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PAPERS: Elizabeth Rees and Janet Hardy Novel consent process for research in dying patients unable to give consent BMJ 2003; 327: 198 [Abstract] [Full text]

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Novel consent-further on

Alison V Kennett   (1 June 2005)

Novel consent-further on 1 June 2005
Alison V Kennett, Research Nurse Royal Marsden NHS Foundation Trust Send response to journal: Re: Novel consent-further on	Dear Editor, In the July 2003 issue of the BMJ, Palliative Care Team at the Royal Marsden Hospital reported on the development of a novel consent process for research in dying patients unable to give consent. The study compared the use of Robinul and Hyoscine in the management of death rattle/retained secretions. We are now in a position to review this process. We would broadly support and embrace the use of advance consent as a valuable tool for recruiting this patient population to clinical trials. However we would make some observations and suggestions to refine and develop the novel/advanced consent process. We had designed our trial so that having obtained initial informed consent from a patient, re-consent would be sought from that patient at each subsequent admission. The ethical rationale for this was to allow patients to change their minds and was in line with the provision for the patient under the advanced directive. This proved a laborious and clumsy method which staff at different grades and disciplines shied away from. Each time a patient was consented was more traumatic for both patient and staff. Re-consenting reinforced and increased the understanding of an unpleasant terminal event that may never happen to that particular patient. Of the 190 patients screened for the study, 105 refused or were ineligible. (see figure). This confirmed that patients were under no pressure and felt free to refuse entry into the study. 85 patients consented to the study. Only one patient withdrew consent at re-admission. The risk /benefit outcome of re-consenting is therefore deemed to be too high. In summary we therefore support a novel consent process for research in dying patients unable to give consent. It is essential that the initial consenting is done sensitively and allows patients the ability to refuse easily. We do however, not recommend that a patient is re-consented to the same study at each admission. Reference Novel consent process for research in dying patients unable to give consent. E. Rees, J. Hardy BMJ 2003;327:198-200 Number of patients screened/approached for the study 190 Number of patients consented 85 Number of patients Refused/declined/ineligible Initial entry 105 Number of patients who died 81 Number of patients randomised 34* Number of patients not randomised 47 Number of patients re-consented once 13 Number of patients who refused consent 1 Number of patients re-consented more than once 1 *Majority of patients died on admission when initially consented Competing interests: None declared