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Ethics, governance and consent in the UK: implications for research into the longer-term outcomes of congenital heart defects
BMJ - Archives of Diseases in Childhood, 10/06/09
Knowles RL et al. – Decision–making about childhood interventions should be influenced by evidence about long–term outcomes, however current UK research regulations are an impediment to follow–up in multicentre studies. Stipulations preventing researchers contacting families directly with research invitations appear disproportionate to the risks, impede equitable access to research opportunities and introduce bias. The requirement for an individual's consent to confirm whether they are alive and monitor survival precludes effective long–term follow–up.
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