When ethical review is not required

When questionnaires are sent to patients for completion concerning an aspect of their care, then LREC review is not routinely required, as the requirement to complete and return the form gives the opportunity to decline.  When this is proposed then:

  • a check on the patient’s living status must be performed
  • a stamped addressed envelope for reply must be included.

When patients are interviewed (in whatever location) by a member of Trust staff concerning an aspect of their treatment/care, and their replies are recorded, then LREC review is not routinely required provided:

  • patients are selected after discussion with the ward/clinic nursing staff.  This ensures that the patients are capable of understanding and answering questions and are emotionally and mentally fit to be involved
  • the reasons for the questionnaire are fully explained to the patient and permission is sought and granted to ask the questions.

If more than six months elapses between the treatment event and the questionnaire, there is a possibility that the two points above may not be adequately covered.  It is also possible that the questionnaire may constitute research rather than audit.  Ethical review may therefore be required.

When patients are selected by the ward staff, care must be taken not to compromise the methodology.

If in any doubt, then seek advice.