Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. We present a (...) case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public health research project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant funded research, and in our case £560 000 of public and charitable money was spent on research staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities to research ethics committees, and by allowing “opt-out” consent for many public health research projects. (shrink)

The field of bioethics is increasingly coming into contact with empirical research findings. In this article, we ask what role empirical research can play in the process of ethical clarification and decision-making. Ethical reflection almost always proceeds in three steps: the description of the moral question,the assessment of the moral question and the evaluation of the decision-making. Empirical research can contribute to each step of this process. In the description of the moral object, first of all, empirical research has a (...) role to play in the description of morally relevant facts. It plays a role in answering the “reality-revealing questions” (what, why,how, who, where and when), in assessing the consequences and in proposing alternative courses of action. Secondly, empirical research plays a role in assessing the moral question. It must be acknowledged that research possesses “the normative power of the factual,” which can also become normative by suppressing other norms. However, inductive normativity should always be balanced out by a deductive form of normativity. Thirdly, empirical research also has a role to play in evaluating the decision-making process. It can rule out certain moral choices by pointing out the occurrence of certain unexpected consequences or effects. It can also be useful, however, as a sociology of bioethics in which the discipline of bioethics itself becomes an object of research. (shrink)

Conducting research with vulnerable populations involves careful attention to the interests of individuals. Although it is generally understood that informed consent is a necessary prerequisite to research participation, it is less clear how to proceed when potential research participants lack the capacity to provide this informed consent. The rationale for assessing the assent or dissent of vulnerable individuals and obtaining informed consent by authorized representatives is discussed. Practical guidelines for recruitment of and data collection from people in the middle or (...) late stage of dementia are proposed. These guidelines were used by research assistants in a minimal risk study. (shrink)

Commerce can be defined as an exchange of goods and services using money as the medium for the exchange. People engage in commerce to make money. It has the potential to remain morally neutral. But when the emphasis on making money becomes the goal or value that directs the process, rather than the value of the endeavor itself, things can become distorted. Making money as a primary goal is understood and recognized for the venture capitalist, but it is less attractive (...) when identified as the goal of medical care. Society, or at least medical practitioners, hold their profession to duties beyond the pursuit of personal gain. Medical duties toward beneficence, justice, and respect for autonomy are deemed far too important to be distracted by the desire for financial reward. Any conduct that seems to place the physician's self-interest above that of the patient's reduces the respect and moral authority claimed by the profession. (shrink)

The specific problems of consent for the mentally incompetent are reviewed. Scientific research is essential to test the validity of present treatments and to develop new ones. The respective roles of the physician and the researcher have to be clearly defined. The vulnerability of psychiatric patients has to be taken into consideration in such a way that some research can be conducted. It is emphasised that the ethical restrictions for research, although highly justified and necessary, are in part responsible for (...) the relatively slow progress in the application of modern neurosciences to psychiatric diseases. (shrink)

Taking the critical turn is one of the main tools of the humanities and inculcates an intellectual discipline that prevents ossification of thinking about issues and of organizational policies in clinical ethics. The articles in this "Clinical Ethics" number of the Journal take the critical turn with respect to cherished ways of thinking in Western clinical ethics, life extension, the clinical determination of death, physicians' duty to treat even at personal risk, clinical ethics at the interface of research ethics, and (...) the pertinence of the Hippocratic Oath to clinical ethics. These articles challenge clinical ethicists to inculcate the intellectual discipline of the critical turn into everyday practice and continuous quality enhancement of clinical ethics. (shrink)

The study reported in this paper explored the ethical requirements of social research participants, an area where there is still little empirical research, by interviewing people who had participated in one of five recent social research studies. The findings endorse the conceptualization of informed consent as a process rather than a one-off event. Four different dynamics of decision-making were followed by participants in terms of the timing of decisions to participate and the information on which they were based. Multiple information (...) events were important, as was verbal as well as written information. Study participants reacted unfavourably to the idea of written consent. Although prior information was relevant to participant experience of the interview, what emerged more strongly as relevant was the behaviour of interviewers and the interviewing strategy used. The authors suggest that naturalistic, authentic approaches to information-giving are necessary, and that in scrutinizing them research ethics committees need to look not only at written information but also at verbal information giving, and how interviewer information-giving is supported by training and supervision. They suggest that committees also need to concern themselves more broadly with who will carry out interviews and the training, mentoring and monitoring in place to shape their conduct of interviews. In considering research instruments, research ethics committees need to consider not only whether interviewers will capture accurate and appropriate data but also whether they are likely to lead to a satisfactory interaction for participants. Given the impossibility of anticipating each individual participants information needs and their reaction to the interviewing strategy, the authors suggest that interviewers and participants need to be encouraged to negotiate the conduct of interviews jointly, and discuss how such negotiating roles might be supported. (shrink)

Doctors have an ethical and legal duty to respect patient confidentiality. We consider the basis for this duty, looking particularly at the meaning and value of autonomy in health care. Enabling patients to decide how information about them is disclosed is an important element in autonomy and helps patients engage as active partners in their care.Good quality data is, however, essential for research, education, public health monitoring, and for many other activities essential to provision of health care. We discuss whether (...) it is necessary to choose between individual rights and the wider public interest and conclude that this should only rarely be necessary. The paper makes some recommendations on practical steps which could help ensure that good quality information is available for work which benefits society and the public health, while still enabling patients’ autonomy to be respected. (shrink)

This paper highlights a feature common to many ethical guidelines—namely, the idea that the interests of the individual shall always prevail over the interests of science and society. The paper presents how some major ethical guidelines treat the balancing of research interests against those of research subjects and spells out the difficulties in interpreting the principle of the primacy of the individual in a way that can be action-guiding. It suggests various alternative interpretations of the primacy of the individual and (...) argues that they do not hold. Finally, the implications of this analysis for ethical guidelines are discussed. (shrink)

Freely given informed consent to participation is the ethical cornerstone of research in health care. However, in mental health settings, there are many patients who lack the capacity to give such consent to participate in research. There is an abundance of guidance now available on how researchers might think about this issue and the Royal College of Psychiatrists has also recently reviewed its guidance to members about the ethics of research. In this piece, I will discuss some of the issues (...) that were raised during the revision process, and add some reflections of my own. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

There has been longstanding interest in the consistency of decisions made by research ethics committees in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on seven applications. An (...) analysis of the agreement between decisions of RECs yielded an overall measure of agreement of κ = 0.286 , indicating a level of agreement that, although probably better than chance, may be described as “slight”. The small sample size limits the robustness of these findings. Further research on reasons for inconsistencies in decision making between RECs, and on the importance of such inconsistencies for a range of arguments, is needed. (shrink)

Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. We present a (...) case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public health research project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant funded research, and in our case £560 000 of public and charitable money was spent on research staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities to research ethics committees, and by allowing “opt-out” consent for many public health research projects. (shrink)

Two separate regulatory regimes govern research with adults who lack capacity to consent in England and Wales: the Mental Capacity Act (MCA) 2005 and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Regulations”). A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements. With the use of a coding scheme and qualitative software, a sample of REC decision letters where applicants indicated that their project involved adults who lacked mental capacity was analysed. (...) The analysis focuses on 45 letters about projects covered by the MCA and 12 letters about projects covered by the Regulations. The legal requirements for involving incapacitated adults in research were not consistently interpreted correctly. Letters often lacked explicitness and clarity. Neither consent nor assent from third parties is a legally valid concept for purposes of the MCA, yet they were suggested or endorsed in 10 post-MCA letters, and there was evidence of confusion about the consultee processes. The correct terms were also not consistently used in relation to clinical trials. Inappropriate use of terms such as “relative” had the potential to exclude people eligible to be consulted. Unless the correct terms and legal concepts are used in research projects, there is potential for confusion and for exclusion of people who are eligible to be consulted about involvement of adults who lack capacity. Improved clarity, explicitness and accuracy are needed when submitting and reviewing applications for ethical review of research in this area. (shrink)

Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences of the pediatric (...) oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents. Due to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes. (shrink)

Informed consent is increasingly heralded as an ethical panacea, a tool to counter autocratic and paternalistic medical practices. Debate about the implementation of informed consent is constricted and polarised, centring on the right of individuals to be fully informed and to freely choose versus an autocratic, paternalistic practice that negates individual choice. A bioethical framework, based on a principle-led form of reductive/deductive reasoning, dominates the current model of informed consent. Such a model tends to abstract the process of consent from (...) its clinical and social setting. By fleshing out the social process involved when patients and healthy volunteer subjects consent to take part in clinical drug trials, this paper attempts to address the problem arising from the current ‘empty ethics’ model. My arguments are substantiated by qualitative interview data drawn from a study I conducted on the process of consent as experienced by participants in clinical drug trials. (shrink)

Despite the burgeoning of publications in nursing ethics, only more recently has empirical evidence on nursing ethics been published. How nursing ethics can be empirically studied as well as enriched by empirical data will be the focus of this paper. Two empirical studies will be briefly presented and their contribution to ethics discussed. The first one is a quantitative research project about nurses' ethical behavior in daily practice. Using an adapted version of Kohlberg's theory of moral development, this study tried (...) to describe and explore nurses' responses to ethical dilemmas in daily nursing practice. The second study attempted to describe the specificity of residential palliative care. A qualitative approach was used to explore and describe the processes that take place on an inpatient palliative care unit, and the experiences of patients, relatives and palliative care team members. The analysis of the value of both research projects for ethics underlines the power of empirical understanding in the relationship between research and ethics. The need for integration of both qualitative and quantitative research methodologies is argued. (shrink)

In 2011, the Department of Health and Human Services proposed changes to the regulations that govern human subjects protection in federally funded research. The proposed changes involve modifying inclusion standards for minimal-risk research and removing the necessity of review from certain categories of noninvasive research. All studies would instead be required to comply with privacy protections as initiated by the Health Information Portability and Accountability Act . We argue that relying on HIPAA to protect participants from participation-related risks in noninvasive (...) research is insufficient to protect the autonomy and psychological health of potential research participants. Instead, we suggest a streamlined review format for these categories of research. (shrink)

This paper recognizes the complexity of the debate on informed consent and discusses the importance of the ongoing process of consent for people affected by Huntington's disease (HD). Although written information may not be the most appropriate form of obtaining informed consent in qualitative research, it remains an important part of the ethical approval process for health research in the UK. This paper draws on a study in which the information sheet and consent form were specifically designed to help obtain (...) consent from people who may be impaired by the cognitive and physical effects of HD. The forms were developed by drawing on expert opinion and relevant literature and fall in line with recommendations from the Mental Capacity Act 2005 to encourage people to make their own decisions. The paper describes the feasibility of a method for obtaining consent as an ongoing process with patients affected by HD using information sheets and consent forms specifically designed for people with potential cognitive and/or physical impairments. In conclusion, this paper adds a pragmatic approach to the debate on informed consent by describing the development of a written information sheet and consent form being used in a current social research study. Particular emphasis is placed on the importance of written information being adapted according to the needs of potential participants. (shrink)

The World Medical Association's Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been revised six times in an effort to maintain its (...) influence. While all revisions were the result of vigorous debate, the 2000 revision and two subsequent notes of clarification spurred particular controversy surrounding the use of placebo in clinical research and the standard of care and post-trial obligations in research in developing countries. Several institutions opted to cite earlier versions of the Declaration, and the U.S. Food and Drug Administration recently removed all reference to the Declaration in its approval requirements for drugs and biological products that are studied outside the United States. (shrink)

The Tuskegee Syphilis Study is surrounded by illuminating misconceptions—myths that cannot be blithely dismissed because they actually provide some insight into the significance of the study. One of those is that the men were deliberately infected with syphilis; another is that they obtained no treatment for the disease. Some other errors are alleged in two recent articles about the study, but these articles themselves create their own fictions.

The turn to empirical ethics answers two calls. The first is for a richer account of morality than that afforded by bioethical principlism, which is cast as excessively abstract and thin on the facts. The second is for the facts in question to be those of human experience and not some other, unworldly realm. Empirical ethics therefore promises a richer naturalistic ethics, but in fulfilling the second call it often fails to heed the metaethical requirements related to the first. Empirical (...) ethics risks losing the normative edge which necessarily characterizes the ethical, by failing to account for the nature and the logic of moral norms. I sketch a naturalistic theory, teleological expressivism (TE), which negotiates the naturalistic fallacy by providing a more satisfactory means of taking into account facts and research data with ethical implications. The examples of informed consent and the euthanasia debate are used to illustrate the superiority of this approach, and the problems consequent on including the facts in the wrong kind of way. (shrink)