alexa Insurance Policies for Clinical Trials in the United St
ISSN: 2155-9627

Journal of Clinical Research & Bioethics
Open Access

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Research Article

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

Sabina Gainotti1* and Carlo Petrini2

1Department of Cell Biology & Neurosciences Istituto Superiore di Sanita’, Viale Regina Elena 299 00161 Roma, Italy

2Bioethics Unit, Offi ce of the President, IstitutoSuperiore di Sanità, v.le Regina Elena 299, 00161, Rome, Italy

*Corresponding Author:
Sabina Gainotti
Department of Cell Biology & Neurosciences Istituto Superiore di Sanita’
Viale Regina Elena 299 00161 Roma Italy
Tel: +39-06 4990 4245
Fax: +39-06 4990 4248
E-mail: [email protected]

Received date: July 29, 2010; Accepted date: August 19, 2010; Published date: August 19, 2010

Citation: Gainotti S, Petrini C (2010) Insurance Policies for Clinical Trials in the United States and in some European Countries. J Clinic Res Bioeth 1:101. doi: 10.4172/2155-9627.1000101

Copyright: © 2010 Gainotti S. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



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.

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