In clinical research there are important moral arguments supporting the need to offer a compensation to the injured
research participants. Beneﬁ cence justiﬁ 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
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 beneﬁ cence, autonomy and justice in research.
The export option will allow you to export the current search results of the entered query to a file. Different
formats are available for download. To export the items, click on the button corresponding with the preferred download format.
By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.
To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export.
The amount of items that can be exported at once is similarly restricted as the full export.
After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.