Building an Opt-Out Model for Service-Level Consent in the Context of New Data Regulations.

The General Data Protection Regulation (GDPR) was introduced in 2018 to harmonize data privacy and security laws across the European Union (EU). It applies to any organization collecting personal data in the EU. To date, service-level consent has been used as a proportionate approach for clinical trials, which implement low-risk, routine, service-wide interventions for which individual consent is considered inappropriate. In the context of public health research, GDPR now requires that individuals have the option to choose whether their data may be used for research, which presents a challenge when consent has been given by the clinical service and not by individual service users. We report here on development of a pragmatic opt-out solution to this consent paradox in the context of a partner notification intervention trial in sexual health clinics in the UK. Our approach supports the individual's right to withhold their data from trial analysis while routinely offering the same care to all patients.

An analysis of decision letters by research ethics committees: the ethics/scientific quality boundary examined.

OBJECTIVES: The performance of NHS research ethics committees (RECs) is of growing interest. It has been proposed that they confine themselves to "ethical" issues only and not concern themselves with the quality of the science. This study aimed to identify current practices of RECs in relation to scientific issues in research ethics applications. METHODS: Letters written by UK RECs expressing provisional or unfavourable opinions in response to submitted research applications were sampled from the research ethics database held by the Central Office for Research Ethics Committees. Ethnographic content analysis (ECA) was used to develop a coding framework. QSR N6 software was used to facilitate coding. RESULTS: "Scientific issues" were raised in 104 (74%) of the 141 letters in our sample. The present data suggest that RECs frequently considered scientific issues and that judgments of these often informed their decisions about approval of applications. Current processes of peer review seemed insufficient to reassure RECs about the scientific quality of applications they were asked to review. CONCLUSIONS: This study provides evidence that scientific issues are frequently raised in letters to researchers and are often considered a quality problem by RECs. In the discussion, the authors reflect on how far issues of science can and should be distinguished from those of ethics and the policy implications.

Interventions for improving patients' trust in doctors and groups of doctors.

BACKGROUND: Trust is a fundamental component of the patient-doctor relationship and is associated with increased satisfaction, adherence to treatment, and continuity of care. It is not clear if there are interventions known to be effective in enhancing patient trust in doctors. OBJECTIVES: To assess the effects of interventions intended to improve a patient's trust in the doctor or a group of doctors. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1 2003), MEDLINE(1966 to week 4 2003), EMBASE (1985 to July 2003), Health Star (1975 to July 2004), PsycINFO (1967 to July 2004), CINAHL (1982 to June 2003), LILACS (1982 to April 2003), African Trials Register (1948 to April 2003), African Health Anthology (1924 to April 2003), Dissertation Abstracts International (1861 to April 2003) and the bibliographies of studies assessed for inclusion. We also searched the bibliographies of studies assessed for inclusion, and contacted researchers active in the field. SELECTION CRITERIA: Randomised controlled trials (RCTs), controlled clinical trials, controlled before and after studies, and interrupted time series studies of interventions (informative, educational, behavioural, organisational) directed at doctors or patients (or carers) where trust was assessed as a primary or secondary outcome. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. MAIN RESULTS: Three RCTs, all published in English and set in North American primary care, and involving 1916 participants, were included. There was considerable heterogeneity in terms of aims, format and content of the interventions. One trial of a training intervention for family doctors to improve communication behaviours (20 doctors assessed by 414 patients) showed no effect on trust. The other two interventions were patient focussed. One explored the impact on trust of disclosing physician incentives to patients (n= 918) in a Health Maintenance Organisation (HMO) and showed no diminution in trust. Another investigated the effect of induction visits on new HMO members' (n=564) trust in their HMO doctors. Trust in doctors rose compared with control following the visit for one type of induction visit, the group visit (Trust out of 10 (standard deviation (SD)) was 8.8 (1.5) and 7.1 (2.2), difference 1.7, (95% confidence interval 1.22 to 2.18)). However there were many drop-outs and analysis was not on intention to treat. AUTHORS' CONCLUSIONS: Overall there remains insufficient evidence to conclude that any intervention may increase or decrease trust in doctors. Further trials are required to explore the impact of policy changes, guidelines and specific doctors' training on patients' trust.

Further ethical and social issues in using a cocaine vaccine: response to Hall and Carter.

Evaluation of the potential of a cocaine vaccine requires a detailed understanding of the intended and unintended social consequences of its use. Prospective technology assessment is always difficult, but in the case of treatment and prevention of cocaine addiction we need to understand not only the neuroscience and pharmacology of cocaine addiction, but also social attitudes to drug use and addiction, the social context of drug use, and the factors which make drug use a rational strategy for an addict and make treatment seeking or relapse more or less likely. By considering different scenarios related to differing levels of effectiveness of the vaccine, the authors argue that vaccination will be at best a useful adjunct to existing methods of treatment, rather than a substitute for them.

Current epistemological problems in evidence based medicine.

Evidence based medicine has been a topic of considerable controversy in medical and health care circles over its short lifetime, because of the claims made by its exponents about the criteria used to assess the evidence for or against the effectiveness of medical interventions. The central epistemological debates underpinning the debates about evidence based medicine are reviewed by this paper, and some areas are suggested where further work remains to be done. In particular, further work is needed on the theory of evidence and inference; causation and correlation; clinical judgment and collective knowledge; the structure of medical theory; and the nature of clinical effectiveness.

American biofutures: ideology and utopia in the Fukuyama/Stock debate.

Francis Fukuyama, in his Our Posthuman Future, and Gregory Stock, in his Redesigning Humans, present competing versions of the biomedical future of human beings, and debate the merits of more or less stringent regimes of regulation for biomedical innovation. In this article, these positions are shown to depend on a shared discourse of market liberalism, which limits both the range of ends for such innovation discussed by the authors, and the scope of their policy analyses and proposals. A proper evaluation of the human significance and policy imperatives for biomedical innovation needs to be both more utopian in its imagination, and more sophisticated in its political economy. In essence, the Fukuyama/Stock debate tells us more about current US political ideology than it does about the morality of human genetic and biopsychological engineering.

Some popular versions of uninformed consent.

A patient's informed consent is required by the Nuremberg code, and its successors, before she can be entered into a clinical trial. However, concern has been expressed by both patients and professionals about the beneficial or detrimental effect on the patient of asking for her consent. We examine advantages and drawbacks of popular variations on consent, which might reduce the stress on patients at the point of illness. Both informed and uninformed responses to particular trials, and trials in general, are discussed. The selection by doctors of patients, to whom entry to trials will be offered, is explored. Alternative forms of consent require restrictions on patients' knowledge, personal responsibility and freedom of choice.

Ethical issues in teleradiology.

Teleradiology is the electronic transmission of radiographic images from one geographic location to another for the purposes of diagnosis and/or consultation. It raises interesting ethical and practical issues which have received relatively little attention in the radiology or ethics literature to date. These include confidentiality, data security and technological reliability, consent, competence, interprofessional and professional-patient relationships, and the organization of medical services. This paper reviews these issues, discussing how far these are new concerns in radiological practice, and makes suggestions for minimum ethical and professional standards for teleradiological practice.

Solidarity, society and the welfare state in the United Kingdom.

Political argument and institutions in the United Kingdom have frequently been represented as the products of a blend of nationalistic conservatism, liberal individualism and socialism, in which consensus has been prized over ideology. This situation changed, as the standard story has it, with the rise of Thatcherism in the late 1970s, and again with the arrival of Tony Blair's "New Labour" pragmatism in the late 1990s. Solidarity as an element of political discourse makes its appearance in the UK late in the day. It has been most strongly linked to the Third Way debate, as framed most influentially in the work of Prof. Anthony Giddens. In this paper we review the history and pre-history of the debate on solidarity in the UK, focussing mostly on its implications for welfare state reform. In particular we discuss the proposals for the long-term care of the Elderly issued by the Royal Commission on long-term care in 1999. In this context we critically examine the idea that solidarity is a new concept in British political culture, and that it is a concept which has real political "bite" in the project of welfare reform. We examine this through a consideration of Gidden's attempted synthesis of political argument and social theory.

Teaching for patient-centred ethics.

In this paper three models of teaching and learning medical ethics are discussed critically, the traditional and revised vocational models, and the patient-centred model. The autonomy-oriented patient-centred ethics of Beauchamp and Childress is rejected in favour of a hermeneutic practical ethics. A performative conception of ethics teaching is recommended as the most appropriate model for use in the theory and practice of ethics pedagogy.

Implications of socio-cultural contexts for the ethics of clinical trials.

BACKGROUND: Health technology assesment (HTA) requires scientifically rigorous experimentation involving patients as subjects. HTA itself is required so that treatment given to patients will be both effective and efficient; this requirement is itself ethical in nature. At the same time it is essential that the methods used in HTA are ethically sound. Most healthcare researchers agree that the most effective and soundest method for assessing treatments is the randomised controlled trial (RCT). However, some researchers believe that the RCT is unethical, either in essence, or for use in some forms of medical research and HTA. Furthermore, many patients seem unable to understand the principles and purposes of the RCT, a factor which is highly detrimental for the validity of informed consent. Informed consent is the key to the ethics of medical research, both in most theories and in all codes of research conduct. Many RCTs therefore risk being unethical in practice, even if ethical in principle. AIM OF REPORT: To survey the main objections to the RCT and its alternatives. To assess the philosophical and methodological basis of these objections, and of the methods recommended for addressing them. To identify areas where objections are founded in social or cultural factors normally overlooked in ethical argument about the RCT methodology. To identify alternative arguments or methods which might resolve ethical conflicts in this area. HOW THE RESEARCH WAS CONDUCTED: The methods used were adapted from systematic reviews in medicine. Systematic searches of Medline, Psychlit and Sociofile CD-ROM databases; hand-searches of the major journals in general medicine and surgery, medical ethics and philosophy; and searches of books were carried out. The literature survey was restricted to articles published or abstracted in English. A database of the most relevant and useful materials was compiled, and is accessible on the Internet (http://www.liv.ac.uk/sdthomps/page1.html). RESEARCH FINDINGS: UNDERSTANDING RCTS AND THEIR ALTERNATIVES: There is some evidence of difficulty in understanding the aims and methods of RCTs, and some disquiet about elements of the RCT methodologies. These objections are well known and much discussed, and concern the use of placebo, the continuation of trials after significant differentials in benefit or harm are apparent, and randomisation. CULTURAL OR RELIGIOUS OBJECTIONS: There was an absence of evidence of cultural or religious objections to randomisation, placebo or other kinds of controlled prospective trials. This most likely reflects an absence of research rather than absence of objections. (ABSTRACT TRUNCATED)