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Parental consent for research and sudden infant death

2008; Elsevier BV; Volume: 372; Issue: 9640 Linguagem: Inglês

10.1016/s0140-6736(08)61298-2

1474-547X

Sudhin Thayyil, Nicola J. Robertson, Angie Scales, Neil J. Sebire, Andrew M. Taylor,

Ethics and Legal Issues in Pediatric Healthcare

There is a need for further research into the pathophysiology of sudden unexpected death in infancy (SUDI). However, implications of the Human Tissue Act and Coroner's Amendment Rules have resulted in pessimism regarding future, prospective SUDI research in the UK.Such SUDI cases are investigated by the coronial system, and although parental consent is not required for further retention of tissue after diagnostic investigations into the cause of death, additional samples cannot be obtained specifically for research purposes without prospective explicit parental consent. There is wide variation in the interpretation and application of these rules by coroners,1Delaney RJ Roberts IS Implementation of the 2005 Coroners Rules Amendments: a survey of practice in England and Wales.J Clin Pathol. 2007; 60: 419-421Crossref PubMed Scopus (7) Google Scholar and written parental consent for research is provided by this route in only a minority of cases.2Weber MA Epstein J Simons J Malone M Ashworth M Sebire NJ Challenges to implementation of the new Coroners' (Amendment) Rules 2005: experience from a tertiary paediatric pathology centre.Med Sci Law. 2007; 47: 293-298Crossref PubMed Scopus (4) Google Scholar Additionally, many prospective autopsy research studies would require specific specimens to be obtained during the autopsy to maximise scientific yield.3Krous HF Byard RW Rognum TO Pathology research into sudden infant death syndrome: where do we go from here?.Pediatrics. 2004; 114: 492-494Crossref PubMed Scopus (9) Google ScholarSince it has often been considered unethical and impractical to approach newly bereaved parents for research consent, in California, USA, legislation was recently amended for mandatory inclusion of SUDI cases into research programmes, without parental consent.3Krous HF Byard RW Rognum TO Pathology research into sudden infant death syndrome: where do we go from here?.Pediatrics. 2004; 114: 492-494Crossref PubMed Scopus (9) Google Scholar A similar model has not been adopted in many other countries, making research use of postmortem tissue, "opt-in".As part of a less invasive autopsy study comparing postmortem MRI with conventional autopsy, we attempted to obtain prospective informed consent by telephone from SUDI parents in London, UK, by means of a family liaison nurse with experience in bereavement counselling. Our research ethics committee approved the study, and permission from the coroner was obtained to approach the parents in all cases.Of 40 cases referred during the period, parental contact details were provided in 26. The research nurse contacted these 26 parents; 25 gave verbal research consent in a median telephone conversation time of 15 min (range 5–90 min). The study information leaflet and consent form, sent by post, were subsequently received back from all parents, 1–8 weeks after telephone consenting, without any additional reminders. 12 of the 25 parents gave "helping others in future" and four gave "wanted as much information possible" as reason for participating in research. None of these parents had objections to the process of telephone consenting, with one commenting that the process "had a strangely calming effect", and three others stating that they found it useful to discuss the post-mortem process with a bereavement nurse.Current hurdles remain the coronial system for death investigation, which does not allow this process to occur in many cases. Nevertheless, we encourage all those involved in SUDI to consider this model for prospective research consenting.We declare that we have no conflict of interest. There is a need for further research into the pathophysiology of sudden unexpected death in infancy (SUDI). However, implications of the Human Tissue Act and Coroner's Amendment Rules have resulted in pessimism regarding future, prospective SUDI research in the UK. Such SUDI cases are investigated by the coronial system, and although parental consent is not required for further retention of tissue after diagnostic investigations into the cause of death, additional samples cannot be obtained specifically for research purposes without prospective explicit parental consent. There is wide variation in the interpretation and application of these rules by coroners,1Delaney RJ Roberts IS Implementation of the 2005 Coroners Rules Amendments: a survey of practice in England and Wales.J Clin Pathol. 2007; 60: 419-421Crossref PubMed Scopus (7) Google Scholar and written parental consent for research is provided by this route in only a minority of cases.2Weber MA Epstein J Simons J Malone M Ashworth M Sebire NJ Challenges to implementation of the new Coroners' (Amendment) Rules 2005: experience from a tertiary paediatric pathology centre.Med Sci Law. 2007; 47: 293-298Crossref PubMed Scopus (4) Google Scholar Additionally, many prospective autopsy research studies would require specific specimens to be obtained during the autopsy to maximise scientific yield.3Krous HF Byard RW Rognum TO Pathology research into sudden infant death syndrome: where do we go from here?.Pediatrics. 2004; 114: 492-494Crossref PubMed Scopus (9) Google Scholar Since it has often been considered unethical and impractical to approach newly bereaved parents for research consent, in California, USA, legislation was recently amended for mandatory inclusion of SUDI cases into research programmes, without parental consent.3Krous HF Byard RW Rognum TO Pathology research into sudden infant death syndrome: where do we go from here?.Pediatrics. 2004; 114: 492-494Crossref PubMed Scopus (9) Google Scholar A similar model has not been adopted in many other countries, making research use of postmortem tissue, "opt-in". As part of a less invasive autopsy study comparing postmortem MRI with conventional autopsy, we attempted to obtain prospective informed consent by telephone from SUDI parents in London, UK, by means of a family liaison nurse with experience in bereavement counselling. Our research ethics committee approved the study, and permission from the coroner was obtained to approach the parents in all cases. Of 40 cases referred during the period, parental contact details were provided in 26. The research nurse contacted these 26 parents; 25 gave verbal research consent in a median telephone conversation time of 15 min (range 5–90 min). The study information leaflet and consent form, sent by post, were subsequently received back from all parents, 1–8 weeks after telephone consenting, without any additional reminders. 12 of the 25 parents gave "helping others in future" and four gave "wanted as much information possible" as reason for participating in research. None of these parents had objections to the process of telephone consenting, with one commenting that the process "had a strangely calming effect", and three others stating that they found it useful to discuss the post-mortem process with a bereavement nurse. Current hurdles remain the coronial system for death investigation, which does not allow this process to occur in many cases. Nevertheless, we encourage all those involved in SUDI to consider this model for prospective research consenting. We declare that we have no conflict of interest. Department of ErrorThayyil S, Robertson NJ, Scales A, Sebire NJ, Taylor AM. Parental consent for research and sudden infant death. Lancet 2008; 372: 715—In this Correspondence letter (Aug 30), the first sentence of the second paragraph should have read: "Such SUDI cases are investigated by the coronial system, and although parental consent is not required for further retention of tissue for diagnostic investigations into the cause of death, additional samples cannot be obtained specifically for research purposes without prospective explicit parental consent." Full-Text PDF