Ethical status of authors’ actions?

Case number:
99-05

Case text (Anonymised)

A consultant in public health and a consultant clinical biochemist employed by a health authority submitted a paper. It sought to address the question of benzodiazepine abuse and re-sale on the black market. The authors identified the practices with the highest prescribing rates for benzodiazepines, and asked GPs to agree to request urine samples from patients with a benzodiazepine prescription.The paper presented no clear patient selection criteria, except that cases were selected by GPs according to whether they felt confirmation of compliance would be useful.They found that only 83 of 158 patients prescribed benzodiazepines had positive urine samples, and concluded that “random urine testing is a good idea.” The paper did not make clear whether the prescriptions requested were first or subsequent prescriptions. No mention was made of ethics committee approval or of patient consent. When these issues were raised with the authors they responded very promptly, agreeing with the concerns. They argued that it was a mistake to have called this piece of work a study.They outlined the background of concern which led to this piece of work, and argued that rather than a study, their work represented a decision to extend the availability of urine testing for benzodiazepines to three practices that were under considerable pressure at the time.They argued that they did not see this as a research project, but as a means of coping with a difficult situation by extending to these practices good practice and facilities already available to the community drugs team. Cost considerations, they said, had prevented open general practitioner access to urine testing for drugs. This, they said was why they did not submit the proposed change for ethics committee approval. There was also no specific consent sought from patients other than the standard consent obtained under a doctor’s duty of care. They argued, however, that the testing of urine for drugs of dependency is standard practice for a community drugs teams, and in general practice, in some cases. The authors requested advice on to how to present such a piece of basic public health work in an ethical manner. They also asked what were the ethics of publishing pieces of work that were never intended as research, but which turn up important information; and conversely, what were the ethical implications of not making available important information arrived at during routine work, and how one should deal with the ethics of obtaining genuine informed consent from patients for a test that is being used to assess their honesty. The responsible editor thanked the authors for their swift reply, but pointed out that on purely scientific grounds the journal did not want to publish the study. What is COPE’s view of the ethics of the authors’ actions? How else might the editors respond to the questions they raise? Should the journal take any further action?

Advice: 

_ Explain that this is a study for which ethical committee approval is needed. _ Tell authors they have misbehaved, although we can understand how it happened. _ Don’t involve GMC, but tell authors that if they want their work to be considered as research, they need to design a proper study and obtain the appropriate approval. _ The health authority funded the study: should they be informed? If the health authority’s consent were obtained, it would make a good illustrative case study to report. _ Journal to write an editorial to raise awareness of the issue.

Follow up: 

A notice of duplicate publication was issued. The paperwork for the case was lost, stimulating the journal to adopt a different filing system.

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