HC Deb 01 March 1995 vol 255 cc609-11W
Dr. David Clark

To ask the Secretary of State for Defence when the ethics committee overseeing the service volunteers programme at the Chemical and Biological Defence Establishment at Porton Down was set up; for what reasons it was established; what is the purpose and nature of the committee's work; how often it meets; how many members sit on the committee; how many of these members are drawn from outside Porton Down; and who is the current chairman.

Mr. Soames

This is a matter for the Chemical and Biological Defence Establishment, Porton Down under its framework-document. I have asked the chief executive, CBDE to write to the hon. Member.

Letter from Graham Pearson to Dr. David Clark, dated 1 March 1995: 1. Your Parliamentary Question to the Secretary of State for Defence asking when the Ethics Committee overseeing the Service volunteers programme at the Chemical and Biological Defence Establishment at Porton Down was set up; for what reasons it was established; what is the purpose and nature of the committee's work; how often it meets; how many members sit on the committee; how many of these members are drawn from outside Porton Down; and who is the current chairman has been passed to me to answer as Chief Executive of the Chemical and Biological Defence Establishment. 2. The role of the Chemical and Biological Defence Establishment is to ensure that the UK Armed Forces have effective protective measures against the threat that chemical or biological weapons may be used against them. In order to carry out this work, it is necessary to use Service volunteers to:

  1. a. Assess the ability of Service personnel to function with new equipment and procedures.
  2. b. Develop medical countermeasures to protect Service personnel and,
  3. c. Evaluate the effects of very low and medically safe concentrations of CW agents on the ability of unprotected personnel to operate normally.
No studies involving volunteers are carried out unless there is a clear military need and a detailed protocol has been reviewed and approved by an independent Ethics Committee in accordance with the guidelines laid down by the Royal College of Physicians. 3. The creation of an independent Ethics Committee at the Chemical and Biological Defence Establishment followed the publication of guidelines from the Royal College of Physicians. The CBDE Ethics Committee was established in July 1991. The Ethics Committee has subsumed previous arrangements for the ethical review of proposed volunteer studies. For some 30 years, a committee on the safety of human experiments had been set up at this Establishment involving all the medical officers on the staff of the Establishment whose task was to review all the protocols for proposed volunteer studies to ensure that they were as safe as possible; this committee had the right of veto. Following such reviews, protocols were then considered by an ethical sub group of the Medical Committee of the Defence Scientific Advisory Council which involved independent experts. 4. The purpose of the CBDE Ethics Committee is to consider the medical-ethical aspects of all proposed studies involving human volunteers. Its role is to review and approve detailed protocols for any studies carried out involving the use of volunteers. Such studies are only carried out if there is a clear military need and the protocol has been designed to ensure that any possible risks, however slight, are minimised. The protocol also includes a full explanation in lay terms of the study which will be read to the volunteer by a military officer unconnected with the study so that informed consent based on the volunteer's complete understanding of the nature of the study and any perceived hazards can be sought. 5. The CBDE Ethics Committee consists of 11 members of whom 9 are drawn from outside of the Ministry of Defence. It meets four times a year although there is provision to meet on a more frequent basis if required. The Committee is chaired by Professor Hugh Dudley, CBE, ChM, FRCSE, Professor Emeritus of Surgery, University of London.

Dr. David Clark

To ask the Secretary of State for Defence if he will make a statement on the nature of the guidelines and rules provided by the Royal College of Physicians, London and the British Psychological Society with regard to the service volunteers programmes at the Chemical and Biological Defence Establishment at Porton Down; and when these guidelines were adopted by the establishment.

Mr. Soames

This is a matter for the Chemical and Biological Defence Establishment, Porton Down under its framework document. I have asked the chief executive, CBDE to write to the hon. Member.

Letter from Graham Pearson to Dr. David Clark, dated I March 1995: 1. Your Parliamentary Question to the Secretary of State for Defence asking if he will make a statement on the nature of the guidelines and rules provided by the Royal College of Physicians (London) and the British Psychological Society with regard to the Service volunteers programmes at the Chemical and Biological Defence Establishment at Porton Down; and when these guidelines were adopted by the Establishment has been passed to me to answer as Chief Executive of the Chemical and Biological Defence Establishment. 2. The role of the Chemical and Biological Defence Establishment is to ensure that the UK Armed Forces have effective protective measures against the threat that chemical or biological weapons may be used against them. In order to carry out this work, it is necessary to use Service volunteers to:

  1. a. Assess the ability of Service personnel to function with new equipment and procedures.
  2. b Develop medical countermeasures to protect Service personnel and,
  3. c. Evaluate the effects of very low and medically safe concentrations of CW agents on the ability of unprotected personnel to operate normally.
3. Studies and tests at CBDE which involve Service volunteers are only carried out where there is a clear military need and a detailed protocol has been reviewed and approved by an independent Ethics Committee in accordance with the guidelines laid down by the Royal College of Physicians and British Psychological Society. 4. In 1984 the Royal College of Physicians published Guidelines on the practice of Ethics Committees in medical research which were subsequently updated in 1990 and taken into account when the CBDE Ethics Committee was established in July 1991. These guidelines provide advice inter alia on terms of reference, membership, methods of working, application, responsibilities. consent, definition and classes of research and payments. The British Psychological Society guidelines were taken into account shortly after their publication in 1993. These provide inter alia advice on the code of conduct for psychologists and the ethical principles for work with human participants. 5. Although these guidelines have only recently been published, there has been an ethical review of proposed volunteer studies at CBDE for over 30 years. Prior to the establishment of the CBDE Ethics Committee there was a committee on the safety of human experiments which had been set up at this Establishment involving all the medical officers on the staff of the Establishment whose tasks was to review all the proposals for proposed volunteer studies to ensure that they were as safe as possible; this committee had the right of veto. Following such reviews, protocols were then considered by an ethical sub group of the Medical Committee of the Defence Scientific Advisory Council which involved independent experts.