§ Mr. FatchettTo ask the Secretary of State for Defence (1) if he will outline the past and present procedures followed by the Chemical and Biological Defence Establishment at Porton Down to monitor the continued health of volunteers who have taken part in experiments;
(2) for what period of time the Chemical and Biological Defence Establishment at Porton Down continues to monitor the health of volunteers after the end of experiments in which they were involved.
§ Mr. SoamesThese are matters 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 Mr. Derek Fatchett, dated 7 March 1995:
1. Your Parliamentary Questions to the Secretary of State for Defence asking if he will outline the past and present procedures followed by the Chemical and Biological Defence Establishment at Porton Down to monitor the continued health of volunteers who have taken part in experiments and for what period of time Porton Down continues to monitor the health of volunteers after the end of studies in which they were involved, have 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:
- a. assess the ability of Service personnel to function with new equipment and procedures,
- b. develop medical countermeasures to protect Service personnel, and
- c. evaluate the effects of very low and medically safe concentrations of CW agents on the ability of unprotected personnel to operate normally.
The purpose of the volunteer studies programme is to ensure that any protective measure is acceptable from a military point of view and is safe before it is recommended for introduction into service. Such measures need to be evaluated first in the safety of a laboratory or hospital environment, with full medical and scientific back-up at hand.3. The principles of how volunteer studies are to be conducted are enshrined by international agreement in the Helsinki declaration. Further detailed guidance has been issued by the Royal College of Physicians (London). Volunteer studies at CBDE Porton Down are overseen by an independent panel of experts who form the CBDE Ethics Committee. The role of the Ethics Committee is to ensure the safety of the subjects and to safeguard the scientific staff who carry out the human studies from criticism which may be informed or otherwise. They evaluate each protocol well in advance and only approve a protocol if they are satisfied that there will be no harm to the health of the volunteers. Human studies at CBDE are conducted with volunteers drawn from the three Armed Services, namely from amongst the men and women we seek to protect. The volunteers apply in response to requests officially promulgated months in advance.4. Before any exposure of volunteers to drugs or other substances takes place, it is explicit duty of the Medical Office (MO) assigned to each study to assess risks, and recommend a study design so as to minimise them. This is done by preparing a detailed protocol which is first scrutinised by an in-house Committee, and finally by the independent CBDE Ethics Committee. Exposure of volunteers where side effects last longer than the one or two weeks stay of the volunteer on site are never acceptable.120W5. Service volunteers on arrival at CBDE are first given a medical examination to determine if they are healthy and fit to take part in the study. The study is explained to them in lay terms by a military officer who is not involved in the study and it is made clear to the volunteer that they can withdraw from the study at any stage without any explanation being required. On leaving CBDE on completion of the study the volunteers are given a further medical examination.6. Service volunteers return to their units on completion of the study, where they are, medically, the responsibility of the unit Medical Officer. There is no history of Service doctors in their units seeking advice from CBDE Porton Down on any subsequent illnesses that may have been reported by volunteers who have been exposed to agent during studies at CBDE.7. Some volunteers have volunteered to return repeatedly to CBDE for different studies at irregular intervals. In such cases CBDE invariably refer to the volunteer's previous records. These opportunities, which are spontaneous and sporadic, to examine medically the volunteers have shown no evidence of any change to the health of the volunteers as a result of their earlier participation at CBDE, provides assurance that volunteers have not suffered any harm to their health.8. From time to time after specific studies, those volunteers that participated in them are called back to CBDE for a further set of tests or measurements in order to check on the consistency of the method used in the tests or measurement and to demonstrate its invariance with time. As an example, in one study six volunteers were recalled twice so that the consistency of the method used in a particular study could be checked and in another study seven volunteers were recalled for the same reason. Such recalls can take place as much as one or two years after the original study. In all these cases there was no evidence that the health of the volunteers had changed or been harmed as a result of their participation in the study at CBDE Porton Down.9. Health checks are carried out regularly on Service personnel and the frequency of such checks is determined by the age of the Serviceman or Servicewoman and if any need has arisen for more regular health review such as diagnosis of some pathological condition such as hypertension. Similarly, postings to military duties requiring a very high standard of physical and mental well-being such as tour of duty in the submarine service will necessitate further medical checks for the individual concerned. In addition, the Service medical records of some part volunteers have been scrutinised from time to time, and the conclusion drawn that their health and sickness record is in no way different from a control group.
§ Mr. FatchettTo ask the Secretary of State for Defence how many human volunteers have been involved in experiments at the Chemical and Biological Defence Establishment at Porton Down since 1965; if he will give the number of volunteers for each of the last five years for which figures are available; and if he will make a statement.
§ Mr. SoamesThis 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 Mr. Derek Fatchett, dated 7 March 1995:
1. Your Parliamentary Question to the Secretary of State for Defence asking how many human volunteers have been involved in experiments at the Chemical and Biological Defence Establishment at Porton Down since 1965; if he will give the number of volunteers for each of the last five years for which figures are available; and if he will make a statement, has been passed to me to answer as Chief Executive for 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: 121W
- a. assess the ability of Service personnel to function with new equipment and procedures,
- b. develop medical countermeasures to protect Service personnel, and
- 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 number of Service volunteers who have participated in studies during the period 1965–1994 was about 5,400 and the number in each of the last five years for which figures are available were as follows:
- 1990: 83
- 1991: 50
- 1992: 112
- 1993: 64
- 1994: 104
§ Mr. FatchettTo ask the Secretary of State for Defence if he will outline the type of experiments carried out on human volunteers at Porton Down in the last three years for which information is available; and if he will make a statement.
§ Mr. SoamesThis 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 Mr. Derek Fatchett, dated 7 March 1995:
1. Your Parliamentary Question to the Secretary of State for Defence asking if he will outline the type of experiments carried out on human volunteers at Porton Down in the last three years for which information is available, and if he will make a statement, 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:
- a. assess the ability of Service personnel to function with new equipment and procedures,
- b. develop medical countermeasures to protect Service personnel, and
- 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 types of studies which have been carried out over the past three years have been to assess the performance of Service personnel whilst wearing individual protective equipment (IPE), the efficacy and effectiveness of experimental IPE using simulants, and the evaluation of possible side effects on military performance from the administration of improved medical countermeasures.
§ Mr. FatchettTo ask the Secretary of State for Defence if he will give the rates of payment for volunteers taking part in experiments at Porton Down in each year since 1979.
§ Mr. SoamesThis 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.
122WLetter from Graham Pearson to Mr Derek Fatchett, dated 7 March 1995:
1. Your Parliamentary Question to the Secretary of State for Defence asking if he will give the rates of payment for volunteers taking part in experiments at Porton Down in each year since 1979 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:
- a. assess the ability of Service personnel to function with new equipment and procedures,
- b. develop medical countermeasures to protect Service personnel, and
- 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. Service volunteers receive compensation for the inconvenience associated with individual tests carried out within each study. The number of tests in any study vary between about a minimum of 100 to a maximum of 400 as studies vary between three days to four week in duration.4. The rates of payment per test over the past five years are as follows:
- 1990: £1.34
- 1991: £1.50
- 1992: £1.60
- 1993: £1.62
- 1994: £1.66
The current rate of payment per test is £1.70. The total amount of compensation ranges from about £170 to £500 and is subject to tax.5. Our records are not maintained in such a way as to easily provide the rates of payment for volunteers who have taken part in studies at Porton Down in each year since 1979 and to seek this information would involve disproportionate effort and cost.
§ Mr. FatchettTo ask the Secretary of State for Defence how many deaths have been recorded as a direct result of experiments carried out on volunteers at Porton Down.
§ Mr. SoamesThis 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 Mr. Derek Fatchett, dated 7 March 1995:
1. Your Parliamentary Question to the Secretary of State for Defence asking him how many deaths have been recorded as a direct result of experiments carried out on volunteers at Porton Down, 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:123W
- a. assess the ability of Service personnel to function with new equipment and procedures,
- b. develop medical countermeasures to protect Service personnel, and
- 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. Since the start of the Service Volunteer programme in the 1920s, there has been a single fatality in 1953 as reported in the Official Report (9 June 1953, Volume 516, Col 7-8 and 22 June 1953, Volume 516, Col 105) when Leading Aircraftsman Ronald Maddison died from the effects of asphyxia after taking part in a trial at the then Chemical Defence Experimental Establishment at Porton Down. A detailed inquiry was held into the circumstances and following this inquiry which was carried out by eminent independent scientists, new guidelines were laid down to ensure the safety of Service volunteers. In the subsequent 40 years, there has been no fatality nor has there been any evidence that any Service volunteers have suffered any deterioration in their health as a result of participating in studies at Porton Down.
§ Mr. FatchettTo ask the Secretary of State for Defence what representations he has received regarding people who have suffered ill health subsequent to taking part in experiments at Porton Down in the last 12 months; and if he will make a statement.
§ Mr. SoamesThis 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 Mr. Derek Fatchett, dated 7 March 1995:
- 1. Your Parliamentary Question to the Secretary of State for Defence asking what representations he has received regarding people who have suffered ill health subsequent to taking part in experiments at Porton Down in the last 12 months; and if he will make a statement, 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 United Kingdom 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:
- a. assess the ability of Service personnel to function with new equipment and procedures,
- b. develop medical countermeasures to protect Service personnel, and
- 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.We have received enquiries from a variety of sources over the past year relating to the studies in which volunteers participated. We have received and responded to 13 Parliamentary Enquiries, 2 enquiries from General Practitioners, 10 from the War Pensions Agency and 9 direct from volunteers.There is no evidence over the past 40 years to suggest that Service volunteers who have participated in studies at the Chemical and Biological Defence Establishment at Porton Down have suffered any harm to their health. Indeed, some volunteers have volunteered to participate in studies at CBDE on more than one occasion and some have also been recalled so that measurements could be checked. volunteers are medically examined on arrival at CBDE Porton Down and are informed that they may leave the study at any stage without giving any explanation. They are also medically examined at the end of their stay at CBDE Porton Down to ensure that they are fit before they return to their units. In addition, there is no history of service doctors in their units seeking advice from CBDE Porton Down on any subsequent illnesses that may have been reported by volunteers who have been exposed to agent. There is therefore no 124W reason to suggest that volunteers have suffered any harm to their health.5. The medical records of the Servicemen are provided on request to their General Practitioner as is information from CBDE Porton Down on the studies in which they participated. This information is provided to the medical practitioners as they are best placed to judge if any of the experience throughout the Service career of the individual has any relevance to their current medical conditions.6. It is important to recognise that the human body is remarkably effective in dealing with toxic pollutants to which we are exposed in our daily lives and the participation in a study at CBDE Porton Down involving a short exposure to chemical warfare agent has to be considered in the context of whole life exposures to other toxic pollutants.7. Finally, the Ministry of Defence is very grateful to all Service personnel who have served as volunteers in studies at CBDE Porton Down as their participation has been vital to ensuring that the members of the UK Armed Forces are provided with the most effective protective measures possible against the threat that chemical or biological weapons may be used against them. Such studies are vital to the defence of the realm and we are very grateful to the Servicemen who have helped achieve the high standards of protection that are available for the members of the UK Armed Forces.
§ Mr. FatchettTo ask the Secretary of state for Defence how many(a) prisoners of war, (b) physically disabled people, (c) people with learning difficulties and (d)> people with a mental illness have been used in experiments at (i) Porton Down or (ii) other MOD establishments since 1965; and if he will make a statement.
§ Mr. SoamesThis 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 Mr. Derek Fatchett, dated 7 March 1995:
1. Your Parliamentary Question to the Secretary of State for Defence asking how many (a) prisoners of war, (b) physically disabled people, (c) people with learning difficulties, and (d) people with a mental illness have been used in experiments at: (i) Porton Down, or (ii) other MOD establishments since 1965; and if he will make a statement, 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:
- (a) assess the ability of Service personnel to function with new equipment and procedures,
- (b) develop medical countermeasures to protect Service personnel, and
- (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. Human studies at CBDE are conducted with volunteers drawn from the three Armed Services, namely from amongst the men and women we seek to protect. No prisoners of war, physically disabled volunteers, volunteers with learning difficulties or volunteers with a mental illness has participated in studies by the Ministry of Defence.4. In addition, to ensure that individual Service personnel are both physically and mentally fit before they participate in the human volunteer programme at Porton Down, their Service medical documents are reviewed at CBDE before the volunteers attend for studies. No volunteer is accepted for studies at CBDE with a medical history which indicates a physical disability, a mental illness or a learning difficulty. Finally, all volunteers on arrival at CBDE Porton 125W Down are given an initial medical examination to ensure that they are fit before they participate in the study.