预防接种知情告知专家共识（上）

《中华人民共和国疫苗管理法》和其他相关法律法规对受种者或其监护人的疫苗和预防接种工作知情提出了要求,对预防接种告知方式和内容作出了规定。本共识以该法和《预防接种工作规范》为基础,借鉴国内外经验,阐述了预防接种知情告知的发展和形式,制定了预防接种知情告知理论框架、标准流程和信息、非免疫规划疫苗知情告知原则以及各疫苗知情同...     

Proposing modesty for informed consent

The extension of informed consent into social science research has met with considerable opposition. The history and concept of informed consent, however, is based on a substantive ethical notion of the research relationship as informed and voluntary that is appropriate for social science research relationships. Yet social science research might sometimes be different from health research in ways that justify a different approach to informed consent and research relationships. Social science research tends to have a lower magnitude of risk, usually does not need to disrupt the therapeutic assumption common in health research contexts or when researchers are health professionals, and recruitment is sometimes incremental and reflects a building of trust and development of the research participant's role. These differences may sometimes justify novel approaches to the research relationship and require case-by-case evaluation to determine their relevance to establishing the informed and voluntary nature of the relationship through the use of informed consent procedures. Ultimately, respect for research participants requires social research into practices that can support or replace informed consent. The institutional role of informed consent and the goal of informed and voluntary research participation serve modest but important roles in health and social research. Their proper role in health and social research requires flexibility and experimentation, but does not justify abdication of informed consent or the notion of informed and voluntary participation.     

论生物医学研究中受试者知情同意权的保护

保护生物医学研究中受试者的知情同意权具有重要意义.本文从国内外法律依据、研究者的义务、伦理委员会的作用及受试者自身的维权等方面,探讨如何保护受试者的知情同意权.     

患者知情同意权实施中的问题

从医学伦理学的角度，分析了知情同意权在实施过程中可能出现的一些问题，比如存在“知情同意”与繁复的医疗过程的矛盾、行使“知情同意权”与保护性医疗制度的矛盾、“知情同意”与医患双方医疗知识不平等的矛盾、患方选择与正常医疗行为的矛盾、特殊情况下患方权利人的“知情同意”与医生责任的矛盾等，同时还要考虑医生的因素、病情的因素及患者的因素等。     

Changing constructions of informed consent: qualitative research and complex social worlds

Informed consent is a concept which attempts to capture and convey what is regarded as the appropriate relationship between researcher and research participant. Definitions have traditionally emphasised respect for autonomy and the right to self-determination of the individual. However, the meaning of informed consent and the values on which it is based are grounded in society and the practicalities of social relationships. As society changes, so too do the meaning and practice of informed consent. In this paper, we trace the ways in which the meaning and practice of informed consent has changed over the last 35 years with reference to four qualitative studies of parenting and children in the UK which we have undertaken at different points in our research careers. We focus in particular on the shifting boundaries between the professional and personal, and changing expressions of agency and power in a context of heightened perceptions of risk in everyday life. We also discuss developments in information and communication technologies as a factor in changing both the formal requirements for and the situated practicalities of obtaining informed consent. We conclude by considering the implications for informed consent of both increasing bureaucratic regulation and increasingly sophisticated information and communication technologies and suggest strategies for rethinking and managing 'consent' in qualitative research practice.     

临床医学科研中的知情同意之我见

结合临床医学科研伦理管理中的经验,对知情同意的要素、知情同意的方式、知情同意的主体、知情告知的主要内容、知情告知的过程、知情同意书的签署、知情同意书的保存等方面进行了探讨,提出了一些见解、体会和经验,供广大医学科学研究工作者和医学科研管理人员参考.     

Improving vaccination programmes in the European Union

Aim  In this article, we describe what the role of the European Centre for Disease Control and Prevention (ECDC) is and should be in supporting national vaccination programmes and improving the exchange of data and best practice. Subjects and methods  On the basis of information provided to the ECDC by two networks (EUVAC, VENICE) as well as the World Health Organisation (WHO) data, we examine childhood vaccination programmes in the European Union (EU), components of national vaccination programmes, and decision-making processes both at regulatory (EU) and epidemiological, socio-economic (national) levels. Results  The ECDC provides added value to national vaccination policies by sharing data in the areas of epidemiology, vaccination coverage, vaccine schedules and schemes, and evaluation of national programmes. Conclusion  National sovereignty in the field of vaccination policy should prevail; however, international support is paramount if we wish to enhance performance by sharing experience.     

Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast

In our research unit on the Kenyan Coast, parents sign consent for over 4000 children to be involved in research activities every year. Children are recruited into studies ranging from purely observational research to the testing of new procedures and drugs. Thousands more community members consent verbally or in writing to the interviews and sometimes invasive procedures required in community-based research. Although every study and consent form is reviewed in advance by independent national and international committees, the views and understanding of the 'subjects' of these activities had not been documented before this study. In this paper, we focus on participant understanding of one field-based and two hospital-based studies, all of which involve blood sampling. The findings highlight a range of inter-related issues for consideration in the study setting and beyond, including conceptual and linguistic barriers to communicating effectively about research, the critical and complex role of communicators (fieldworkers and nurses) in consent procedures, features of research unit-community relations which impact on these processes, and the special sensitivity of certain issues such as blood sampling. These themes and emerging recommendations are expected to be relevant to, and would benefit from, experiences and insights of researchers working elsewhere.     

Strengthening vaccination programmes and health systems in the European Union: A framework for action

Vaccination is one of the most cost-effective public health interventions. However, the EU is facing increasing outbreaks of vaccine preventable diseases, with some fatal cases of measles. This paper reviews the main factors influencing vaccination uptake, and assesses measures expected to improve vaccination coverage. Obstacles to vaccination include concerns about vaccine safety and side effects, lack of trust, social norms, exposure to rumours and myths, and access barriers. Responses fall into three broad categories. Regulation, including the introduction of mandatory vaccination, can be justified but it is important to be sure that it is an appropriate solution to the existing problem and does not risk unintended consequences. Facilitation involves ensuring that there is an effective vaccination programme, comprehensive in nature, and reducing the many barriers, in terms of cost, distance, and time, to achieving high levels of uptake, especially for marginalised or vulnerable populations. Information is crucial, but whether in the form of public information campaigns or interactions between health workers and target populations, must be designed very carefully to avoid the risk of backfire. There is no universal solution to achieving high levels of vaccine uptake but rather a range or combinations of options. The choice of which to adopt in each country will depend on a detailed understanding of the problem, including which groups are most affected.     

Risk perception and decision processes underlying informed consent to research participation

According to the rational choice model, informed consent should consist of a systematic, step-by-step evaluation of all information pertinent to the treatment or research participation decision. Research shows that people frequently deviate from this normative model, however, employing decision-making shortcuts, or heuristics. In this paper we report findings from a qualitative study of 32 adolescents and (their) 31 parents who were recruited from two Northeastern US hospitals and asked to consider the risks of and make hypothetical decisions about research participation. The purpose of this study was to increase our understanding of how diabetic and at-risk adolescents (i.e., those who are obese and/or have a family history of diabetes) and their parents perceive risks and make decisions about research participation. Using data collected from adolescents and parents, we identify heuristic decision processes in which participant perceptions of risk magnitude, which are formed quickly and intuitively and appear to be based on affective responses to information, are far more prominent and central to the participation decision than are perceptions of probability. We discuss participants' use of decision-making heuristics in the context of recent research on affect and decision processes, and we consider the implications of these findings for researchers.     

上海市部分公立医院涉及人体的医学研究项目知情同意的效果评价

对上海市40名曾参加过药物临床试验的高校学生进行了有关知情同意方面的问卷调查。结果显示，研究项目知情同意的状况基本被学生受试者接受，但作者建议今后应更好地保护学生受试者。     

Informed consent: Interpretations and practice on social surveys

This paper discusses interpretations and practical requirements for fulfilling informed consent on social surveys, particularly in the health field, in order to achieve a balance between two competing principles: the public good of carrying out high-quality survey research which requires unbiased representative participation; and respect for individuals’ rights to refuse to participate.     

Hepatitis B vaccination coverage and uptake in prisons across England and Wales 2003-2010: a retrospective ecological study

Objective

To describe the custodial hepatitis B vaccination programme performance and examine these data by geographical region and prison category.

Design

Retrospective ecological study.

Data source

Health Protection Agency (HPA) published data.

Setting

Custodial primary healthcare providers located in prisons across England and Wales.

Participants

147 prisons which reported vaccination data between July 2003 and April 2010 to the HPA Prison Infection Prevention team.

Main outcome measures

Hepatitis B vaccination coverage (July 2003 to April 2010) and uptake (December 2007 to April 2010).

Results

Median hepatitis B vaccination coverage was 22% (interquartile range [IQR] 5–49%) and uptake was 36% (IQR 16–59%). Vaccination coverage varied significantly between July 2003 and November 2007 compared to December 2007 and April 2010 (median 12% [IQR 2–31%] versus median 48% [IQR 26–67%], Mann–Whitney W = 14,689,158.0, p < 0.001). There was significant variation between vaccination coverage (Kruskal–Wallis H = 613.44, DF = 9, p < 0.001) and uptake (Kruskal–Wallis H = 247.99, DF = 9, p < 0.001) across the HPA regions. Compared to England and Wales, estimated population median vaccination coverage was significantly (p ≤ 0.05) lower in three regions and one prison category and higher in four regions and seven prison categories; estimated population median vaccination uptake was significantly lower in three regions and three prison categories and higher in two regions and four prison categories.

Conclusion

Prisoners are a vulnerable group with a high prevalence of hepatitis B infection and the custodial setting plays an important role in the delivery of hepatitis B vaccination to this hard to reach group. This study suggests that variation in hepatitis B vaccination coverage and uptake may exist by geographical region and prison category. Further research is required to confirm and identify possible explanations for our findings.     

上海市部分公立医院涉及人体的医学研究项目知情同意的效果评价

对上海市40名曾参加过药物临床试验的高校学生进行了有关知情同意方面的问卷调查.结果显示,研究项目知情同意的状况基本被学生受试者接受,但作者建议今后应更好地保护学生受试者.     

Interest in having HPV vaccination among adolescent boys in England

Background and purpose

The United States’ Centers for Disease Control and Prevention recommends that boys aged 11–12 be vaccinated against HPV to reduce the risk of genital warts and HPV-related cancers. No recommendation has been made in England although there have been calls to widen access to the vaccine. This study aimed to assess boys’ willingness to have HPV vaccination, eliciting reasons for their decisions.

Methods

528 boys aged 16–18 years completed a questionnaire in school. Measures included demographic characteristics, HPV awareness, willingness to have the vaccine, and reasons for the vaccine decision. Coding of open responses was informed by social cognition model constructs.

Results

A large proportion of the sample (41%) intended to have the vaccine, however, slightly more were unsure (49%) and a small number (10%) would not get vaccinated. Uncertainty was associated with lack of previous awareness of HPV and perceived lack of adequate information. Boys who would not have the vaccine did not feel at risk or did not see the need for it.

Conclusion

These preliminary data suggest that HPV vaccination may be acceptable to boys, and confirm previous findings that information is vital in the decision-making process.     

Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast

Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met. Common recommendations to strengthen consent in low income settings include seeking permission from community members through existing structures before approaching individuals, considering informed consent as a process rather than a single event, and assessing participant understanding using questionnaires. In this paper, we report on a qualitative study exploring community understanding and perceptions of a malaria vaccine trial (MVT) conducted in a rural setting on the Kenyan Coast. The MVT incorporated all of the above recommendations into its information-giving processes. The findings support the importance of community level information-giving and of giving information on several different occasions before seeking final individual consent. However, an emerging issue was that inter-personal interactions and relationships between researchers and community members, and within the community, play a critical role in participants' perceptions of a study, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. These relationships are based on and continually tested by information-giving processes, and by context specific concerns and interests that can be difficult to predict and are well beyond the timescale and reach of single research activities. On the basis of these findings, we suggest that the current move towards increasingly ambitious and stringent formal standards for information-giving to individuals be counter-balanced with greater attention to the diverse social relationships that are essential to the successful application of these procedures. This may be assisted by emphasising respecting communities as well as persons, and by recognising that current guidelines and regulations may be an inadequate response to the complex, often unpredictable and ever shifting ethical dilemmas facing research teams working 'in the field'.     

喉癌患者本人知情前后情绪和免疫功能变化的对比研究

目的探讨喉癌患者本人知情同意对情绪和免疫功能的影响。方法60例喉癌患者按随机数字表法分为患者本人知情同意组（A组）30例和家属知情同意组（B组）30例。采用焦虑自评量表（SAS）和抑郁自评量表（SDS）评分评估两组患者知情同意前及术后2周焦虑、抑郁程度;检测两组患者知情同意前及术后2周的细胞免疫功能水平。结果两组知情同意前SAS、SDS评分及细胞免疫功能水平比较差异均无统计学意义（P〉0．05）。术后2周,A组SAS、SDS评分分别为（43．17±7．63）、（37．43±8．69）分,均低于B组的（47．84±8．46）、（42．67±9．82）分,差异有统计学意义（P〈0．05）;A组术后2周CD3、CD4、NK细胞分别为0．5762±0．0941、0．3832±0．0751和0．1521±0．0491,明显高于B组的0．5160±0．0821、0．3140±0．0561和0．1163±0．0422,差异有统计学意义（P〈0．05）,而两组CD8和CD4/CD8比较差异无统计学意义（P〉0．05）。结论本人知情同意有利于缓解喉癌患者术后情绪障碍,并可在一定程度上防止免疫功能下降。     

医疗技术人体试验中受试者的知情同意权

自纽伦堡大审判以来,医疗技术人体试验中取得受试者的知情同意已经成为人体试验的首要原则.受试者知情同意权包括知情权和同意权.对缺陷告知而实质上影响到受试者的选择权或未经受试者同意实施的试验行为,不管在人体试验中试验者是否尽到注意义务,由此试验行为造成的损害均由试验者承担.