Journal of Clinical Research & Bioethics

Abstract

Insurance Policies for Clinical Trials in the United States and in some European Countries

Sabina Gainotti and Carlo Petrini

In clinical research there are important moral arguments supporting the need to offer a compensation to the injured research participants. Bene fi cence justi fi es compensation at least for the expenses of “reparative” health care, while justice requires that the risks of research do not fall exclusively on the research participants. Although the ethical arguments for compensating injured participants are generally acknowledged, the practical details are complicated — particularly the determination of the extent and duration of coverage and the assignment of responsibility for paying compensation.
In this paper we analyze how several national legislations, in the United States and Europe deal with the following problems: the voluntary or compulsory requirement to draw up an insurance for the research participants; the kind of compensable injuries including death, serious harm, pain, suffering and economic losses; the compensability of harms which are inevitable in a trial and of health problems which can depend on a subject’s noncompliance or on the natural progression of the subject’s disease; the importance of the informed consent document and the details to be given to the research participants; the rules for compensation in phase 1 and phase 2 trials and in phase 3 and phase 4 trials, or the distinction among trials involving different levels of risk; the possibility to provide a no-fault compensation to the injured research participants when negligence cannot be established; the rules on insurance and compensation in public and private research; the actors responsible to provide compensation to the injured subjects (the State, private insurances, or both); the availability of temporal indications for the compensation of research participants.
The comparative analysis highlights the strengths and weaknesses of the analyzed legislations and proposes a model for the insurance and compensation of the injured research participants, which hopefully promotes the principles of bene fi cence, autonomy and justice in research.