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1.
Gefenas E 《Science and engineering ethics》2007,13(3):281-288
This paper attempts to provide a broader view into the ethical issues surrounding the field of emergency medicine (EM) research.
It starts from defining bioethically relevant features of EM and presents this field in the context of different models of
health care provider–patient relationship. The paper also provides a short overview of the “post-Nuremberg” evolution of the
main international research ethics guidelines relevant to EM research which demonstrates a tendency of liberalization of research
on incapable persons. This tendency culminates with the exceptions to informed consent for EM research which is supposed to
be balanced by other research ethics principles, especially a careful rationing of risks and benefits. This finally brings
us towards a critical analysis of the minimal risk standard which is one of the main fundamental safeguards in EM research.
An earlier version of this paper was presented at The 7th International Conference on Bioethics on “The Ethics of Research
in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland. 相似文献
2.
Halila R 《Science and engineering ethics》2007,13(3):305-313
Different ethical principles conflict in research conducted in emergency research. Clinical care and its development should
be based on research. Patients in critical clinical condition are in the greatest need of better medicines. The critical condition
of the patient and the absence of a patient representative at the critical time period make it difficult and sometimes impossible
to request an informed consent before the beginning of the trial. In an emergency, care decisions must be made in a short
period of time, and the more time is wasted, the more the risk of death or severe tissue damage and incapacity increases.
Consent requests take time, and so the time period before treatment might put the patient’s life in jeopardy. Not requesting
consent before a trial is also contradictory. A person should not be forced to participate in a trial against his or her will.
Due to the dark history of medical research previously, international declarations and conventions have set up ethical principles
for medical research. They emphasize the autonomy of the research participant—or his or her legal representative—to give a
free and informed consent prior to the initiation of research. In the case of a critical emergency, the unconscious state
of the patient, the emotional stress of family members or the lack of time to start life-sustaining measures may often restrict
the possibilities of communicating with the patient or his/her representative. Therefore, written informed consent is difficult
to achieve, and its voluntariness in emergency situations is, at best, open to question. The mortality of patients is high
without clinical interventions in emergency research. Random selection of patients is difficult and requires extra work from
personnel in the emergency rooms. Recruitment, information and asking for consent may also take time, postpone the initiation
of treatment and increase the risk of death and irreversible tissue and organ damage, and therefore be risky for the patient.
It is therefore essential that the health care professionals recruiting suitable research participants are well motivated
and well trained. Medical research in an emergency setting should always be regarded as an exceptional situation requiring
special provisions. Only such research should be done as cannot be done in other conditions. An independent body must approve
the research protocol and the ways in which the consent of the participant or proxy are to be sought. In addition, the trial
must be expected to result in direct and significant benefit for the research participants. If research without prior consent
is not approved, the development of emergency care is threatened. On the other hand, if prior consent is not required, a person
could be recruited into a clinical trial against his or her will. Doing good and avoiding harm, and respecting the autonomy
of the patient are in conflict in the context of emergency medical research. To develop better medicines for patients experiencing
acute medical emergencies, research into such conditions should be allowed. Research participants should have the possibility
to participate or refuse to participate in research that may benefit them and other patients. The risk of irreversible damage
occurring as the consequence of time delays for seeking consent is unacceptable. A prior wish about participation in clinical
trials should be respected, if known. The conditions under which medical research in emergencies can be considered acceptable
can be determined and agreed upon nationally and internationally.
An earlier version of this paper was presented at The 7th International Conference on Bioethics on “The Ethics of Research
in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland. 相似文献
3.
Sonja Grover 《Journal of Academic Ethics》2003,1(4):349-383
This paper considers what are the appropriate limits of parental or guardian proxy consent for a child's participation in
medical or social science research. Such proxy consent, it is proposed, is invalid in regards “non-therapeutic research.”
The latter research may add to scientific knowledge and/or benefit others, but any benefit to the child research participant
is but a coincidental theoretical possibility and not a primary objective. Research involving children, without intended and
acceptable prospect of beneficial outcome to the individual participant, even if with negligible risk, does not meet the test
for “best interests.” Proxy consent for children's involvement in research is justifiable only when given for and on behalf
of the child in his or her best interest to enhance the child's well-being. Only in the latter case is the parental proxy
consent situation analogous in regards key criteria to a competent individual consenting to research participation.
This revised version was published online in August 2006 with corrections to the Cover Date. 相似文献
4.
Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible. 相似文献
5.
This paper elaborates on discussions in Germany regarding some of the ethical and legal issues in the area of the use and
patenting of inventions involving human tissue. The issues discussed pertain to the benefits and problems regarding informed
consent and the issue of property rights as they relate to the donation of cells and tissue.
An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights
and Patents,” held in Warsaw, Poland on 23–24 April, 2004. 相似文献
6.
Jafarey AM 《Science and engineering ethics》2002,8(3):353-362
Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when
motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind
clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable
by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the
reasons that make this population vulnerable to exploitation. Informed consent in the process of research is an area where
such conflicts are prone to arise. In order to ensure that conflicting interests of researchers and funding agencies are kept
in check, the processes of informed consent and ethical review of research need to be strengthened. Suggestions are put forward
to modify the consent process to match the needs of South Asia and to strengthen the ethical review process for safeguarding
the rights of the study subjects. But perhaps the most important safeguard against exploitation is the virtuous researcher
himself with noble intentions.
An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance
in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002. 相似文献
7.
I argue that Nafsika Athanassoulis fails to establish the main contention of her paper (“The Role of Consent in Sado-MasochisticPractices”,
Res Publica 8, 2 (2002)), namely that, given liberalism, consent should be a defence to a charge of assault occasioning actual bodily
harm even when the harm is a consequence of a sado-masochistic encounter.
This revised version was published online in August 2006 with corrections to the Cover Date. 相似文献
8.
朱伟 《医学与哲学(人文社会医学版)》2006,27(2):60-62
急诊医疗中的知情同意似乎与通常的临床情形不同,它不需要完全的知情同意,甚至可以被免除。这一特点可能给人以一种印象,即在急诊情况下对知情同意的考量,或可与其他情形有所不同。其实急诊情形下之所以出现知情同意的例外或免除,并非知情同意原则在急诊情况下不适用,或者是知情同意原则做出了让步。真正的原因是,知情同意在急诊治疗中往往以特殊或不同的形式表现出来。 相似文献
9.
Iwanowski PS 《Science and engineering ethics》2007,13(3):333-336
Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere
to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency
patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to
give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants.
Whereas the Declaration of Helsinki, Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention
concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow
waivers from participants’ consent or deferred consent for emergency research, the regulations of most European Community
countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent
for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting
regulations on a waiver from a participant’s consent in emergency research exist and the regulations on surrogate consent
of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not
or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred
consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should
become a large part of important public health priorities. 相似文献
10.
Joerden JC 《Science and engineering ethics》2004,10(1):65-72
This article considers issues concerning cases where the use of placebo is lawful or is not lawful under aspects of German
criminal law. It will differentiate between cases of individual therapy and cases of supervised experiments within the scope
of medical tests. Thereby, it reveals that a medication of placebo with regard to an individual patient seems to be lawful
if there is no alternative possibility of a better treatment using a chemically effective medicine and if the limits of presumed
consent are complied with. On the other hand, in the context of the supervised experiment, the assignment of a patient to
a group treated with placebo is only lawful if the patient has been fully informed about the possibilities of a treatment
and if the patient has given consent to it.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003.
The author’s interests include International Criminal Law, Comparative Criminal Law and Philosophy of Law. 相似文献
11.
Benedetto Vitiello 《Ethics & behavior》2013,23(2-3):182-198
With the recent expansion of child mental health research, more attention is being paid to the process of informed consent for research participation. For the consent to be truly informed, it is necessary that the relevant information be both disclosed and actually understood. Traditionally, much effort has gone to ensuring the comprehensiveness of consent/assent documents, which have progressively increased in length and complexity, whereas less attention has been paid to the comprehensibility of these documents. Available data indicate that many parent and children have difficulties appreciating the research nature of treatment studies and that a higher level of formal education among the parents is associated with a greater degree of understanding. Promising approaches to achieving truly informed research participation have emerged, such as additional time for parents to meet with the researchers and using postexplanation questionnaires for identifying issues in need of further clarification. Research is needed to develop and test strategies for improving the effectiveness of the informed consent process in child mental health. 相似文献
12.
The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians
and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The
great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different
clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design
of these studies. One of the most important changes in this field has been the use of placebo groups in double-blind controlled
studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but
also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents
the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and
the use of placebo controls in clinical trials.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
13.
AbstractThe past decade has witnessed escalating legal and ethical challenges to the diagnosis of death by neurologic criteria (DNC). The legal tactic of demanding consent for the apnea test, if successful, can halt the DNC. However, US law is currently unsettled and inconsistent in this matter. Consent has been required in several trial cases in Montana and Kansas but not in Virginia and Nevada. In this paper, we analyze and evaluate the legal and ethical bases for requiring consent before apnea testing and defend such a requirement by appealing to ethical and legal principles of informed consent and battery and the right to refuse medical treatment. We conclude by considering and rebutting two major objections to a consent requirement for apnea testing: (1) a justice-based objection to allocate scarce resources fairly and (2) a social utility objection that halting the diagnosis of brain death will reduce the number of organ donors. 相似文献
14.
知情同意在我国临床医疗中的实施 总被引:24,自引:0,他引:24
马先松 《医学与哲学(人文社会医学版)》2003,24(1):1-4
知情同意在我国至少已倡导与实践了20年,由伦理要求上升到法律准则无疑是一个跨越式的进步。当前,医院落实知情同意的实践滞后于患者要求,除了主观方面的原因外,客观上存在知情同意与保护性医疗,病人自主权与医生处置权、医学对疾病的已知与未知等诸多盾与难点。要使知情同意在我国临床医疗中真正落实尚有许多工作要做;提高医务人员尊重病人权利的意识;完善执行知情同意的方式与程序;细化与知情同意的实施原则;营造良好的社会氛围,探索非西方环境下知情同意实现途径。 相似文献
15.
Respect for the dignity and autonomy of patients has long been a fundamental principle of ethical decision making. As a practical matter, a primary way of maintaining this ethical standard is by obtaining an individual’s informed consent prior to intervening or collecting data. By giving individuals clear information about alternative treatments and potential risks and benefits, the practitioner tries to ensure that the patient can make an informed choice. However, there are cases in which those seeking informed consent have very different values and belief systems from those whose consent is being sought. In this article we explore such discrepancies using informed consent with Navajo clients as an example, illustrate potential challenges with case examples, and propose ways in which ethical dilemmas may be successfully navigated. 相似文献
16.
Bell DR 《Theoretical medicine and bioethics》2003,24(5):381-393
In his paper, “The Relevance of Rawls’ Principle of Justice for Research on Cognitively Impaired Patients” (Theoretical Medicine and Bioethics 23 (2002):45–53), Giovanni Maio has developed athought-provoking argument for the permissibility of non-therapeutic research
on cognitively impaired patients. Maio argues that his conclusion follows from the acceptance of John Rawls’s principles of
justice, specifically, Rawls’s “liberty principle” Maio has misinterpreted Rawls’s “libertyprinciple” – correctly interpreted
it does notsupport non-therapeutic research on cognitivelyimpaired patients. Three other ‘Rawlsian’ arguments are suggested
by Maio’s discussion –two “self-respect” arguments and a “presumed consent” argument – but none of them are convincing. However,
an alternative argument developed from Rawls’s discussion of “justice in health care” in his most recent book, Justice as Fairness: A Restatement, may justify certain kinds of non-therapeutic research on some cognitively impaired patients in special circumstances. We
should not expect anything more permissive from a liberal theory of justice.
This revised version was published online in June 2006 with corrections to the Cover Date. 相似文献
17.
谈医疗行为中患者知情同意权的实现 总被引:7,自引:0,他引:7
程红群 《医学与哲学(人文社会医学版)》2003,24(1):17-19
目前,关于患者的知情同意权的讨论引起了众多医院管理者的关注。对知情同意与医疗行为的矛盾冲突进行探讨,提出医疗行为为中实现患者知情同意的对策及伦理原则。 相似文献
18.
美国医疗知情同意案例评介 总被引:9,自引:4,他引:5
王元昆 《医学与哲学(人文社会医学版)》2003,24(1):26-31
在美国的医疗活动中,知情同意是规范医患关系的一项伦理道德原则,同时,美国司法活动也在医疗事故背景下适用知情同意说,并形成一些司法适用的医疗知情同意的标准和告知责任的范围,介绍和讨论对涉及到这些问题的三个有影响的判例。 相似文献
19.
对知情同意书和知情同意过程的探讨 总被引:19,自引:5,他引:14
宋天然 《医学与哲学(人文社会医学版)》2005,(11)
在《医疗事故处理条例》实施中,存在着一种现象:重视一张由患者签字的知情同意书,轻待知情同意过程。签字的知情同意书不等于知情同意,知情同意书不等于“生死契约”。知情同意的本义:对患者权利、尊严、人格和自由的尊重,只有在知情同意过程中获得。因此知情同意过程应该重要于知情同意书。医生严格履行好法定的告知和说明义务,尊重患者的知情同意权,就是尊重法律,也是医生保护自己的最好方式。 相似文献
20.
In his paper entitled “Ethics and the Funding of Research and Development at Universities”1 Spier examines some of the potential problems of the relationship between 1) corporate sponsors of research and 2) the universities
(and faculty) that receive that funding. Citing “He who pays the piper, calls the tune,” Spier suggests that a better way
of funding research would be to “set up a dedicated publicly sponsored research establishment” with the stated goal of achieving
particular technical or engineering objectives. (Spier cited the successful Animal Virus Research of the UK as an example).
Spier states that researchers at these establishments are “not subjected to the triple requirement to teach, research and
administer as are university members, so they do not have to face the same ethical challenges of the academics.” This paper
will examine the stated dangers of public/corporate research partnerships and whether the proposed alternative shares equally
troubling ethical issues. 相似文献