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To conduct of scientific research involving human beings, their biological samples and/or their personal and health data, requires knowledge of the requirements and obligations established, both from an ethical and legal point of view. Ethical guidelines are a prerequisite for regulation in this area, while, at the same time, allowing the law to adapt to new scientific realities. However, while ethical guiding principle constitutes a voluntarily acceptable guide, laws establish mandatory rules and their nonobservance may give rise to legal liability on the part of scientists. In any case, scientific progress and the improvement of knowledge of diseases must be developed with respect for the people under study establishing the necessary guarantees. So that, their involvement in research must carried out bearing in mind, among other issues: safety, confidentiality, beneficence, and risk minimization. The chapter has attempted to highlight the most relevant issues from an ethical and legal perspective in biomedical research. The sections into which the chapter is structured are: The Relationship Between Ethics and Law, Ethical Principles and Research Ethics Committees, The Regulatory Framework for Biomedical Research, and The New Regulatory Framework for the Protection of Personal Data and New Technologies and Research with Health Data.

Rapid deployment aortic valve replacement has been recently introduced in clinical practice. Different studies have reported a significant reduction in surgical times with excellent hemodynamic profiles and short-term results. However, an increase in permanent pacemaker requirements compared with conventional aortic valve replacement has been described. Nevertheless, risk factors for postoperative pacemaker implantation are not well known. The aim of this study is to report our early outcomes with rapid deployment aortic valve replacement within the RADAR Registry, especially focusing on risk factors for postoperative pacemaker implantation. Between April 2012 and January 2016, 164 patients undergoing isolated or combined aortic valve replacement with Edwards INTUITY Elite (Edwards Lifesciences, Irvine, CA, USA) were included in the RADAR Registry. Pre-, intra- and postoperative clinical data results and complications were recorded, especially focusing on risk factors for the development of postoperative complete or high-grade AV block requiring pacemaker implantation. Patients were followed up for up to 1 year with evaluation of clinical and echocardiographic outcomes. A total of 164 consecutive patients were included in this study, where 128 patients (78.05%) had an isolated aortic valve replacement (group 1) and 36 (21.95%) a concomitant procedure (group 2). The surgical approach was ministernotomy in 61 patients (37.20%) and median sternotomy in 100 patients (60.98%). Complications with valve implantation were observed in three patients. Postoperative complete or high-degree AV block requiring a permanent pacemaker implantation developed in ten patients (6.9%). Seven patients died in-hospital (4.27%). No significant differences between groups were found in terms of stroke, postoperative infection, mortality, atrial fibrillation and postoperative atrioventricular block. Seven patients presented acute renal impairment (5.51%) in group 1 versus seven patients (20%) in group 2 (p = 0.007). In multivariate analysis, low weight and preoperative arrhythmia (atrial fibrillation, bifascicular block, left bundle branch block) emerged as risk factors for postoperative AV block requiring a pacer. In median follow-up of 1 year, seven (4.27%) patients died, and no cases of structural valve deterioration or endocarditis were observed. Significant patient-prosthesis mismatch was found in seven (4.27%) patients. Initial experience with rapid deployment aortic valve replacement in the RADAR Registry demonstrates low rates of implantation complications and good perioperative and 1-year clinical and echocardiographic outcomes. Incidence of postoperative AV block requiring a pacer correlated with low weight and preoperative arrythmias (atrial fibrillation, bifascicular block and left bundle branch block). Avoidance of oversizing and careful consideration of implantation of this technology in patients with pre-existing arrythmias could minimize the risk for postoperative pacemaker implantation.

Objective: The aim of our study is to report our initial results with rapid deployment aortic valve replacement within the Spanish RADAR Registry, especially focusing on the incidence of patient-pr...

Resumen La realidad de la investigacion biomedica en Espana, exige tener un conocimiento actualizado de la realidad investigadora y de su marco etico/legal. Los estudios de investigacion con muestras biologicas humanas deben realizarse con un numero de muestras lo suficientemente amplio para reflejar la diversidad de la poblacion humana. Asimismo, deben cumplir los requisitos estandarizados de calidad optima para garantizar los resultados de la investigacion a desarrollar. Ademas, la investigacion con seres humanos, y la obtencion y/o derivacion de muestras biologicas humanas e informacion clinica a estudios de investigacion, esta sujeta a una serie de requisitos y restricciones legales. Los biobancos y las redes de biobancos se constituyen como la estructura optima que favorece el almacenamiento de grandes volumenes de muestras biologicas humanas gestionadas en base a criterios que garanticen su optima calidad, armonizacion y seguridad, respetando en todo momento los requisitos eticos y legales que garantizan los derechos de los ciudadanos.

The reality of biomedical research in Spain requires having an updated knowledge of the research reality and its ethical/legal framework. Research studies with human biological samples should be made with a sufficiently large number of samples to reflect the diversity of the human population, which meets the standard requirements to ensure optimum quality of the research results for further development. Furthermore, research with humans and obtaining and/or deriving human biological samples and clinical research studies information are subject to a number of legal requirements and restrictions. Biobanks and biobank networks are established as the optimal structures that favor the storage of large volumes of human biological samples based on criteria to ensure their optimum quality, harmonization and security, respecting at all times, the ethical and legal requirements guaranteeing the rights of citizens.