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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. [ABSTRACT FROM AUTHOR]

Research ethics committees (RECs) are charged with adjudicating the ethical status of research projects, and determining the conditions necessary for such projects to proceed. Both because of their position in the research process and because of the controversial nature of ethical judgements, RECs' views and decisions need to be accountable. In this paper we use techniques of discourse analysis to show how REC decision letters 'do' accountability. Using a sample of 260 letters from three datasets, we identify a range of discursive devices used in letters written by RECs. These include drawing attention to: the process behind the decision, including its collaborative nature; holding the applicants accountable, by implying that any decision made by the REC can be attributed to the performance of the applicants; referring to specialist expertise; and calling upon external authorities. These tactics 'do' accountability by showing that routines of ethical assessment have been enacted, by establishing the factuality of claims, and by managing questions of fault and blame attribution. They may, however, also risk undermining legitimacy by failing to acknowledge the inherent contestability of ethical decision making or the limited nature of the cultural authority accorded to RECs, and thus may appear as an illegitimate exercise of power. [ABSTRACT FROM AUTHOR]

Research that follows people over a period of time (longitudinal or panel studies) is increasingly recognised as of great importance in helping us to understand the ageing process and changes over time in the lives of older people. If people drop out of studies -- which older people are more likely to do -- the value of the study diminishes. This research draws on evidence from ongoing and previous longitudinal studies of people aged 55 and over to examine what factors encourage the retention of participants and what causes them to drop out. The research is synthesising existing evidence, drawing together the experiences of researchers involved in longitudinal studies, and collecting some new evidence about the views of survey participants. This article reports on the first part of the research by drawing together evidence from other studies. These show that there are some factors that are related to attrition whereas for others the evidence is mixed. Methods employed by these studies to reduce attrition and retain participants are examined. It must be noted that apart from the consistent finding that attrition is associated with age, education, socio-economic status and cognitive impairment, not all studies examined the same variables; some only being explored by one study. This makes it difficult to draw any further conclusions and indicates that attrition needs to be addressed in a uniform manner by more studies. This article identifies some implications for policy-makers and practitioners. [ABSTRACT FROM AUTHOR]

Summary: UK National Health Service Trust hospitals are required to report meticillin-resistant Staphylococcus aureus bloodstream infection (MRSA BSI) and also have targets for their reduction. We argue that the MRSA BSI target influences local priorities, and that the high priority given to control of MRSA BSI is not fair or cost-effective when account is taken of the much larger number of patients who develop other types of serious hospital-acquired infection. Reasons for infection control priorities should be made explicit. Use of a formal and reasoned process of priority setting would also counteract the potential distortion of local priorities by national targets. [Copyright &y& Elsevier]

Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection of research participants, confidentiality, recruitment and documentation. Community considerations were least frequently raised. There was evidence of variability in the ethical troubles identified and the remedies recommended. This analysis suggests that some principles may be more institutionalized than others, and offers some evidence of inconsistency between RECs. Inconsistency is often treated as evidence of incompetence and caprice, but a more sophisticated understanding of the role of RECs and their functioning is required. [ABSTRACT FROM AUTHOR]

Pathologists have been establishing archives of human organs and tissue for research use for many years now. Controversy has arisen recently over these collections, particularly with regard to the right of patients or relatives to consent to removal and retention of tissue, genetic research using stored tissue samples, and commercial exploitation of tissue collections and genetic material. This paper discusses the ethics of reusing existing archives of tissue. New archives are established under much more stringent conditions than in the past. What rules should apply to existing archives? Guidelines to regulate such use are useful, but face serious difficulties in balancing the variety of public and private interests relating to tissue banking. Consent cannot be obtained retrospectively, but public trust can be established by open acknowledgement of the evolution of ethical standards and strict adherence to current best practice. Guidelines and standards vary from country to country, but ethical principles should not. The implications of this view for pathologists worldwide are discussed. [ABSTRACT FROM AUTHOR]

This article provides a critical overview of the most important issues pertaining to the ongoing debate on international research ethics. It critically describes three problems of continuing concern: 1) the question of whether the distinction between therapeutic and non-therapeutic research should be upheld; 2) the questions of whether the currently demanded best proven diagnostic and therapeutic method of treatment for all research subjects is feasible both in developed and in developing countries, and whether it should be upheld; 3) the questions of who owns international research ethics guidelines and regulatory frameworks and, how decisions about changes to such international guidelines can possibly be achieved, given that it seems to be the case that genuine disagreement about issues of content is possible and likely. [ABSTRACT FROM AUTHOR]