Governing health services research: is it working?

Research governance is an issue that constantly troubles our members who feel that a system that has been set up to deal with clinical research unfairly places an excessive level of regulatory burden on much lower risk HSR, which is largely non-clinical and non-invasive. As part of HSRN's programme of work looking at this issue, we commissioned Mary Dixon Woods and Karen Yeung to write this viewpoint to help us understand and provide some questioning of how the current system operates. The views expressed are those of the authors and not necessarily those of the HSRN

Why do people cooperate with medical research? Findings from three studies

In this paper, we distinguish decisions about cooperation with medical research from decisions about research participation. We offer an empirical and theoretical exploration of why people in three different UK-based medical research projects chose to cooperate. Data analysis of the accounts of 128 participants across the three studies was based on the constant comparative method. Participants' cooperation was engaged by a perception that they would be contributing to the ‘public good’, but they also wanted to justify their decision as sensible and safe. Critical to their cooperation was their belief that researchers would fulfil their side of the cooperative bargain, by not exposing participants to risks of harm or exploitation. Although participants were generally unaware of the details of the regulatory regime for research, they demonstrated a generalised reliance on regulation as a feature of everyday life that would provide a safe context for cooperation. In their assessment of particular projects, participants made judgements about whether to cooperate based on more specific cues, which acted as signs to assure them that researchers shared their cooperative intentions. These cues included organisational and professional credentials, the role identities and perceived trustworthiness of those involved in recruiting to research, and visible signs of reasonable practice mandated by regulatory systems. Thus participants drew on their understandings of an institutional field that was much broader than that of research alone. We propose that the social organisation of research is fundamental to the judgements people make about cooperation with research. Cooperation may be a more useful way of thinking about how people come to engage in collaboratively oriented actions such as research participation, rather than currently dominant individualistic models. Attention to the institutional context of research is critical to understanding what makes cooperation possible, and has important implications for the design of regulatory regimes for research

Prostate specific antigen testing for prostate cancer

Prostate specific antigen testing for prostate cance

Qualitative research in systematic reviews

Qualitative research in systematic review

Defending Rights or Defending Privileges? Rethinking the ethics of research in public service organizations

Conducting research in public services organizations raises important but often neglected questions about the status of managers and staff as research subjects. An approach that prioritizes the protections and entitlements due to research subjects may thwart the public interest. An approach that grants laissez faire to researchers may threaten the legitimate rights and interests of managers and staff. Ethics review systems are currently poorly equipped to engage in useful debates about the drawing of appropriate boundaries for inquiry. We urge a recasting of the role of ethics review from research subject's sole protector to honest broker

Research involving adults who lack capacity: how have research ethics committees interpreted the requirements?

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 are

Do research ethics committees identify process errors in applications for ethical approval?

We analysed research ethics committee (REC) letters. We found that RECs frequently identify process errors in applications from researchers that are not deemed “favourable” at first review. Errors include procedural violations (identified in 74% of all applications), missing information (68%), slip-ups (44%) and discrepancies (25%). Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled

Researching chronic childhood illness: the example of childhood cancer

Objectives: To provide an overview of issues raised by conducting research in the area of chronic childhood illness, using the example of childhood cancer. Methods: This literature review used informal methods. Results: Children with cancer and their families may participate in a wide variety of studies in different research traditions, including social science studies, epidemiological, biological and genetic research, and clinical trials. Different concerns about research participation have been raised in these different contexts. Sociological debate has tended to characterize exclusion from research as a manifestation of assumptions of poor competence on the part of children, and to see inclusion in research as a means of restoring proper balance in power relations and giving children a voice. The ethical imperative within clinical research, on the other hand, has been in favour of protection of individuals from risk or direct harm. Lack of consensus on issues such as the status of children’s consent for research participation persists, in part because debates have taken place within rather than across disciplinary boundaries, and in part because of a tendency to debate issues as ethical principles in an empirical vacuum. The lack of research on the experiences and views of those asked to take part in childhood cancer research is striking. Discussion: It is important that debates about the involvement of children in research are informed by high-quality social science research and by interdisciplinary dialogue

What is the right approach to infection prevention and control for children living at home with invasive devices

Infection prevention and control (IPC) efforts and research thus far have primarily focused on the acute care setting and on the behaviours and practices of healthcare workers, but recognition is increasingly growing that infection risks are not contained within organizational boundaries, and that many individuals who are not healthcare professionals may be involved in managing those risks. Children living long-term with invasive devices such as central lines, gastrostomy tubes, dialysis catheters, and tracheostomies are an example of a patient group that is particularly vulnerable to infection and who may be cared for primarily at home by family members.1 and 2 The number of these children appears to have increased rapidly in recent years, largely due to changing patterns of care for children, and to therapeutic advances in neonatology, oncology, cardiology, and transplant medicine (to name but a few).3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 Caring for children in their own homes has significant benefits for their quality of life, but this places special demands on families, who have to deliver complex care.13, 14, 15 and 16 These children have a high rate of unplanned hospital admissions for infective complications, causing disruption to the children and their families.17 and 18 Infection and its possible consequences are a source of pervasive anxiety and fear for families, given the risks associated with long-term antibiotics and vulnerability to sepsis.19, 20 and 21 The implications for health services are also significant: it costs almost US$70,000 to treat a central line infection in a child.22 and 23 Yet the rise of homecare for children with complex medical needs has not been accompanied by a parallel rise in the recognition of these risks, nor in the development of strategies to mitigate them.24, 25, 26 and 27 The ways in which families and children may best be supported in preventing and controlling infection in the community remain poorly understood

The role of primary care professionals in women's experiences of cervical cancer screening: a qualitative study

BACKGROUND: The UK Cervical Screening Programme, delivered mostly through primary care, commands impressive levels of public support. However, considerable evidence suggests that women find the experience of screening problematic. OBJECTIVE: To investigate this tension using women's accounts of cervical screening, with a view to informing practice to better meet their needs. METHODS: A qualitative interview study with 34 participants focussed on their experiences and understandings of cervical cancer screening in the UK. Analysis was based on the constant comparative method. RESULTS: The highly intimate and personal nature of the test is challenging, and many women report unsatisfactory experiences. Problematic issues include: embarrassment and discomfort (sometimes severe) in exposing an intimate and personal part of their body; surrendering control and finding the test painful, uncomfortable and personally threatening. Though there is an important role for primary health care professionals in easing discomfort and facilitating positive experiences, women often report feeling disappointed with how the procedure is conducted. Women suggest that practitioners' attempts to normalize the interaction and maintain a degree of detachment could have the perverse effect of making them feel more uncomfortable and that more personalization would be welcome. CONCLUSIONS: This work identifies the ways in which women may find personal engagement with cervical screening difficult and demonstrates the important role of primary care practitioners in contributing to women's experiences of the encounter. We draw on Erving Goffman's work on the 'interaction order' to explain some of the problems reported by women and to help inform good practice in primary care