| Literature DB >> 7674282 |
J M Barton1, M S Macmillan, L Sawyer.
Abstract
The problem of 'no fault' compensation for patients who suffer adverse effects as a result of their participation in clinical trials is discussed in the light of the guidelines issued by the Association of the British Pharmaceutical Industry (ABPI) and our recent experiences in reviewing protocols submitted to the local ethics of surgical research sub-committee. We have found a variety of qualifications being applied by pharmaceutical firms which are not in the spirit of the guidelines, let alone the interests of the patient, and we suggest a means whereby the patients can be assured of fair treatment in the event of 'no fault' injury.Entities:
Keywords: Association of the British Pharmaceutical Industry; Biomedical and Behavioral Research; Committee on Safety of Medicines (Great Britain); Department of Health (Great Britain); Legal Approach; Medical Research Council (Great Britain); Royal College of Physicians
Mesh:
Year: 1995 PMID: 7674282 PMCID: PMC1376693 DOI: 10.1136/jme.21.3.166
Source DB: PubMed Journal: J Med Ethics ISSN: 0306-6800 Impact factor: 2.903