Clinical trials in neonates: ethical issues

Clinical trials in neonatology often raise complex ethical problems. This paper suggests that in tackling these it is useful to identify and separate out those elements of the problem that are genuinely ethical (e.g. can I enter a child into a trial if I am not in personal equipoise?) from those that are empirical (e.g. what is the evidence for a treatment's effectiveness?) and those that are formal (e.g. what do codes or the law permit?) The genuinely ethical elements are examples of philosophical problems and must be tackled in a way appropriate to such problems. In practice this usually means some form of systematic argument. This is often frustrating to clinicians who are more used to the assuredness of empirical research. The paper next examines two ethical problems that arise frequently in neonatal trials. The first is equipoise and the related issue of recruiting parents who are not in equipoise because they strongly desire that their baby get the active treatment. We briefly defend the recruitment of such "desperate volunteers". The second is informed consent. We discuss the nature and value of informed consent and suggest that clinicians can often obtain worthwhile consent even in very difficult trials. The final section of the paper uses the example of clinical trials for brain injury to illustrate the difficulties.</p

Should research samples reflect the diversity of the population?

Recent research governance documents say that the body of research evidence must reflect population diversity. The response to this needs to be more sophisticated than simply ensuring minorities are present in samples. For quantitative research looking primarily at treatment effects of drugs and devices four suggestions are made. First, identify where the representation of minorities in samples matters - for example, where ethnicity may cause different treatment effects. Second, where the representation of a particular group matters then subgroup analysis of the results will usually be necessary. Third, ensuring representation and subgroup analysis will have costs; deciding on whether such representation is worthwhile will involve cost benefit analysis. Fourth, the representation of minorities should not be seen as mainly a locality issue. For qualitative research it is argued that the representation of diversity is often important. Given the small samples of many qualitative projects, however, the best way to ensure representation occurs is to allow a proliferation of such research, not to stipulate such representation in samples

Shaping healthy communities: a report on the second symposium on the role of local authorities in reducing health inequalities.

Sheffield City Council achieved Beacon Status for its work on reducing health inequalities in 2007. The Council is hosting a series of three symposiums to promote more effective dialogue and action in this important area of local authority (LA) business. The first symposium - was held on 5th November 2008. This aimed to share an understanding of what works in tackling health inequalities and how, collectively, the region can develop significant and sustainable programmes of work in this area. A report of the symposium was compiled by staff of the Centre for Health and Social Care. The second symposium - was held on 20th July 2009. Its focus was LA practice in tackling health inequality: what are they doing well and where could practice be improved. This document reports from the second symposium

Delivering effective NHS services to our multiethnic population: collection and application of ethnic monitoring within primary care

Government health policy has emphasised the importance of understanding and tackling ethnic disparities in health and healthcare for at least four decades. Yorkshire & the Humber includes areas with large, well-established minority ethnic populations. In addition, most cities in the region, including those that have in the past been dominated by the White British majority, are now experiencing rapid migration. Persistent patterns of health disadvantage among established minority ethnic communities are now compounded by the differing health needs of new migrant populations. NHS organisations in Yorkshire & the Humber have begun to respond more systematically to the needs of minority ethnic groups. However, there is still progress to be made on establishing basic requirements for effective commissioning, including effective ethnic monitoring systems that provide high quality intelligence to commissioners, service managers and health professionals. While there are examples of innovation and good practice, there is significant variation across the region and a lack of sharing and learning between organisations. Here we report on a workshop that was convened by the Strategic Health Authority in June 2009 as a first step towards addressing this recognised area of need. The Workshop Chair was John Chuter, Chair of NHS Bradford & Airedale. The aims of the workshop were to: • Highlight the policy context and imperatives for ethnic monitoring. • Raise awareness of the current position with regard to ethnic monitoring and use of data in Yorkshire & the Humber. • Share emerging good practice. • Identify ways to move forward to improved ethnic monitoring across the region

Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process

Objectives: To assess whether continuous consent, a process whereby information is given to research participants at different stages in a trial, plus clinician training in that process was effective when used by clinicians gaining consent to the TOBY trial. The TOBY trial is a randomised controlled trial investigating the use of whole body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for TOBY is difficult; as such, it is a good test of the effectiveness of continuous consent. Methods: Semi-structured interviews were conducted with 30 sets of parents who gave consent to TOBY and with 10 clinicians who sought it using the continuous consent process. Analysis focused on the validity of parental consent based upon the consent components of competence, information, understanding and voluntariness. Results: 19/27 (70%) couples had no significant problems with consent validity at the point of signature. Problems lay mainly with the parents’ competence and understanding. Mothers particularly had competence problems in the early stages of consent. The understanding problems were primarily to do with side effects. Problems in both areas (competence and understanding) reduced markedly, particularly for mothers, in the post signature phase when further discussion took place. Randomisation was generally understood but unpopular. Clinicians did not always give information in stages during the short period of time available before parents gave consent. However, most clinicians were able to give follow up information. Discussion: The consent validity compares favourably with similar trials examined in a comparable study (the Euricon study). Conclusion: Researchers should consider adopting elements of the continuous consent process and clinician training in RCTs, particularly where they have concerns about the quality of consent they are likely to obtain using a conventional process.</p

Should desperate volunteers be included in randomised controlled trials?

Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. Some claim this practice is unethical for at least three reasons. The first is that the notion of equipoise, which is often used as a justification for running a RCT, is subjective and value-based. Desperate volunteers are clearly not in equipoise and it is their values that should take precedence. The second is that clinicians who enter patients onto trials are disavowing their therapeutic obligation to deliver the best treatment to patients; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. This leads to the third reason: desperate volunteers do not give a proper consent; they are, in effect, coerced. We begin our reply by advocating a notion of equipoise based on, first, expert knowledge and, second, widely shared values. Where such collective, expert equipoise exists there is a prima facie case for a RCT. Next we argue that trial entry does not involve clinicians’ disavowing their therapeutic obligation; individualised care based on whims and fancies is not in patients’ best interest. Finally, we argue that where equipoise exists it is acceptable to limit access to experimental agents. In the cases desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire. </p