Research ethics committee decision-making in relation to an efficient neonatal trial.

OBJECTIVE: Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs). DESIGN: We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC. SETTING: RECs in the UK. MAIN OUTCOME: Number of REC granting favourable opinions. RESULTS: The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid. CONCLUSIONS: A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials.

[Red blood transfusion in palliative care situation]. / Transfusion de globules rouges en situation oncologique palliative.

Anemia is frequent in oncology. We debate the decision-making process of erythrocyte transfusion in palliative care situation from a case report. A patient with a prostatic metastatic cancer was in palliative situation with asthenia and coronary symptom. We analyze, in this particular case that does not describe reality of normal practice, the decision-making process of erythrocyte transfusion. These transfusions were based, in this case, on the evaluation of oncology prognosis, the short-term vital threats, life project and clinical safety of the transfusion. The patient has received 5 erythrocyte transfusions in 4 months until a multidisciplinary meeting decided to stop transfusion because of poor prognostic situation and bad tolerance of the act. This patient could be a collegial model used to measure the reasonable nature of prescription depending on the purpose and the goal of the patient but does not allow generalization. Although there is low risk of erythrocyte shortage, it seems important to train doctors to reduce abusive transfusion and define transfusion thresholds. Different levels of erythrocyte transfusion security would raise the issue of management of several stocks. Erythrocyte transfusion in palliative care can be considered subject to prognostic information and the palliative aim of the transfusions, multidisciplinary decision-making, during short hospitalizations and with evaluation of the act and consequences for the patient.

Attempting to Honor Beliefs of Jehovah's Witnesses at the Edge of Viability in an Infant Born at 23 Weeks' Gestational Age.

BACKGROUND: Infants born at 23 weeks' gestation have a poor prognosis and require intensive care, including blood transfusions, to survive. Generally speaking, the decision to forgo life support is acceptable. Jehovah's Witnesses believe that life is sacred and want lifesaving interventions except for blood transfusions. Therefore, an ethical dilemma exists when a baby is born on the edge of viability to parents that are Jehovah's Witnesses. In this case, if parents and healthcare professionals disagree on the best interests of the child, the medical team should obtain a court order from the state to intervene. CASE REPORT: We present the case of an infant born at 23 weeks' gestation to parents who are Jehovah's Witnesses. The parents wanted full life-support, except for blood transfusions, to be given. The clinical team obtained a court order to transfuse the infant. The infant unfortunately died despite all efforts. CONCLUSIONS: Currently, it is nearly impossible to honor the beliefs of Jehovah's Witnesses to provide lifesaving treatments without blood transfusions for infants born at the border of viability. If the goal is to prolong life, the standard of care for a premature infant is for a doctor to obtain a court order to override the beliefs and wishes of Jehovah's Witness parents and transfuse blood products as medically indicated. Although bloodless techniques for high-risk surgeries are under development, care for premature infants at 23 weeks' gestation necessitates red cell transfusions.

Some ethical issues regarding xenotransfusion.

BACKGROUND: The use of porcine red blood cells has recently been proposed as a possible solution to the shortage of blood for human transfusion. OBJECTIVES: The purpose of this paper is to compare some ethical issues regarding xenotransfusion (XTF) with those relating to xenotransplantation (XT) of organs, tissues and cells. MATERIALS AND METHODS: Various ethical concerns and viewpoints relating to XTF are discussed. RESULTS: The main ethical obstacles to XT do not apply to XTF. It is much more ethically acceptable to raise pigs for regular blood collection as it doesn't damage the health of the animal. Porcine endogenous retrovirus infection, the major concern associated with XT, does not apply to XTF, since red blood cells have no DNA and have a very short lifespan. Clinical trials will be possible in humans once XTF has been demonstrated to be effective and harmless in non-human primates. Transgenesis is acceptable for pig blood donors because only a limited number of genes are involved, and these animals will never enter into the livestock gene pool or the food chain. CONCLUSION: Because the need for blood is less pressing than that for organs, tissues or cells, the use of animal blood for human transfusion is not an absolute necessity. However, it represents a real opportunity. The ability to gain access to an unlimited quantity of blood is a reasonable justification for XTF. Because its technical and ethical hurdles are less stringent, XTF could be the first large-scale clinical application of XT.