Abstract
The novel nature of certain investigational medicinal products may indicate that someone particularly knowledgeable about the risks involved should be the ‘first-in-man’ subject. Such self-experimentation has a noble and ethical heritage, and whilst its practice has declined of late it is perhaps timely to reconsider this situation.
References
1.Expert group on phase one clinical trials: final report . Expert group chaired by Sir Gordon W Duff. DoH . London : The Stationery Office , 2006 . Available at http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT-ID=4141039&chk=Qczxoq.
2.
Altman
LK
. Who goes first? The story of self-experimentation in medicine . Berkeley : University of California Press 1988 .
3.
Beecher
HK
. Ethics and clinical research . New England Journal of Medicine 1966 ; 274 : 1354 –60 .
4.
Beecher
HK
. Experimentation in man . Journal of the American Medical Association 1959 ; 169 : 461 –478 .
5.
Jonas
H
. Philosophical reflections on experimenting with human subjects . Dædalus 1969 ; 98 : 219 –47 .
6.
Heyd
D
. Experimentation on trial: why should one take part in medical research? Annual review of law and ethics 1996 ; 4 : 189 –204 .
7.CERES newsletter . Winter 1997/98 ; No. 23: 20.
8.
Arnstein
H
. (letter) The Times 20 November 2006 ; p22.
9.
Martin
R
. Constraints on public health . In
Martin
R
Johnson
L
(Eds.) Law and the public dimension of health . London : Cavendish Publishing , 2001 . pp33 –73 .
10.Critical care decisions in fetal and neonatal medicine: ethical issues . Nuffield Council on Bioethics 2006 . http://www.nuffieldbioethics.org/go/ourwork/prolonginglife/publication-406.html. Report available at www.nuffieldbioethics.org/fileLibrary/pdf/CCD-web-version-8-November.pdf (Accessed 20 November 2006).
11.Response to the Nuffield Council on Bioethics proposed guidelines on treating premature babies . Royal College of Paediatrics and Child Health . Media statement , 15 November 2006 . www.rcpch.ac.uk/publications/recent-publications/press/nuffieldpremature%20babies-nov%2006.pdf (Accessed 20 November 2006).
12.
Kennedy
D.
Gledhill
R
. Sick babies can be left to die, Church says . www.timesonline.co.uk/article/0,2-2451191,00.html (Accessed 20 November 2006 ).