Medical devices; exception from general requirements for informed consent. Interim final rule

The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.     

Informed consent for patient care--VA. Final rule

This document amends VA medical regulations concerning informed consent for patient care. It describes the requirements for obtaining and documenting informed consent. It also describes the types of treatments or procedures for which the patient's or surrogate's signature on a VA-authorized form is required and establishes a list and priority of surrogates authorized to act on behalf of patients who lack decision-making capacity. Further, it establishes an internal decision-making process for patients who lack decision-making capacity and who have no authorized surrogate. This is intended to protect patient rights and ensure that the patient (or the patient's surrogate or representative) receives sufficient information to make an informed health-care decision. authorized form is required and establishes a list and priority of surrogates authorized to act on behalf of patients who lack decision-making capacity. Further, it establishes an internal decision-making process for patients who lack decision-making capacity and who have no authorized surrogate. This is intended to protect patients rights and ensure that the patient (or the patient's surrogate or representative) receives sufficient information to make an informed health-care decision.     

Human drugs and biologics; determination that informed consent is NOT feasible or is contrary to the best interests of recipients; revocation of 1990 interim final rule; establishment of new interim final rule. Food and Drug Administration, HHS. Interim final rule; opportunity for public comment

The Food and Drug Administration (FDA) is revoking its 1990 interim final regulations that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. FDA also is issuing a new interim final rule addressing waiver of informed consent in military operations. FDA is taking these actions based on its analysis and consideration of all relevant facts, including its evaluation of the Department of Defense's (DOD) experience during the Persian Gulf War, its evaluation of the comments received by the agency in response to the agency's July 31, 1997, request for comments on whether the agency should revise or revoke the interim regulations, and the enactment of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (the Defense Authorization Act). Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's (the act) informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests. In light of the enactment of the Defense Authorization Act, with an immediate effective date, and because the President could be called upon to make a waiver determination for military personnel engaged in a specific military operation at any time, the agency believes that it is critical to have in place adequate criteria and standards for the President to apply in making an informed consent waiver determination. Therefore, FDA is issuing a new interim final regulation with an immediate effective date to establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the best interests of the individual recipients.     

论知情同意的豁免

本文围绕医疗实务中的知情同意豁免，首先讨论了知情同意豁免规则的法律政策，详细分析了紧急情形豁免、治疗豁免、知情同意权的放弃和强制治疗这四种豁免情形，简述了医务人员在适用知情同意豁免规则时可能的法律责任。     

Medical devices; exception from general requirements for informed consent. Final rule

The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled "Medical Devices; Exception From General Requirements for Informed Consent." This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. This final rule adds a requirement that the investigator submit the required documentation to FDA, in addition to submitting it to the reviewing Institutional Review Board (IRB).     

Investigational new drug application; exception from informed consent; technical amendment--FDA. Final rule

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to clarify that, within 30 days after the receipt of an IND for any clinical investigation involving an exception from informed consent, FDA will provide a written determination as to whether the investigation may begin. This action is intended to clarify a recent amendment to the IND regulations for clinical investigations involving an exception from informed consent that states that FDA will provide a written authorization within 30 days of receipt of the IND.     

Competence to give informed consent for medical procedures

This study shows that referrals to psychiatry for evaluation for competence to give informed consent generally were made on patients who refused medical treatment. In this sample of referred patients, the only patients found to be incompetent to give informed consent were those with organic brain syndromes. No one with either schizophrenia or depression was found to be incompetent. It is possible that schizophrenic and depressed patients may generally be competent to give informed consent to medical treatment. This finding might be true notwithstanding the fact that many such patients have been found in other studies to be incompetent to consent to voluntary psychiatric treatment. For example, a patient may have delusions that others can read his mind and thoughts, but he still can understand that he needs dialysis for renal failure. Alternatively, it may be relatively rare that an emergency procedure is necessary before a patient's psychosis can be brought under control and consequently internists and surgeons themselves may prefer to wait. The significance of the results is unclear. Because of active interest in the doctrine of informed consent for psychiatric and medical patients by both physicians and attorneys and the few studies within this population, there is a strong need for more study regarding competence to give informed consent. Further study is especially important for psychotic patients for whom psychiatric consultation is not requested.(ABSTRACT TRUNCATED AT 250 WORDS)     

Human subjects protections in biomedical enhancement research: assessing risk and benefit and obtaining informed consent

The protection of human subjects in biomedical research relies on two principal mechanisms: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects' informed consent. While these have been discussed extensively in the literature, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual appearance, performance, or capability ("enhancement research") rather than to prevent, cure, or mitigate disease ("health-oriented research"). This essay examines this question in order to ensure that subjects in biomedical enhancement research receive adequate protection.     

Researcher liability for negligence in human subject research: informed consent and researcher malpractice actions

Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.     

Accessibility to new drugs for use in military and civilian exigencies when traditional human efficacy studies are not feasible; determination under the interim rule that informed consent is not feasible for military exigencies; request for comments--FDA. Request for comments

The Food and Drug Administration (FDA) is requesting written comments related to the advisability of revoking or amending the interim final rule that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. The agency is also soliciting written comments identifying the evidence needed to demonstrate safety and effectiveness for such investigational drugs that cannot ethically be tested on humans for purposes of determining their efficacy. FDA is seeking written comments from all interested groups, including, but not limited to: Consumers, patient groups, veterans and veteran groups, active-duty military personnel, organizations and departments, ethicists, scientists, researchers with particular expertise in this area, and health care professionals. The written comments are intended to provide FDA with information to help the agency in making policy decisions on the use of investigational products during military exigencies and the appropriate evidence needed to demonstrate safety and effectiveness for drug and biological products used in military or other exigencies when traditional human efficacy studies are not feasible.     

What constitutes a psychiatric emergency: clinical and legal dimensions

In true medical emergencies, informed consent is presumed or implied without application of the usual standard. In the litigation over the right to refuse treatment in psychiatry, a limited right for involuntarily committed patients to refuse treatment has been upheld, absent a finding of a psychiatric emergency. Increasingly, clinicians may find that their sole extrajudicial option in instituting treatment over the patient's objection is in invoking a psychiatric emergency. The purpose of this communication is to discuss the clinical and legal issues in defining and invoking a psychiatric emergency in treatment refusal. The substantive and procedural issues in the use of the emergency exception in treatment refusal are discussed with recommendations for their use in clinical practice.     

新冠肺炎等传染病与法医学鉴定评述

新冠肺炎致死或引发的其他法律纠纷可能涉及法医学病理解剖或者法医临床学鉴定。在日常法医学解剖中时有遇到因传染性疾病死亡患者的尸体,法医鉴定机构及鉴定人应当有风险识别意识,充分认识到在解剖、检查这类尸体时的被传染风险。法医鉴定人需要采取充分有效的防护措施。由于新冠肺炎属于新型传染性疾病,相关研究成果、信息资料更新快,鉴定中的信息参考要慎重选择。同时本文对因传染性疾病死亡患者的尸体解剖中常见的职业伦理、知情同意、保险理赔和环境保护等问题进行讨论。     

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.     

The genomic data deficit: On the need to inform research subjects of the informational content of their genomic sequence data in consent for genomic research

Research subject consent plays a significant role in the legitimation of genomic research in Europe – both ethically and legally. One key criterion for any consent to be legitimate is that the research subject is ‘informed’. This criterion implies that the research subject is given all relevant information to allow them to decide whether engaging with a genomic research infrastructure or project would be normatively desirable and whether they wish to accept the risks associated with engagement. This article makes the normative argument that, in order to be truly ‘informed’, the research subject should be provided with information on the informational content of their genomic sequence data. Information should be provided, in the first instance, prior to the initial consent transaction, and should include: information on the fact that genomic sequence data will be collected and processed, information on the types of information which can currently be extracted from sequence data and information on the uncertainties surrounding the types of information which may eventually be extractable from sequence data. Information should also be provided, on an ongoing basis, as relevant and necessary, throughout the research process, and should include: information on novel information which can be extracted from sequence data and information on the novel uses and utility of sequence data. The article argues that current elaborations of ‘informed’ consent fail to adequately address the requirements set out in the normative argument and that this inadequacy constitutes an issue in need of a solution. The article finishes with a set of observations as to the fora best suited to deliver a solution and as to the substantive content of a solution.     

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。     

Informed consent elements. Final rule

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.     

'The good that is interred in their bones': are there property rights in the child?

Bone marrow donation between siblings is a common medical procedure. In some instances, the donor will be a young child incapable of providing either consent or assent, and the intervention is made lawful through the consent of the parent(s). Although a number of justifications have been formulated to cover this act with legitimacy, these fail to describe accurately the transaction that takes place. In the absence of the child authorising his parents to act as his proxy, it is unclear why parental consent is sufficient to permit the redistribution of his biological wealth. Instead, where the donor is such a young child, the whole procedure may be construed as the appropriation of bodily tissue from one unconsenting human and its conveyance to a third, albeit related, party. This paper argues that if the parentally authorised transfer of biological material from an unconsenting human to another is legally permissible, it must be on the basis of an implicitly acknowledged property right in the child.     

Cervical manipulation--how might informed consent be obtained before treatment?

This article discusses methods and mediums of obtaining informed consent in physiotherapy clinical practice, specifically in relation to cervical manipulation. Whilst cervical manipulation is a useful method of treatment for spinal joint pain and dysfunction, it has also been shown to be ineffective or even positively harmful. Legal precedents have set boundaries for informing patients of such adverse consequences. However, a degree of uncertainty exists in the physiotherapy profession, as in other health care professions, as to how to obtain informed consent in a busy clinical setting in order to discharge the legal duties owed. Obtaining meaningful informed consent in clinical practice raises issues of patient comprehension, memory and decision-making capacity. A large quantity of research directed at enhancing patient understanding has been undertaken in recent years. The important findings are that a variety of communication methods and mediums need to be employed in both providing information and assessing patient understanding. A combination of verbal, written and audiovisual information provides patients with maximum opportunity to be involved in treatment decisions.     

医疗的知情同意与个人自由和责任——从肖志军拒签事件切入

从肖志军拒签事件切入,在社会科学的背景下,本文具体分析了医疗法律中的知情同意、紧急情况、强制救治、亲属签字等某些微观制度的安排,力求在患者权利的法律保护以及相关社会和制度背景下展示这些制度的实践意义和可能后果;分析了患者无法回避的责任;并针对中国相关法律制度,提出了一些完善相关法律的建议。     

Competence to consent to treatment as a psycholegal construct

The issue of whether civilly committed patients should be extended the right to accept or refuse treatment has generated much controversy and litigation during the past 15 years. In general, the current rule is that in nonemergency situations, individuals who are competent to give informed consent to treatment should be extended the right to refuse it. Obviously, the manner in which this rule is implemented partly depends on how competence to consent to treatment is defined and measured. Most researchers have implicitly assumed that an understanding of treatment information is the sole criterion of competence. It is argued that such a definition may be incomplete and is in need of reexamination. Following a review and analysis of the relevant legal and psychological literature, a comprehensive construct of competency to consent to treatment is proposed and future directions for research are discussed.