Using patient identifiable data without consent Obtaining individual consent may hinder studiesEditor-The editorial by Al-Shahi and Warlow is timely and well argued. 1 The implications of a strict requirement for written consent from patients in observational and epidemiological research are extremely serious.Research in histopathology would be particularly severely affected.It is essential that patients' consent is obtained in interventional studies or where information, or, in the case of pathology, tissue, is collected solely for the purpose of research.However, applying this requirement for every study of archived biopsy, surgical or necropsy tissue blocks, or review of patient records, where diagnosis has been made and where patient management will not be affected, is impracticable.Studies of archival material have been the core of research in histopathology.A glance at the methods section of the papers of any pathology journal reveals that most have used archival tissue with no indication that specific patient consent has been obtained.For recent issues of the Journal of Pathology, Histopathology, and the Journal of Clinical Pathology the proportions of archi-val, non-consented research were 9/16, 9/9, and 11/13 papers, respectively.Until now, this form of research has been simple and cheap to undertake, and has provided valuable information on the causes and pathology of many human diseases.It is unlikely that any of the large studies of gastric biopsies, cancers, etc would have been conducted had every patient or their relatives had to be contacted to obtain consent.We would be left with only anecdotal information on which to base prognosis and treatment for many common cancers and we would know much less about many common diseases.Despite considerable problems in obtaining funding for research in histopathology, authors in the United Kingdom continue to produce papers of high quality, but it is doubtful that this will continue if individual consent for each study becomes a legal requirement.Either a general consent for use of residual tissues for research should be allowed or alternatively the NHS needs to fund the staff necessary to obtain the consent from central or regional research and development budgets, which could be accessed by researchers wishing to undertake archival studies.This would, however, be both cumbersome and costly.If observational research in pathology or other subjects and epidemiological studies are to be outlawed, the public interest will be damaged and patients in the future will be the losers.
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Stewart W Mercer (2001) studied this question.
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