The impact of consent on observational research: a comparison of outcomes from consenters and non consenters to an observational study

MacLeod, U. and Watt, G.C.M. (2008) The impact of consent on observational research: a comparison of outcomes from consenters and non consenters to an observational study. BMC Medical Research Methodology, 8(15), pp. 1-6. (doi: 10.1186/1471-2288-8-15)

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Background Public health benefits from research often rely on the use of data from personal medical records. When neither patient consent nor anonymisation is possible, the case for accessing such records for research purposes depends on an assessment of the probabilities of public benefit and individual harm. Methods In the late 1990s, we carried out an observational study which compared the care given to affluent and deprived women with breast cancer. Patient consent was not required at that time for review of medical records, but was obtained later in the process prior to participation in the questionnaire study. We have re-analysed our original results to compare the whole sample with those who later provided consent. Results Two important findings emerged from the re-analysis of our data which if presented initially would have resulted in insufficient and inaccurate reporting. Firstly, the reduced dataset contains no information about women presenting with locally advanced or metastatic cancer and we would have been unable to demonstrate one of our initial key findings: namely a larger number of such women in the deprived group. Secondly, our re-analysis of the consented women shows that significantly more women from deprived areas (51 v 31%, p = 0.018) received radiotherapy compared to women from more affluent areas. Previously published data from the entire sample demonstrated no difference in radiotherapy treatment between the affluent and deprived groups. Conclusion The risk benefit assessment made regarding the use of medical records without consent should include the benefits of obtaining research evidence based on 100% of the population and the possibility of inappropriate or insufficient findings if research is confined to consented populations.

Item Type:Articles
Glasgow Author(s) Enlighten ID:MacLeod, Dr Una and Watt, Professor Graham
Authors: MacLeod, U., and Watt, G.C.M.
Subjects:R Medicine > RA Public aspects of medicine
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > General Practice and Primary Care
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing > Clinical Specialities
Journal Name:BMC Medical Research Methodology
Publisher:BioMed Central
First Published:First published in BMC Medical Research Methodology 8(15):1-6
Publisher Policy:Reproduced in accordance with the copyright policy of the publisher

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