Regulating the Statutory Duty of Candour

By John Tingle

Patients are very much the weaker party in the care equation. Doctors and nurses are always in a much more powerful position as they have the command of a discrete, specialised body of professional knowledge which the patient has not got and often urgently needs. To make the National Health Service (NHS) much more patient centered and to improve the quality of care we need to take account of this imbalance in the care equation which favours healthcarers. We can do this by explaining more carefully to patients about their treatment options and respecting their autonomy as individuals.

All organisations and those working in them need to be honest, open and truthful in all their dealings with patients and the public. A statutory duty of candour now exists in law in the NHS through regulations and is enforced by the Care Quality Commission (CQC), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20. The CQC can prosecute for a breach of parts 20(2) (a) and 20(3) of this regulation and can move directly to prosecution without first serving a Warning Notice. Additionally, CQC may also take other regulatory action.

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Social Media Use in Research Recruitment: A New Guidance Document from Petrie-Flom and Harvard Catalyst

stethoscope_computerImagine this scenario: you are a researcher conducting a clinical trial on a promising treatment for a rare but serious heart condition. Unfortunately, you are struggling to locate and enroll enough eligible participants and your study is at risk of not completing. Then you discover a Facebook support group for precisely the condition you are studying. The group is open: you do not need to be invited or to suffer from the condition to become a member—anyone can join. Here are the eligible participants you have been looking for!

But what are your obligations in approaching members of this group for recruitment? Would such recruitment be ethically advisable? Under what conditions? And what ethical norms apply when approaching sick and potentially vulnerable people for recruitment over social media? How should you (and the IRB) evaluate this type of activity from an ethical perspective?

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