Participation in biobanks for research by incapacitated adults: review and discussion of current guidelines

OBJECTIVE: Biobanks for research and genetic research are important opportunities to create new understanding of complex disorders, such as psychiatric disorders and dementia. The management of biobanks for subjects with psychiatric disorders or dementia raises additional challenges because of the ethical issues regarding the potentially impaired decision-making capacities of the subjects. The aim of this paper is to study (i) how guidelines address the matter and (ii) how they can be implemented in real research situations with patients suffering from psychiatric disorders and dementia. METHOD: We collected and analysed all the relevant guidelines and position papers from national and international organizations dealing with research on biological materials and selected documents mentioning the participation of incapacitated adults in genetic research and biobanks. RESULTS: Eighteen of the 30 analysed documents contain explicit references to adults who are unable to give consent. The main topics addressed by the guidelines are the following: (i) informed consent; (ii) principles of non-therapeutic research; and (iii) ethics committee review. CONCLUSIONS: In biomedical research, guidelines are an important instrument for facilitating research while promoting subjects' rights and well-being. Compared with legally binding documents, guidelines are more flexible and can be more easily revised according to evolving research situations and for adaptation to real persons and research settings. We suggest measures to implement the analysed guidelines taking into consideration the case for the participation of patients with neuropsychiatric disorders, who can have impairment of decision-making capacities without being obviously incompetent, in genetic research and biobanks.status: publishe

Decreased number of circulating endothelial progenitor cells in patients with Graves’ hyperthyroidism.

OBJECTIVE: A relevant biological role of circulating endothelial progenitor cells (EPC) was recently demonstrated. EPC are generated in the bone marrow, and interact with damaged endothelium, restoring the integrity of the monolayer. Therefore, aim of the present study was to evaluate EPC in the blood of patients with untreated Graves' hyperthyroidism (GD), in whom an increased oxidative stress was observed. DESIGN AND METHODS: Twenty-three patients with untreated active GD and 18 matched normal controls (NC) were included in the study. Circulating EPC were isolated from peripheral blood. Mononuclear cells were cultured with endothelial basal medium supplemented with EGM SingleQuots, and were identified by positive double staining after 7 days in culture. Circulating levels of C reactive protein, total antioxidant power, interleukin (IL)-6, IL- 18, monocyte chemoattractant protein-1, tumor necrosis facotr- α, soluble vascular cell adhesion molecule (VCAM) and intracellular adhesion molecule were evaluated by enzymelinked immunosorbent assay kit. EPC number was also evaluated in a subgroup of GD patients after restoration of euthyroidism. RESULTS: Systolic blood pressure resulted increased in GD patients compared with control subjects whereas diastolic blood pressure was not significantly different. Patients with GD showed an increase in circulating levels of IL-18 and VCAM-1 and a reduction of total antioxidant power (p<0.05) compared to NC. Moreover, a reduced number of EPC was observed in patients with GD compared to NC (p<0.05) which turned to NC values after restoring euthyroidism. CONCLUSION: Patients with GD showed a reduction in the physiological protective mechanisms against endothelial damage, probably induced by increased inflammation and oxidative stress

Pseudo-tunneling procedure: an advantageous and safe technique for brachial catheters in younger children

Background: The aim of this study is to present our experience with the use of a particular tunneling technique called pseudo-tunnelling, during insertion of peripherally inserted central catheters (PICCs) and Midlines in younger patients. The children's brachial veins at the middle third of the arm are usually too small for cannulation. So the veins in the axilla are the best option for implantation of a four or five French catheter. A pseudo-tunneling procedure can create an exit site at the middle of the arm without using other procedural sets. Methods: From January 2014 to August 2022, 60 PICCs and 113 midlines were inserted in children admitted to Children Hospital of Brescia. Results: Every procedure was successfully performed during the first or the second time at latest. The time of procedure was not significantly different from non tunnelized procedures. No insertion related complications were observed. Conclusions: Our data suggests that pseudo-tunneling is a safe and effective procedure for brachial device implants to avoid central venous catheterization even in pediatric patients

Guidewire replacement of tunneled central venous catheters in children reusing the same subcutaneous route

Background: Tunneled centrally inserted central venous catheters (CICCs) are a type of catheters used especially in cancer pediatric patients or affected from short bowel disease and malabsorption. Recently, thanks to biomedical research progresses, polyurethane catheters have resulted in high surgical performances with a low caliber but extremely fast infusion rate. Sometimes the replacement procedure over a Seldinger guidewire could be an appreciable technique especially reusing the same vein and the same tunnel of the previous catheter, with local anesthesia. The aim of this article was to explain our replacement technique over guidewire of tunneled CICCs on pediatric patients. Methods: The casuistry presented was evaluated at the Unit of Vascular Access of ASST Spedali Civili in Brescia, Italy. The study involved 7 successful catheter replacement over guidewire, meanwhile cases where patients presented sepsis, exit site infection or catheter damage were premeditatedly excluded. Three of them were tunneled and cuffed. Five catheters were in brachiocephalic vein and 2 in internal jugular vein. Results: Every procedure was ended without complications. Of seven patients, five of them underwent to the procedure only with local anesthesia and 2 patients require premedication with Midazolam. No one required general anesthesia. The maneuver was always conducted following the same procedure without noticing particular complications associated with CICC insertion. Indeed, the operation was quick, feasible and safe. Septic, thromboembolic, or hemorrhagic complications also related to patients presenting dysfunctional coagulation cascade were not encountered. Conclusions: Our experience regarding the replacement technique of tunneled catheters over guidewire was considered feasible, accurate and efficient for all patients treated, even in those presenting thrombocytopenia or dysfunctional coagulation cascade

How to remove a tunneled and cuffed central venous catheter quickly and safely? A little trick useful in children

Background: The aim of this study was to present our experience with a use of own variation of the traditional technique for tunneled and cuffed catheters removal. Methods: From July 2021 to March 2023, 110 tunneled cuffed centrally inserted central catheters (CICCs) were removed at the Vascular Access Unit of ASST Spedali Civili of Brescia using our particular technique; pediatric patients were 15 admitted to "Children Hospital" of Brescia. The catheter is cut with its adhesions above the cuff and then pulled out. The cuff is then removed with all adhesions attached. Results: Each procedure was successfully performed to the end with local anesthesia, also in younger children. The maneuver was very short and well tolerated. No related complications were observed. The maneuver has always been considered easy even by less experienced surgeons. The scars were aesthetically good and well accepted by the patients. Conclusions: The technique described has the advantage of not requiring the careful lysis of the adherence from the cuff. If the procedure is quick it can be performed without general anesthesia and without significant psychological trauma also in less compliant children. The skin cut very short leaves an almost invisible scar. It is another notable advantage especially for young girls

Biobanche. Aspetti scientifici ed etico-giuridici

La biobanca quale raccolta di materiali biologici umani offre alla ricerca medica un numero fino a pochi anni orsono inimmaginabile di reperti omogenei per certe caratteristiche e di informazioni da essi desumibili. Talora, si pensi alla banche di sangue cordonale, offre altres\uec elementi che possono essere utilizzati in ambito terapeutico. Si tratta, quindi, di una risorsa caratterizzata da una peculiare finalizzazione solidaristica. Ma quanto essa mette a disposizione \ue8 straordinariamente delicato: perch\ue9 se ne potrebbe far uso per gli scopi pi\uf9 diversi; perch\ue9 \ue8 in grado di fornire conoscenze sensibili sulla salute del donatore e dei suoi consanguinei; perch\ue9 potrebbe suscitare interesse da punti di vista del tutto differenti rispetto a quello sanitario. Gli elementi biologici umani sono espressione dell\u2019identit\ue0 di un individuo e ne portano i caratteri. Ciascuno, pertanto, ha il diritto e il dovere di sovrintendere al loro utilizzo, prestando il proprio consenso sulla base di un\u2019adeguata identificazione dell\u2019ambito di ricerca presente e futura (o di gestione per fini terapeutici) cui siano destinati o escludendo tipologie di utilizzo ritenute inaccettabili. Tale responsabilit\ue0 non viene meno solo perch\ue9 si renda irriconoscibile, mediante procedure di anonimizzazione, il rapporto tra un certo materiale biologico e l\u2019individuo da cui proviene. Quel rapporto, del resto, deve poter essere ricostruito ai fini della comunicazione di dati che abbiano interesse sanitario (da realizzarsi sempre attraverso un serio counseling medico e psicologico). La sensibilizzazione a donare materiali biologici s\u2019intreccia cos\uec con l\u2019esigenza che questi siano gestiti in modo trasparente e scientificamente qualificato, come pure con la necessit\ue0 di un costante dialogo tra i donatori e le loro famiglie, la comunit\ue0 dei ricercatori e tutti i potenziali beneficiari delle attivit\ue0 svolte in una biobanca. Il volume, dunque, raccoglie interventi che provengono da competenze diverse (biologia, medicina, filosofia, diritto, bioetica), miranti a evidenziare nodi problematici e a formulare proposte per fini di regolamentazione etica e giuridica