Towards Principled Responsible Research and Innovation: Employing the Difference Principle in Funding Decisions

Responsible Research and Innovation (RRI) has emerged as a science policy framework that attempts to import broad social values into technological innovation processes whilst supporting institutional decision-making under conditions of uncertainty and ambiguity. When looking at RRI from a ‘principled’ perspective, we consider responsibility and justice to be important cornerstones of the framework. The main aim of this article is to suggest a method of realising these principles through the application of a limited Rawlsian Difference Principle in the distribution of public funds for research and innovation. There are reasons why the world's combined innovative capacity has spewed forth iPhones and space shuttles but not yet managed to produce clean energy or universal access to clean water. (Stilgoe 2013, xii) I derive great optimism from empathy's evolutionary antiquity. It makes it a robust trait that will develop in virtually every human being so that society can count on it and try to foster and grow it. It is a human universal. (de Waal 2009, 209) Responsible Research and Innovation (RRI) has emerged as a science policy framework that attempts to import broad social values into technological innovation processes whilst supporting institutional decision-making under conditions of uncertainty and ambiguity. In this respect, RRI re-focuses technological governance from standard debates on risks to discussions about the ethical stewardship of innovation. This is a radical step in Science & Technology (S&T) policy as it lifts the non-quantifiable concept of values into the driving seat of decision-making. The focus of innovation then goes beyond product considerations to include the processes and – importantly – the purposes of innovation (Owen et al. 2013, 34). Shared public values are seen as the cornerstone of the new RRI framework, while market mechanisms and risk-based regulations are of a secondary order. What are the values that could drive RRI? There are different approaches to the identification of public values. They can be located in democratically agreed processes and commitments (such as European Union treaties and policy statements) or they can be developed organically via public engagement processes. Both approaches have advantages and disadvantages. For instance, although constitutional values can be regarded as democratically legitimate, their application to specific technological fields can be difficult or ambiguous (Schroeder and Rerimassie 2015). On the other hand, public engagement can accurately reflect stakeholder values but is not necessarily free from bias and lobbyist agenda setting. We argue that if RRI is to be more successful in resolving policy dilemmas arising from poorly described and uncertain technological impacts, basic universal principles need to be evoked and applied. When looking at RRI from a ‘principled’ perspective, we consider responsibility and justice to be important cornerstones of the framework. One could describe them in the following manner: Research and innovation should be conducted responsibly. Publicly funded research and innovation should be focused fairly on socially beneficial targets. Research and innovation should promote and not hinder social justice. The main aim of this article is to suggest a method of realising these principles through the application of a limited Rawlsian Difference Principle in the distribution of public funds for research and innovation. This paper is in three parts. The first part discusses the above principles and introduces the Rawlsian Difference Principle. The second part identifies how RRI is currently applied by public funding bodies. The third part discusses the operationalisation of the Rawlsian Difference Principle in responsible funding decisions

Current management of symptomatic vesicoureteral reflux in pediatric kidney transplantation-A European survey among surgical transplant professionals.

peer reviewed[en] BACKGROUND: Vesicoureteral reflux (VUR) is common in children and adolescents undergoing kidney transplantation (KTx) and may adversely affect allograft kidney function. METHODS: To explore the current management of symptomatic native and allograft VUR in pediatric KTx recipients, an online survey was distributed to European surgical transplant professionals. RESULTS: Surgeons from 40 pediatric KTx centers in 18 countries participated in this survey. Symptomatic native kidney VUR was treated before or during KTx by 68% of the centers (all/selected patients: 33%/67%; before/during KTx: 89%/11%), with a preference for endoscopic treatment (59%). At KTx, 90% favored an anti-reflux ureteral reimplantation procedure (extravesical/transvesical approach: 92%/8%; preferred extravesical technique: Lich-Gregoir [85%]). Management strategies for symptomatic allograft VUR included surgical repair (90%), continuous antibiotic prophylaxis (51%), bladder training (49%), or noninterventional surveillance (21%). Redo ureteral implantation and endoscopic intervention for allograft VUR were equally reported (51%/49%). CONCLUSIONS: This survey shows uniformity in some surgical aspects of the pediatric KTx procedure. However, with regard to VUR, there is a significant variation in practice patterns that need to be addressed by future well-designed and prospective studies. In this way, more robust data could be translated into consensus guidelines for a more standardized and evidence-based management of this common condition in pediatric KTx

Current practice of antithrombotic prophylaxis in pediatric kidney transplantation-Results of an international survey on behalf of the European Society for Paediatric Nephrology

BACKGROUND Renal graft thrombosis (RGT) is one of the main causes for early graft loss in pediatric kidney transplantation (KTx). Despite the lack of evidence-based recommendations, antithrombotic prophylaxis (aP) is used to prevent RGT. METHODS An online survey supported by the European Society for Pediatric Nephrology was developed to investigate the current practice of aP in pediatric KTx recipients <18 years. RESULTS A total of 80 pediatric KTx centers from 37 countries participated in the survey. Antithrombotic prophylaxis was performed in 96% of the pediatric renal transplant centers (all/selected patients: 54%/42%). The main overall used drugs were as follows: low-molecular-weight heparin (89%), unfractionated heparin (UFH) (69%), and acetylsalicylic acid (ASS) (55%). Ten different aP management strategies were identified as follows: 51% used a single drug and 48% combined two drugs sequentially. The corresponding centers started aP predominantly within 24 hours after pediatric KTx; 51% preferred UFH for starting aP. In centers switching to a second drug (51%), this change was performed after 10 ± 6 days; of these 57% preferred ASS for maintenance aP. Reported median aP duration was 51 days (range 1-360). CONCLUSIONS Despite the use of aP in almost all responding pediatric KTx centers, there is no uniform management strategy. Notwithstanding, UFH seems to be the preferred drug for the early post-operative period of pediatric KTx, and ASS for maintenance prophylaxis following pediatric KTx. Prospective studies are needed to further evaluate the benefits and risks of aP, preferably resulting in guidelines for the management in pediatric KTx

An evaluation study of national procedural laws and practices in terms of their impact on the free circulation of judgments and on the equivalence and effectiveness of the procedural protection of consumers under EU consumer law

In response to the tender specifications the study consists of two parts. The first examines whether divergences in national procedural laws and practices constitute obstacles to mutual trust and, in the affirmative, identifies the locus and the scale of such obstacles; it thereby facilitates the identification of the areas in which mutual trust needs to be further enhanced in line with the European Council Conclusions of 26/27 June 2014. In addition, the study addresses possible obstacles to legal certainty when businesses and citizens engage in cross-border litigation. The second strand of the study evaluates whether and to what extent national procedural laws and practices ensure the effective procedural protection of EU consumers. Both strands of the study investigate the legal and the practical situations in the civil procedural laws of the 28 EU Member States

Diagnostic and therapeutic management of vesico-ureteral reflux in pediatric kidney transplantation-Results of an online survey on behalf of the European Society for Paediatric Nephrology

Background: Vesico-ureteral reflux (VUR) is considered to be a risk factor for recurrent febrile urinary tract infections and impaired renal transplant survival. Methods: An online survey supported by the European Society for Paediatric Nephrology was designed to evaluate current management strategies of VUR in native and transplanted kidneys of recipients aged &lt;18 years. Results: Seventy-three pediatric transplant centers from 32 countries contributed to the survey. All centers performed urological evaluation prior to pediatric kidney transplantation (KTx) with subsequent interdisciplinary discussion. Screening for VUR in native kidneys (30% in all, 70% in selected patients) led to surgical intervention in 78% (11% in all, 89% in selected patients) with a decided preference of endoscopic intervention over ureterocystoneostomy. Following KTx, continuous antibiotic prophylaxis was applied in 65% of the patients and screening for allograft VUR performed in 93% of selected patients. The main management strategies of symptomatic allograft VUR were continuous antibiotic prophylaxis (83%) and surgical treatment (74%) (endoscopic intervention 55%, redo ureterocystoneostomy 26%). Conclusions: This survey demonstrates the high variability in the management of VUR in pediatric KTx recipients, points to knowledge gaps, and might serve as a starting point for improving the care for patients with VUR in native and transplanted kidneys.</p

The use of cinacalcet after pediatric renal transplantation: an international CERTAIN Registry analysis

BACKGROUND Secondary hyperparathyroidism (SHPT) may persist after renal transplantation (RTx), inducing hypophosphatemia and hypercalcemia that precludes the use of vitamin D analogs. The calcimimetic cinacalcet improved plasma calcium and parathyroid hormone (PTH) levels in randomized controlled trials in adults after RTx, but pediatric data are scarce. METHODS In this retrospective study, we analyzed 20 pediatric patients from the Cooperative European Paediatric Renal TransplAnt Initiative (CERTAIN) Registry who received cinacalcet after RTx. The results are presented as median and interquartile range (25th-75th percentile). RESULTS At 13.7 (11.0-16.5) years of age, 20 pediatric patients received a renal allograft. Cinacalcet was introduced at 0.4 (0.3-2.7) years post-transplant at an estimated glomerular filtration rate (eGFR) of 50 (34-66) mL/min/1.73 m$^{2}$, plasma calcium of 2.58 (2.39-2.71) mmol/L, age-standardized (z score) phosphate of - 1.7 (- 2.7-- 0.4), and PTH of 136 (95-236) ng/L. The starting dose of cinacalcet was 0.5 (0.3-0.8) mg/kg per day, with a maximum dose of 1.1 (0.5-1.3) mg/kg per day. With a follow-up of 3.0 (1.5-3.6) years on cinacalcet therapy, eGFR remained stable; PTH levels decreased to 66 (56-124) ng/L at the last follow-up (p = 0.015). One patient displayed hypocalcemia (1.8 mmol/L). Cinacalcet was withdrawn in three patients (hypocalcemia, parathyroidectomy, incompliance). Nephrocalcinosis of the graft was not reported. CONCLUSIONS This pilot study suggests that cinacalcet as off-label therapy for SHPT after pediatric RTx is efficacious in controlling post-transplant SHPT with acceptable tolerability. Continuing cinacalcet even with normal PTH can lead to dangerous life-threatening hypocalcemia. Therefore, at each subsequent visit, the need to continue cinacalcet must be assessed

Corrigendum: Molecular HLA mismatching for prediction of primary humoral alloimmunity and graft function deterioration in paediatric kidney transplantation

Peer reviewed: Tru