Some authors tested the effect of a food on the menstrual cycle. The manuscript included patient identifiable information, but the authors did not provide formal confirmation that the patients consented to publication of the study. Information was sent to the corresponding author, outlining legal obligations in respect of patients' consent to publication. But the authors stated that they considered themselves exempt from these regulations because they are research scientists and not healthcare providers. Furthermore, under the guidelines of their university's privacy office, all personal information relating to study subjects must remain confidential. To provide the journal with the appropriate authorisation from the patients would therefore contravene these guidelines. Under certain circumstances, the privacy review board may waive authorisation and allow publication without explicit consent to publish from patients. - Should the regulations apply equally to healthcare providers and research scientists? - In what circumstances would the privacy review board's waiver of authorisation be acceptable?
- The journal should set guidelines as to the standard of consent to publication that it required. To publish, authors would have to meet this standard. - These regulations do not allow for named consent, and they work prospectively in that patients give their consent to any future publication. The publisher must then keep that information confidential. - Were the subjects of the study patients or healthy volunteers as there is a different framework if the research subjects are not patients? - Ultimately, it is not possible to provide an answer to the editor’s questions. - The editor should contact the agency responsible for administering the regulations.