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EDITORIALS: Michael D E Goodyear Further lessons from the TGN1412 tragedy BMJ 2006; 333: 270-271 [Full text]

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Ethics and Pharmaceutical Medicine - Faculty of Pharmaceutical Medicine Guidelines

Kathryn H Swanston   (8 August 2006)

Ethics and Pharmaceutical Medicine - Faculty of Pharmaceutical Medicine Guidelines 8 August 2006
Kathryn H Swanston, Chief Executive Faculty of Pharmaceutical Medicine, NW1 4LB Send response to journal: Re: Ethics and Pharmaceutical Medicine - Faculty of Pharmaceutical Medicine Guidelines	Dr Goodyear refers to the Ethics and Pharmaceutical Medicine guidelines published by the Faculty of Pharmaceutical Medicine in his editorial in the BMJ of August 5th on the TGN1412 clinical trial. While the Faculty agrees that guidelines are important we would wish to emphasise that our guidelines were not written to cover all possible eventualities related to clinical trial design but to remind those responsible that they should think very carefully about the consequences of any action before exposing a research subject to risk. The greatest consideration should go into ensuring that sufficient expertise has been brought to bear on the question of the study design, for no guidelines can foresee the potential problems that novel research materials may present. It is the view of this Faculty that good science is indivisible from good ethics, and it is the responsibility of the pharmaceutical physician who is acting as principle investigator to ensure that the safety of the patient or research subject must always take precedence over any other interest. The investigator must ensure that appropriate expertise is sought and incorporated into a clinical trial design before research subjects are exposed to risk. Competing interests: This response is submitted on behalf of the Faculty of Pharmaceutical Medicine who are my employers