Morocco's First Biobank: Establishment, Ethical Issues, Biomedical Research Opportunities, and Challenges.

BACKGROUND: Biobanks are highly organized infrastructures that allow the storage of human biological specimens associated with donors' personal and clinical data. These infrastructures play a key role in the development of translational medical research. In this context, we launched, in November 2015, the first biobank in Morocco (BRO Biobank) in order to promote biomedical research and provide opportunities to include Moroccan and North African ethnic groups in international biomedical studies. Here, we present the setup and the sample characteristics of BRO Biobank. METHODS: Patients were recruited at several departments of two major health-care centers in the city of Oujda. Healthy donors were enrolled during blood donation campaigns all over Eastern Morocco. From each participant, personal, clinical, and biomedical data were collected, and several biospecimens were stored. Standard operating procedures have been established in accordance with international guidelines on human biobanks. RESULTS: Between November 2015 and July 2020, 2446 participants were recruited into the BRO Biobank, of whom 2013 were healthy donors, and 433 were patients. For healthy donors, the median age was 35 years with a range between 18 and 65 years and the consanguinity rate was 28.96%. For patients, the median age was 11 years with a range between 1 day and 83 years. Among these patients, 55% had rare diseases (hemoglobinopathies, intellectual disabilities, disorders of sex differentiation, myopathies, etc.), 13% had lung cancer, 4% suffered from hematological neoplasms, 3% were from the kidney transplantation project, and 25% had unknown diagnoses. The BRO Biobank has collected 5092 biospecimens, including blood, white blood cells, plasma, serum, urine, frozen tissue, FFPE tissue, and nucleic acids. A sample quality control has been implemented and suggested that samples of the BRO Biobank are of high quality and therefore suitable for high-throughput nucleic acid analysis. CONCLUSIONS: The BRO Biobank is the largest sample collection in Morocco, and it is ready to provide samples to national and international research projects. Therefore, the BRO Biobank is a valuable resource for advancing translational medical research.

Causas de rechazo de donantes de sangre de un hospital del sur peruano / Reasons for blood donor deferral in a Southern Peruvian hospital

Introducción: La donación de sangre salva vidas, por lo que la seguridad de la sangre es lo más importante de todo el proceso. La localización demográfica conduce a tener causas específicas de diferimiento. Vivir en zonas altoandinas produciría cambios adaptativos hematológicos. Es por esta razón que resulta importante conocer las causas de rechazo y así poder reorientar los programas de promoción de donación de sangre. Objetivo: Determinar las causas de rechazo de donantes de sangre de un hospital del sur peruano a 3825 m. s. n. m. Métodos: Se realizó un estudio transversal, de corte retrospectivo, sobre las causas de rechazo de posibles donantes de sangre del Hospital III EsSalud, Juliaca. Se analizaron los registros de predonantes que fueron rechazados, desde enero del 2014 a diciembre del 2018. Los datos se analizaron en el programa STATA v.14. Resultados: De los posibles predonantes seleccionados (4057), 1699 (41,87 por ciento) fueron mujeres y 2358 (58,13 por ciento) fueron varones. Fueron diferidos 1458 (41,87 por ciento), los varones tuvieron la tasa de rechazo más alta 882 (60,49 por ciento) en comparación con las mujeres 576 (39,51 por ciento). La polieritrocitemia fue la causa más frecuente de rechazo 669 (45,8 por ciento). Conclusiones: La tasa de rechazo fue moderada (35,93 por ciento) y la principal causa, fue el hematocrito alto (68,4 por ciento), seguido por el bajo (6,8 por ciento).

Introduction: Blood donation saves lives. Blood safety is thus the most important factor throughout the whole process. Demographic location accounts for specific reasons for deferral. Living in high Andean areas causes adaptive hematological changes. Therefore, it is important to be aware of the reasons for deferral with a view to reorienting blood donation promotion programs. Objective: Determine the reasons for blood donor deferral in a Southern Peruvian hospital 3 935 m amsl. Methods: A retrospective cross-sectional study was conducted of the reasons for deferral of potential blood donors in EsSalud III Hospital in Juliaca. An analysis was performed of the records of pre-donors deferred from January 2014 to December 2018. The data were processed with the software STATA version 14. Results: Of the potential pre-donors selected (4 057), 1 699 (41.87 percent) were women and 2 358 (58.13 percent) were men. A total 1 458 (41.87 percent) were deferred. Men had the highest deferral rate with 882 (60.49 percent), whereas the rate for women was 576 (39.51 percent). Polyerythrocythemia was the most common reason for deferral with 669 (45.8 percent). Conclusions: The deferral rate was moderate (35.93 percent) and the main reason was high hematocrit (68.4 percent), followed by low hematocrit (6.8 percent)(AU)

[The limits of a principlist approach in the ethics of donation of elements and products of the human body. About some examples]. / Les limites d'une approche principiste dans l'éthique du don d'éléments et produits du corps humain. À propos d'exemples.

Voluntary, non-remunerated donations are fundamental principles with anonymity regarding donations of elements and products of the human body in France. Blood donation was a model to organize donation of organs, hematopoietic stem cell or gamete. These principles, which at first glance appear to be intangible, commonly accepted and transposable between the different types of donation, though reveal singularities regarding to a collective imagination, a biological reality, evolution of society, medicine and science. Through the study of these different principles applied to donated human body parts, this article aims to highlight the ethical limitations of a single principlist approach. The notions of anonymity, consent, voluntariness, non for profit, under their universal aknowledge, reveal variability of interpretation and scope due to the heterogeneous characteristics, implications and purposes between these donations of different elements and the uses made of them.

Importancia de la sangre, hemoderivados y las donaciones voluntarias de sangre / Importance of voluntary blood donations. Blood and blood products

RESUMEN La terapia transfusional demanda de sólidos conocimientos para lograr planear y ejecutar un plan de trabajo integral para el logro del bienestar de la persona que lo requiera. El personal que desarrolla su profesión en aspectos relacionados con las transfusiones sanguíneas debe estar en una actualización continua de conocimientos, orientados a desarrollar nuevas técnicas así como medidas de seguridad. El objetivo de este trabajo fue abordar acerca de la importancia del uso de la sangre como recurso terapéutico, y el valor hermanado de la donación voluntaria y generoso de sangre lo que vincula al individuo a una nueva conducta y actitud hacia el mundo exterior natural, socia. La sangre constituye la materia prima esencial para los bancos de sangre, de ella se obtiene el plasma, glóbulos rojos, glóbulos blancos, plaquetas, hemoderivados y otros productos biológicos para terapias en la medicina transfusional. La donación voluntaria es una acción desprendida por el solo hecho de ayudar a otros a los que no se conoce, no sólo es la más generosa y la más ética, es el pilar de los servicios modernos de donación y transfusión sanguínea (AU).

SUMMARY Transfusion therapy demands solid knowledge to plan and perform a comprehensive work plan to achieve the wellbeing of persons needing it. The staff whose profession is related with blood transfusions should be continuously updating their knowledge, trying to develop new techniques and secure practices. The aim of this article was approaching the importance of using blood as therapeutic resource and the associated value of generous and voluntary donation, linking individuals to a new behavior and attitude to the natural and social outside world. Blood is the essential raw material for blood banks, obtaining from it plasma, red blood cells, white blood cells, platelets, blood products and other biological products for therapies in transfusion medicine. Voluntary donation is a disinterested action just for the fact of helping unknown persons. It is not only the most generous and the most ethical action, but it is also the support of the modern blood donation and transfusion services (AU).

Donor blood screening and moral responsibility: how safe should blood be?

Some screening tests for donor blood that are used by blood services to prevent transfusion-transmission of infectious diseases offer relatively few health benefits for the resources spent on them. Can good ethical arguments be provided for employing these tests nonetheless? This paper discusses-and ultimately rejects-three such arguments. According to the 'rule of rescue' argument, general standards for cost-effectiveness in healthcare may be ignored when rescuing identifiable individuals. The argument fails in this context, however, because we cannot identify beforehand who will benefit from additional blood screening tests. On the 'imposed risk' argument, general cost-effectiveness standards do not apply when healthcare interventions impose risks on patients. This argument ignores the fact that imposing risks on patients is inevitable in healthcare and that these risks can be countered only within reasonable limits. Finally, the 'manufacturing standard' argument premises that general cost-effectiveness standards do not apply to procedures preventing the contamination of manufactured medical products. We contend that while this argument seems reasonable insofar as commercially manufactured medical products are concerned, publicly funded blood screening tests should respect the standards for general healthcare. We conclude that these particular arguments are unpersuasive, and we offer directions to advance the debate.

Seroprevalence of transfusion transmitted infection among blood donors at Jijiga blood bank, Eastern Ethiopia: retrospective 4 years study.

BACKGROUND: A transfusion transmissible infection (TTI) is any infection that is transmissible from person to- person through parenteral administration of blood or blood products. The magnitude of transfusion-transmitted infections (TTI) varies from country to country depending on TTI's load in that particular population. Measuring their severity, WHO (World Health Organization) has recommended pre-transfusion blood test for Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C Virus (HCV) and Syphilis as mandatory. The aim of the current study was to assess the trend and prevalence of TTI among blood donors in Jijiga Blood Bank between 2010 and 2013. METHODS: A Retrospective cross-sectional study was conducted by reviewing the records from 2010 to 2013 at Jijiga Blood Bank. All blood donors who presented to the blood bank and screened for TTI during the study period were included. The data was collected, entered and analyzed using Epi Info 3.5.1 & Microsoft Excel 2007. The descriptive statistics were determined in means of percentages. Chi-square was used for trend analysis and p-value was used to declare the statistical significance between the variable. RESULT: There were a total of 4224 people donated blood during study period. Males formed the majority of the donor population accounting for 4171 (98.7%). Majority 4139 (98%) of donors were Replacement donors. The overall prevalence of transfusion-transmitted infection was 487/4224 (11.5%). The prevalence for HBsAg, HCV, HIV, & Syphilis antibodies was 460 (10. 9%), 17 (0.4%), 6 (0.1%) and 4 (0.1%) respectively. Majority 460/487 (94.5%) of infection was HBsAg. Statistically significant difference was observed in number of donation as well as sero-positivity from year 2010 to 2013 (Chi-square 9.24, p value = 0.02), in Trends of HBsAg from year to year (Chi-square 11.14, p value = 0.01), HIV virus was seen as the age of donors increases (Chi-square 8.37, p value = 0.01) and There was also statistically significance difference (p value = 0.01) in prevalence of HBsAg distribution by sex. CONCLUSION: The present study clearly documents high Seroprevalence (487 out of 4,224, 11.5%) of TTI, low percentage of voluntary donors and low participation of female donors. Promoting the culture of voluntary donors, recruitment of female blood donors and proper testing of donor's blood by using standard methods are recommended.

¿ Es útil la prueba de lipemia predonación para la selección de donantes de sangre? / Is the pre-donation lipemia test useful for blood donor selection?

En el Banco de Sangre Provincial de Cienfuegos se incluye, además de las pruebas reguladas en Cuba para la selección de los donantes de sangre, la prueba de lipemia predonación. Un plasma con apariencia turbia es causa de exclusión transitoria del donante. A fin de evaluar la eficacia diagnóstica de esta prueba se realizaron dos estimaciones visuales del plasma en busca de turbidez, la primera antes de donar y la segunda en la unidad de plasma obtenida a partir de la sangre total colectada, esta última utilizada como prueba de referencia para este estudio. Ambas observaciones fueron realizadas por el mismo observador siguiendo un protocolo establecido. Como parte del estudio, la presencia de una prueba de lipemia positiva predonación no constituyó causa de exclusión de donantes. Se calculó la sensibilidad y especificidad diagnóstica, el valor predictivo positivo (VPP) y el valor predictivo negativo (VPN), además la eficiencia de la prueba dentro de un intervalo de confianza del 95 por ciento. Se obtuvo el 98,4 por ciento de especificidad, el 80 por ciento de sensibilidad, así como el 66,6 por ciento de valor predictivo positivo y el 99,0 por ciento de valor predictivo negativo, con el 95,7 por ciento de eficiencia diagnóstica. La prueba resulta útil en la selección de donantes de sangre y se recomienda su uso en todas las dependencias de colecta de sangre que cuenten con las condiciones técnicas para su realización...

In addition to the Cuban regulated tests for donor selection, the Cienfuegos provincial blood bank uses a predonation lipemia test. The present study evaluates the diagnostic efficacy of this test. Two visual estimates of plasma for turbidity were performed: the first before donation and the second one to the plasma unit obtained from the whole blood collected, this one used as a reference test for this study. Both observations were made by the same observer following an established protocol. As part of the study, the presence of a positive test predonation lipemia was not cause for excluding donors. Diagnostic sensitivity and specificity, positive predictive value (PPV) and negative predictive value (NPV) and efficiency of the test within a confidence interval of 95 percent were calculated. We obtained 98,4 percent specificity, 80 percent sensitivity and 66,6 percent positive predictive value and 99,0 percent negative predictive value, with 95,7 percent diagnostic accuracy. The test is useful for the selection of blood donors and we recommended its use in all blood collection services having technical conditions for its fulfillment...

La hemovigilancia de las reacciones adversas a la donación de sangre / Hemovigilance of adverse reactions to blood donation

Introducción: en la provincia de Matanzas, de enero del 2003 a diciembre de 2011, se desarrolló un programa de hemovigilancia para incrementar la seguridad de la cadena transfusional. Objetivo: analizar los efectos de este programa sobre las reacciones adversas en los donantes de sangre. Métodos: Se identificó el estado de la notificación de los eventos adversos de la donación en el año 2002, etapa previa al programa. Se mejoró el servicio de donaciones con la revisión de los procederes y las buenas prácticas; a la metodología para la selección del donante se incorporaron los datos geográficos epidemiológicos de cada territorio. A partir de 2003, se notificaron las reacciones adversas de la donación mediante un formulario diseñado para ese fin, se analizaron sus causas, se tomaron las medidas preventivas y correctivas pertinentes. Se efectuaron acciones para prevenir estas y mejorar la calidad de la colecta como capacitación y consejería a los donantes. Se organizó un sistema de alerta rápida para detectar y minimizar los riesgos relacionados con la donación y la calidad de la colecta. Resultados: se disminuyó la tasa de reacciones del donante de 10,1 por mil donaciones en 2002 a 1,4 por mil donaciones en 2011. Se eliminaron las reacciones graves y se minimizaron las moderadas. La reacción más frecuente fue la vasovagal leve. Conclusiones: la hemovigilancia es una herramienta eficaz para incrementar la seguridad de los donantes y mejorar la calidad de la colecta de sangre y puede implementarse con escasos recursos

Introduction: from January 2003 to December 2011 a program of hemovigilance was developed to increase the safety of transfusion in the province of Matanzas. Objective: to analyze the effects of this program on the adverse reactions of blood donors. Methods: adverse reactions to blood donation were identified in 2002 prior to the introduction of the program. The donation service was improved with the revision of procedures and standard practice; epidemiological and geographic data was included in the donor's selection process. From 2003 on, the adverse reactions to donations were notified using a form specially designed; causes were analyzed and prevention and corrective actions were taken. Other proceedings were applied to prevent negative reactions at donation and to improve the quality of blood collection, such as training and advice to donors. A quick alert system was set up to detect and to correct the risks related to donation and the quality of the collection. Results: there was a decrease on the donor's reaction rate from 10, 1 out of 1 000 donations in 2002 to 1,4 out of 1000 in 2011. Severe adverse reactions were eliminated and moderate reactions were minimized. The most frequent was the vasovagal reaction. Conclusions: hemovigilance is an effective tool to increase donors' safety and to improve the quality of blood collection and it can be implemented with scarce resources

Vigilancia activa de enfermedades infecciosas en donantes de sangre / Active surveillance of infectious diseases in blood donors

En Cuba es de carácter obligatorio realizar al 100 por ciento de la sangre donada, pruebas de laboratorio para detectar anticuerpos contra los Virus de Inmunodeficiencia Humana 1 y 2 (VIH), antígeno de superficie del Virus de la Hepatitis B (VHB), anticuerpos contra el Virus de la Hepatitis C (VHC) y la detección indirecta de Treponema pallidum por pruebas serológicas (VDRL o RPR), como ha regulado la Organización Panamericana de la Salud y el Centro para el Control Estatal de Control de la Calidad de los Medicamentos. Se decriben los resultados de esta vigilancia activa en donantes de sangre de la provincia de Cienfuegos desde 1989 hasta el 2009. Se aprecia notable descenso en la detección de casos positivos para la hepatitis B y sífilis a través de los años, mientras que el VIH mantiene un comportamiento caracterizado por cifras muy bajas, incluyendo varios años con ningún caso reportado. Finalmente la hepatitis C muestra una marcada tendencia al incremento en su incidencia entre este grupo poblacional

In Cuba is binding make the detection of antibodies against the 1 and 2 Human Immunodeficiency Virus (HIV), Antigen of the Virus surface of Hepatitis B (HBV) and antibodies against the Virus of Hepatitis C (HCV) and the realization of VDRL, 100 por ciento of donated blood, as it has regulated the Pan American Health Organization and the Center for the State Control of the quality of the medicines Control. This article describes the results of this active surveillance in donor of the Cienfuegos province from 1989 until 2009. Shows remarkable decline in the detection of Hepatitis B and syphilis over the years, while the HIV remains a behavior characterized by very low figures, including several years with no reported case. Finally the Hepatitis C shows a marked tendency to the increase in its incidence

O itinerário de doadores de sangue: reflexões acerca da micropolítica no cuidado de enfermagem / The blood donors' itinerary: reflections on micro-policy in the nursing care

Estudo qualitativo, desenvolvido à luz da etnometodologia, com o tratamento dos dados a partir da análise do discurso das 26 entrevistas não-estruturadas e dos registros da observação participante em diário de campo. Teve como objetivo analisar o itinerário de candidatos a doadores de sangue num serviço de hemoterapia (SH) do Rio de Janeiro. O itinerário dos doadores de sangue se constitui desde a sensibilização até o transcurso para a doação, envolvendo a saúde e os múltiplos contextos da vida dos candidatos, e toma corpo no espaço micropolítico de trabalho. Prevaleceram os doadores de reposição (65,4 por cento), caracterizados por grupos de familiares, de amigos, colegas de trabalho, vizinhos e, em menor número, por pessoas que doam sem nenhuma relação com o receptor. Destacamos o acesso dos doadores ao SH devido às Áreas Programáticas (AP) em que residem 46,1 por cento dos doadores serem distintas da AP do SH e 23,1 por cento residirem em outros municípios. No itinerário percorrido, existem as etapas antecedentes e as posteriores à triagem clínica, sendo esta destacada pela possibilidade da expressão da tecnologia leve no cuidado de enfermagem. Os significados atribuídos à doação e à motivação são individuais para cada doador. O conhecimento do itinerário possibilita a reflexão sobre o gerenciamento do espaço micropolítico em que usuários e enfermeiras se encontram, tanto apresentando o caminho que o doador percorre no sistema de saúde, como a possível definição de um modelo assistencial à luz das necessidades de saúde dos doadores para o cuidado de enfermagem em hemoterapia.

Qualitative study conducted in the light of ethnomethodology, with the processing of data from the discourse analysis of 26 interviews and unstructured records of participant observation in the field diary. It aimed to examine the route of blood donor candidates at a hematology service (HS) in Rio de Janeiro. The itinerary of blood donors starts with their awareness to the course for the donation, including health and the several contexts of the lives of candidates, and takes shape in the micro-political work. Replacement donors (65.4 percent) prevailed, characterized by groups of relatives, friends, coworkers, neighbors, and in smaller numbers, by people who do not even know the receiver. Among these donors, 46.1 percent live in areas other than where the HS is located, and 23.1 percent live in other cities. Along the itinerary, there are previous and posterior steps leading to the screening clinic, which is highlighted by the possibility of the expression of light technology in nursing care. The meanings attributed to the donation and motivation are individual for each donor. The knowledge of the route allows the reflection on the management of the micro-political space in which users and nurses meet, both showing the path that the donor takes in the health system, and a possible definition of a health care model in the light of the health needs of donors for nursing care in hemotherapy.

Disguised information.

The author heard an interesting idea on how to collect blood for medical usage. The idea is "to tell the patient's cousins to donate blood for the patient's usage before a surgery". The physician that proposed this idea mentioned that it was an effective method and sometimes receives plenty of donated blood The topics to be discussed on this blood bank practice based on clinical pathology ethics include: (1) This is a donation thus, is acceptable. However, it is a directed donation. The donor has to pay for the management cost to the blood bank. (2) This may be a lie to the patient's cousins. Often, the patients use placebo in medical research or therapy. Furthermore, medical research or therapy must follow scientific standards and ethical control. Obviously, asking for a donation in the quoted manner might be effective persuasion; however, some problems can be expected. Although the cousin donates blood, the blood might not match or the amount may exceed the real need of the patient. In addition, the donation might be done based on the implied physician's words, although the patient does not need blood transfusion. (3) Generally, an informed consent is necessary before doing any medical procedure. In this case, although it is not the case of a patient, it is of a cousin and the information is given. However, the information is problematic as there may be some disguised and incorrect content. Therefore, this is a lie in Buddhism, as it cannot be said that this is to help the patient. (4) Giving disguised or incomplete information should be avoided A physician should provide transparency and complete information. This can prevent possible problems and make the physician' listener continue to respect the physician's words.

Biobanks, bioethics and concepts of donated blood in the UK.

In recent years international bioethics bodies have made prominent declarations about the uses of donated tissue and related information in genetic research(1). Following the 'legislative' mode of bioethics(2), these organisations have put forward a number of general principles with a view to promoting the fair and equitable use of donated tissue in such research. However, government policies in this field are shaped differently in different national regimes. In this paper, I use recent debates in the UK about a national genetic 'biobank' to illustrate how the shape and texture of policy discussions surrounding the use of donated blood for genetic research have been built upon a prior national consensus that regarded blood as a public good.

Ethical issues in transfusion medicine.

The practice of transfusion medicine involves a number of ethical issues because blood comes from human beings and is a precious resource with a limited shelf life. In 1980 the International Society of Blood Transfusion endorsed its first formal code of ethics, which was adopted by the World Health Organisation and the League of Red Crescent Societies. A revised code of ethics for donation and transfusion was endorsed in 2000. Blood donation as a gift, donor confidentiality, donor notification and donor consent, consent for transfusion, the right to refuse blood transfusion, the right to be informed if harmed, and ethical principles for establishments, are discussed in the international and Indian contexts.