Questions related to Biomedical Ethics
The International Committee of Medical Journal Editors (ICMJE) criteria does provide clarity on who qualifies to be an author but I have not been able to find any guidelines about the last author.
1. What is the main senior supervisor's correct position (order of authorship)?
2. Is the second position more valuable than the last one?
3. Do the first and last authors have the same value?
4. In case an author does qualify the ICJME criteria but contributes the least, would it be ideal to place the author last or as the penultimate author to the main senior author?
5. What value does being a corresponding author hold? Since its often used as an important criterion for promotions.
Does Big Pharma play too big a role in directing and funding Global reasearch?
Should academics be banned from ANY interaction with Big Pharma?
A need to check different aspects of Teledentistry in COVID-19 situation.
A need to discuss on the topic.
Reply or feedback on various content of the topic is welcomed.
I have never read a systematic review or meta-analysis where a study was excluded due to not being pre-registered as is required by the Declaration of Helsinki. Is this a matter of "the ends do not justify the means" or is it not one to be concerned about?
Measles has been globally well-contained for decades, thanks to the widespread MMR vaccine, which protects children against measles, mumps, and rubella.
However, in recent years, an alarmingly increasing number of parents have decided against vaccinating their children as anti-vaccination "literature" or "culture" has proliferated online, claiming the vaccinations could create worse health issues.
With decreased vaccination coverage, those infections are coming back among children and societies, such as the recent measles outbreak in New York.
What can we do to help prevent such issues in the future?
There are many predatory journals online available and also growing day by day. How to detect that the journal is predatory, As I found there is site where there is list of predatory journals but how we will come to know these sites information is correct or not?
Any other way to find out?
As there is continuous threat that somebody may waste their data in publishing in these journals.
My questions are divided into two different parts:
1) There are a lot of mosquito control products int he market. I am currently working with one company dedicated to mosquito control, as everyone discusses the new sciences eg. genetic engineering or new larvicide or adulticide but I am interested in knowing the real business after the first testing is done.Kindly suggest some papers.
2) I have been thrown into a question that what if I have been given 10 Million dollars and preliminary results from a potentially applicable model for mosquito control, so how I am going to use those 10 Million dollars, should I get convinced by the preliminary results and go for further testing or should straight away not get convinced by the results and go with other projects.
If this is an issue of microorganism contamination, is it too inefficient to disinfect serum from adult sacrificed animals? Or does adult bovine serum just not work in cell culture? I am asking because I recently read that fetal blood drawal is quite cruel and ethically debated.
How should be young practitioner guided towards the ethical issue in this regard? What are the difficulties during making a clinical decision and judgment?
Can you also describe other documents needed like informed consent forms, conflicts of interests, research protocols, etc? Samples will be appreciated as well as any guidelines with examples (because those we use in Ukraine might be different from those accepted in EU).
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).
In 12 years of experience with Parkinson's clients the neurological community has agreed with many of my CAM suggestions and even admitted not having thought of supplements recommended. Effectiveness-based results seem to get credibility.
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?
(ex. hospitals, non-hospital settings, homes, universities, etc.) What components and characteristics comprise these test beds? Are there different types of medical device test beds(ex. hardware, software, etc)? Where do these devices operate in the radio frequency? Is there a central repository of test results/data that the medical community and other stakeholders can access? What types of medical devices and innovations are being tested? How are tests and simulations being conducted in these settings? What testing standards, if any, are being applied for current wireless medical device test beds? Who are the primary users of wireless medical device test beds (researchers, doctors, innovators, entrepreneurs) and what knowledge can be gleaned from them?
I assume that we want to conduct a small observational-retrospective human genetic study and publish it to a journal. Example subject: detected Down syndrome rate in a city from 2001 to 2010. Our laboratory already has necessary data because we have done this test for ten years and data were save automatically by the data management system.
So do we need an ethical approval, why and how to get it?
If we need one, so how do the national health statistics office conduct their job in this case, for a nation?
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 recently was told that there may be new regulations and I was curious if there were and what people thought of them.
Although verbal consent is approved in some research (e.g., emergency medicine), it is often not allowed by institutional review boards for standard outpatient protocols. Are there circumstance under which verbal consent, for minimal risk research studies, be allowed?
Obviously a subject with a great deal of baggage attached to it, but try to forget that and focus purely from a scientific (genetic) point of view what defining features does it have?
My interest in this comes from the recent debate here in the UK about whether mitochondrial replacement therapy constitutes genetic modification. Opinion is divided but the Department of Health thinks it is not. They say that GM is "the germ-line modification of nuclear DNA (in the chromosomes)" - specifically excluding the mitochondrial genome.
See page 15 of this PDF file:
My own opinion is that this definition is not correct but, really, I am most interested to hear how other people (particularly the scientists on ResearchGate!) might define it.
Most of the big companies sponsor clinical trials for their product. But usually trials are directed and inclusion/exclusion criteria will look perfect when reality we can see different results.
Clearing ethical issues is one of the important steps in bio-medical research/clinical research. What are the issues to be concerned while writting or publishing a case report?
Entomological Studies involving mosquitoes or other arthropods of medical importance requires collection of mosquitoes (adults, larvae, pupa) from human habitation including house-holds, house campuses, agriculture/civil land properties belonging to humans as well as from government lands, forests etc. Is there any ethical issue involve that must be followed and how?
This is a weird question on a taboo topic.
I have been discussing some issues about data manipulation with colleagues. Some of them believe that considerable manipulation is done in statistical description of experimental data when unethical researchers want to "prove" their point with statistical analysis. This is made easier by the traditional practice of not publishing raw data behind statistical tests and data descriptions.
However asking to see the raw data is often prized as the ultimate test for veracity. My friends insist that there must be a simple tool, even in Excel, of generating random numbers that would be fit any given (plausible) description of mean +/- SD within an interval, which could be used to bypass such proof tests by giving a false superficial impression of data veracity. I particularly think that such a generated random numbers would not fit statistical tests perfectly, especially if the index values given were also manipulated. This comparison sounds like be an interesting way of using the same tool to double-check statistical data, and seems like it could be automated and even applied to random published literature as a (very controversial yet interesting) scan test.
This is an awkward idea that crossed my mind, and I got curious. I could not find any discussion on this and I find this relevant.
Maybe others here would know more about this?
Ethical codes are often treated with almost religious reverence but on examination translate to not much more than a rule book. Medical ethics have been with us since Imhotep devised some in around 2600BCE and for over four and a half thousand years have guided medical practice. Are they a higher form of philosophy or just a list of do's and don'ts?
More journals these days are requiring an ethics statement if a human was involved in an experiment. But are there some trivial no-risk classes of experiment for which no approval is universally accepted? Or must one really seek approval for every tiny thing?
For example if I write a paper that records and analyses pedestrian movement in streets is that ok without ethics approval? The data there can be de-identified motion vectors.
Now what about if I study the natural motions of individual people? Is that still ok if the data is de-identified?
Getting ethical approval is essential to conduct a study in any society. Thus establishing ethical committees or institutions are mandatory to approve proposals and to monitor the research activities in any societies. However, in some developing countries there are no such committees or institutions; in these cases is it possible to conduct studies without getting ethical approval?
Exparel is a medication used in surgery. It is the liposomal version of bupivacaine. The company did 3 "pivotal" trials for its approval (www.fda.gov). 2 of these were against placebo and 1 was against bupivacaine. Exparel did better than placebo, but not better than bupivacaine. The exparel versus bupivacaine study was never published. The 2 placebo trials are heavily marketed.
Exparel is $300 versus $2 for bupivacaine.
I have put together an article with above details as well as other information that shows similar outcomes with exparel and bupivacaine and just submitted to pharmacy journal. However, seems like I should do more.