瑞典修改《医疗生物银行法》对我国的启示

瑞典的《医疗生物银行法》在实施过程中出现适用范围有限、伦理原则缺失、有关职责界定不清等问题，科学界和医疗界提议出台新的生物银行法以替代旧法，促进医疗领域健康发展。瑞典新的生物银行法报告在尊重个体完整和隐私的前提下，将监管所有人类组织样本的收集、存储和使用，并将完善样本捐献者的知情同意，强化样本捐献者的自决权，增加可追溯性规定和样本库个人资料处理原则，申明生物样本跨界合作的安全问题，对正在修订《涉及人的生物医学研究伦理审查办法》的我国具有借鉴意义。     

Ethical Issues in Coparent Counseling

Coparent counseling is a method of helping moderate- and high-conflict divorced or separated parents improve their shared caretaking of their children. Because it is a relatively new modality, its practitioners face ambiguity and uncertainty in their efforts to practice ethically. In the present article, information and recommendations are provided regarding confidentiality, separate meetings with parents, interactions with attorneys and the court, meetings with the children, insurance billing, competence, and informed consent.     

Challenges of operationalizing trauma‐informed practice in child protection services in New Zealand

New Zealand is undergoing major change in service delivery to children and families. A new Ministry for Children Oranga Tamariki has been established to oversee 5 work streams, one of which provides intensive intervention with families requiring a statutory response to child protection concerns. The government minister responsible promised that the service would be child‐centred and trauma‐informed. To date, these terms remain undefined, and there is no shared understanding of their meaning. Practice frameworks to support the work of the new ministry are still being developed, creating something of a vacuum in the meantime. The focus of this paper is the challenge of implementing trauma‐informed practice in the child protection service provided by the Intensive Intervention work stream. Limited research or commentary on trauma‐informed practice in this context currently exists. Drawing on the relevant available literature, the concept and its application in child protection social work is explored. An ecological framework is used to discuss the changes needed to achieve this. Particular attention is paid to the impact of historical trauma for indigenous people due to New Zealand's colonial history and their over‐representation in care and protection services.     

Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network

PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.     

同意观念的历史谱系与当代困境

通过提出明示同意与默示同意这两个不同的同意概念并强调有别于集体同意之个体同意的重要性，特别是通过对默示同意的分析和说明，洛克使得近代意义上的同意理论逐渐浮出水面。同意理论在颠覆君权神授理论、确认人民主权思想的过程中有着无可置疑的历史价值。虽然在现当代，同意理论因遭遇到越来越多的诟病而逐渐步入困境，但同意理论并非一无是处。对于当代中国社会来说，强调政府及政府行为必须经过人民的同意这一点，对于政治体制的改革以及政治秩序的合法构建来说仍然具有极为重要且深远的意义。     

Applying the ‘Experience-Near’ Principle To Research: Psychoanalytically Informed Methods1

This article is about how to preserve the vitality of the meaning conveyed to social science researchers by participants. I use the example of a qualitative, psycho-social project on the topic of how women's identities change when they become mothers for the first time. Psychoanalysis was used and adapted to understand both participants' and researchers' experience, and the relation of these to each other. I describe two psychoanalytically informed research methods, free association narrative interviewing and infant observation, and give examples of how, separately and together they can go beyond a text-based method and conceptualise identities in ways that avoid reproducing assumptions of rational, unitary, discursive subjectivity. In assessing how well the two methods worked, I focus my discussion on the observation method using four themes: dimensions of time, embodiment and practices, spatial sensitivity and multiple positioning, and how knowing is accomplished in research.     

“Consent is sexy”: A poster campaign using sex-positive images and messages to increase dyadic sexual communication

Abstract

Objective: “Consent is Sexy” (CIS) is a poster campaign incorporating sex-positive messages to promote consent and increase sexual communication among college students. We assess reactions to the campaign and associations between campaign recall and communication attitudes and behaviors. Participants: Male and female undergraduates at a Midwestern university were recruited (N?=?284). Methods: A cross-sectional survey was conducted. t-Tests, logistic and multiple linear regressions were used to analyze the data. Results: Over half (56%) of participants recalled the campaign and reactions were positive. Students who recalled CIS had more positive attitudes towards sexual communication (p?=?.04) and greater perceived behavioral control (PBC; p?<?.01). Conclusions: Results show many students paid attention and reacted positively to CIS posters and results offer dissemination insights. Consent campaigns should continue to cultivate positive attitudes and PBC in regards to sexual communication.     

Understanding sex: the right to legal capacity to consent to sex

This article addresses the right to legal capacity to consent to sex of people with intellectual disabilities. Article 12 of the Convention on the Rights of Persons with Disabilities guarantees the right to legal capacity on an equal basis in all areas of life. This article discusses sex as an area of life in which people with intellectual disabilities are frequently not being granted legal capacity on an equal basis. The article examines current capacity to consent to sex law in Ireland, England and Wales in light of Article 12. It proposes an ‘agreement model’ as a potential alternative that would be Article 12 compliant.     

Competence and consent to research: A critique of the recommendations of the national bioethics advisory commission*

Concern about the participation of incompetent subjects in psychiatric research has grown in the last several years. In response, the National Bioethics Advisory Commission (NBAC) recommended in its recent report that all investigations involving persons with mental disorders that may be associated with cognitive impairment that may pose greater than minimal risk to subjects utilize independent assessors to verify the capacities of subjects prior to entry into the study. This recommendation poses several problems for the conduct of research and the protection of research subjects. First, it fails to target that group of subjects most likely to be at risk for incapacity. Second, it focuses on too broad a range of research projects, many of which pose little risk to participants. The substantial costs of this approach are therefore not likely to be outweighed by concomitant benefits. In place of the NBAC recommendation, the author proposes a more flexible system of capacity assessment, designed to balance the costs with a greater likelihood of achieving meaningful protection for research subjects with mental disorders.     

Accountability in research using persons with mental illness

Although medical research involving the use of persons with mental illness is critically important, in order for the research to be ethical and legal there are certain considerations and restrictions which should be immediately readdressed in order to insure that the welfare of these vulnerable research subjects is protected, and their best interests are assured. A brief historical examination of medical research codes, guidelines, recommendations and Federal Regulations reveals the various considerations and restrictions on informed consent and accountability applicable to the use of persons with mental illness in medical research. Several concerns are raised about how these considerations and restrictions have been interpreted, and specific recommendations are offered to improve them immediately by means of representation from consumers and/or their families, and organizations, e.g., NAMI members.