The problem/issue

‘Virtual Organisations for Trials and Epidemiological Studies (VOTES)’ is a major collaborative research project that aims to develop a validated Grid-based resource to provide an infrastructure for efficient recruitment, data collection and management, study administration and coordination in large-scale randomised trials and observational studies. The VOTES project is a collaboration between the universities of Oxford, Glasgow, Leicester, Manchester, Nottingham and Salford; the National e-Science Centre, the London e-Science Centre and Imperial College London. The project is funded by the Medical Research Council.

A ‘Grid’ can be defined as a software infrastructure (including computer systems and data storage resources) that enables flexible, secure, co-ordinated resource sharing among dynamic collections of individuals, institutions and resources (e.g. databases). In the context of epidemiological research Grid-based resources of this kind offer the potential for improved procedures for patient identification and recruitment, data collection and study management. For example, subject to strict ethical, data-protection and security constraints, information could be shared between databases established for routine clinical use (such as general practice and hospital records).

The successful and appropriate research use of Grid-based resources depends upon identification and analysis of the key ethical and regulatory issues and the development of appropriate forms of support and training for researchers and clinicians. For this reason, an important part of the research carried out by the VOTES consortium will be the exploration of the ethical and regulatory implications of the use of resources of this kind in epidemiology. This work, which is being led by Michael Parker at the Ethox Centre, involves the establishment of an Ethical and Legal Advisory Board for the VOTES project and the carrying out of empirical and philosophical research on ethical issues such those concerning the relationship between public interest and informed consent in epidemiological research on patient records. The qualitative empirical research involves participant observation of the Ethical and Legal Advisory Board and interviews with key stakeholders such as: controllers of external resources, members of the Ethical and Legal Advisory Group, project partners, health professionals and patients. This research will be supervised by Michael Parker and Mary Dixon-Woods.

The project

The Researcher in Public Health Ethics, based at the Ethox Centre and working closely with colleagues at the Clinical Trials Service Unit, will take responsibility for establishing and servicing the VOTES Ethical and Legal Advisory Board; carrying out qualitative research with key stakeholders to identify ethical issues and concerns; and carrying out literature-based and philosophical research on the ethical and regulatory dimensions of the relationship between public interest and informed consent in research on medical records.

Outputs

• Establish and service the Ethical and Legal Advisory Board which will provide advice to the VOTES project steering committee and management team
• Carry out qualitative research to identify key ethical concerns of key stakeholders e.g. controllers of external resources, members of the Ethical and Legal Advisory Group, project partners, health professionals and patients.
• Carry out ethics research on the relationship between public interest and informed consent in research on patient records.
• On the basis of this research develop and publish papers in peer-reviewed journals and recommendations on good practice
• Provide training workshops for members of research ethics committees and for the VOTES team

For more information about this project contact Michael Parker