Research ethics committees and paternalism

In this paper the authors argue that research ethics committees (RECs) should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: (1) competent individuals are epistemologically and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the "normal" constraints on people taking risks with themselves; (2) RECs do not judge individual competence (that is for researchers and psychiatrists); (3) individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; (4) RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, (5) the moral and political authority of RECs has not been established in this respect.     

The rights and wrongs of intentional exposure research: contextualising the Guatemala STD inoculation study

In its recent review of the US Public Health Service Sexually Transmitted Disease Inoculation Study, conducted in Guatemala from 1946 to 1948, the Presidential Commission for the Study of Bioethical Issues identified a number of egregious ethical violations, but failed to adequately address issues associated with the intentional exposure research design in particular. As a result, a common public misconception that the study was wrong because researchers purposefully infected their subjects has been left standing. In fact, human subjects have been exposed to disease pathogens for experimental purposes for centuries, and this study design remains an important scientific tool today. It shares key features with other types of widely accepted research on human subjects and can be conducted ethically, provided certain safeguards are implemented. That these safeguards were not implemented in Guatemala is what made that study wrong, rather than the fact of intentional exposure itself. To preserve public trust in the clinical research enterprise, this conclusion ought to be stated explicitly and emphasised.     

Clinical research with economically disadvantaged populations

Concerns about exploiting the poor or economically disadvantaged in clinical research are widespread in the bioethics community. For some, any research that involves economically disadvantaged individuals is de facto ethically problematic. The economically disadvantaged are thought of as "vulnerable" [corrected] to exploitation, impaired decision making, or both, thus requiring either special protections or complete exclusion from research. A closer examination of the worries about vulnerabilities among the economically disadvantaged reveals that some of these worries are empirically or logically untenable, while others can be better resolved by improved study designs than by blanket exclusion of poorer individuals from research participation. The scientific objective to generate generalisable results and the ethical objective to fairly distribute both the risks and benefits of research oblige researchers not to unnecessarily bar economically disadvantaged subjects from clinical research participation.     

Ethical approval in developing countries is not optional

When conducting health and medical research it is important to do the research ethically and to apply for prior ethical approval from the relevant authorities. The latter requirement is true for developed countries as well as developing countries. The authors argue that simply applying for research ethics approval from an institutional review board at a university based in a developed country is not enough to start a health research project in a developing country. The paper also suggests a number of reasons why researchers may fail to seek local research ethics permission in developing countries. The authors use a recent paper reporting research conducted in Nepal and published in an international journal as a case study to highlight the importance of being sensitive to local requirements regarding applying for and registering health and medical research.     

社区卫生服务研究中的隐喻问题

社区卫生服务中的隐喻反映了居民对社区卫生服务的期望和需要。本文归纳了居民对看病、医院和医生的各种隐喻,并探讨了隐喻的修辞意义和认知意义,认为社区卫生服务研究者应从居民的隐喻中找到其对社区卫生服务的期望,并以此为依据制定满足居民愿望和需要的社区卫生服务政策和服务计划。建议重视在社区卫生服务研究中获得包括语言学等社会科学的支持,正确对待在隐喻研究中发现的负面隐喻,建立用事实和居民的认知来检验理论和政策的研究思路,重视认知理论在社区卫生服务研究中的应用。     

Enabling collaborative research using the Biomedical Informatics Research Network (BIRN)

Objective

As biomedical technology becomes increasingly sophisticated, researchers can probe ever more subtle effects with the added requirement that the investigation of small effects often requires the acquisition of large amounts of data. In biomedicine, these data are often acquired at, and later shared between, multiple sites. There are both technological and sociological hurdles to be overcome for data to be passed between researchers and later made accessible to the larger scientific community. The goal of the Biomedical Informatics Research Network (BIRN) is to address the challenges inherent in biomedical data sharing.

Materials and methods

BIRN tools are grouped into ‘capabilities’ and are available in the areas of data management, data security, information integration, and knowledge engineering. BIRN has a user-driven focus and employs a layered architectural approach that promotes reuse of infrastructure. BIRN tools are designed to be modular and therefore can work with pre-existing tools. BIRN users can choose the capabilities most useful for their application, while not having to ensure that their project conforms to a monolithic architecture.

Results

BIRN has implemented a new software-based data-sharing infrastructure that has been put to use in many different domains within biomedicine. BIRN is actively involved in outreach to the broader biomedical community to form working partnerships.

Conclusion

BIRN''s mission is to provide capabilities and services related to data sharing to the biomedical research community. It does this by forming partnerships and solving specific, user-driven problems whose solutions are then available for use by other groups.     

Research on human subjects: Australian ethics committees take tentative steps.

Australian medical researchers are attempting to formulate a response to some of the ethical issues in medical research. The debate over the in vitro fertilisation programme has highlighted some community concern about research ethics and the role of the ethics committee. While very little is known about Australian ethics committees, it appears that a two-tiered approach comprising both ethical review and scientific review is acceptable to the research community. However, this approach plus some problems with the nature of informed consent, begs the question of the role of these committees in the broader context of medical research in the community. Important aspects of a seminar for members of hospital ethics committees are reported.     

社区独居老人健康和生活状况调查

目的 了解独居老人健康状况和生活需求，探讨社区老年保健服务的意义。方法 以访谈的形式对133名60岁以上独居老人进行问卷调查。调查内容包括年龄、性别、文化程度、退休状况、身体状况、服务照顾需求、健康需求、特长爱好、精神文化需求、经济状况等。结果 男性老人的高学历组构成和经济收入均高于女性；79．70％的独居老人患有慢性疾病，且有迫切的健康需求；69．17％的独居老人有一种或多种特长爱好。结论 独居老人有较好的体力和精力。社区应有针对性地提供老年保健服务和文化娱乐活动，提高独居老人的生活质量。     

试析伦理审查会议中的常见问题

伦理委员会会议审查常见问题是会议冗长、效率低、审查水平不能充分体现,这需要伦理委员会规范并完善会议规则、会议程序,对审查的项目进行科学性、伦理性审查,并重点关注基于风险和受益考虑的受试者安全、权益方面的科学性及伦理性,这样不仅能高效有序的进行会议审查,并能不断提高伦理委员及参会主要研究者的伦理素养。     

The role of futility judgments in improperly limiting the scope of clinical research.

In medical research, the gathering and presenting of data can be limited in accordance with the futility judgments of the researchers. In that case, research results falling below the threshold of what the researchers deem beneficial would not to be reported in detail. As a result, the reported information would tend to be useful only to those who share the valuational assumptions of the researchers. Should this practice become entrenched, it would reduce public confidence in the medical establishment, aggravate factionalism within the research community, and unduly influence treatment decisions. I suggest alternative frameworks for measuring survival outcomes.     

Two concepts of therapeutic optimism

Researchers and ethicists have long been concerned about the expectations for direct medical benefit expressed by participants in early phase clinical trials. Early work on the issue considered the possibility that participants misunderstand the purpose of clinical research or that they are misinformed about the prospects for medical benefit from these trials. Recently, however, attention has turned to the possibility that research participants are simply expressing optimism or hope about their participation in these trials. The ethical significance of this therapeutic optimism remains unclear. This paper argues that there are two distinct phenomena that can be associated with the term 'therapeutic optimism'-one is ethically benign and the other is potentially worrisome. Distinguishing these two phenomena is crucial for understanding the nature and ethical significance of therapeutic optimism. The failure to draw a distinction between these phenomena also helps to explain why different writers on the topic often speak past one another.     

"Cold calling" in psychiatric follow up studies: is it justified?

BACKGROUND: The ethics of cold calling-visiting subjects at home without prior appointment agreed-in follow up research studies has received little attention although it is perceived to be quite common. We examined the ethical implications of cold calling in a study of subjects with defined neurotic disorders followed up 12 years after initial assessment carried out to determine outcome in terms of symptoms, social functioning, and contact with health services. The patients concerned were asked at original assessment if they would agree to be followed up subsequently and although they agreed no time limit was put on this. OBJECTIVES: To decide if cold calling was ethically justifiable and, if so, to set guidelines for researchers. DESIGN: The study was a cohort study of patients with neurotic disorder treated initially for 10 weeks in a randomised controlled trial. FINDINGS: At follow up by a research medical practitioner 18 of the 210 patients had died and of the remaining 192 patients 186 (97%) were seen or had a telephone interview. Four patients refused and two others did not have interviews but agreed to some data being obtained. However, only 104 patients (54%) responded to letters inviting them to make an appointment or to refuse contact and the remainder were followed up by cold calling, with most patients agreeing readily to the research interview. The findings illustrate the dilemma of the need to get the maximum possible data from such studies to achieve scientific validity (and thereby justify the ethics of the study) and the protection of subjects' privacy and autonomy. CONCLUSIONS: More attention needs to be paid to consent procedures if cold calling is to be defended on ethical grounds but it is unreasonable to expect this to be obtained at the beginning of a research study in a way that satisfies the requirements for informed consent. A suggested way forward is to obtain written consent for the research at the time that cold calling takes place before beginning the research.     

Net economic costs of dementia in Canada.

OBJECTIVE: To estimate the net economic costs of dementia in Canada in 1991 by comparing costs related to elderly patients with dementia with those related to elderly people without dementia. DESIGN: Cost-of-illness study. DATA SOURCES: Most of the data analysed in this study were from the Canadian Study of Health and Aging (CSHA), in which 10,263 Canadians aged 65 years and over were randomly selected, surveyed and, when appropriate, given clinical examinations. Data on patients with dementia and on people without cognitive impairment (control subjects) were used for this analysis. Data on activities of daily living (ADLs) were taken from a separate study under the CSHA, in which the principal caregivers of the subjects in the prevalence study were interviewed. SETTING: Community and institutional settings in Canada, excluding those in the territories. PATIENTS: All patients with dementia 65 years and older as determined from the CSHA. Patients with dementia under 65 were also considered. OUTCOME MEASURES: Costs of paid and unpaid services in the community, care in long-term care institutions, drugs, hospitalization, diagnosis and research. RESULTS: The total annual net cost of dementia was estimated to be over $3.9 billion. Costs associated with elderly patients in the community were estimated to be $1.25 billion ($615 million for paid services, $636 million for unpaid services), whereas costs for patients in long-term care institutions were $2.18 billion. Costs were about $74 million for drugs, hospitalization and diagnosis, $10 million for research and $389 million related to patients under age 65. CONCLUSION: The annual net economic cost of dementia in Canada is at least $3.9 billion. The most significant component of the total cost was for care in long-term care institutions and for assistance with ADLs by professionals, family and friends in the community. The economic burden of dementia is significant not only for patients, their families and friends, but also for society.     

动物实验在伦理学上可以得到辩护吗?

动物实验在伦理学上可以得到辩护的条件是:经权衡比较后,动物实验是医学科学研究中不得不用的手段;实验动物所遭受的痛苦必须减少到最低水平。动物伦理委员会的审查和相关法律的制定是确保动物实验符合伦理学标准的必要措施。     

Assent in paediatric research: theoretical and practical considerations

Guidelines around the world require children to provide assent for their participation in most research studies. Yet, little further guidance is provided on how review committees should implement this requirement, including which children are capable of providing assent and when the requirement for assent may be waived on the grounds that the research offers participating children the potential for important clinical benefit. The present paper argues that the assent requirement is supported by the importance of allowing children who are capable to make their own decisions. This suggests children are capable of assent when they become able to understand the research in question. While development varies across individual children, existing data suggest most children develop this ability by approximately age 14. Until instruments are developed to assess the assent capacity of individual children, this age should be used as the threshold for assent. In addition, the importance of protecting children from harm suggests that the sustained dissent of all children, including those who are unable to provide assent, should be respected. While the assent requirement may be waived when research participation offers the potential for important medical benefit that is unavailable outside the research context, analysis suggests that children's sustained dissent should be respected in all cases.     

Enhancing the ethical conduct of genetic research: investigating views of parents on including their healthy children in a study on mild hearing loss

Clinical genetic research is often regarded as more ethically problematic than other forms of research, and in some countries is subject to specific regulation, requiring researchers to follow specialised guidelines. In this paper, an approach to enhancing the ethical conduct of genetic research is proposed, which is believed to be more effective than simply attempting to follow general guidelines. The potential concerns, likely areas of misunderstanding and negative reactions of the participant group are systematically investigated before starting a study on genetics. This would constitute, in effect, an ethical pilot study, similar to a feasibility pilot study to test equipment, procedures and logistics. The findings of the ethical pilot study would be used to help in designing ethically important aspects of research protocol, such as recruitment procedures, written and other information for potential participants, informed consent processes and reporting of results including ambiguous or uncertain results.     

Medical research in clinical emergency settings in Europe

Clinical emergencies necessitate immediate action to avert the danger to the patient's life or health. Emergency patients might be in greatest need of novel therapies, and even presumed willing to assume some risk, but research into emergency conditions should be conducted under commonly accepted principles that fulfil the scientific, ethical, and legal criteria. Such criteria already exist in the US, but are still under development in Europe. This article introduces criteria upon which trials in emergency settings may be ethically and legally justified in Europe. Based on both legal texts and professional guidelines, the author has established seven conditions for emergency research, of which informed consent and its substitutes, as well as the conditions of direct benefit requirement and necessity, are considered most problematic and therefore analysed more closely. Other conditions include absence of alternative methods, scientific validity, and approval by an ethics committee.     

104例青年人黄斑色素密度的调查分析

目的研究中国青年人黄斑色素密度(MPOD),以及MPOD与屈光度、性别、吸烟、饮酒、年龄相关性黄斑变性家族史等相关因素的分析。方法 2007级和2008级就读于北京大学医学部预防医学系学生56人以及社会青年志愿者48人,共计104人,208只眼纳入研究,所有受试者完整回答调查问卷,包括是否有吸烟史、饮酒史、黄斑变性家族史等问题,并进行统一流程的屈光度的检查,所有受试者采用异色闪烁光度测量法进行黄斑色素密度的测量。结果全部受试者共208只眼的MPOD均值为0.625±0.191,对所有男性与女性、主导眼与非主导眼、有吸烟史与无吸烟史和有饮酒史与无饮酒史的MPOD值进行比较,差异无统计学意义;对有黄斑变性家族史与无家族史的研究者MPOD值进行比较,差异有统计学意义;MPOD值与屈光度无相关性(r=-0.107,P=0.124)。结论有黄斑变性家族史的青年人MPOD值下降。     

Abortion decisions as inclusion and exclusion criteria in research involving pregnant women and fetuses

From the perspective of investigators conducting research involving pregnant women and fetuses, a woman's decision about whether to have an abortion can sometimes be relevant to the suitability of the woman and fetus as research subjects. However, prominent ethicists disagree over whether it is permissible for a woman's decision about abortion to be an inclusion or exclusion criterion for participation in research. A widely held view is that fetuses to be aborted and fetuses to be carried to term should be treated equally as research subjects. Some hold that this principle implies that a woman's decision about whether to have an abortion should not be an inclusion or exclusion criterion. This paper identifies types of research in which investigators might want to have inclusion or exclusion criteria based on decisions about abortion. It examines the arguments for and against having the woman's decision about abortion included in such criteria. It is argued that there are types of research in which such criteria are ethically permissible.