Blood Donation and COVID-19: Reconsidering the 3-Month Deferral Policy for Gay, Bisexual, Transgender, and Other Men Who Have Sex With Men.

In April 2020, in light of COVID-19-related blood shortages, the US Food and Drug Administration (FDA) reduced the deferral period for men who have sex with men (MSM) from its previous duration of 1 year to 3 months.Although originally born out of necessity, the decades-old restrictions on MSM donors have been mitigated by significant advancements in HIV screening, treatment, and public education. The severity of the ongoing COVID-19 pandemic-and the urgent need for safe blood products to respond to such crises-demands an immediate reconsideration of the 3-month deferral policy for MSM.We review historical HIV testing and transmission evidence, discuss the ethical ramifications of the current deferral period, and examine the issue of noncompliance with donor deferral rules. We also propose an eligibility screening format that involves an individual risk-based screening protocol and, unlike current FDA guidelines, does not effectively exclude donors on the basis of gender identity or sexual orientation. Our policy proposal would allow historically marginalized community members to participate with dignity in the blood donation process without compromising blood donation and transfusion safety outcomes.

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).

Quality of the blood donation campaign in the military: A sample from Turkey.

OBJECTIVES: In this study, the conformity of blood donation services performed by Turkish Red Crescent Mobile Medical Team in a Basic Military Training Centre to quality standards was researched and the results were discussed by taking the principles of biomedical ethics into consideration. MATERIALS AND METHODS: This descriptive study was conducted at the Basic Military Training Centre, Canakkale, Turkey. In total, 269 voluntary non-remunerated blood donors who made blood donation between 10 and 12 August 2015 formed the population of the study. All of the donors were recruits who had joined the army to carry out their military service. A questionnaire for assessing the quality of the blood donation services was administered to the participants after the blood donation. SPSS 15.0 software package was used for data analysis. RESULTS: In the study, 232 voluntary non-remunerated blood donors were reached with a response rate of 86.2%. It was seen that the phlebotomists in the mobile medical team followed the quality standards in the blood donation process with the rate of 91.8% to 100%. However, outstanding omissions were found in informing the donors about blood donation process. CONCLUSION: In blood donation campaigns conducted in the institutions such as military units, the quality standards developed in line with the principles of biomedical ethics should not be neglected citing some reasons such as excessive numbers of donors, time limitations and organisational deficiencies. Increasing the quality in blood donation services will increase both donor satisfaction and their motivation to donate blood again in the future.

When are infection risks of blood transfusion tolerable? Towards understanding the ethical views of stakeholders in the blood supply.

BACKGROUND AND OBJECTIVES: The perception of transfusion-transmitted infections (TTIs) is sensitive to various concerns besides the probability and impact of infection, and some of these concerns may be ethically relevant. This paper aims to advance thinking about blood safety policies by exploring and explaining stakeholders' reasons to consider TTI risks tolerable or intolerable. MATERIALS AND METHODS: Inspired by critical empirical ethics and phenomenological hermeneutics, we held interviews and focus group discussions to explore the moral experience of policymakers, hematologists, blood donors and recipients. Respondents were invited to discuss general concerns about the blood supply, to address the tolerability of TTI risks compared with other hazards and to comment on the costs of blood safety. Arguments for tolerance or intolerance towards TTI risks were analysed qualitatively. RESULTS: Stakeholders' views could be clustered into seven categories: (1) clinical impact; (2) probability of infection; (3) avoidability of infection; (4) cost and health benefits; (5) other consequences of safety measures; (6) non-consequentialist ethical arguments; and (7) stakeholders' interests. Various arguments were offered that resonate with current ethical thinking about blood safety. Assuming that resources spent on inefficient blood safety measures could be applied more beneficially elsewhere, for example, responders typically expressed tolerance towards TTI risks. Some other arguments seem novel, for instance arguments for risk intolerance based on the low probability of infection and arguments for risk tolerance if patients have a poor prognosis. CONCLUSION: Understanding the moral experience of stakeholders enriches ethical debate about blood safety and prepares developing more widely acceptable policies.

Attitudes of blood donors to their sample and data donation for biobanking.

Modern biomedical and genetic studies require large study cohorts; blood donors have been suggested to represent an appropriate group for recruiting healthy cohorts. The Blood Service Biobank (BSB) in Finland was recently established to recruit blood donors willing to give broad biobank consent. The aim of the present study is to understand how the blood bank context influences views on donating samples and health data. We organised 61 interviews and 10 group discussions with current and potential blood donors. Using qualitative content analysis, we identified three discussion frameworks that summarise the results. We found that frequent blood donors associated the voluntary act of donation with caring for patients. The blood donation experience was considered to accommodate biobank participation, but also allowed critical observations on the integration of research data collection into blood donation. Research participants identified an important difference between the blood bank and biobank contexts. In the biobank context, the focus shifts from donating blood to patients into donating personal and genetic data for research use. Blood donors' anxiety over data use was balanced with their experience of the trustworthiness of the Blood Service. These experiences indicated that the new biobanking activity could be trusted to a familiar organisation. To build donors' trust, biobanks should invest in their institutional reputation, donor experience and dialogue with donors. These findings can be applied to other institutions that are considering setting up biobanks with broad consent for personal data use.

Why Prohibiting Donor Compensation Can Prevent Plasma Donors from Giving Their Informed Consent to Donate.

In recent years, there has been a considerable increase in the degree of philosophical attention devoted to the question of the morality of offering financial compensation in an attempt to increase the medical supply of human body parts and products, such as plasma. This paper will argue not only that donor compensation is ethically acceptable, but that plasma donors should not be prohibited from being offered compensation if they are to give their informed consent to donate. (While this paper will focus on the ethics of compensating plasma donors, its arguments are also applicable to the ethics of offering compensation for other body parts, such as kidneys.) Regulatory regimes that prohibit donor compensation thus unethically prevent the typical donor from being able to give her informed consent to donate.

The ethics of ordinary and exact justification in blood donation deferral categories for men who have sex with men.

In 2015, the United States Food and Drug Administration (FDA) changed their indefinite deferral policy towards donors who were men who had sex with men (MSM). I develop an empirical case for the current, revised MSM deferral policy and show that rights-based objections fail. This empirical case, however, misleadingly accounts for an elevated risk for MSM donors because it lumps two distinct kinds of MSM donors into the same category. Building on some recent work that has been published since the revision, I introduce and defend a distinction between MSM donors who have what I call 'exact justification' and those who have what I call 'ordinary justification'. MSM donors with exact justification present no risk with respect to the deferral and should be allowed to donate. I conclude by addressing a practical issue about how primary partner testimony is not enough to create exact justification, but it is enough to sustain it.

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.

[Not-for-profit: A report from the fourth annual symposium of ethics held by the National Institute for Blood Transfusion (France)]. / À propos du non-profit : rapport du quatrième symposium annuel d'éthique transfusionnelle de l'Institut national de la transfusion sanguine.

The not-for-profit issue has been debated in November 2016 in Paris; this issue is one of the four canonical pillars of ethical blood donation. It is intimately bound to benevolence though it is distinct, as not-for-profit calls for institutions while benevolence calls for individuals. It is indeed intended that voluntary blood donors do not benefit from their donation and are thus non-remunerated. Not-for-profit is essential since it refers to the public character of blood as a putative public resource aimed at being shared as a tribute of solidarity. A central question however is linked to the capacity- or not -of public sectors to ensure that blood components are universally available, with special mention to plasma derived drugs, without the contribution of the for profit, private sector.

Knowledge, attitude, and practice towards blood donation among health care providers in hospitals at Bahir Dar City, Ethiopia.

Like other sub-Saharan Africa, in Ethiopia there is a shortage of adequate and safe blood supplies. Health care providers are potential resource and promoter of voluntary blood donation. This study was conducted to determine the knowledge, attitude and practice towards blood donation among health care providers in Bahir Dar City, Ethiopia. Paper based questionnaire was distributed to 276 health care providers from May 01 to June 30, 2016. Overall, 42.8% had donated blood at least once. Of these, males accounted for 60%. The median age of blood donors was 26 years. Voluntary-unpaid donation was 21.2%. Overall, 75.5% health care providers were knowledgeable. The levels of knowledge were significantly different among different disciplines (One-way ANOVA; F=69.7; P=0.004). Males were more knowledgeable than females (P<0.05). The overall favorable attitude was 78.6%. Previous practice of blood donation determined the odds of favorable attitude to be a future regular voluntary-unpaid blood donor (OR: 5.7, 95% CI: 3.2-10.4). Majority of health care providers had adequate knowledge and favorable attitude. However, voluntary-unpaid donation practice (21.1%) was lower compared to 100% target of voluntary-unpaid donation. There should be motivation packages to enhance voluntary-unpaid blood donation among health care professionals.

An end to lifetime blood donation ban in Israel for MSM would be a major step toward a science-based policy that reduces stigma.

In recent years, countries around the world have revised their blood donation policies regarding gay and bisexual men, and other men who have sex with men (MSM). The United States lifted the lifetime ban on MSM from donating blood in 2015, replacing it with a 1 year deferral policy allowing MSM to donate if they abstain from sex for 12 months. Other countries followed suit, while Italy and Spain have implemented deferral policies based on individual risk assessments regardless of sexual orientation. If Israel were to adopt a one year deferral policy for MSM, as recommended by Drs. Ginsberg et al. in this issue, the increase in risk to the blood supply would be minimal. Moving to a 1 year deferral policy would be an important step forward, but it could still be seen as stigmatizing to gay and bisexual men. We recommend that Israel consider a deferral policy based on individual risk assessment rather than a blanket deferral for all MSM. MSM can engage in low- and high-risk sexual behaviors. Those who consistently engage in low-risk behaviors, such as using condoms and pre-exposure prophylaxis consistently, pose little risk to the blood supply. An individual risk assessment policy would screen potential donors of all sexual orientations for low-, medium-, and high-risk behaviors. Potential donors identified as high-risk, such as injection drug users, would justifiably be subject to lengthy or permanent bans. MSM who engage in low-risk sexual behaviors would be allowed to donate without deferral. Medium-risk donors, such as men who have recently had unprotected anal sex with another man, would be subject to a deferral period of 1 month, which is in line with the window period of current HIV screening technology. Most fourth generation HIV tests can detect HIV within a month, and the nucleic acid test used to screen blood can detect HIV in just 9-11 days. Various studies have developed questions for ascertaining HIV risk among MSM which could be used in blood donor questionnaires. Using tablets or other technology that enhances privacy to conduct the blood donor questionnaire could improve collection of this sensitive information.

Hepatitis E Virus Infection after Platelet Transfusion in an Immunocompetent Trauma Patient.

Hepatitis E virus (HEV) infection causes acute liver disease, but severe infections are rare in immunocompetent patients. We describe a case of HEV infection in a previously healthy male trauma patient in France who received massive transfusions. Genotyping confirmed HEV in a transfused platelet pool and the donor.