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

Abstract

NHS R&D HTA Programme T he overall aim of the NHS R&D Health Technology Assessment (HTA) programme is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and work in the NHS. Research is undertaken in those areas where the evidence will lead to the greatest benefits to patients, either through improved patient outcomes or the most efficient use of NHS resources. The Standing Group on Health Technology advises on national priorities for health technology assessment. Six advisory panels assist the Standing Group in identifying and prioritising projects. These priorities are then considered by the HTA Commissioning Board supported by the National Coordinating Centre for HTA (NCCHTA). This report is one of a series covering acute care, diagnostics and imaging, methodology, pharmaceuticals, population screening, and primary and community care. It was identified as a priority by the Methodology Panel (see inside back cover). The views expressed in this publication are those of the authors and not necessarily those of the Standing Group, the Commissioning Board, the Panel members or the Department of Health.

Representation of South Asian people in randomised clinical trials: analysis of trials' data

“…Excluding patients of ethnic minority groups from clinical trials is unethical,1 introduces substantial bias, and means that findings are based on unrepresentative populations 2. The National Institutes of Health Revitalization Act 1993 requires that all minority groups be represented in the sample in research projects supported by the National Institutes of Health, unless there is a clear and compelling justification not to do so.…”

Including Culturally Diverse Samples in Health Research: A Case Study of an Urban Trial of Social Support

“…Our experience in recruiting to the SSFH Study also highlights certain critical assumptions of the 'normal' consent process which may be challenged in culturally diverse contexts. A review carried out for the Health Technology Assessment Programme found a similar variation by cultural group in the desire for information in the consent process and the role of the family and others (Ashcroft et al 1997). There are issues about cultural differences in literacy and the reliance on written materials in research that we have not explored; for example, the relationship between the written and spoken word is not necessarily the same in South Asian as it is in Western languages.…”

“…Not very much is known about the resources and strategies needed to promote the inclusion of socially heterogeneous samples in health research (Ashcroft et al 1997), and there has been little formal evaluation of recruitment strategies (Swanson and Ward 1995). This paper reports on one attempt to recruit a multi-ethnic and multi-language sample in a study of social support for families living in a socially disadvantaged area of London.…”

“…Heterogeneity of research participants, where this reflects the populations from which they are drawn, expands the external validity of research findings by increasing the representativeness of research samples (Anderson 1983), though these issues vary in relevance across different study designs and research questions. People also have a right to participate in research, and researchers have an obligation to treat potential participants equitably (Ashcroft et al 1997). However, while complete, comprehensive and standardized description of recruitment information in research reports is recommended (Prescott et al 1999), and there is increasing attention to ethical issues in research design (Edwards et al 1998), the reporting of much research falls short of these standards.…”

European register of patients with sickle cell disease treated with hydroxyurea is being set up

“…Many reasons are cited for low patient recruitment into trials which necessarily will be aggravated in patient groups who may already consider themselves misunderstood by society,3 as is reported in sickle cell disease. In a pilot study of combination treatment with hydroxyurea and a short chain fatty acid, sodium valproate, we were able to recruit, albeit slowly, the 10 patients we needed.…”