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Medical Ethics and Law - Science topic

In this group, ethical and legal aspects of medical research and practice can be discussed.
Questions related to Medical Ethics and Law
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Greetings
The authorship criteria by ICMJE is clearly mentioned. My query is when a surgeon of lab physician is involved only as treating physician or surgeon doing the patient management as per the patient's requirement and within standard operating procedure of the institute; no active intervention or beyond the routinely required intervention is performed by them; or study methodology does not require any change in the routing care from the surgical of paraclinical laboratory department- is it mandatory to include a surgeon or lab physician as investigator? If not done- how does it breach ethical principles or authorship criteria? What does your (country) rule say?
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Dear Sir,
At first I am a retired surgeon. Then, to perioperative outcome a surgeon and lab are dealt, in therapy and research and both could be investigators.
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Is institutional ethical clearance required for questionnare based (knowledge, attitude and practices based) research projects in which patient is not involved and no treatment is needed.
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Consent, privacy, respect, confidentiality etc. will be found in any book of research methodology. Pl go through a book before performing any research.
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  • So many young researchers/scientists even after helping/commitment don’t want to add (≤9) or in rare cases, supervisors/mentors not allowed?
  • Still few researchers delete authors after revising/accepting the paper due to double-digit (>9) authors and vice versa?
  • Why do young researchers behave like this and prefer single-digit (≤ 9) author’s paper?
  • Your opinion matters and will be gratefully appreciated.
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Andrew Paul McKenzie Pegman is correct. I am not aware of addition or deletion of authors after acceptance of MS.
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Why or why not?
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Killing for mercy is difficult to differentiate from murder; for killing is synonymous with taking life or homicidal. The difference could be if there is an authentic intention to take the life of a fellow who suffers and for mercy it ends this suffering.
On the other hand, in murder, an intention to harm is inferred, to deliberately kill with a perverse intention; where whoever is killed is not suffering and could suffer at the time of the murder.
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I have secured several "informed consent" to terminate life-support after more than twenty years in medical practice, but the number of cases does not make the subsequent cases easier for me. I find every case ethically and legally taxing. One of the most common and challenging issue I have to face is an immediate family member asking me "[W]ho will switch off the device?" In our country, there is no law yet governing end-of-life decisions.
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Generally, turning off life support leads to death which most legal system consider a crime and unethical especially where there is no advance directive or it is done without the consent of the patient, same could be done safely with a court order though
as in the case of Nancy Cruzan and Quin Ann.
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when i search the governmental act/ regulation of Nepal about whole body donation i could not found anything. there is organ transplantation act (latest amendment in 2016 AD) but it does not include whole body donation which is one of the source of cadaver for learning purpose in medical colleges. if anybody had some information about it please contribute.
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In my book titled authors Jasenko Karamehic and associates "Transplants Kidney and Pancreas Clinical and immunological aspects of pharmacotherapy" issued 2,012 years:
 PRESENTATION OF EXISTING LEGISLATION FROM TRANSPLANTATION AUTHORITIES IN THE FEDERATION OF BOSNIA AND HERZEGOVINA
HAVE CHAPTER 13 RELATING TO YOUR QUESTION!
The book is supplied in electronic form in my bibliography on Reaserch Gate.
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In the on call duty, a patient presented to the ER. Retrospectively there was suspected major medical negligence and near miss, who is legally responsible; the attendant physician was a junior resident in hospital. The on call rota includes a resident + a specialist and a consultant. In the case of legal complaint who is responsible if the specialist and the consultant were not informed about the case and if they were informed and have not seen the patient.
second question; who should be responsible for admission of cases; junior resident, senior resident, specialist or consultant?
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Dr. Sersar,
The answer to your question is decided by the judicial system where the medical negligence exists.  You are in Saudi Arabia and I can't speak to the rules regarding medical jurisprudence in your country.   
In the USA there are 4 elements to malpractice.
Duty – A duty must have been owed to a patient by a healthcare practitioner charged with that patient’s care. The doctor-patient relationship is a common example of a situation where that duty would exist.
Breach of Duty –The healthcare practitioner who had the duty of care for that patient must have failed in his/her duty by not exercising the degree of care or medical skill that another healthcare professional in the same specialty would have used in an equal situation. (This is when an expert is often called in to testify as to what an appropriate standard of care would be.)
Damage – The patient must have suffered emotional or physical injury while in the care of the healthcare practitioner. The injury can be a new one, or an aggravation of an existing injury.
Cause – There must be solid proof that the breach of duty by the healthcare practitioner caused the patient’s injury.
A successful medical malpractice suit will have proven that all four of these factors exist. If the defendant or healthcare practitioner being sued can prove that one or more of the elements does not exist, then the plaintiff would not prevail.
Each individual involved in medical negligence can be found at fault. Not just the attending physician.   Negligence cases can target multiple individuals.
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People who are diagnosed with cancer often experience a wide range of problems, as well as a sense of urgency to get into treatment as soon as possible.
However, most health care providers expect a patient accept the care and treatment without telling anything about their experiences, credentials and etc..  . What is your opinion about rights of the people who are diagnosed with cancer?
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I am a chaplain trained at University of Arkansas for the Medical Sciences.  I was assigned the Cancer, Palliative Care, and Neurological Wards in a hospital setting.  The hospital provided compassionate care involving all persons significant to the patient and a multidisciplinary team with the chaplain as a primary contact person for coordinating and responding to the family.
The patient who is dealing with cancer has all of the rights of patients listed in the standard Patient Bill of Rights.  In post hospital care right to continued support if desired such as Cancer survivor support. Serious consideration must be given to the clients right to be involved in care decisions and right to determine course of treatment ie. whether to go the route of surgery, chemo, radiation, etc.  right to compassionate end of life care at home or in hospice. 
Also right to life or decision regarding end of life and involvement of spiritual assistance if desired.  Allowing clergy and other family support systems to be involved in care to the extent that the 
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I am finding it very difficult to access information on the academic program that is specific for Nurses who want to gain expertise and knowledge in medical law and ethics which then can be utilized within scope of Nursing Practice.
Any suggestions?
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You might like to have a look at an old chapter 'Doctors' handmaidens: the legal contribution' from January 1992 in book: Health, Health Regulation and the Law, Publisher: Dartmouth Publishing Co., Aldershot, Editors: McVeigh S & Wheeler S, pp.141-168. The text is here on ResearchGate. The legal details are outdated, but the issues seem current.
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I am presently reviewing "dying declaration" cases decided by the Supreme Court of the Philippines. As a rule of evidence courts have given so much premium on "dying declarations" of victims. I am focusing on cases were the victim made the declarations just minutes prior to his demise or out of hospital declarations. Simply put, those cases where in the victim have not yet receive any medical interventions and subsequently died. I believe, however, that at that point significant physiologic changes are already in play that significantly affects the cognitive functions of the brain, specifically "recall of antecedent facts". Stated otherwise, a victim in shock can suffer acute brain dysfunction that affects the veracity of his "dying declarations."
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The dying declaration exception to the rule against hearsay permits out of court statements by a person to prove the matter they asserted out of court. At its narrowest the witness must be dead, that is generally no longer the case. They must however been in imminent fear of death. Their testimony is allowed because it is presumed the fear of death will make them more honest, whether for religious or practical grounds, and also because the dead witness is as unavailable as it gets. scholar.google.com or ssrn.com are good starting points. i do not yet know how to research through academia.edu or researchgate. this is a well known topic. u.s. federal rules of evidence fre are online for free as a pdf just sarch.
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Or could someone kindly point me in the right direction with a link?
Would be greatly appreciated..
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The department of health should have the answer.
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Physicians so often are reminded to respect patient's rights. So often, that in fact some physicians are starting to feel that the public at large has unfairly painted physicians as "professionals without any rights." Of course, physicians have rights, too. I have encountered a lot of physicians who were candid enough to tell me that they don't know how to exercise or invoke those rights. Some also admitted that they don't even know that such rights existed as a matter of law.
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Dear Rodel,
You may find the attached useful:
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I am working with South Australian law but am interested in international law.  Who are the carers?.  What support do they receive?   Have used deontological and utilitarian ethics, where does ethic of care come in?  How can the needs of the patient be balanced with the needs of carers, families and communities?  Stereotyping of the patients and their needs is a  problem. 
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Depending on the quality of the care a person receives, he or she may transform from being 'involuntary' to being 'voluntary'. It doesn't always happen, but many times it does, so it is always worth trying to try one's best to do whatever evidence has shown to be most effective for the majority.
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From ancient times, surgeons have been viewed differently and have been held more accountable for their decisions. This trend is currently more prevalent; where, in the UK, the government has mandated individual surgeon data to be published online. Do you think it takes a different sort of personality to be a good surgeon? Do we and should we rely solely on more evidence-based science in our operative decisions or is individual observation, training and experience of equal importance? I believe the later to be true and this is what current literature reports. I am interested in the valued opinion of international peers. Thanks.
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A good surgeon is simply a good physician, like any good internist, cardiologist, nephrologist, psychiatrist and so on........The core character traits are the same regardless of the discipline one chooses to practice. Stating the obvious, each discipline will have their own respective manual skills demanded by their respective discipline. In my law practice surgeons or "cutting doctors" have the highest number of malpractice cases, which will beg the question "is it the different character traits" that brings about the increase number? To be candid about, as an internist I continue to be awed by  good surgeons.
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If anyone could refer any insightful articles on this topic it would be greatly appreciated!
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Hi - late answer, I know, but in case you are still interested in this issue, there was a recent case that might be of interest to you in the UK called F v F (MMR Vaccine).   I wrote on this and have uploaded a publication on it (also if you google it you'll find a link to the BBC coverage of the case and an overview of the general issues in law).
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Medical ethics are a concern especially for the poor in Indonesia
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To improve the access of medical facilities to lower sections of the society and cover a wide population mass, the Medical services through joint foreign participation would be beneficial, with ownership retained by Indonesian investors
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Ethical question
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This is just my opinion, but it may be wise to have a family member or other professional witness the conversation and testify as to the fairness and objectivity of the process.
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Please include experiences on how to obtain ethical approval and informed consent for research among sexual minorities (LGBTI) in a country where the practices are illegal. Thank you
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The key is to outreach the population. In Guatemala, we're building an experience to increase coverage in MSM. Is important to mention that in Guatemala isn't an unfreandly legal system for LGBTI, however stigma is a major concern in our context.
The close work with a community based organization, and promotion through social network as Facebook, Twitter; and "gay apps" such as Grindr and Manhunt; are an important strategy to contact MSM. 
Also, Mpowerment model 
Here are some publications that may help you:
Goldenberg T, McDougal JS, Sullivan SP, Stekler DJ, Stephenson R. Preferences for a Mobile HIV Prevention App for Men Who Have Sex With Men. JMIR mHealth uHealth [Internet].
Young SD, Szekeres G, Coates T. The Relationship between Online Social Networking and Sexual Risk Behaviors among Men Who Have Sex with Men (MSM). PLoS One. 2013;8(5):15–8.
Usher D, Frye V, Shinnick J, Greene E, Baez E, Benitez J, et al. Recruitment by a Geospatial Networking Application for Research and Practice: The New York City Experience. JAIDS J Acquir Immune Defic Syndr [Internet]. 2014;67(5).
Suthar AB, Ford N, Bachanas PJ, Wong VJ, Rajan JS, Saltzman AK, et al. Towards Universal Voluntary HIV Testing and Counselling: A Systematic Review and Meta-Analysis of Community-Based Approaches. PLoS Med. 2013;10(8).
Kegeles SM, Hays RB, Coates TJ. The Mpowerment project: A community-level HIV prevention intervention for young gay men. Am J Public Health. 1996;86(8 I):1129–36.
Kahn JG, Kegeles SM, Hays R, Beltzer N. Cost-Effectiveness of the Mpowerment Project, a Community-Level Intervention for Young Gay Men. JAIDS J Acquir Immune Defic Syndr [Internet]. 2001;27(5)
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I am planning to collect hair samples from patients for measurement of cortisol (up to a pencil thickness in diameter cut as close to the root as possible) but I am not sure how difficult it will be to get a young person to agree to this. Anyone who can comment on their experiences with hair sample collection will be much appreciated.
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Thanks Taciane, we have had positive experiences as well with our first few study recruits. Apologies I did not see your comment earlier. Kind regards, Mazen
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Ethics
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That is a good question. If participating is likely to result in (net) benefits for the subject (and the subject is indeed deemed incompetent) then a proxy decision maker (here: legal representative) might have reason to allow the subject to be enrolled in that research. If on the other hand the subject is not predicted to benefit from participating, then it is difficult to make sense of any reason to allow the subject to be enrolled (from the perspective of the proxy that is).
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Dear everybody, 
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?
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You should acquire informed consent by those involved in the study, even if you believe that the anonymity and confidentiality of the patients is being ensured. Research on anonymised data sets have shown that by combining the anonymised data with other open information sources, then deanonymisation is often possible. This risk may be especially large if you talk about a rare disease. It is therefore better to be on the safe side and acquire informed consent by the patients, which they most often will accept doing.
Here is one example of a paper on deanonymising anonymised users:
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A patient with asymptomatic chronic retention was tipped into needing self catheterisation after GA for epigastric hernia repair. No renal failure.
Patient considers his need for self catheterisation, which he finds intolerable, was entirely a result of the surgery which he would not have had, had he known the risk.  He does not accept that he had chronic retention and would have come to this management in good time, anyway.
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Urinary retention can raise the blood pressure and produce abdominal pain and patient distress. Certain drugs like clonidine for paravertebral block to reduce pain of mastectomy can cause urinary retention in 20 to 25% of patients. Surgery can take longer than expected and patients may seem to void post-op due to overflow incontinence. Recent recommendations about evaluating bladder distension should include bladder catheterization and/or bladder sonography.
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Currently, I have been given the duty to perform an in depth series of interviews/oral histories with an elderly patient with severe Alzheimer's.  The purpose of the interviews is to obtain historically significant details of a life/era which will shortly disappear from memory.  However, the subjects condition is so severe that they regularly forget what year it is, let alone that they have agreed to a series of interviews.  My question, can someone with severe Alzheimer's possess the capacity for 'informed consent'?  Any literature/thoughts on the matter are highly appreciated.
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Hi Nicholas,
Informed Consent is absolutely necessary in research involving humans unless the institutional review board finds allows the otherwise on basis of very careful decision. The only reason for not taking informed consent before an intervention or a research is an emergency. In case of patients with serious cognitive disabilities where they might not be able to give consent, a consent from the 'custodian' (a person or an institution) is necessary. Additionally, assent is necessary is children below 18 years who have developed acceptable cognitive abilities.
In your case, I find no reason why the patient may not be able to understand and give consent. Further, the patient has the freedom to opt out of the study whenever he feels like. The consent is never a 'binding agreement'. If your patient, therefore, feels that he does not want to continue, he is free to leave (regardless of his consent or dementia).
I am attaching links of some literature that will be useful to you.
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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 ?  
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Dear Andre: in Argentina, if yo probe that a medical act was performed by imprudence, negligence or without due expertise it can be considered  a criminal ofense, whether it only provokes physical or psychological damage (art. 94 Criminal Code)  whether it ends in patient's death. (art. 84 CP). From long ago we are discussing medical doctor's criminal responsability in those cases. Some of us believe that criminal process is usually used as a way to preconstitute probes (as it comes before civil suit) and as a way to pressure for an arrangement in civil suit (if you are found guilty in criminal process then you can´t argue civil responsability, you just argue money compensation)........this situation makes medical doctors feel really afraid of liability and fell in a bad medical practice which is called "defensive medicine"........medical doctors feel that nobody is going to sue them because they do things in the patient (studies and medical procedures, even though they may be not necessary) but somebody can sue them because of what they don't do.........Argentine society is a very controversial and one, and generally speaking, sues a lot.
Cheers. Susie.
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Medical Errors.
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Evidence of disobedience to Lex Artis rules, and the duty to take care over the medical procedures, shows up as the main cause of iatrogenic disease, and medical errors. Mainly regarding to the informed consent of the patient over the procedure recommended by physician. It´s obvious that a high quality medical act demand high quality means to provide medical services in the better patterns possible.  The great need for health care by patients, and the less numbers of physicians able to take specific action to engage treatment is one of the main causes of medical errors, also we fell that the inobservance of the recommended technical procedures on specific cases may increase the level of occurrences of medical errors and iatrogenic diseases. A good reference for this matter is the study publish by Dr. Barbara Starfield on Journal of American Medical Association about Iatrogenic Diseases.  It´s also important to take a look above physicians behavior on duty, that might be guide through ethics e technical references.  
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According to the Freedom of Information Act, American patients can access their health information upon their request. I wonder if there is a global consensus over this issue? Do other countries have a similar legislation?
In my country, doctors can refuse to show the patients their own information. They believe and say that the doctor and not the patient owns the patient's information. Is it legal? Is it ethical?
ps. By "owning the health information" I mean "the right to read, copy, or keep a copy of everything written in the patient's record".
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Increasingly, hospitals give patients electronic access to parts of the electronic medical record, i.e. the physician's conclusions at the end of a visit, new test results etc. In addition,  patients  can request access to all the evaluation and treatment information that pertains to them. They are also the ones that can pass this information on to others, something that the physician or the hospital cannot do (with some legally defined exceptions). All this is part of the notion that there is an ethical obligation to empower the patients and to respect their right to control what happens to them . Thus, the ethical issue may be one of patient empowerment rather than "ownership".
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I'm facing two different questions.
(1) Are plants produced by conventional breeders' breeding processes (i.e. cross, select, etc), patentable? This is now before the EBA at the European Patent Office (I believe G-1/98 is wrong), and 
(2) Does a method of diagnosis in medicine have to be of a disease condition, and does there have to be a cure available if suffering from the condition is diagnosed? (I believe G-1/04 is wrong). This is now the subject of an opposition.
On both, I have to put my case together in the next week or so. In neither case do I have a financial interest - I just want the law to get back on track.
Can anyone help? Is anyone willing to help? More particularly, are there any non-OB/GYN medics out there who would be willing to talk?
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The current legal status of these issues at the European Patent Office is as follows.
(1) Are plants produced by conventional breeders' breeding processes (i.e. cross, select, etc), patentable?
According to Art. 53(b) of the European Patent Convention, plant or animal varieties or essentially biological processes for the production of plants or animals are excluded from patentability. In the past, there has been questions on what exactly is means by "essentially biological processes". This resulted in two referrals to the Enlarged Board of Appeal of the European Patent Office (G 2/07 and G 1/08) which then made the following statements.
1. A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being "essentially biological" within the meaning of Art. 53(b) EPC.
2. Such a process does not escape the exclusion of Art. 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants.
3. If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under Art. 53(b) EPC.
4. In the context of examining whether such a process is excluded from patentability as being "essentially biological" within the meaning of Art. 53(b) EPC, it is not relevant whether a step of a technical nature is a new or known measure, whether it is trivial or a fundamental alteration of a known process, whether it does or could occur in nature or whether the essence of the invention lies in it.
Following this case law, one cannot patent plants that are produced by conventoinal breeders' breeding processes. However, one can protect such plants using the breeder's right.
Unfortunately, this is not the end of my answer, since meanwhile new questions have been referred to the Enlarged Board of Appeal in G 2/12 and G 2/13. These questions are the following.
G 2/12:
1. Can the exclusion of essentially biological processes for the production of plants in Art. 53(b) EPC have a negative effect on the allowability of a product claim directed to plants or plant material such as a fruit?
2. In particular, is a claim directed to plants or plant material other than a plant variety allowable even if the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application?
3. Is it of relevance in the context of questions 1 and 2 that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Art. 53(b) EPC?
G 2/13:
1. Can the exclusion of essentially biological processes for the production of plants in Art. 53(b) EPC have a negative effect on the allowability of a product claim directed to plants or plant material such as plant parts?
2. In particular:
(a) Is a product-by-process claim directed to plants or plant material other than a plant variety allowable if its process features define an essentially biological process for the production of plants?
(b) Is a claim directed to plants or plant material other than a plant variety allowable even if the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application?
3. Is it of relevance in the context of questions 1 and 2 that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Art. 53(b) EPC?
Hence, your question can currently not be answered completely. We will have to wait and see as to what the Enlarged Board of Appeal will decide in these matters.
(2) Does a method of diagnosis in medicine have to be of a disease condition, and does there have to be a cure available if suffering from the condition is diagnosed?
The answer to this question is simpler. For patentability, methods of diagnosis are similar regardless the technical field. Hence, it does not matter whether the method of diagnosis is in the medical field or not. Even if it is in the medical field, the diagnosis does not necessarily have to deal with a disease condition, as long as something is diagnosed. Also, a cure does not have to be available. For example, a method for diagnosing whether a certain individual suffers from ebola may be patentable, even though currently no cure exists.
There is case law on methods of diagnosis however, since Art. 53(c) EPC states that methods for treatment of the human body by surgery or therapy and diagnostic methods practised on the human body or animal body are excluded from patentability. With respect to diagnostic methods under Art. 53(c) EPC the Enlarged Board of Appeal listed the following requirements in G 1/04.
1. In order that the subject-matter of a claim relating to a diagnostic method practised on the human or animal body falls under the prohibition of Art. 52(4) EPC [now Art. 53(c)], the claim is to include the features relating to:
(i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise,
(ii) the preceding steps which are constitutive for making that diagnosis, and
(iii) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.
2. Whether or not a method is a diagnostic method within the meaning of Art. 52(4) EPC may neither depend on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medical or technical support staff, the patient himself or herself or an automated system. Moreover, no distinction is to be made in this context between essential method steps having diagnostic character and non-essential method steps lacking it.
3. In a diagnostic method under Art. 52(4) EPC, the method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis for curative purposes stricto sensu must satisfy the criterion "practised on the human or animal body".
4. Art. 52(4) EPC does not require a specific type and intensity of interaction with the human or animal body; a preceding step of a technical nature thus satisfies the criterion "practised on the human or animal body" if its performance implies any interaction with the human or animal body, necessitating the presence of the latter.
I hope this information is helpful to you.
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Ethics is an important element in the field of medicine, and it is astonishing to note that is a constant decline over the period of years, it is a must to address this issue to preserve the field from further deterioration. 
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There is definitely a decline in ethics in the field of Medicine and in the society as a whole. We read the chapter on ethics and its almost restricted only to the books. The factors would be the greed to become rich. money always becomes a priority nowadays than moral values. Being ethical, following strict moral values doesn't make you rich and sometimes doesn't allow you to progress in the profession too. So, its like you are forced to be become unethical in the present generation which is so competitive. There can be times where you are forced to be unethical since the top management is.
However, those who don't follow ethics maybe rich and be successful but the conscience will haunt them forever. “There are two types of people in this world, good and bad. The good sleep better, but the bad seem to enjoy the waking hours much more.” ― Woody Allen. Ultimately peace of mind is very important for a person than loads of money. “There may be times when we are powerless to prevent injustice, but there must never be a time when we fail to protest.”
― Elie Wiesel
I hope we all start to think from our heart than from our brain and be ethical and provide quality service in the field of medicine and be a good person and not cheat your conscience.
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The Eureka that greeted Bolitho may have not been sustained, although Bolitho has chipped away Bolam’s influence, but it is not exactly the big bang that some legal observers expected.
Although Bolam was a lower court decision in a different era, yet it continues to remain influential in clinical negligence. The often cited innate reluctance by English judges to discard Bolam--stems not so much from their conservative and deferential attitude towards the medical profession--may be due lack of other real safe alternatives. The dynamics that apply in diagnosis, treatment, causation and patient-doctor relationships are complex and could not be completely delineated with a high degree of certainty. Inferential interpretations where there is an obvious limited knowledge in the scientific evidence, are emotive with social, moral and ethical implications. English judges tend to tread carefully on these matters hence some may inadvertently view this as an over reliance on medical opinion. 
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I'm not sure which legal jurisdiction you may have based your argument, but in England and Wales, Bolam remains an important case law in clinical negligence.
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In a case where a radiologist misses a lung cancer the only information he might have at the time is "patient has cough". Once the cancer is diagnosed and said patient sues the radiologist for negligence, does the patient's expert radiologist have more information when reviewing the original image? If so, surely there is hindsight bias which should deem the evidence unreliable.
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Ideally a medical expert witness would have only the information available to the treating physician at the time of consultation. However, in reality the outcome is always known when a malpractice case is launched, and experts for both sides know the outcome. An ethical witness should restrict consideration to those facts that either were known or should have been known to the treating physician at the time of the consultation when rendering an opinion about the reasonableness of a certain action or inaction. However, hindsight bias can of course be instrumental, and often is influential. It is the job of defense counsel to try to put this into perspective for the decisionmaker. However, in a jury system of jurisprudence, almost all expert testimony is admitted, and the lay jury is expected to be able to interpret testimony and determine fact from bias. In the U.S. no special qualifications exist for medical experts in many jurisdictions, for example a technician or nurse can testify against a physician as an expert and vice versa, a specialist can testify for/against a generalist. The judge will make the determination as to expertise on a case by case basis. Expert witnesses in most jurisdictions do not even need to prove that they have had the training or experience (for example a medical degree or specialty training) that they claim to use in arriving at an opinion. Nor do they need to defend their sometimes astronomical fees. Again it is up to opposing counsel to expose any misinformation, and for the jury to judge. It's a poorly regulated system.
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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?
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In mathematical papers we always list the authors in alphabetical order. This makes life simpler :)
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In the unit of principles of documentation for medical emergency students they want to know who is responsible for medical mistakes, errors, negligence, and so on.
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One of the possible solution is to have a evidence medicine based standard protocols for emergency situations approved e.g. by a professional societies and adhere to these protocols as a gold standard. This could also serve as a error preventing measure.
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Recent high profile reports of Cannabidiol (a natural non-psychoactive component of marijuana) being very effective in treating otherwise intractable seizure disorders have led to families of severely affected children demanding access, but current laws in most countries make both access and controlled research difficult. How can this be better managed both clinically and for research?
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We've been able to acquire many sched 1 drugs for research purposes fairly easily. Just register with DEA, your University also has to be licensed, and you need a DEA-registered vendor for whatever controlled substance you need...that's the process here in FL anyway.
The families demanding access for research purposes should find a relevant clinical trial and enroll or move to a state where MJ has been legalized. In those states, it is very easy to find high Cannabidiol extracts (so I hear). They can also fund the research themselves (I accept donations to support my research) or organize a charity event with all proceeds going to a designated research program to support their agenda.
I'm hopeful that the general public becomes more engaged in supporting research. The recent JOBS Act related to equity based crowd funding should help catalyze this. I've gotten a bit off topic but hope this helps...if only a little.
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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)?
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Bill, I think your perspective is a good one... and I agree with it. My point was simply to point out although we have in our modern society raised logic, intellectualism, and science to a high degree, should never delude ourselves to believe that that they can function independent of our values. So going back to the original question about the "wisdom of repugnance," and whether there is a place for emotion or intuition in our morality... the answer has to be YES.
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Some studies showed that accepting gifts from the pharmaceutical industry by physicians has implications for the doctor-patient relationship as it affects patients’ intent to adhere to medical recommendations.
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However, what is happening nowadays is disappointing. Drug company's representatives are exploiting gifts and other temptations to push physicians to prescribe their products. This is a good reason for banning or at least regulating the personal relation between physicians and drug companies.
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Amidst the plurality of values, ethical collision arises when the values of individual health professionals are dissonant with the expressed requests of patients, the common practice amongst colleagues, or the directives from regulatory and political authorities. When health providers disagree with their patients, colleagues, or regulatory professional bodies about the suitability of specific types of care, there are conflicting views on whether such health providers should be forced to violate their conscience, or punished if they refuse to do so.
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The general ethical and legal consensus in the U.S.A. is that it depends on two things. First, it depends on the seriousness of the action that a practitioner believes immoral. More serious actions, such as physician assisted suicide, are ones where we tend to allows practitioners to refuse to participate. Second, it depends on the broader costs of allowing practitioners to refuse to participate. For example, in cases such as pharmacists refusing to fill prescriptions for birth control or the morning after pill, there are more significant concerns about the costs of allowing such refusals (particularly in rural areas). So we tend to not allow refusals to participate when broader costs become higher.
It's hard to be much more specific, and certainly the laws in the U.S.A. have significant variation amongst states and vary based on the particular issue.
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A cornerstone of medical ethics is the requirement that patients give informed consent to any treatment, and this is supported by U.S. laws guaranteeing that patients should be able to refuse treatment. However, laws on refusal of treatment only apply if the patient has the decision-making capacity necessary to refuse treatment. This creates no special difficulty in cases where a patient clearly lacks decision-making capacity (unconsciousness, very advanced dementia, a ruling declaring legal incompetence, etc.) and also would create no special difficulties in cases where there is sufficient time to allow a patient to regain decision-making capacity, contact surrogates, address advance directives, or if all else fails, consult with the courts. Of course, in any such cases, physicians should clearly document everything and ideally get a second opinion on a patient’s decision-making capacity.
However, in time-sensitive cases where a patient has compromised decision-making capacity I have not yet been able to locate clear laws or cases.
For example, suppose that a patient is brought in with a moderate injury that will get worse without treatment (perhaps a broken ankle). Then suppose that the patient refuses treatment for the injury and wishes to go home. Finally, suppose the patient is clearly quite drunk (or high, or has some other moderate incapacitation) and the physician does not believe that the patient appreciates the consequences of refusing treatment.
If a physician decided to provide treatment on the basis that the patient does not have the capacity to give an informed refusal of the treatment, is the physician exposing themselves to liability or other legal sanction?
Also, if the physician did not provide treatment, is the physician exposing themselves to liability on the grounds of not properly securing an informed refusal of treatment?
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Informed consent in the United States is not a legal absolute required in all health and medical care circumstances. For example, in the case of an emergency and in the absence of an advance directive, the physician must act to save life. That said, not all cases seen in an emergency room are true emergencies (patients requesting refills of prescribed meds, urgent but no emergent decisions). In addition, even if an advance directive for a particular patient exists, it may not been written in such a way that the advance directive can be confidently acted upon.
Here are a set of references that may be useful to you regarding informed consent in areas where questions of informed consent arise in its application in medical and surgical settings in the United States arise: (1) orthopedics in acute care settings, (2) physicians in training, and (3) research on humans in the emergency room:
In clinical care:
1. Gould MT, Langworthy MJ, Santore R, Provencher MT. An analysis of orthopaedic liability in the acute care setting.Clin Orthop Relat Res. 2003 Feb;(407):59-66.
2. Pallin DJ, Harris R, Johnson CI, Giraldez E. Informed consent in thIs consent "informed" when patients receive care from medical trainees? Acad Emerg Med. 2008 Dec;15(12):1304-8.
In research on humans:
1. Largent EA, Wendler D, Emanuel E, Miller FG. Is emergency research without initial consent justified?: the consent substitute model. Arch Intern Med. 2010 Apr 26;170(8):668-74.
Dennis
Dennis Mazur
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Should medical personnel take an active role in investigation or intelligence collection?
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The laws in the countries of sovereign democracy dictate that a professional who has access to personal information of a person, may not disclose such, without the court's permission for the disclosure of personal information, including personal data.
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In your country or globally?
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In essence, ethical decisions are not algorithmical. However there are recommendations around ethical issues as pregnancy interruption. take a look to this: http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2400
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Is it helpful anyway in determining the nature/manner?
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Rule of nine is basically used to estimate the surface area involved with burns to estimate the iv fluid to be infused into the patient. As far as forensic medicine is concerned it can be said whether burn is sufficient to cause death in ordinary course of nature or not.
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Beth, ethics is my field, and I am interested in your question. I didn't understand what you were asking. I took it to be much more broad in scope.
In the seventies and eighties I used to work in New York (I live in Maine now), and I had to deal with the issue of what comprised a valid surrogate interest in another person. Sometimes people wished to designate someone as their decision maker and it was not permissible, or one got a lot of resistance. Maine's laws seem much more reasonable in this regard.
You have a very specific situation in view. I think that if you ask your question again with more details, such as you have provided here, you will probably get a better response to the question. Maybe you can edit the question itself and give more particulars.
Is the lack of the laws of which you speak, and which your State lacks, a help or a hindrance? Is your State making things harder by not having such laws?
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What is the top ethical issue in clinical practice?
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I would dare say that the clinical practice itself is the ethical issue.
Modern medicine is practiced in a dehumanizing environment today. Thanks to the so called "biomedical model", the ever increasing emphasis on "scientific" medicine reduces professionals to technicians and patients to objects. Illness as a personal/subjective/emotional/social experience is no longer considered to have any value in practice. The situation is further complicated by the fact that professionals have mutiple roles and divided loyalties today; therefore, it becomes increasingly difficult to assume that professionals have the best interests of their patients at heart. Under these circumstances, the patient-physician encounter today is, at best, an interaction between two distrusting strangers alienated from each other.
(I must say that my perspective summarized briefly above has been heavily influenced by the writings of authors such as Edmund Pellegrino, Eric Cassel, Alfred Tauber etc...)
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In Turkey, the medical degree/diploma of the physician candidate, when approved by the Ministry of Health, also acts as a licence to practice medicine. There is no separate licensing process for physicians (and for other healthcare professionals). The approval process of the degree does not rely on any well-established criteria (it is simply and seal and sign process) and there is no real system that evaluates the competency of healthcare professionals. Needless to say that, there is no such thing as re-licencing...
I find this situation to be very problematic for a number of reasons that I will not go into detail here, but I would be thankful if you could offer some insight regarding the way licencing procedures are handled in your country. You do not need to offer detailed information; you can simply recommend relevant publications and other sources (such as websites) to point me in the right direction.
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Hei,
UEMS.net provides information ion this adn also in EU pages you will find EU-directive on physician training. Re-lisenscing directive is in parliament and we do not know what is the content as a full.
Kristiina Patja
Finlans
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Informed Consent
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Thanks--then, perhaps, I should ask for clarification of your question. What sort of lack of capacity were you thinking about? I am genuinely interested because lack of capacity to consent is central to my field as well. Crimes, for example, where "consent" is a defense are problematic because one may have said, "I consent" but--if the statement were given at gunpoint it would hardly be considered "consent" in any meaningful sense. My particular comment, however, pertained to, more specifically, how a candidate's lack of knowledge of the true nature of an experiment can render the candidate subject incapable of giving consent. So the measure as to whether capacity exists would be disclosure of information. Were you thinking of circumstances where a person's capacity is measured vis-a-vis some mental disease or defect, or perhaps duress, or were you thinking of something else? Thanks for humoring me on this.
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Medicine is essentially a humanitarian profession. Those favoring the trend toward health care for profit claim that an increased role for entrepreneurs and competition in the delivery of health care will result in a more efficient and effective health care system. What is your opinion?
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In short - NO. The fundamental question to contemplate is: Is health a public good or a commodity? For me the answer is unequivocally clear - health and healthcare is a public good. Commercialization of healthcare results in huge inequalities, exploitation and ultimately poor outcomes.
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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?
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Good question. Taking your term experiment broadly to include observational research with no video or participation by the researcher you are exempt from IRB review. If you have any doubts, you can get what is called an expedited review by the IRB, but you will not be required to use consent forms. In my experience, journals are happy to know that you had an expedited review.
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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?
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I've seen people taking formal approval from their head of department in cases where there was no established committee. You can then mention in the article that since there was no ethical committee, the hospital protocol dictated that approval be taken from the head of department. An even better approach may be to actually approach the head of the institution and ask them to set a committee up.
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In the light of the widespread re-emergence of childhood infectious diseases, (measles, mumps etc.) especially in the UK, can either teachers or play group leaders be held responsible for failing to exclude non-immunised children from groups should other children, despite immunisation, contract these diseases?
Can a mother be held responsible in a court for negligence should a child develop long term sequelae (deafness for example) as a result of a parent or parents electing to avoid vaccination? I am thinking of the road traffic accident analogy.
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In Jordan, I think that there is no special law required parents to vaccinate children for the prevention of infectious diseases, but obligations parents to care for their children to force them to do vaccinate their children, but the question whether Declined parents to do vaccinate their children Is there a legal text punish them for this action?I believe that there is a lack of legislation to treatment this situation in spite of the negative health effectsThat affect society in general in the future and the spread of disease and the financial costs borne by the state to address these diseases.
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Since consent forms don't function like contracts or disclaimers, what legal framework is in place to protect medical practitioners from being held responsible for the adverse effects of medical procedures that they perform or drugs that they prescribe?
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A breached of standard of care is a question of fact initially and eventually a question of law. One has to, by expert witness, establish the standard of care for a particular circumstance and later on how the standard was breached. Different jurisdictions may subscribe to a "locality rule", "modified locality rule" or national standard rule for a particular case. Sometimes, the case might fall under the res ipsa or common knowledge doctrine. Furthermore, even if a breached is establish, it does not necessarily means that "negligence" was committed. The breached must be proven that it was the "proximate cause" of the injury. Only then can there be negligence in contemplation of tort laws.
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Religion and ethics go hand in hand. Does spirituality have evidence based effects on health or is it beyond religion essentially? How can spirituality be best be integrated in health care delivery?
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I think, that he knows it. But he can't write it in scientific book.
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What are the main differences in legal regulation concerning human embrionical stem cell researches comparing with researches with/of grown up people stem cells?
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on patenting the results [rather than carrying out the research], i have a couple of articles, one published in SCRIPTED (google scripted cockbain sterckx), the other in the March or April 2012 issue of Intellectual Property Magazine (again cockbain)