Critical care research and informed consent

The doctrine of informed consent severely limits the ability of medical researchers to develop, evaluate, and refine investigational technologies for the treatment of patients suffering from heart attacks, strokes, and other "critical care" conditions. In this Article, Mr. Saver examines the current doctrine of informed consent as applied to critical care research and its various deficiencies. In addition, he analyzes recent reforms proposed by the Food and Drug Administration, which are intended to remove certain obstacles to critical care research posed by informed consent. While the proposed reforms address several of the current deficiencies, he asserts that they lack the breadth and scope necessary to advance the progress of critical care research in an ethical and sensible manner. Mr. Saver proposes several complementary and alternative reforms that would better accomodate the interests of all affected parties: the patients, their families, the researchers, and the general public.     

Protection of human subjects; informed consent--FDA. Final rule

The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.     

The federal government and academic texts as barriers to informed consent

Informed patient consent for medical treatment is required by both law and medical ethics. Yet, both federal agencies and academicians are participating in the suppression of information about the heightened risk of breast cancer posed by oral contraceptives and induced abortion. There is historical precedent in the long-delayed acknowledgement of the smoking/lung cancer link. By law, a patient has the right to be fully informed of the nature of her medical condition and any proposed course of therapy. It is assumed that a patient will be given the complete and true scientific basis of her diagnosis and treatment, to ensure that her well-being and her autonomy in decision-making are protected. Informed consent is the process by which a patient can participate in choices about medical treatment. It originates from the legal and ethical right of the patient to direct what is done to her body, and from the ethical duty of the physician to involve the patient in her medical care. Our federal government has become a barrier to informed consent concerning oral contraceptive drugs and induced abortion.     

Commercialisation of regenerative human tissue: regulation and reform in Australia and England, Wales and Northern Ireland

The commercialisation of therapeutic products containing regenerative human tissue is regulated by the common law, statute and ethical guidelines in Australia and England, Wales and Northern Ireland. This article examines the regulatory regimes in these jurisdictions and considers whether reform is required to both support scientific research and ensure conformity with modern social views on medical research and the use of human tissue. The authors consider the crucial role of informed consent in striking the balance between the interests of researchers and the interests of the public.     

司法何以如此尴尬——以一起医疗纠纷案件审理为例

不断增多的医疗纠纷及其引发的种种愤懑,使得各种利益纠葛、体制冲突、伦理诉求和法律管制之间形成了一种较之从前更为复杂而微妙的关系。对医患关系的社会调查显示,目前我国医患双方的关系并不融洽,双方缺乏高度的信任感,一旦患者未达到其预期的疗效,势必为双方的矛盾、冲突和纠纷埋下伏笔;医患双方在具体运用知情同意权法则时产生的强烈的错位,使得知情同意权在减少医患纠纷、构建高度信任基础上的医患和谐关系的功能大打折扣。而对实践中的一个真实案例的审理的剖析则反映出我国法律和司法在知情同意权方面是如此的苍白无力,使得知情同意法则的建立迫在眉睫。我国知情同意权法则的理想构架应该包括:知情同意权法则的基本原则,医生的告知义务,患者的同意以及违反告知义务的构成要件。     

Breaking through the silence: illegality of performing resuscitation procedures on the "newly-dead"

Israeli author Daniel Sperling brings to a light a disturbing practice that is taking place in some teaching hospitals throughout the world--the practice of resuscitation procedures on newly dead patients without the consent of the next-of-kin. Mr. Sperling examines some of the policies and procedures in place to prevent such practice and also looks at the ethical principles that should guide such procedures. The paper also reviews the general issue of consent in the context of medical decision-making and discusses potential legal claims that might be available to persons who have not been consulted or informed before such procedures are performed. The evolving jurisprudence surrounding the treatment of the newly dead is analyzed and Mr. Sperling concludes by suggesting ways to improve upon the procedures currently in place at some teaching facilities.     

论医疗知情同意理论

知情同意作为一项有利于实现医疗目的的私法原则,具有其独立的利益设计和价值取向。告知说明义务的履行是实现知情同意原则的前提,而知情同意理论的要件是具体落实知情同意原则的关键,其中判断患者是否具备同意能力是知情同意的重要因素。但在适用知情同意原则时应注意识别几种例外情势。为了切实保障知情同意原则的实现,减少和防范医疗纠纷的发生,构建和谐的医患关系,有必要进一步完善我国知情同意理论体系。     

Public preferences and the challenge to genetic research policy

Modern genetic research requires scientists to collect, store, and study DNA samples and health information from thousands of people. Longstanding policy allows researchers to use samples and information without a person''s informed consent as long as the person''s identity is protected. Under existing policy, researchers must neither disclose study results to interested research participants nor compensate people who contribute to genetic research. Research and ethics experts developed these policy approaches without input from the people whose contributions are essential to the genetic research enterprise. A growing body of evidence shows that many research participants and would-be participants disagree with the current policy approaches. For ethical and practical reasons, participants should have a greater role in determining how genetic research is conducted.     

患者不予签字同意的问题研究

知情同意是患者最基本的权利。知情同意一般分为四个环节:告知、知情、同意、签字。其中,"签字"是知情同意的最终行为方式。由于其在具体实践中常受到告知方式、理解能力、意识状态、法理缺陷等诸多因素的影响而突显出它的复杂性。我国于20世纪70年代后期开始将知情同意引入,并逐渐由医师执业道德范畴过渡到了法律规范的范畴。知情同意在我国发展的几十年中,最为典型的形式就是术前签字制度。文章将集中对患者不予签字同意进行分析和阐述,并从一般状态、患者或近亲属无明确意思表示以及紧急情况三个方面提出笔者的几点设想。     

PGTandMe: social networking-based genetic testing and the evolving research model

The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and--highlighting the challenges associated with a new paradigm of "patient-driven" genomic research--focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article also explores potential ethical, legal, and regulatory issues that arise from the hybrid between personal genomic research and online social networking, particularly regarding informed consent, institutional review board (IRB) oversight, and ownership/intellectual property (IP) considerations.     

Legal prerequisites for clinical trials under the revised Declaration of Helsinki and the European Convention on Human Rights and Biomedicine.

Biomedical research is a perennially controversial subject. While the provisions of the Revised Declaration of Helsinki enjoy world-wide acceptance, they are increasingly placed in question--not least by the Council of Europe's Bioethics Convention, which allows non-therapeutic research in restricted cases on those incapable of giving informed consent. Taking as its starting-point the fundamental conflict between the general interest in research and the individual interests of the patients concerned, this article analyses the conditions under which medical experimentation on human beings is permissible. The article recognises the model of risk/benefit analysis and the doctrine of informed consent as equally valid core principles which do not conflict with restricted, non-therapeutic research, whether on patients who lack the capacity to consent or in placebo-controlled trials.     

Stem cell terminology: practical, theological and ethical implications

Stem cell policy discussions frequently confuse embryonic and fetal sources of stem cells, and label untested, non-reproductive cloning as "therapeutic." Such misnomers distract attention from significant practical and ethical implications: accelerated research agendas tend to be supported at the expense of physical risks to women, theological implications in a multi-faith community, informed consent for participation in research, and treatment decisions altered by unrealistic expectations.     

反思法律对社会关系对立面的强化——从知情同意权切入

信赖、合作、有成效的医患关系是一理想状态,是用以评价实际医患关系的标尺。历史上,基于理想的伦理预设,医生为患者做主,成为理所应当,这便是医疗父杈主义,而当原先的伦理预设被打破后,法律父权主义模式便得以介入,其强调知情同意这一制度,以此改变过去的医患关系模式。然而,由干专业壁垒等因素的存在,知情同意权有被医疗方"工具化"的倾向,难免会使医患双方的对立面被强化。反思这一问题,将对法律父权主义模式向理想模式靠近有积极意义。     

Gavels in the nursery: an Appellate Court shuts out parents and physicians from care decisions

This article explores a recent Wisconsin Court of Appeals decision in a medical malpractice case and its ramifications regarding Wisconsin's informed consent statute. The authors compare and contrast this decision with previous Wisconsin Supreme Court cases and consider the relevance of applicable federal law. The article presents a thoughtful analysis of how the Wisconsin Court of Appeals should have approached the issue, as well as how it created potential conflicts regarding the ethical duties of healthcare providers treating children.     

Ethical and legal issues in suicide research

Moralist, libertarian and relativist ethical positions concerning suicide and its prevention are presented in order to clarify premises upon which ethical issues in suicide research may be resolved. Ethical concerns are differentiated from legal considerations and the implications of the vulnerability of suicidology research participants are discussed. Specific issues that arise in design, choice of participants, interpretation, diffusion of results and evaluative research are treated. These include: experimental methodologies, obtaining informed consent, deception and disclosure, studying innovative and unproven interventions, unknown consequences of participation, rescue criteria, disclosure of information to third parties, research with special populations, risks in publicizing results and measuring the value of human life. When specific legal obligations are lacking, ethical premises concerning the acceptability of suicide and obligations to intervene may influence research protocols.     

Role of Culture and Context: Ethical Issues in Research with Asian Americans and Immigrants in Intimate Violence

Ethical principles are often presented as universal, immutable rules. However, when conducting research with ethnic minority groups, such as Asian Americans and immigrants, ethical issues need to be placed within a sociocultural context as ethical responses are filtered through the specific value orientations and belief systems of the ethnic group under study. Further, when the group is a marginalized population, power dynamics complicate ethical principles of autonomy. The complexities are further accentuated with sensitive topics such as intimate violence or domestic violence. Consequently, ethical questions about autonomy, informed consent, confidentiality, limits to confidentiality, and protecting participants’ safety and reducing distress need to be at the forefront when planning intimate violence research. An overview of sociocultural context of Western biomedical ethics is presented and specific ethical issues that emerge when conducting intimate violence are discussed.     

The medically examined applicant for private insurance and his/her right to informed consent: a comparative analysis

Within the context of health and insurance law, an important question that arises is "to what extent is an applicant for private insurance truly capable of giving his/her 'free' and informed consent for a medical examination?". It should be borne in mind that it is the private insurer who requires a medical examination in order to gather medical information, and, moreover, that the insurer will not be inclined to conclude or carry out an insurance contract without this medical information. A distinction has to be made between not being free by legal coercion and not being (completely) free by factual circumstances. Exercising the right to informed consent involves exactly weighing up the consequences of the decision. Hence the applicant must be put in a position of being able to weigh up the consequences and take them into consideration.     

由谁来行使知情同意的权利:患者还是家属?

知情同意权是患者的一项基本权利,但是在我国目前的医疗实务中,该项权利却普遍地由患者的家属予以行使。本文围绕应当由谁来行使“有同意能力的患者”的知情同意权这一问题,由现行法的态度出发,从正反两个角度论证了应当由患者本人行使其知情同意权的观点。     

Medical: informed consent--designate health care professionals to obtain informed consent. Final rule

This document amends U.S. Department of Veterans Affairs (VA) medical regulations on informed consent. The final rule authorizes VA to designate additional categories of health care professionals to obtain the informed consent of patients or their surrogates for clinical treatment and procedures and to sign the consent form.     

(Why) should we require consent to participation in research?

It is widely accepted that informed consent is a requirement of ethical biomedical research. It is less clear why this is so. As an argumentative strategy the article asks whether it would be legitimate for the state to require people to participate in research. This article argues that the consent requirement cannot be defended by appeal to any simple principle, such as not treating people merely as a means, bodily integrity, and autonomy. As an argumentative strategy the article asks whether it would be legitimate for the state to require people to participate in research. I argue that while it would be legitimate and potentially justifiable to coerce people to participate in research as a matter of first-order moral principles, there are good reasons to adopt a general prohibition on coercive participation as a matter of second-order morality.