TITLE

Ethics, governance and consent in the UK: implications for research into the longer-term outcomes of congenital heart defects

AUTHOR(S)
Knowles, Rachel L.; Bull, Catherine; Wren, Christopher; Dezateux, Carol
PUB. DATE
January 2011
SOURCE
Archives of Disease in Childhood -- Fetal & Neonatal Edition;Jan2011, Vol. 96 Issue 1, p14
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Objective To explore the effect of research ethics, governance and consent requirements and recent reforms on UK-wide follow-up of children with congenital heart defects (CHD). Design Prospective cohort study. Setting UK National Health Service. Patients 3897 children with CHD requiring intervention, or resulting in death, before they were 1-year-old (1993-1995). Main outcomes Impact on study protocol, timeliness and findings of a multicentre study of survival and quality of life. Results The peer-reviewed study protocol was altered to accommodate ethics committee stipulations that researchers should not approach families directly with a request to participate and that the general practitioner's (GP) permission be sought before the local clinician could do so. Individual consent was required to confirm the vital status of participants and for future tracing of public death registrations. Local study registration took a median of 40 weeks (IQR 25-57). 180 (24%) of 739 surviving children (five centres) could not be contacted because their GP was untraceable (32), had changed (128) or considered contact inappropriate (20). Invitations could not be sent to 31% from the most deprived compared with 17% from the least deprived areas. Conclusions Decision making concerning childhood interventions should be influenced by evidence on long-term outcomes. However, current UK research regulations hinder 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.
ACCESSION #
60964149

 

Related Articles

  • CHAPTER 10: CONGENITAL HEART DISEASE IN ADOLESCENTS AND ADULTS.  // Heart;Nov2002 Supplement 3, Vol. 88, pIii36 

    Reports on congenital heart disease in adolescents and adults in Great Britain. Estimated number of adult patients with congenital heart disease in the country; Patterns of care for the patients; Medical staffing requirements for grown-up congenital heart disease.

  • Taussig-Bing syndrome.  // Taber's Cyclopedic Medical Dictionary (2009);2009, Issue 21, p2278 

    An encyclopedia entry for "Taussig-Bing syndrome," which refers to a congenital heart abnormality named after pediatrician Helen B. Taussig and surgeon Richard J. Bing, is presented.

  • CHALLENGES IN THE CARE OF ADULT PATIENTS WITH CONGENITAL HEART DEFECTS. Webb, Gary D. // Heart;Apr2003, Vol. 89 Issue 4, p465 

    Studies the challenges in the care of adult patients with congenital heart defects. Atrial septal defects; Ventricular septal defects; Patent ductus arteriosus; Aortic coarctation; Repaired tetralogy of Fallot; Congenitally corrected transposition of great arteries; Fibromuscular subaortic...

  • Mortality with congenital heart defects in England and Wales, 1959-2009. Much progress, but more to do. Jenkins, Kathy // Archives of Disease in Childhood;Oct2012, Vol. 97 Issue 10, p859 

    The article presents the author's views on mortality due to congenital heart defects in England and Wales. She refers to an epidemiologic research which says that mortality from congenital heart disease reduced significantly during 1959-2009. She says that generally the population-based research...

  • Current perspectives in adult congenital heart disease. Faganello, G.; Stuart, A. G. // British Journal of Cardiac Nursing;Apr2008, Vol. 3 Issue 4, p146 

    The last four decades have witnessed a revolution in the management of patients with congenital heart disease. Life expectancy and quality of life have improved and in the UK there are now more adults than children with congenital heart disease. The demands placed on the medical care system by...

  • Mother wants you to raise funds for her son's heart surgery in US.  // Pulse;4/22/2002, Vol. 62 Issue 16, p36 

    Discusses the financial problems experienced by a mother of a child with complex congenital heart disease in Great Britain. Costs of a heart surgery in the U.S.; Significance of securing a funding trip from the National Health Service of Great Britain.

  • Commentary: Recruitment is ethical. Mellor, Debbie // BMJ: British Medical Journal (International Edition);10/18/2003, Vol. 327 Issue 7420, p928 

    Comments on the ethical nature of recruiting doctors from developing countries. How many doctors are recruited as international fellows and use the opportunity to sample living and working in England; Work the National Health Service of Great Britain does with developing countries.

  • None of your business. Jones, Gary // Nursing Standard;5/23/2012, Vol. 26 Issue 38, p26 

    Imagine what it could be like if the NHS decided to put patient care before finances, writes Gary Jones.

  • NHS morality and care based on compassionate values. Haigh, Rex; Poole, Rob; Cox, John; Gray, Revd DrAlison // BJPsych Bulletin;2015, Vol. 39 Issue 1, p48 

    Several letters to the editor and a response from the authors of the article "The College reply to Francis misses the big question: a commentary," by John Cox and Alison Gray in the 2014 issue are presented.

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sign out of this library

Other Topics