Consent For Transplantation Research Articles

Renal Transplantation in Mansoura, Egypt.

Renal Transplantation in Mansoura, Egypt.

35. Evolution from NHS Heart Valve Bank to University Hospital Ovarian Tissue bank to Oxford Biomedical Research Centre Biorepository Biobank

The Heart Valve Bank (HVB) based in the Heart Centre, Oxford University Hospital NHS Trust (OUH) procures and processes at least 150 cardiovascular tissues each year for transplantation. This HVB service has evolved now to process other tissue for transplantation and for research. The impetus for development was atypical. The HVB team reviews an average of 720 deceased patient notes per annum and interviews families of potential donors to obtain consent for transplantation. Of these, 80% families also consent to research in NHS or university setting (60% in commercial setting). The OUH is one of the largest acute teaching hospitals in the UK. Research is one of the OUH’s three key strategic activities, alongside clinical services and teaching. HVB was encouraged to fulfil the wishes of the donors and to facilitate research within OUH. HVB service has evolved from April 2011 as follows: • 181 corneas retrieved and supplied to eye bank (per annum). • Hearts unsuitable for transplantation used within OUH or Oxford University (OU) for research e.g. study to improve mitral isthmus ablation surgery (hearts placed in head coil inside MRI to enhance image clarity). • 101 aortic valves (calcified) supplied to Sir Magdi Yacoub’s researchers at Harefield Hospital developing a tissue engineered valve and at Imperial College exploring the calcification of the aortic valve using state of the art materials analyses. • More than 30 ‘control’ & diseased brains and spinal cords supplied to OUH/OU brain bank. Brain tissue used to study effects of new therapies e.g. AD vaccine trial, PD cell transplantation, development of transgenic mouse models. • Ovarian tissue cryopreservation set-up for 2013 with OU/OUH to preserve fertility in children and young females who survive cancer treatment (first UK clinical program). HVB already had an embedded system within the OUH and the community for tissue donation for transplantation and a detailed consenting procedure (recorded), working within strict EU and UK legislation e.g. regarding ‘DNA-theft’ and ‘privacy’. Prior to further development however, HVB required support and guidance from the Oxford Biomedical Research Centre (OxBRC), funded by the National Institute for Health Research (NIHR), and aims to align excellence across the Strategic Partnership of the hospital Trust and the University. In practice this means bringing together the research expertise and skills of OU and OUH staff, with the aim of supporting translational research and innovation for maximum patient benefit. The biobank activities of the HVB are standardised and comply with Human Tissue Authority (HTA) licensing and ethical requirements. Access to samples and data is facilitated via a single point of access, open to all researchers via an online website enquiry form. Accessibility, quality control, documentation and distribution are efficiently managed. Public involvement and engagement and independent review are facilitated by OxBRC. HVB now considers specific or generic requests for any tissue required for research along with biofluids and associated medical, behavioural and social data and can create prospective sample collections. HVB requires feedback from researchers to encourage consent. The HVB is thus now acting as a hospital integrated BioResource.

Mandatory Autopsies and Organ Conscription

Laws requiring autopsies have generated little controversy. Yet it is considered unconscionable to take organs without consent for transplantation. We think an organ draft is justified if mandatory autopsies are. We reject the following five attempts to show why a mandatory autopsy policy is legitimate, but organ conscription is not: (1) The social contract gives the state a greater duty to protect its citizens from each other than from disease. (2) There is a greater moral obligation to prevent murders than disease-caused deaths because killing people is morally worse than allowing people to die. (3) Autopsies do not confiscate body parts, but organ transplants do. (4) The citizenry's knowledge that their organs are very likely to be taken will generate more anxiety than the remote possibility of a mandatory autopsy. (5) A religious conviction that one's organs will be needed in order to be resurrected is threatened by organ transplantation but not by autopsies that "return" body parts.

PEDIATRIC BONE MARROW TRANSPLANTATION-A BIO-ETHICAL MODEL

Informed consent for children is traditionally obtained by agreement between physicians and parents acting for themselves and their child. In marrow transplantation, donors undergo a hazardous procedure of no physical benefit. Parental ability to consent for donor or critically ill recipient is compromised. A system was devised to represent the interests of parents, donor and recipient in this setting. This included peer review, a court appointed donor guardian, psychiatric consultation, full age-appropriate explanations to all parties and judicial review. Despite fears about over-publicity and over-informed participants, outside observers agreed that maximum information transfer occurred which allowed easier hospitalization. Three cases of severe unresponsive aplastic anemia are presented in which selection of decision-makers, use of veto power, and the concept of consensus were involved. In 1 consent for transplantation was unanimous. The patient recovered. Parents refused permission in the second case. The patient died. In a third case consent was felt to be unobtainable from a brain damaged donor. A court permitted this donation. Assessing the competence of a minor to protect his interests and to give consent should be a critical objective of developmental pediatrics. Bone marrow transplantation in aplastic anemia can be regarded as a model for the study and development of approaches to ethical decisions in the application of advanced lifesaving technologies.