HL Deb 26 January 2004 vol 656 cc18-9WA
Lord Clement-Jones

asked Her Majesty's Government:

When the Health and Safety Executive (HSE) approved the experiment conducted in 1998 at Inveresk Research, Scotland, in which 50 men were exposed to a dose of the pesticide Azinphos-methyl:

  1. (a) to what extent local research ethics committees (RECs) in 1998 were guided and monitored by the Department of Health;
  2. (b) to what extent non-National Health Service RECs were guided and monitored by the Department of Health; and
  3. (c) whether the Department of Health had a policy of transparency for the operation of RECs; and [HL767]
Whether they propose to change their mode of guidance for, and inspection of, research ethics committees with a view to requiring their operation to be transparent. [HL795]

Lord Warner

In 1991 the Department of Health issued revised guidelines on the establishment, role and functions of local research ethics committees (LRECs) in the National Health Service. These guidelines imposed strict criteria on how LRECs conduct their business and provided clear lines of accountability. The guidelines were replaced in 2001 by theGovernance arrangements for NHS research ethics committees. Both the 1991 guidelines and the 2001 governance arrangements state that LRECs should submit to the appointing health authority an annual report that should also be available for public inspection. Departmental guidance on LRECs provides a model of good practice for research ethics committees outside the NHS. It is not the responsibility of the department to monitor such committees.

The United Kingdom's draft implementing regulations to transpose the Clinical Trials Directive (2001/20/EC) into domestic law were published in February 2003 for consultation. The regulations make provisions concerning the establishment and operation of research ethics committees convened to review clinical trials of medicines.