§ Mr. AshleyTo ask the Secretary of State for Health if he will require all authorities running drug trials to offer no-fault compensation to all participating healthy volunteers.
§ Mrs. Virginia BottomleyGuidance to health authorities, which will be issued shortly, emphasises that those volunteering to participate in research studies should be made aware of what the arrangements are for obtaining compensation in the event of an injury arising from the research. It is then a matter for the individual concerned to decide whether or not the arrangements are acceptable.
§ Mr. AshleyTo ask the Secretary of State for Health (1) if he will place a statutory limit on the number of drug trial studies a healthy volunteer can participate in per year;
(2) if there is any monitoring of the number of drug trials each volunteer student participates in over time;
(3) what safeguards there are to prevent students from taking part in more than one drug trial simultaneously;
(4) if there is any evidence of volunteers taking part in more than one drug trial simultaneously.
§ Mrs. Virginia BottomleyNo information is held centrally about individuals who choose to volunteer to participate in medical research projects. There are no plans to introduce limits on the number of times a person can volunteer.
The Department recommends that a declaration about the state of health and any current medication should be obtained from healthy volunteers. They should also be asked to give their permission for notice to be sent, when necessary, to their general practitioner. Refusal to permit such communication should lead to rejection as a participant.