Study volunteers, payment

Most UK ethics committees will look for confirmation of the intention to apply the ABPl guidelines in the case of company-sponsored studies, even from non-member companies. Where the research is non-therapeutic, ABPl guidance provides for a contractual promise to be made to the volunteer to pay for injury sustained by reason of participation in the study (whether due to the experimental drugs used or to procedures required by the study protocol), irrespective of whether anyone conducting or responsible for the project was at fault. In therapeutic research, no such contractual relationship or obligation is required, and there are some limitations to the circumstances in which voluntary payment will be made. 

Typically, between 20 and 80 healthy adults (this number can certainly be lower) participate in these relatively short studies, and subjects are often recruited from university medical school settings where trials are being conducted. Subjects are typically paid for their participation. (This payment may be one reason why the term volunteers originated to describe these subjects—see the discussion in Section 1.8.2. However, there are financial benefits to many clinical trial participants in later clinical trials too, in that medical procedures involved in trials are conducted at no cost to the subjects.)... 

Participation in a clinical study should be voluntary and there will be no payment unless the study provides no therapeutic benefit, such as pharmacokinetic studies in healthy volunteers. When the new GCP were introduced there was substantial discussion about whether, if patients were required to visit study sites more often than usual, for example to attend additional examinations or treatments, it would be fair to place the whole financial burden on them. 

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