the question is whether biological fatherhood really is morally so important that it makes the biological father responsible for any children that may result from the use of his sperm, independent of the circumstances. In this particular case, of course, the donor was aware that his sperm was to be used to conceive a child, but he also had an agreement with the mother that he would have no further obligations, that his only contribution would be the donation of his sperm. Does this agreement count for nothing because biological fatherhood overrides all other considerations? But why should biology be seen as having such paramount importance? Underlying the comments by those Guardian readers also seems to be the intuition that sperm is not the kind of thing that we should be allowed to sell or give away. It is not a commodity. But again, why exactly is it not? Is it because, as Monty Python put it, "every sperm is sacred"?Following
- Bill Johnson added an answer:3Is there any ethical algorithm for abortion?In your country or globally?I must confess my ignorance here. I am not at all aware of how it would be possible to have an "ethical algorithm". Are you using the process aspect of algorithms (which is similar to that of a flow chart) to speak by way of analogy here? Are you seeking an ethical flow of reasoning, comparable to the flow of an algorithm, by which to determine whether or not an abortion is or isn't ethical?Following
- Closed account added an answer:1It is possible to consider the "after birth abortion" as A. Giubilini and F. Minerva wrote about two months ago? What kind of bioethics is that?In the attached file I send my opinion on abortion in general. If you want to discuss I can replayThere is not much, we two could discuss. As you wrote, the attached file bears your opinion. What is there to discuss? My opinion - an absolute respect of human life- is different from yours, and neither of us will give up or change our opinions, since we have made them after long searching of what we find is truth.Following
- Ulf-Dietrich Reips added an answer:2The Association of Internet Research just published a new ethics guidelines document. What is missing, what is questionable?The doc is at http://aoir.org/documents/ethics-guide/. The guideline seems to draw mostly on US-based literature and approaches and practices common within Northern America and thus may need an extension. Please also write whether you believe the document will hold for needs and practices in your field, especially if you work outside communication.Marcin, can you give an example where European ethics guidelines have a different perspective?Following
- Adrianne John R Galang added an answer:7Modafinil research with healthy volunteers?I would like to do some research with a design similar to this: http://www.ncbi.nlm.nih.gov/pubmed/22820554
What would be the best strategy of pursuing this in a sound, bio-ethical manner in a developing country like the Philippines? I am aware I would need to collaborate with a psychiatrist, but beyond that are there other hurdles that I might need to consider? Would the cost be prohibitive for a modest research budget?Thanks for all the valuable procedural and methodological advice. To give you some context regarding my question, my research on creativity is actually pointing me towards the hypothesis that there might be a functional trade-off to the cognitive enhancements delivered by drugs like Modafinil. Please see my attached mini-proposal for just a bit more background.Following
- Pablo Arango R. added an answer:7What kind of bioethics is more appropriate in developing countries?What kind of Bioethics is more appropriate for resolving moral conflicts related to public health in Latin America and other developing countries? Bioethics of protection or intervention?Regarding the question of what is the difference between bioethics of developed and developing countries I think that bioethics is only one, change the problems that are studied. Bioethics should have some basic principles such as respect for life, respect for human dignity, solidarity, respect for the body, beneficence, autonomy, along with other principles such as responsibility. What changes? That in a developed country do not steal kidneys, if they do in poor countries. That human subjects research is do with extreme caution in developed countries and in poor countries are use people as "guinea pigs". In all places bioethics can provide guidance on how is the best to act according with the principles.
Pablo Arango MD, PhDFollowing
- Marin Gillis added an answer:1Sponsoring distance learning education.Is anyone aware of any organizations that one may apply to for help sponsoring distance learning education in bioethics?Creighton UniversityFollowing
A branch of applied ethics that studies the value implications of practices and developments in life sciences, medicine, and health care.