Gotowa bibliografia na temat „Bible. O.T. Daniel II, 1-45”

Abstract Background: The phase II randomized trial S1616 (NCT03033576) showed that patients with melanoma refractory to anti-PD-1-based therapy had improved progression free survival (HR=0.63, p=0.037) and objective response (28% vs 9%) to the combination of ipilimumab with nivolumab compared to ipilimumab. Here, we report molecular and spatial proteomic features of biopsies collected from patients on S1616, both prior to and during therapy. Methods: Biopsies collected from patients from both arms at baseline (N=68 patients total) and early on-therapy (N=51; 43 with paired timepoints) were analyzed by whole exome sequencing (n=185 samples), RNA sequencing (n=105), histopathologic staining (n=149), and multiplexed ion beam imaging (n=45). Multiple biopsies were available for some patients. Mutations, gene expression, and tumor microenvironment were compared across timepoints and response to combination (N=18 responders [CR/PR], N=44 nonresponders [SD/PD]). Results: Baseline biopsies from patients responsive to combination had increased expression of genes (n=482, FDR<0.05) associated with coagulation and complement, fatty acid metabolism, oxidative phosphorylation, hypoxia, and interferon gamma response gene sets (FDR<0.05), compared to nonresponsive biopsies. Baseline biopsies from responders also had low levels of effector CD8 T cells (PD1+, TIM-3+, GZMB+, Ki67+) colocalized with tumor cells and myeloid populations expressing higher levels of MHC Class II. On-therapy biopsies from responders showed decreased detection of driver mutations by genomics, reduced gene expression of pathways enriched at baseline (oxidative phosphorylation, complement) by transcriptomics, and increased CD8 T cell to tumor cell ratios by histopathology, supporting observations of tumor regression. On-therapy biopsies from responders also had increased gene expression of genes related to inflammatory cytokine signaling. This correlated with increased proportions of effector CD8 T cells, compared to paired baseline or nonresponding biopsies, and increased organization of nonactivated CD8 T cells near mature endothelial structures (SMA+, CD31+ regions) adjacent to tumor. Biopsies from nonresponders did not demonstrate these dynamics and instead contained exhausted CD8 T cells (PD1+, TIM-3+, granzyme B-, Ki67-) colocalized with FOXP3+, CD4+ Tregs and CD163+, PD-L1+ M2 macrophages, both at baseline and on-therapy. Conclusion: In patients with melanoma refractory to anti-PD-1, addition of anti-CTLA-4 facilitates tumor-reactive CD8 T-cell infiltration and decreased suppressor cell dynamics, resulting in regression of some tumors with distinct transcriptome features. Conversely, biopsies from patients whose tumors progress on combination therapy lack expression of metabolic pathways and show CD8 T-cells restricted in proximity to M2 macrophages and Tregs. Citation Format: Katie M. Campbell, Zaid Bustami, Daniel G. Chen, Egmidio Medina, Cynthia R. Gonzalez, Nataly Naser Aldeen, Ignacio Baselga-Carretero, Agustin Vega-Crespo, Jessica Maxey, Jia M. Chen, Lawrence F. Kuklinski, Kari L. Kendra, Bartosz Chmielowski, Thach-Giao Truong, Nikhil I. Khushalani, Frances Collichio, Alexandra Ikeguchi, Adrienne I. Victor, Kim Margolin, Jeffrey A. Sosman, Sapna P. Patel, Siwen Hu-Lieskovan, James Moon, Shay Bellasea, Daniel K. Wells, Christine N. Spencer, Marshall A. Thompson, Michael Wu, Philip O. Scumpia, Ari VanderWalde, Antoni Ribas. Biopsy analysis of trial S1616: Ipilimumab plus nivolumab versus ipilimumab alone in patients with anti-PD-1 refractory melanoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 6550.

Abstract Introduction: Current AACE recommendations is to stop the SGLT-2 inhibitor at least 24 hours prior to elective surgery, planned invasive procedures, or anticipated severe stressful physical activity. However, case reports suggest that the pharmacologic effects of SGLT2 inhibitors persist beyond 5 half-lives of elimination (2–3 days), with glucosuria and ketonemia lasting as long as 9 to 10 days after discontinuation. Case: A 51 year old female with a past medical history of hypertension, morbid obesity, DM type II, admitted to the hospital electively for bariatric surgery. Post-op day 1, she became tachypneic and lethargic. However, alert, oriented and responding appropriately. Lab work showed blood glucose levels <200 mg/dl (70–200 mg/dl), pH 7.21 (7.35–7.45), anion gap of 36 (4–14 mol/L), bicarbonate of 3 (23–34 mmol/L), pCO2 of 6 (35–45) and Potassium of 2.6 (3.5–5.2 mmol). UA showed glucose >500 mg/dl (0 mg/dl) and ketones 80 mg/dl (0 mg/dl). She was transferred to SICU. After reviewing her home medications, she was on Canagliflozin which was stopped 2 days prior to surgery and Glargine/Lixisenatide which was stopped 2 weeks prior to surgery as recommended by her endocrinologist. Patient was then diagnosed with euglycemic DKA. She was started on an insulin drip following potassium replacement and IV fluids. Over the course of few days, she started to feel better. Her PH, bicarb, anion gap and potassium all trended toward normal limits. She was transitioned off insulin drip to basal-bolus insulin regimen and then she was discharged on post-operative day 7 with the instruction to not take any SGLT2 inhibitors. Discussion: SGLT-2 inhibitors is known to cause euglycemic DKA and ketosis. Our case brings to attention that discontinuation of SGLT2 inhibitor treatment 48 hours prior to surgery may not be adequate specially giving the half-life of the medication. The optimal timing of discontinuation remains unknown. Further studies are needed to evaluate if longer withholding period may be necessary (1). 1.Yehuda Handelsman, Robert R. Henry, Zachary T. Bloomgarden, Sam Dagogo-Jack, Ralph A. DeFronzo, Daniel Einhorn, Ele Ferrannini, Vivian A. Fonseca, Alan J. Garber, George Grunberger, Derek LeRoith, Guillermo E. Umpierrez, and Matthew R. Weir (2016) AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY POSITION STATEMENT ON THE ASSOCIATION OF SGLT-2 INHIBITORS AND DIABETIC KETOACIDOSIS. Endocrine Practice: June 2016, Vol. 22, No. 6, pp. 753–762.

Abstract Background: Activation of the RAS/MAPK pathway is associated with reduced tumor-infiltrating lymphocytes and poor outcomes in triple-negative breast cancer (TNBC). This trial evaluated the efficacy of pembrolizumab and MEK inhibitor, binimetinib. Here we evaluated potential biomarkers in peripheral blood to predict response. Methods: Patients with unresectable locally advanced or metastatic TNBC with ≤ 3 prior lines of therapy were enrolled. Treatment includes a 2-week run-in with binimetinib followed by pembrolizumab. There were 2 dose levels (DL) with binimetinib at 45 mg at DL 0 and 30 mg at DL -1. A standard 3+3 design was used in phase I, and Simon’s two-stage Optimal design was used in phase II. Circulating tumor cells (CTC) and circulating cancer-associated macrophage-like cells (CAML) were isolated using CellSieve microfilters and immunofluorescently labeled with PD-L1 and p-ERK. Wilcoxon rank sum test and Cox regression model were used for analysis. Results: A total of 22 patients were enrolled, with a median age of 58 years old. Dose-limiting toxicity (DLT) was observed in 2 out of 4 patients in DL 0, with grade 3 ALT abnormality, flank pain, and nausea. In the next 6 patients in DL -1, there was 1 DLT with grade 3 AST/ALT abnormality. There were 17 patients treated with DL -1 and were evaluable for response. The objective response rate (ORR) was 29.41% (95% CI: 10.31-55.9) with 1 complete response (CR) and 4 partial responses (PR). The clinical benefit rate (CBR ≥ 24 weeks) was 35.29% (95% CI: 14.21-61.67). ORR in patients without liver metastases was 55.56% (95% CI: 21.20 - 86.30), and CBR was 66.67% (95% CI: 29.93-92.51). There was no response observed in all 5 patients with liver metastases. Baseline mean CTC count was 1.3 cells, and CAML count was 8.9 cells/7.5 mL. Baseline PD-L1 in CAML (p 0.04) and decline in CAML size (p 0.02) after 1 cycle were significantly associated with CBR. However, baseline CTC count, CAML count (p 0.64), CAML size (p 0.46), p-ERK in CAML (p 0.23), and changes in CTC count, CAML count (p 0.83), p-ERK (p 0.07), and PD-L1 (p 0.08) in CAML were not significantly associated with responses. Using Cox regression analysis, a reduction in CAML count (p 0.02), CAML size (p 0.01), and PD-L1 in CAML (p 0.03) were associated with significant improvement in overall survival but not the reduction in p-ERK (p 0.6). Conclusions: Pembrolizumab and binimetinib at 30 mg are safe with manageable toxicities. Promising activity was observed in patients without liver metastases. Baseline PD-L1 expression, early reduction in CAML count, size, and PD-L1 expression were significantly associated with subsequent responses, providing potential noninvasive biomarkers to predict response to this combination. Future larger clinical trials are warranted to further evaluate the efficacy of this combination. Citation Format: Saranya Chumsri, Joseph J. Larson, Daniel L. Adams, Kathleen S. Tenner, Cha-Mei Tang, Morgan T. Weidner, Amanda N. Arnold, Dana L. Haley, Pooja Advani, Kostandinos Sideras, Alvaro Moreno-aspitia, Edith A. Perez, Keith L. Knutson. Peripheral blood biomarkers in Phase II study of pembrolizumab in combination with oral binimetinib in patients with unresectable locally advanced or metastatic triple-negative breast cancer. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5454.

Abstract Background: Activation of the RAS/MAPK pathway is associated with reduced tumor-infiltrating lymphocytes and poor outcomes in triple-negative breast cancer (TNBC). This trial evaluated the efficacy of pembrolizumab in combination with binimetinib, a MEK inhibitor. Methods: Patients with unresectable locally advanced or metastatic TNBC with ≤ 3 prior lines of therapy were enrolled. Treatment includes a 2-week run-in with binimetinib followed by pembrolizumab. There were 2 dose levels (DL) with binimetinib at 45 mg at DL 0 and 30 mg at DL -1. A standard 3+3 design was used in Phase I, and Simon’s two-stage Optimal design was used in Phase II. PD-L1 22C3 was performed in archival samples with CPS ≥ 10 considered as positive (PD-L1+). Tumor-infiltrating lymphocytes (TILs) were quantified into 0, 1, 2, and 3+. Circulating tumor cells (CTC) and circulating cancer-associated macrophage-like cells (CAML) were isolated using CellSieve microfilters and immunofluorescently labeled with PD-L1 and p-ERK. Wilcoxon rank sum test, Chi-square test, Cox regression model, and Spearman correlation were used for analysis. Results: 22 patients were enrolled with a median age of 58 years old. Dose-limiting toxicity (DLT) was observed in 2 out of 4 patients in DL 0, with grade 3 ALT abnormality, flank pain, and nausea. In the next 6 patients in DL -1, there was 1 DLT with grade 3 AST/ALT abnormality. There were 17 patients treated with DL -1 and were evaluable for response. The objective response rate (ORR) was 29.41% (95% CI: 10.31-55.9) with 1 complete response (CR) and 4 partial responses (PR). The clinical benefit rate (CBR ≥ 24 weeks) was 35.29% (95% CI: 14.21-61.67). ORR in patients without liver metastases was 55.56% (95% CI: 21.20 - 86.30) and CBR was 66.67% (95% CI: 29.93-92.51). No response was observed in all 5 patients with liver metastases. There were 40.9% of patients with PD-L1 CPS ≥ 10. ORR in patients with PD-L1+ was 80%. However, 11.1% of patients with PD-L1 negative tumors also had an objective response and 44.4% of patients had clinical benefit ≥ 24 weeks. PD-L1 expression in archival tissue was associated with ORR (p 0.032) but not CBR (p 0.198), progression-free survival (PFS, p 0.373), and overall survival (p 0.348). TILs in archival tissue were also not associated with CBR (p 0.155) and PFS (p 0.157). One patient with TILs 0 had a stable disease ≥ 24 weeks and 2 patients TILs 1+ also had an objective response. We further evaluated blood-based biomarkers with CTC and CAML. Baseline PD-L1 in CAML (p 0.04) and decline in CAML size (p 0.02) after 1 cycle was significantly associated with CBR. However, baseline CTC count, CAML count (p 0.64), CAML size (p 0.46), p-ERK in CAML (p 0.23), and changes in CTC count, CAML count (p 0.83), p-ERK (p 0.07), and PD-L1 (p 0.08) in CAML were not significantly associated with responses. Using Cox regression analysis, a reduction in CAML count (p 0.02), CAML size (p 0.01), and PD-L1 in CAML (p 0.03) were associated with significant improvement in overall survival but not the reduction in p-ERK (p 0.6). However, PD-L1 expression in CAML is not associated with PD-L1 expression in archival tissue (Spearman correlation 0.13). Conclusions: Pembrolizumab and binimetinib at 30 mg are safe with manageable toxicities. Consistent with the preclinical data that MEKi can restore T cell function, promising activity was observed even in patients with low TILs and PD-L1 negative, particularly in patients without liver metastases. PD-L1 expression in peripheral blood CAML rather than archival tumor tissue may serve as a better biomarker to predict the clinical benefit of this combination. Early reductions in CAML count and size, were also significantly associated with responses. Future larger clinical trials are warranted to further evaluate the efficacy of this chemotherapy-free combination. Citation Format: Saranya Chumsri, Joseph Larson, Daniel Adams, Kathleen Tenner, Cha-Mei Tang, Morgan Weidner, Amanda Arnold, Dana Haley, Pooja Advani, Kostandinos Sideras, Alvaro Moreno-Aspitia, Edith Perez, Keith Knutson. Phase I/II study of pembrolizumab in combination with oral binimetinib in patients with unresectable locally advanced or metastatic triple-negative breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-06-14.

Abstract Background: Plasma-based tests to quantify circulating cell-free DNA cancer signal have emerged as viable applications across the cancer continuum, from early detection to optimal disease management. Here we demonstrate the feasibility of a tissue-agnostic, genome-wide methylome enrichment platform based on cell-free methylated DNA immunoprecipitation and high throughput sequencing (cfMEDIP-seq) for cancer detection, cancer signal quantification, and prognostication in head and neck cancer (HNC). Methods: Pre-treatment plasma samples from individuals with newly diagnosed stage I-IV HPV+ or HPV- HNC were analyzed with a bisulfite-free, non-degradative, genome-wide methylome enrichment platform using 5-10 ng of cell-free DNA. For cancer detection, a machine learning classifier used differentially methylated regions to distinguish cancers from non-cancer controls. The area under the receiver operating characteristic curve (AUC) and 95% confidence intervals were calculated. Cancer signals were quantified from average normalized counts across informative methylated regions and a 95% specificity threshold. For prognostication, events were defined as recurrence, progression, or death due to HNC, whichever occurred earliest. Time to event was compared for samples with cancer signal quantities above versus below the threshold. Post-treatment and longitudinal plasma samples from individuals with Stage I-IVB HNC (HPV+ and HPV- included) will be analyzed for recurrence prediction and detection of relapse. More than 100 patients and 300 samples will be analyzed. Results: For cancer detection, 92 pre-treatment plasma samples from HNC cases were distinguished from 674 controls with an AUC of 0.96 (0.94, 0.98). The AUC was 0.93 (0.86, 1.0) for Stage I, 0.93 (0.83, 1.0) for Stage II, 0.96 (0.94, 0.99) for Stage III, and 0.97 (0.96, 0.99) for Stage IV. For prognostication, 91 pre-treatment samples were included (7 stage I, 16 stage II, 23 stage III, 45 stage IV). Median follow-up time was 50.6 months with 27 events. Likelihood of recurrence or progression was significantly higher in samples with cancer signal above the threshold [hazard ratio 5.4 (95% CI 2.25, 12.95), log-rank P<0.001]. In the upcoming analysis, data will be reported on the ability to predict recurrence and relapse in post-treatment samples. Conclusions: The cfMeDIP-seq approach demonstrated robust detection of HNC, across all stages and subtypes, and the ability to predict recurrence and progression from pre-treatment samples. We will report training data with cross validation to predict recurrence and relapse using post-treatment and longitudinal sampling. Collectively, data from these studies indicate that genome wide methylome enrichment has multiple use cases across the care continuum for patients with HNC. Citation Format: Geoffrey Liu, Jun Min, Yarong Wang, Justin Burgener, Ben Brown, Karen Budhraja, Junjun Zhang, Owen Hall, Shu Yi Shen, Martha Pienkowski, Shao Hui Huang, Laurie Ailles, Katrina Rey-McIntyre, Jeremy B. Provance, Eduardo Sosa, Cynthia Frye, Scott Bratman, Brian Allen, Joshua T. Jones, Abel Licon, Jing Zhang, Anne-Renee Hartman, Daniel D. De Carvalho. The development of a tissue-agnostic genome-wide methylome enrichment MRD assay for applications across the cancer care continuum for head and neck malignancies [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2427.

This article aims to 1) explore how retired academics experienced work-to-retirement transition and 2) offer insights that can be applied in addressing its potential opportunities and challenges. Toward this end, we conducted face-to-face interviews with retirees (n=7) from a comprehensive private university in Manila, Philippines. The descriptive phenomenological method surfaced a general psychological meaning structure depicting the participants' collective work experiences to retirement transition. Moreover, it identified three distinct but interrelated elements of the retirement phenomenon: moving on, passing time, and coming on stage. This paper contributes and supports accumulated empirical knowledge on the work-to-retirement transition that can be helpful for individuals preparing for or transitioning into retirement.References April, Kurt A., Babar Dharani, and Kai Peters. “Impact of Locus of Control Expectancy on Level of Wellbeing.” Rev. Eur. 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By Stein Edith: Zum problem der Einfühlung, Niemeyer, Halle 1917, Reprint der OriginalausgabeKaffke, München 1980, trad. it. Il problema dell’empatia, trad. di E. Costantini e E. Schulze Costantini, Studium, Roma 1985. Beiträge zur philosophischen Begründ der Psychologie und Geisteswissen schaften: a) Psychische Kausalität; b)Individuum und Gemeinschaft, «Jahrbuch für Philosophie und phänomenologische Forschung», vol. 5, Halle 1922, pp. 1-283, riedito da Max Niemeyer, Tübingen 1970, trad. it. Psicologia e scienze dello spirito. Contributi per una fondazione filosofica, trad. di A. M. Pezzella, pref. di A. Ales Bello, Città Nuova, Roma 1996. Was ist Phänomenologie?, in Wissenschaft/Volksbildung, supplemento scientifico al «Neuen Pfälzischen Landes Zeitung», n. 5, 15 maggio 1924; è stato pubblicato nella rivista «Teologie und Philosophie», 66 (1991), pp. 570-573; trad. it. Che cosa è la fenomenologia? in La ricerca della verità – dalla fenomenologia alla filosofia cristiana, a cura di A. Ales Bello, Città Nuova, Roma 1993, pp. 55-60. Endliches und ewiges Sein. VersucheinesAufstiegszum Sinn des Sein (ESW II), hrsg. von L. Gelber und R. Leuven, Nauwelaerts-Herder, Louvain-Freiburg 1950, trad. it. Essere finito e essere eterno. Per una elevazione al senso dell’essere, trad. it. di L. Vigone, rev. di A. Ales Bello, Città Nuova, Roma 1988. Welt und Person. BeträgezumchristlichenWahrheitstreben (ESW VI), hrsg. von L. Gelber und R. Leuven, Newelaerts – Herder, Louvain – Freiburg 1962, trad. it. Natura, persona, mistica. Per una ricerca cristiana della verità, trad. it. di T. Franzoni, M. D’Ambra e A. M. Pezzella, a cura di A. Ales Bello, Città Nuova, Roma 1999. AusdemLebeneinerjüdischenFamilie (ESW VII), Herder, Freiburg i. Br. 1987, trad. it. Storia di una famiglia ebrea. Lineamenti autobiografici: l’infanzia e gli anni giovanili, Città Nuova, Roma 1992. Einführung in die Philosophie (ESW XIII), hrsg. von L. Gelber und M. Linssen, Herder, Freiburg i. Br. 1991, trad. it. Introduzione alla filosofia di A. M. Pezzela, pref. di A. Ales Bello, Città Nuova, Roma 1998. Briefean Roman Ingarden 1917-1938 (ESW XIV), Einleitung von H. B. Gerl-Falkovitz, Anmerkungen von M. A. Neyer, hrsg. von L. Gelber und M. Linssen, Herder, Freiburg i. Br. 1991, trad. it. Lettere a Roman Ingarden, trad. it. di E. Costantini e E. Schulze Costantini, Libreria Editrice Vaticana, Città del Vaticano 2001. Potenz und Akt. StudienzueinerPhilosophie des Seins (ESW XVIII), bearbeitet und miteinerEinfürungversehen von H. R. Sepp, hrsg. von L. Gelber und M. Linssen, Herder, Freiburg i. Br. 1998, trad. it. Potenza e atto. Studi per una filosofia dell’essere, trad. di A. Caputo, pref. di A. Ales Bello, Città Nuova, Roma 2003. By others on Edith Stein and Empathy: Albiero, Paolo and Matricardi Giada, Che cos’è l’empatia, Carocci, Roma, 2006. Ales Bello, Angela, Empathy, a return to reason, in The self and the other. The irreducibile element in a man. Part I, ed. by A. T. Tymieniecka, Dordrecht-Boston, Reidel Publishing Company, in «Analecta Husserliana», 6 (1977), pp. 143-149. – Edith Stein: da Edmund Husserl a Tommaso D’Aquino. In Memorie Domenicane, n. 7, n.s., 1976. – Edmund Husserl e Edith Stein. La questione del metodo fenomenologico, in «Acta Philosophica», 1 (1992), pp. 167-175. – Fenomenologia dell’essere umano – Lineamenti di una filosofia al femminile, Città Nuova, Roma 1992. – Analisi fenomenologica della volontà. Edmund Husserl ed Edith Stein, in «Per la filosofia», 1994, n. 31, pp. 24-29. – Lo studio dell’anima fra psicologia e fenomenologia in Edith Stein, in Sogno e mondo, Edizioni Scientifiche Italiane, Napoli 1995, pp. 7-25. – Edith Stein. Invito alla lettura, Edizioni San Paolo, Milano 1999. – Edith Stein, Piemme, Casale Monferrato 2000. – Empatia e dialogo: un’analisi fenomenologica, in A. DENTONE (a cura di), Dialogo, silenzio, empatia, Bastoni Editrice Italiana, Foggia 2000, pp. 65-85. – L’universo nella coscienza. Introduzione alla fenomenologia di Edmund Husserl, Edith Stein, Hedwig Conrad-Martius, Edizioni ETS, Pisa 2003. – Persona e Stato in Edith Stein in D’Ambra, Michele(a cura di), Edith Stein. Una vita per la verità, «Quaderni dell’AIES», n. 1, Edizioni OCD, Roma 2005. – Edith Stein: lo spirito umano in cammino verso la santità in D’Ambra, Michele(a cura di), Edith Stein.Lo Spirito e la santità, «Quaderni dell’AIES», n. 2, Edizioni OCD, Roma 2007. Alfossi, Maura. et al., Guarire o curare? Comunicazione ed empatia in medicina, La Meridiana, Molfetta (BA), 2008. Balzer, Carmen, The Empathy Problem in Edith Stein, in Huusserlian Phenomenology in a New Key. Intersubjectivity, Ethos, the Social Sphere, Human Encouter, Pathos, ed. by A. T. Tymieniecka, Kluwe Academic Publisher, Dordrecht-Boston-London, in «AnalectaHusserliana», 35 (1991), pp. 271-278. Baron-Cohen, Simon., La scienza del male. L’empatia e le origini della crudeltà, Cortina, Milano, 2012. Bellingreri, Antonio, Per una pedagogia dell’empatia, Vita e Pensiero, Milano, 2005. Bettinelli, Carla,Il pensiero di Edith Stein. Dalla fenomenologia alla scienza della Croce, Vita e Pensiero, Milano 1976. – Il problema dell’Einfülung, in «Hermeneutica», 9 (1989), pp. 291-304. – La fenomenologia, uno sguardo sulla verità, in «Aquinas», 37 (1994), pp. 377-386. – L’itinerario di Edith Stein: dalla psicologia alla metafisica, alla mistica, in «Letture», 32 (1997), pp. 505-524. Boella, Laura and Buttarelli Annarosa,Per amore di altro. L’empatia a partire da Edith Stein, Raffaello Cortina Editore, Milano 2000. – Grammatica del sentire. Compassione, Simpatia, Empatia, CUEN, Milano, 2004. Bonino, Silvia, et al. (a cura di), Empatia. I processi di condivisione delle emozioni, Giunti, Firenze, 1998. Bronzino, Cristina, Sentire insieme. Le forme dell’empatia, ArchetipoLibri, Bologna, 2010. Challita, Marie, The empathic brain as the neural basis of moral behaviour Presented from interdisciplinary perspectives, Dissertatio ad Doctoratum in Facultate Bioethicæ Pontificii Athenæi Regina Apostolorum, Rome 2014. Cerri Musso, Renza,La pedagogia dell’Einfühlung. Saggio su Edith Stein, La Scuola, Brescia, 1955. Costantini, Elio,Einfühlung und Intersubjektivitätbei Edith Stein und bei Husserl, in The Great Chain of Being and Italian Phenomenology, in «AnalectaHusserliana»,, 11 (1981), pp. 335-339. – Edith Stein. Profilo di una vita vissuta alla ricerca della verità, Libreria Editrice Vaticana, Città del Vaticano 1987. – Note sull’empatia nell’approccio interpersonale, in «Aquinas», 30 (1987), pp. 135-140. – L’empatia, conoscenza dell’”Io” estraneo, in «Studium», 86 (1990), pp. 73-91. D’Ambra, Michele,Il mistero e la persona nell’opera di Edith Stein, in «Aquinas», 34 (1997), pp. 581-591. D’Ippolito, Maria Bianca,L’analisi fenomenologica dell’anima, in«Aquinas», 41 (1997), pp. 61-67. De Waal Frans., L’età dell’empatia. Lezioni della natura per una società più solidale, Garzanti, Milano, 2011. Di Muzio, Luigi Carlo,I giorni della verità. La vicenda di Edith Stein, La sorgente, Vicenza, 1974. Epis, Massimo,Io, anima, persona nella fenomenologia di Edith Stein, in «Teologia», 27 (2000), pp. 52-70. – Fenomenologia della soggettività, LED, Milano 2003. Fidalgo, Antonio,Edith Stein, Theodor Lipps und die Einfühlungsproblematik, in R. L. FETZ - M. RATH – P. SHULZ(hrsgg.), Studien zur Philosophie von Edith Stein – Internationales Edith-Stein-Symposion Eichstätt 1991, in «Phänomenologische Forschungen», 26/27, 1993, pp. 90-106. Fortuna Federico, Tiberio Antonio, Il mondo dell’empatia. Campi di applicazioni, Franco Angeli, Milano, 20012. Freedberg David and Gallese Vittorio, Movimento, emozione ed empatia nell’esperienza estetica. In Teorie dell’immagine. Il dibattito contemporaneo, a cura di Pinotti, Andrea and Somaini Antonio Cortina, Milano, 2009. Galeazzi, Umberto., La lezione di Husserl nell’itinerario di ricerca di Edith Stein, in «Hermeneutica», 1989, n. 9, pp. 363-384. Galofaro, Joseph,La tesi di laurea sull’empatia, in «Rivista di Vita Spirituale», 41 (1987), pp. 255-261. Gamarra, Daniel, Edith Stein: il problema dell’empatia, in «Divus Thomas», 91 (1988), pp. 181-189. Geiger, Mattis, Sul problema dell’empatia di stati d’animo, in Besoli, Stefano and Guidetti, Luca, (a cura di) Il realismo fenomenologico. Sulla filosofia dei circoli Monaco e Gottinga, Quodlibet, Macerata 2000. – Essenza e significato dell’empatia, in Pinotti, Andrea (a cura di) Estetica ed Empatia. Antologia, Guerini e associati, Milano. 1997. Ghigi, Nicoletta, L’orizzonte del sentire in Edith Stein, Nimesis, Milano-Udine, 2011. Giusti, Edoardo and Locatelli, Maura, L’empatia integrata. 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Photo ID 158378414 © Eduard Muzhevskyi | Dreamstime.com ABSTRACT There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities. INTRODUCTION Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve. BACKGROUND Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes.[1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research.[2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.”[3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops.[4] Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture. I. Global Cultural Perspective of Embryonic Stem Cells Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense,[5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research.[6] Consequently, global engagement in ESC research depends on social-cultural acceptability. a. US and Rights-Based Cultures In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism,[7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.”[8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed.[9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field.[10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture.[11] b. Ubuntu and Collective Cultures African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama, which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,”[12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth.[13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole. Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value.[14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society. Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.”[15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail. Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable.[16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus[17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines.[18] Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim.[19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research.[20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF. Their use is conditioned on consent, and available only to married couples.[21] The community's receptiveness to stem cell research depends on including communitarian African ethics. c. Asia Some Asian countries also have a collective model of ethics and decision making.[22] In China, the ethics model promotes a sincere respect for life or human dignity,[23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM), [24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life.[25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research.[26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions.[27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency.[28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021.[29] However, issues still need to be addressed in implementing effective IRB review and approval procedures. The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy,[30] research ethics should also adapt to ensure respect for the values of its represented peoples. Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies.[31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells.[32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval,[33] and in another instance, the oocyte source was unclear and possibly violated ethical standards.[34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust. d. Middle East Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells,[35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research.[36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors.[37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so.[38] Jordan has a positive research ethics culture.[39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial.[40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation.[41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.”[42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes. e. Europe In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected.[43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research. [44] For example, in Germany, Lebenzusammenhang, or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.”[45] Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount.[46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007.[47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization.[48] Spain’s approach differs still, with a comprehensive regulatory framework.[49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility.[50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices.[51] II. Religious Perspectives on ESC Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives. The Qur'an states: “And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.”[52] Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception.[53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible.[54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research.[55] In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided.[56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden.[57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all.[58] Acceptance varies on applied beliefs and interpretations. Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero,[59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all.[60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime.[61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit.[62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets.[63] Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life.[64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception:[65] “If she is found pregnant, until the fortieth day it is mere fluid,”[66] Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation.[67] Stem cell research is accepted due to application of these religious laws. We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory, which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions.[68] We only wish to show that the interaction with morality varies between cultures and countries. III. A Flexible Ethical Approach The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities. While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe.[69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation. For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent.[70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context,[71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders. This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research. Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values.[72] An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions.[73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion. IV. Concerns Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values.[74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions. Other concerns include medical tourism, which may promote health inequities.[75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments.[76] For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.”[77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices.[78] The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.”[79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds.[80] CONCLUSION While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research. For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society. This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model. - [1] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice. 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[14] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics, 22(2), 112–122. https://doi.org/10.1111/dewb.12324 [15] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics, 22(2), 112–122. https://doi.org/10.1111/dewb.12324 [16] Jackson, C.S., Pepper, M.S. Opportunities and barriers to establishing a cell therapy programme in South Africa. Stem Cell Res Ther 4, 54 (2013). https://doi.org/10.1186/scrt204; Pew Research Center. (2014, May 1). Public health a major priority in African nations. Pew Research Center’s Global Attitudes Project. https://www.pewresearch.org/global/2014/05/01/public-health-a-major-priority-in-african-nations/ [17] Department of Health Republic of South Africa. (2021). Health Research Priorities (revised) for South Africa 2021-2024. 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Middle East Fertil Soc J 24, 8 (2020). https://doi.org/10.1186/s43043-019-0011-0; Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142 [22] Pang M. C. (1999). Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions. Journal of medical ethics, 25(3), 247–253. https://doi.org/10.1136/jme.25.3.247 [23] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences, 8(1). https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199 [24] Wang, Y., Xue, Y., & Guo, H. D. (2022). Intervention effects of traditional Chinese medicine on stem cell therapy of myocardial infarction. Frontiers in pharmacology, 13, 1013740. https://doi.org/10.3389/fphar.2022.1013740 [25] Li, X.-T., & Zhao, J. (2012). Chapter 4: An Approach to the Nature of Qi in TCM- Qi and Bioenergy. In Recent Advances in Theories and Practice of Chinese Medicine (p. 79). InTech. [26] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students. Stem cells international, 2021, 6667743. https://doi.org/10.1155/2021/6667743 [27] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students. Stem cells international, 2021, 6667743. https://doi.org/10.1155/2021/6667743 [28] Zhang, J. Y. (2017). Lost in translation? accountability and governance of Clinical Stem Cell Research in China. Regenerative Medicine, 12(6), 647–656. https://doi.org/10.2217/rme-2017-0035 [29] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences, 8(1). https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199 [30] Chen, H., Wei, T., Wang, H. et al. Association of China’s two-child policy with changes in number of births and birth defects rate, 2008–2017. BMC Public Health 22, 434 (2022). https://doi.org/10.1186/s12889-022-12839-0 [31] Azuma, K. Regulatory Landscape of Regenerative Medicine in Japan. Curr Stem Cell Rep 1, 118–128 (2015). https://doi.org/10.1007/s40778-015-0012-6 [32] Harris, R. (2005, May 19). Researchers Report Advance in Stem Cell Production. NPR. https://www.npr.org/2005/05/19/4658967/researchers-report-advance-in-stem-cell-production [33] Park, S. (2012). South Korea steps up stem-cell work. Nature. https://doi.org/10.1038/nature.2012.10565 [34] Resnik, D. B., Shamoo, A. E., & Krimsky, S. (2006). Fraudulent human embryonic stem cell research in South Korea: lessons learned. Accountability in research, 13(1), 101–109. https://doi.org/10.1080/08989620600634193. [35] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6 [36]Association for the Advancement of Blood and Biotherapies. https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia [37] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6 [38] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6 Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics, 23(3), 260–268. https://doi.org/10.1111/dewb.12355; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know. Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know [39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics. Research Ethics, 17(2), 228-241. https://doi.org/10.1177/1747016120966779 [40] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics. Research Ethics, 17(2), 228-241. https://doi.org/10.1177/1747016120966779 [41] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East. Nature 510, 189. https://doi.org/10.1038/510189a [42] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East. Nature 510, 189. https://doi.org/10.1038/510189a [43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3 [44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France. Biotechnology Law Report, 32(6), 349–356. https://doi.org/10.1089/blr.2013.9865 [45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3 [46] Tomuschat, C., Currie, D. P., Kommers, D. P., & Kerr, R. (Trans.). (1949, May 23). Basic law for the Federal Republic of Germany. https://www.btg-bestellservice.de/pdf/80201000.pdf [47] Regulation of Stem Cell Research in Germany. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany [48] Regulation of Stem Cell Research in Finland. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland [49] Regulation of Stem Cell Research in Spain. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain [50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered: Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110. Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ... Revista do Colegio Brasileiro de Cirurgioes, 41(5), 374–377. https://doi.org/10.1590/0100-69912014005013 Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India. Routledge. For further research on specific European countries regarding ethical and regulatory framework, we recommend this database: Regulation of Stem Cell Research in Europe. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-europe [51] Klitzman, R. (2006). Complications of culture in obtaining informed consent. The American Journal of Bioethics, 6(1), 20–21. https://doi.org/10.1080/15265160500394671 see also: Ekmekci, P. E., & Arda, B. (2017). Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights. Cultura (Iasi, Romania), 14(2), 159–172.; For why trust is important in research, see also: Gray, B., Hilder, J., Macdonald, L., Tester, R., Dowell, A., & Stubbe, M. (2017). Are research ethics guidelines culturally competent? Research Ethics, 13(1), 23-41. https://doi.org/10.1177/1747016116650235 [52] The Qur'an (M. Khattab, Trans.). (1965). Al-Mu’minun, 23: 12-14. https://quran.com/23 [53] Lenfest, Y. (2017, December 8). Islam and the beginning of human life. Bill of Health. https://blog.petrieflom.law.harvard.edu/2017/12/08/islam-and-the-beginning-of-human-life/ [54] Aksoy, S. (2005). Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research. Journal of Medical Ethics, 31:399-403.; see also: Mahmoud, Azza. "Islamic Bioethics: National Regulations and Guidelines of Human Stem Cell Research in the Muslim World." Master's thesis, Chapman University, 2022. https://doi.org/10.36837/ chapman.000386 [55] Rashid, R. (2022). When does Ensoulment occur in the Human Foetus. Journal of the British Islamic Medical Association, 12(4). ISSN 2634 8071. https://www.jbima.com/wp-content/uploads/2023/01/2-Ethics-3_-Ensoulment_Rafaqat.pdf. [56] Sivaraman, M. & Noor, S. (2017). Ethics of embryonic stem cell research according to Buddhist, Hindu, Catholic, and Islamic religions: perspective from Malaysia. Asian Biomedicine,8(1) 43-52. https://doi.org/10.5372/1905-7415.0801.260 [57] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.), Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues (pp. 79-94). Berkeley: University of California Press. https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005 [58] Lecso, P. A. (1991). The Bodhisattva Ideal and Organ Transplantation. Journal of Religion and Health, 30(1), 35–41. http://www.jstor.org/stable/27510629; Bodhisattva, S. (n.d.). The Key of Becoming a Bodhisattva. A Guide to the Bodhisattva Way of Life. http://www.buddhism.org/Sutras/2/BodhisattvaWay.htm [59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. ((King James Bible. (1999). Oxford University Press. (original work published 1769)) Jerimiah 1: 5 “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…” In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David. Psalm 139: 13-14 “…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…” These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth. [60] It should be noted that abortion is not supported as well. [61] The Vatican. (1987, February 22). Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day. Congregation For the Doctrine of the Faith. https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html [62] The Vatican. (2000, August 25). Declaration On the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells. Pontifical Academy for Life. https://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html; Ohara, N. (2003). Ethical Consideration of Experimentation Using Living Human Embryos: The Catholic Church’s Position on Human Embryonic Stem Cell Research and Human Cloning. Department of Obstetrics and Gynecology. Retrieved from https://article.imrpress.com/journal/CEOG/30/2-3/pii/2003018/77-81.pdf. [63] Smith, G. A. (2022, May 23). Like Americans overall, Catholics vary in their abortion views, with regular mass attenders most opposed. Pew Research Center. https://www.pewresearch.org/short-reads/2022/05/23/like-americans-overall-catholics-vary-in-their-abortion-views-with-regular-mass-attenders-most-opposed/ [64] Rosner, F., & Reichman, E. (2002). Embryonic stem cell research in Jewish law. Journal of halacha and contemporary society, (43), 49–68.; Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.), Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues (pp. 79-94). Berkeley: University of California Press. https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005 [65] Schenker J. G. (2008). The beginning of human life: status of embryo. Perspectives in Halakha (Jewish Religious Law). Journal of assisted reproduction and genetics, 25(6), 271–276. https://doi.org/10.1007/s10815-008-9221-6 [66] Ruttenberg, D. (2020, May 5). The Torah of Abortion Justice (annotated source sheet). Sefaria. https://www.sefaria.org/sheets/234926.7?lang=bi&with=all&lang2=en [67] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.), Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues (pp. 79-94). Berkeley: University of California Press. https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005 [68] Gert, B. (2007). Common morality: Deciding what to do. Oxford Univ. Press. [69] World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA, 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 Declaration of Helsinki – WMA – The World Medical Association.; see also: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html [70] Zakarin Safier, L., Gumer, A., Kline, M., Egli, D., & Sauer, M. V. (2018). Compensating human subjects providing oocytes for stem cell research: 9-year experience and outcomes. Journal of assisted reproduction and genetics, 35(7), 1219–1225. https://doi.org/10.1007/s10815-018-1171-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063839/ see also: Riordan, N. H., & Paz Rodríguez, J. (2021). Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial. Stem Cells Translational Medicine, 10(12), 1715–1716. https://doi.org/10.1002/sctm.21-0234 [71] Klitzman, R., & Sauer, M. V. (2009). Payment of egg donors in stem cell research in the USA. Reproductive biomedicine online, 18(5), 603–608. https://doi.org/10.1016/s1472-6483(10)60002-8 [72] Krosin, M. T., Klitzman, R., Levin, B., Cheng, J., & Ranney, M. L. (2006). Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa. Clinical trials (London, England), 3(3), 306–313. https://doi.org/10.1191/1740774506cn150oa [73] Veatch, Robert M. Hippocratic, Religious, and Secular Medical Ethics: The Points of Conflict. Georgetown University Press, 2012. [74] Msoroka, M. S., & Amundsen, D. (2018). One size fits not quite all: Universal research ethics with diversity. Research Ethics, 14(3), 1-17. https://doi.org/10.1177/1747016117739939 [75] Pirzada, N. (2022). The Expansion of Turkey’s Medical Tourism Industry. Voices in Bioethics, 8. https://doi.org/10.52214/vib.v8i.9894 [76] Stem Cell Tourism: False Hope for Real Money. Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism, See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis. Voices in Bioethics, 3. https://doi.org/10.7916/vib.v3i.6027 [77]Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation, New Genetics and Society, 30:2, 141-153, DOI: 10.1080/14636778.2011.574375 [78] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East. Nature 510, 189. https://doi.org/10.1038/510189a [79] International Society for Stem Cell Research. (2024). Standards in stem cell research. International Society for Stem Cell Research. https://www.isscr.org/guidelines/5-standards-in-stem-cell-research [80] Benjamin, R. (2013). People’s science bodies and rights on the Stem Cell Frontier. Stanford University Press.

Photo by 187929822 © Victor Moussa | Dreamstime.com INTRODUCTION The nonconsensual taking of a human organ to use in transplantation medicine violates ethical principles, including autonomy, informed consent, and human rights, as well as criminal laws. When such an organ harvesting is not just nonconsensual, but performed in a way that causes a death or uses the pretense of brain death without meeting the criteria, it also violates the dead donor[1] rule.[2] The dead donor rule is both ethical and legal. It prevents organ retrieval that would predictably cause the death of the organ donor.[3] Retrieval of a vital organ is permissible only after a declaration of death.[4] Forced organ harvesting may breach the dead donor rule as it stands. A reimagined, broader dead donor rule could consider a larger timeframe in the forced organ harvesting context. In doing so, the broad dead donor rule could cover intent, premeditation, aiding and abetting, and due diligence failures. A broad definition of forced organ harvesting is ‘‘the removal of one or more organs from a person by means of coercion, abduction, deception, fraud, or abuse of power. . .’’[5] A more targeted definition is “[t]he killing of a person so that their organs may be removed without their free, voluntary and informed consent and transplanted into another person.”[6] In the global organ harvesting context, forced organ harvesting violates the World Health Organization (WHO) Guiding Principle 3, which says “live organ donors should be acting willingly, free of any undue influence or coercion.”[7] Furthermore, WHO states live donors should be “genetically, legally, or emotionally” attached to the recipient. Guiding Principle 1 applies to deceased donors, covers consent, and permits donation absent any known objections by the deceased.[8] Principle 7 says, “Physicians and other health professionals should not engage in transplantation procedures, and health insurers and other payers should not cover such procedures if the cells, tissues or organs concerned have been obtained through exploitation or coercion of, or payment to, the donor or the next of kin of a deceased donor.”[9] There are underground markets in which organ hunters prey on the local poor in countries with low wages and widespread poverty[10] and human trafficking that targets migrants for the purpose of organ harvesting.[11] This paper explores forced harvesting under the backdrop of the dead donor rule, arguing that a human rights violation so egregious requires holding even distant participants in the chain of events accountable. By interfering with resources necessary to carry out bad acts, legislation and corporate and institutional policies can act as powerful deterrents. A broader dead donor rule would highlight the premeditation and intent evidenced well before the act of organ retrieval. I. Background and Evidence In China, there is evidence that people incarcerated for religious beliefs and practices (Falun Gong) and ethnic minorities (Uyghurs) have been subjects of forced organ harvesting. A tribunal (the China Tribunal) found beyond a reasonable doubt that China engaged in forced organ harvesting.[12] Additionally, eight UN Special Rapporteurs found a system of subjecting political prisoners and prisoners of conscience to blood tests and radiological examinations to determine the fitness of their organs.[13] As early as 2006, investigators found evidence of forced organ harvesting from Falun Gong practitioners. [14] Over a million Uyghurs are in custody there, and there is ample evidence of biometric data collection.[15] An Uyghur tribunal found evidence of genocide.[16] “China is the only country in the world to have an industrial-scale organ trafficking practice that harvests organs from executed prisoners of conscience.”[17] Witnesses testified to the removal of organs from live people without ample anesthesia,[18] summonses to the execution grounds for organ removal,[19] methods of causing death for the purpose of organ procurement,[20] removing eyes from prisoners who were alive,[21] and forcing live prisoners into operating rooms.[22] The current extent of executions to harvest organs from prisoners of conscience in China is unknown. The Chinese press has suggested surgeons in China will perform 50,000 organ transplants this year.[23] Doctors Against Forced Organ Harvesting (DAFOR) concluded, “[f]orced organ harvesting from living people has occurred and continues to occur unabated in China.”[24] China continues to advertise in multiple languages to attract transplant tourists.[25] Wait times for organs seem to remain in the weeks.[26] In the United States, it is common to wait three to five years.[27] II. The Nascent System of Voluntary Organ Donation in China In China, throughout the 1990s and early 2000s, the supply of organs for transplant was low, and there was not a national system to register as a donor. A 1984 act permitted death row prisoners to donate organs.[28] In 2005, a Vice Minister acknowledged that 95 percent of all organ transplants used organs from death row prisoners.[29] In 2007 the planning of a voluntary system to harvest organs after cardiac death emerged. According to a Chinese publication, China adopted brain death criteria in 2013.[30] There had been public opposition due partly to cultural unfamiliarity with it.[31] Cultural values about death made it more difficult to adopt a universal brain death definition. Both Buddhist and Confucian beliefs contradicted brain death.[32] Circulatory death was traditionally culturally accepted.[33] The Ministry of Health announced that by 2015 organ harvesting would be purely voluntary and that prisoners would not be the source of organs.[34] There are cultural barriers to voluntary donation partly due to a Confucian belief that bodies return to ancestors intact and other cultural and religious beliefs about respect for the dead.[35] An emphasis on family and community over the individual posed another barrier to the Western approach to organ donation. Public awareness and insufficient healthcare professional knowledge about the process of organ donation are also barriers to voluntary donation.[36] Although the Chinese government claims its current system is voluntary and no longer exploits prisoners,[37] vast evidence contradicts the credibility of the voluntary transplant program in China.[38] III. Dead Donor Rule: A Source of Bioethical Debate It seems tedious to apply this ethical foundation to something as glaring as forced organ harvesting. But the dead donor rule is a widely held recognition that it is not right to kill one person to save another.[39] It acts as a prohibition on killing for the sake of organ retrieval and imposes a technical requirement which influences laws on how death is declared. The dead donor rule prevents organ harvesting that causes death by prohibiting harvesting any organ which the donor agreed to donate only after death prior to an official declaration of death. There is an ongoing ethical debate about the dead donor rule. Many in bioethics and transplant medicine would justify removing organs in specific situations prior to a declaration of death, abandoning the rule.[40] Some use utilitarian arguments to justify causing the death of someone who is unconscious and on life support irreversibly. Journal articles suggest that the discussion has moved to one of timing and organ retrieval.[41] Robert Truog and Franklin Miller are critics of the dead donor rule, arguing that, in practice, it is not strictly obeyed: removing organs while a brain-dead donor is still on mechanical ventilation and has a beating heart and removing organs right after life support is removed and cardio-pulmonary death is declared both might not truly meet the requirement of the dead donor rule, making following the rule “a dubious norm.”[42] Miller and Truog question the concept of brain death, citing evidence of whole body integrated functions that continue indefinitely. They challenge cardio-pulmonary death, asserting that the definition includes as dead, those who could be resuscitated. Their hearts could resume beating with medical intervention. Stopping life support causes death only in those whose lives are sustained by it. Some stipulate that the organ retrieval must not itself cause the death. Some would rejigger the cause of death: Daniel Callahan suggests that the underlying condition causes the death despite removal of life support.[43] But logically, a person could continue life support and be alive, so clearly, removing life support does cause death. Something else would have caused brain death or the circumstance that landed the person on mechanical ventilation. To be more accurate, one could say X caused the irreversible coma and removing life support caused the death itself. Miller and Truog take the position that because withdrawal of life support does cause death, the dead donor rule should be defunct as insincere. To them, retrieving vital organs from a technically alive donor should be permissible under limited conditions. They look to the autonomous choices of the donor or the surrogate (an autonomy-based argument). They appreciate the demand for organs and the ability to save lives, drawing attention to those in need of organs. Live donor organ retrieval arguably presents a slippery slope, especially if a potential donor is close to death, but not so close to label it imminent. They say physicians would not be obligated to follow the orders of a healthy person wishing to have vital organs removed, perhaps to save a close friend or relative. Similarly, Radcliffe-Richards, et al. argue that there is no reason to worry about the slippery slope of people choosing death so they can sell their vital organs, whether for money for their decedents or their creditors.[44] The movement toward permissibility and increased acceptance of medical aid in dying also influence the organ donation arena. The slippery slope toward the end of life has potential to become a realistic concern. Older adults or other people close to death may want to donate a vital organ, like their heart, to a young relative in need. That could greatly influence the timing of a decision to end one’s life. IV. Relating the Dead Donor Rule to Forced Organ Harvesting There is well documented evidence that in China organs have been removed before a declaration of death.[45] But one thing the dead donor rule does not explicitly cover is intent and the period prior to the events leading to death. It tends to apply to a near-death situation and is primarily studied in its relationship to organ donation. It is about death more than it is about life. Robertson and Lavee investigated data on transplantation of vital organs in China and they document cases where the declaration of death was a pretense, insincere, and incorrect. Their aim was to investigate whether the prisoners were in fact dead prior to organ harvesting.[46] (The China Tribunal found that organs have been removed from live prisoners and that organ harvesting has been the cause of death.) They are further concerned with the possible role of doctors as executioners, or at least as complicit in the execution as the organ harvesting so closely follows it. V. A Broader Dead Donor Rule A presumed ethical precursor to the dead donor rule may also be an important ethical extension of the rule: the dead donor rule must also prohibit killing a person who is not otherwise near death for the purpose of post-death organ harvesting. In China, extra-judicial killings of prisoners of conscience are premeditated ― there is ample evidence of blood tests and radiology to ensure organ compatibility and health.[47] To have effective ethical force, the dead donor rule should have an obvious application in preventing intentional killing for an organ retrieval, not just killing by way of organ retrieval. When we picture the dead donor rule, bioethicists tend to envision a person on life support who will either be taken off it and stop breathing or who will be declared brain dead. But the dead donor rule should apply to healthy people subject to persecution at the point when the perpetrator lays the ground for the later killing. At that point, many organizations and people may be complicit or unknowingly contributing to forced organ harvesting. In this iteration of the dead donor rule, complicity in its violations would be widespread. The dead donor rule could address the initial action of ordering a blood or radiology test or collecting any biometric data. Trained physicians and healthcare technicians perform such tests. Under my proposed stretch of the dead donor rule, they too would be complicit in the very early steps that eventually lead to killing a person for their organs. I argue these steps are part of forced organ harvesting and violate the dead donor rule. The donor is very much alive in the months and years preceding the killing. A conspiracy of indifference toward life, religious persecution, ethnic discrimination, a desire to expand organ transplant tourism, and intent to kill can violate this broader dead donor rule. The dead donor rule does not usually apply to the timing of the thought of organ removal, nor the beginning of the chain of events that leads to it. It is usually saved for the very detailed determination of what may count as death so that physicians may remove vital and other organs, with the consent of the donor.[48] But I argue that declaring death at the time of retrieval may not be enough. Contributing to the death, even by actions months or years in advance, matter too. Perhaps being on the deathbed awaiting a certain death must be distinguished from going about one’s business only to wind up a victim of forced organ harvesting. Both may well be declared dead before organ retrieval, but the likeness stops there. The person targeted for future organ retrieval to satisfy a growing transplant tourism business or local demand is unlike the altruistic person on his deathbed. While it may seem like the dead donor rule is merely a bioethics rule, it does inform the law. And it has ethical heft. It may be worth expanding it to the arena of human trafficking for the sake of organ removal and forced organ harvesting.[49] The dead donor rule is really meant to ensure that death was properly declared to protect life, something that must be protected from an earlier point. VI. Complicity: Meaning and Application Human rights due diligence refers to actions that people or institutions must take to ensure they are not contributing to a human rights violation. To advise on how to mitigate risk of involvement or contribution to human rights violations, Global Rights Compliance published an advisory that describes human rights due diligence as “[t]he proactive conduct of a medical institution and transplant-associated entity to identify and manage human rights risks and adverse human rights impacts along their entire value and supply chain.”[50] Many people and organizations enable forced organ harvesting. They may be unwittingly complicit or knowingly aiding and abetting criminal activity. For example, some suppliers of medical equipment and immunosuppressants may inadvertently contribute to human rights abuses in transplantation in China, or in other countries where organs were harvested without consent, under duress, or during human trafficking. According to Global Rights Compliance, “China in the first half of 2021 alone imported ‘a total value of about 24 billion U.S. dollars’ worth of medical technology equipment’, with the United States and Germany among the top import sources.”[51] The companies supplying the equipment may be able to slow or stop the harm by failing to supply necessary equipment and drugs. Internal due diligence policies would help companies analyze their suppliers and purchasers. Corporations, educational institutions, and other entities in the transplantation supply chain, medical education, insurance, or publishing must engage in human rights due diligence. The Global Rights Compliance advisory suggests that journals should not include any ill-gotten research. Laws should regulate corporations and target the supply chain also. All actors in the chain of supply, etc. are leading to the death of the nonconsenting victim. They are doing so while the victim is alive. The Stop Forced Organ Harvesting Act of 2023, pending in the United States, would hold any person or entity that “funds, sponsors, or otherwise facilitates forced organ harvesting or trafficking in persons for purposes of the removal of organs” responsible. The pending legislation states that: It shall be the policy of the United States—(1) to combat international trafficking in persons for purposes of the removal of organs;(2) to promote the establishment of voluntary organ donation systems with effective enforcement mechanisms in bilateral diplomatic meetings and in international health forums;(3) to promote the dignity and security of human life in accordance with the Universal Declaration of Human Rights, adopted on December 10, 1948; and(4) to hold accountable persons implicated, including members of the Chinese Communist Party, in forced organ harvesting and trafficking in persons for purposes of the removal of organs.[52] The Act calls on the President to provide Congress a list of such people or entities and to sanction them by property blocking, and, in the case of non-US citizens, passport and visa denial or revocation. The Act includes a reporting requirement under the Foreign Assistance Act of 1961 that includes an assessment of entities engaged in or supporting forced organ harvesting.[53] The law may have a meaningful impact on forced organ harvesting. Other countries have taken or are in the process of legal approaches as well.[54] Countries should consider legislation to prevent transplant tourism, criminalize complicity, and require human rights due diligence. An expanded dead donor rule supports legal and policy remedies to prevent enabling people to carry out forced organ harvesting. VII. Do Bioethicists Mention Human Rights Abuses and Forced Organ Harvesting Enough? As a field, bioethics literature often focuses on the need for more organs, the pain and suffering of those on organ transplant waitlists, and fairness in allocating organs or deciding who belongs on which waitlist and why. However, some bioethicists have drawn attention to forced organ harvesting in China. Notably, several articles noted the ethical breaches and called on academic journals to turn away articles on transplantation from China as they are based on the unethical practice of executing prisoners of conscience for their organs.[55] The call for such a boycott was originally published in a Lancet article in 2011.[56] There is some acknowledgement that China cares about how other countries perceive it,[57] which could lead to either improvements in human rights or cover-ups of violations. Ill-gotten research has long been in the bioethics purview with significant commentary on abuses in Tuskegee and the Holocaust.[58] Human research subjects are protected by the Declaration of Helsinki, which requires acting in the best interests of research subjects and informed consent among other protections.[59] The Declaration of Helsinki is directed at physicians and requires subjects enroll in medical research voluntarily. The Declaration does not explicitly cover other healthcare professionals, but its requirements are well accepted broadly in health care. CONCLUSION The dead donor rule in its current form really does not cover the life of a non-injured healthy person at an earlier point. If it could be reimagined, we could highlight the link between persecution for being a member of a group like Falun Gong practitioners or Uyghurs as the start of the process that leads to a nonconsensual organ retrieval whether after a proper declaration of death or not. It is obviously not ethically enough to ensure an execution is complete before the organs are harvested. It is abuse of the dead donor rule to have such a circumstance meet its ethical requirement. And obviously killing people for their beliefs or ethnicity (and extra-judicial killings generally) is not an ethically acceptable action for many reasons. The deaths are intentionally orchestrated, but people and companies who may have no knowledge of their role or the role of physicians they train or equipment they sell are enablers. An expanded dead donor rule helps highlight a longer timeframe and expanded scope of complicity. The organ perfusion equipment or pharmaceuticals manufactured in the United States today must not end up enabling forced organ harvesting. With an expanded ethical rule, the “donor is not dead” may become “the donor would not be dead if not for. . .” the host of illegal acts, arrests without cause, forced detention in labor camps, extra-judicial killings, lacking human rights due diligence, and inattention to this important topic. The expanded dead donor rule may also appeal to the bioethics community and justify more attention to laws and policies like the Stop Forced Organ Harvesting Act of 2023. - [1] The word “donor” in this paper describes any person from whom organs are retrieved regardless of compensation, force, or exploitation in keeping with the bioethics literature and the phrase “dead donor rule.” [2] Robertson, M.P., Lavee J. (2022). Execution by organ procurement: Breaching the dead donor rule in China. Am J Transplant, Vol.22,1804– 1812. doi:10.1111/ajt.16969. [3] Robertson, J. A. (1999). Delimiting the donor: the dead donor rule. Hastings Center Report, 29(6), 6-14. [4] Retrieval of non-vital organs which the donor consents to donate post-death (whether opt-in, opt-out, presumed, or explicit according to local law) also trigger the dead donor rule. [5] The Stop Forced Organ Harvesting Act of 2023, H.R. 1154, 118th Congress (2023), https://www.congress.gov/bill/118th-congress/house-bill/1154. [6] Do No Harm: Mitigating Human Rights Risks when Interacting with International Medical Institutions & Professionals in Transplantation Medicine, Global Rights Compliance, Legal Advisory Report, April 2022, https://globalrightscompliance.com/project/do-no-harm-policy-guidance-and-legal-advisory-report/. [7] WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation, as endorsed by the sixty-third World Health Assembly in May 2010, in Resolution WHA63.22 https://apps.who.int/iris/bitstream/handle/10665/341814/WHO-HTP-EHT-CPR-2010.01-eng.pdf?sequence=1. [8] WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation (2010). [9] WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation (2010). [10] Promchertchoo, Pichayada (Oct. 19, 2019). Kidney for sale: Inside Philippines’ illegal organ trade. https://www.channelnewsasia.com/asia/kidney-for-sale-philippines-illegal-organ-trade-857551; Widodo, W. and Wiwik Utami (2021), The Causes of Indonesian People Selling Covered Kidneys from a Criminology and Economic Perspective: Analysis Based on Rational Choice Theory. European Journal of Political Science Studies, Vol 5, Issue 1. [11] Van Reisen, M., & Mawere, M. (Eds.). (2017). Human trafficking and trauma in the digital era: The ongoing tragedy of the trade in refugees from Eritrea. African Books Collective. [12] The Independent Tribunal into Forced Organ Harvesting from Prisoners of Conscience in China (China Tribunal) (2020). https://chinatribunal.com/wp-content/uploads/2020/03/ChinaTribunal_JUDGMENT_1stMarch_2020.pdf [13] UN Office of the High Commissioner, Press Release, China: UN human Rights experts alarmed by ‘organ harvesting’ allegations (UN OTHCHR, 14 June 2021), https://www.ohchr.org/en/press-releases/2021/06/china-un-human-rights-experts-alarmed-organ-harvesting-allegations. [14] David Matas and David Kilgour, Bloody Harvest. The killing of Falun Gong for their organs (Seraphim Editions 2009). [15] How China is crushing the Uyghurs, The Economist, video documentary, July 9, 2019, https://youtu.be/GRBcP5BrffI. [16] Uyghur Tribunal, Judgment (9 December 2021) (Uyghur Tribunal Judgment) para 1, https://uyghurtribunal.com/wp-content/uploads/2022/01/Uyghur-Tribunal-Judgment-9th-Dec-21.pdf. [17] Ali Iqbal and Aliya Khan, Killing prisoners for transplants: Forced organ harvesting in China, The Conversation Published: July 28, 2022. https://theconversation.com/killing-prisoners-for-transplants-forced-organ-harvesting-in-china-161999 [18] Testimony demonstrated surgeries to remove vital organs from live people, killing them, sometimes without ample anesthesia to prevent wakefulness and pain. China Tribunal (2020), p. 416-417. https://chinatribunal.com/wp-content/uploads/2020/03/ChinaTribunal_JUDGMENT_1stMarch_2020.pdf; Robertson MP, Lavee J. (2022), Execution by organ procurement: Breaching the dead donor rule in China. Am J Transplant, Vol.22,1804– 1812. doi:10.1111/ajt.16969. [19] Doctors reported being summoned to execution grounds and told to harvest organs amid uncertainty that the prisoner was in fact dead. China Tribunal (2020), p. 52-53. [20]In testimony to the China Tribunal, Dr. Huige Li noted four methods of organ harvesting from live prisoners: incomplete execution by shooting, after lethal injection prior to death, execution by removal of the heart, and after a determination of brain death prior to an intubation (pretense of brain death). China Tribunal (2020), pp. 54-55. https://chinatribunal.com/wp-content/uploads/2020/03/ChinaTribunal_JUDGMENT_1stMarch_2020.pdf [21] A former military medical student described removing organs from a live prisoner in the late 1990s. He further described his inability to remove the eyes of a live man and his witnessing another doctor forcefully remove the man’s eyes. China Tribunal (2020), p. 330. [22] In 2006, a nurse testified that her ex-husband, a surgeon, removed the eyes of 2,000 Falun Gong practitioners in one hospital between 2001 and 2003. She described the Falun Gong labor-camp prisoners as being forced into operating rooms where they were given a shot to stop their hearts. Other doctors removed other organs. DAFOH Special Report, 2022. https://epochpage.com/wp-content/uploads/sites/3/2022/12/DAFOH-Special-Report-2022.pdf [23] Robertson MP, Lavee J. (2022), Execution by organ procurement: Breaching the dead donor rule in China. Am J Transplant, Vol.22,1804– 1812. doi:10.1111/ajt.16969. [24] DAFOH Special Report, 2022. https://epochpage.com/wp-content/uploads/sites/3/2022/12/DAFOH-Special-Report-2022.pdf; DAFOH’s physicians were nominated for a Nobel Prize for their work to stop forced organ harvesting. Šućur, A., & Gajović, S. (2016). Nobel Peace Prize nomination for Doctors Against Forced Organ Harvesting (DAFOH) - a recognition of upholding ethical practices in medicine. Croatian medical journal, 57(3), 219–222. https://doi.org/10.3325/cmj.2016.57.219 [25] Robertson and Lavee (2022). [26] Stop Organ Harvesting in China, website (organization of the Falun Dafa). https://www.stoporganharvesting.org/short-waiting-times/ [27] National Kidney Foundation, The Kidney Transplant Waitlist – What You Need to Know, https://www.kidney.org/atoz/content/transplant-waitlist [28] Wu, Y., Elliott, R., Li, L., Yang, T., Bai, Y., & Ma, W. (2018). Cadaveric organ donation in China: a crossroads for ethics and sociocultural factors. Medicine, 97(10). [29] Wu, Elliott, et al., (2018). [30] Su, Y. Y., Chen, W. B., Liu, G., Fan, L. L., Zhang, Y., Ye, H., ... & Jiang, M. D. (2018). An investigation and suggestions for the improvement of brain death determination in China. Chinese Medical Journal, 131(24), 2910-2914. [31] Huang, J., Millis, J. M., Mao, Y., Millis, M. A., Sang, X., & Zhong, S. (2012). A pilot programme of organ donation after cardiac death in China. The Lancet, 379(9818), 862-865. [32] Yang, Q., & Miller, G. (2015). East–west differences in perception of brain death: Review of history, current understandings, and directions for future research. Journal of bioethical inquiry, 12, 211-225. [33] Huang, J., Millis, J. M., Mao, Y., Millis, M. A., Sang, X., & Zhong, S. (2015). Voluntary organ donation system adapted to Chinese cultural values and social reality. Liver Transplantation, 21(4), 419-422. [34] Huang, Millis, et al. (2015). [35] Wu, X., & Fang, Q. (2013). Financial compensation for deceased organ donation in China. Journal of Medical Ethics, 39(6), 378-379. [36] An, N., Shi, Y., Jiang, Y., & Zhao, L. (2016). Organ donation in China: the major progress and the continuing problem. Journal of biomedical research, 30(2), 81. [37] Shi, B. Y., Liu, Z. J., & Yu, T. (2020). Development of the organ donation and transplantation system in China. Chinese medical journal, 133(07), 760-765. [38] Robertson, M. P., Hinde, R. L., & Lavee, J. (2019). Analysis of official deceased organ donation data casts doubt on the credibility of China’s organ transplant reform. BMC Medical Ethics, 20(1), 1-20. [39] Miller, F.G. and Sade, R. M. (2014). Consequences of the Dead Donor Rule. The Annals of thoracic surgery, 97(4), 1131–1132. https://doi.org/10.1016/j.athoracsur.2014.01.003 [40] For example, Miller and Sade (2014) and Miller and Truog (2008). [41] Omelianchuk, A. How (not) to think of the ‘dead-donor’ rule. Theor Med Bioeth 39, 1–25 (2018). https://doi-org.ezproxy.cul.columbia.edu/10.1007/s11017-018-9432-5 [42] Miller, F.G. and Truog, R.D. (2008), Rethinking the Ethics of Vital Organ Donations. Hastings Center Report. 38: 38-46. [43] Miller and Truog, (2008), p. 40, citing Callahan, D., The Troubled Dream of Life, p. 77. [44] Radcliffe-Richards, J., Daar, A.S., Guttman, R.D., Hoffenberg, R., Kennedy, I., Lock, M., Sells, R.A., Tilney, N. (1998), The Case for Allowing Kidney Sales, The Lancet, Vol 351, p. 279. (Authored by members of the International Forum for Transplant Ethics.) [45] Robertson and Lavee, (2022). [46] Robertson and Lavee, (2022). [47] China Tribunal (2020). [48] Consent varies by local law and may be explicit or presumed and use an opt-in or opt-out system and may or may not require the signoff by a close family member. [49] Bain, Christina, Mari, Joseph. June 26, 2018, Organ Trafficking: The Unseen Form of Human Trafficking, ACAMS Today, https://www.acamstoday.org/organ-trafficking-the-unseen-form-of-human-trafficking/; Stammers, T. (2022), "2: Organ trafficking: a neglected aspect of modern slavery", Modern Slavery and Human Trafficking, Bristol, UK: Policy Press. https://bristoluniversitypressdigital.com/view/book/978144736. [50] Do No Harm: Mitigating Human Rights Risks when Interacting with International Medical Institutions & Professionals in Transplantation Medicine, Global Rights Compliance, Legal Advisory Report, April 2022, https://globalrightscompliance.com/project/do-no-harm-policy-guidance-and-legal-advisory-report/. [51] Global Rights Compliance, p. 22. [52] The Stop Forced Organ Harvesting Act of 2023, H.R. 1154, 118th Congress (2023). https://www.congress.gov/bill/118th-congress/house-bill/1154. [53] The Stop Forced Organ Harvesting Act of 2023, H.R. 1154, 118th Congress (2023), https://www.congress.gov/bill/118th-congress/house-bill/1154. [54] Global Rights Compliance notes that Belgium, France (passed law on human rights due diligence in the value supply chain), United Kingdom, United States, Canada, Australia, and New Zealand have legal approaches, resolutions, and pending laws. p. 45. [55] For example, Caplan, A.L. (2020), The ethics of the unmentionable Journal of Medical Ethics 2020;46:687-688. [56] Caplan, A.L. , Danovitch, G., Shapiro M., et al. (2011) Time for a boycott of Chinese science and medicine pertaining to organ transplantation. Lancet, 378(9798):1218. doi:10.1016/S0140-6736(11)61536-5 [57] Robertson and Lavee. [58] Smolin, D. M. (2011). The Tuskegee syphilis experiment, social change, and the future of bioethics. Faulkner L. Rev., 3, 229; Gallin, S., & Bedzow, I. (2020). Holocaust as an inflection point in the development of bioethics and research ethics. Handbook of research ethics and scientific integrity, 1071-1090. [59] World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended multiple times, most recently by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

Photo by Spencer Davis on Unsplash ABSTRACT Current conceptions of solidarity impose a morality and sacrifice that did not prevail in the case of COVID-19 vaccine distribution. Notably, the vaccine distribution disparity revealed that when push came to shove, in the case of global distribution, self-interested persons reached inward rather than reaching out, prioritized their needs, and acted to realize their self-interest. Self-interest and loyalty to one’s own group are natural moral tendencies. For solidarity to be normatively relevant in difficult and emergency circumstances, solidarity scholars ought to leverage the knowledge of the human natural tendency to prioritize one’s own group. This paper recommends a nonexclusive approach to solidarity that reflects an understanding of rational self-interest but highlights commonalities among all people. A recommended task for future studies is to articulate what the account of solidarity informed by loyalty to the group would look like. INTRODUCTION The distribution of COVID-19 vaccines raises concerns about the normative relevance of the current conceptions of solidarity. Current conceptions of solidarity require individuals to make sacrifices they will reject in difficult and extreme situations. To make it more relevant in difficult situations, there is a need to rethink solidarity in ways that align with natural human dispositions. The natural human disposition or tendency is to have loyalty to those to whom one relates, to those in one’s own group (by race, ethnicity, neighborhood, socioeconomic status, etc.), or to those in one’s location or country. While some may contend that such natural dispositions should be overcome through moral enhancement,[1] knowledge about self-interest ought to be leveraged to reconceptualize solidarity. Notably, for solidarity to be more relevant in emergencies characterized by shortages, solidarity ought to take natural human behaviors seriously. This paper argues that rather than seeing solidarity as a collective agreement to help others out of a common interest or purpose, solidarity literature must capitalize on human nature’s tendency toward loyalty to the group. One way to do this is by expanding the group to the global community and redefining solidarity to include helping the human race when emergencies or disasters are global. The first section describes the current conception of solidarity, altruism, and rational self-interest. The second section discusses how the moral imperative to cooperate by reaching out to others did not lead to equitable COVID-19 vaccine distribution. The third section argues that solidarity should be rethought to align with natural human dispositions toward loyalty to groups and rational self-interest. The final section briefly suggests the global community be the group for nonexclusive solidarity. I. Solidarity: Understanding Its Normative Imperatives Solidarity literature is vast and complex, attracting contributions from authors from countries of all income levels.[2] Notably, the literature addresses how solidarity develops from interpersonal, then group to institutional, and how it is motivated and maintained at different levels.[3] Solidarity is unity among people with a shared interest or goal.[4] The term was popularized during an anti-communist labor movement in Poland.[5] While a show of solidarity traditionally meant solidarity within a group, for example, workers agreeing with and supporting union objectives and leaders,[6] it has come to include sympathy/empathy and action by those outside the group who stand with those in need. In bioethics, the Nuffield Council defines solidarity as “shared practices reflecting a collective commitment to carry financial, social, emotional, and or other ‘costs’ to assist others.”[7] As conceptualized currently, solidarity prescribes a morality of cooperation and may incorporate altruism. Solidaristic actions like aiding others or acting to enhance the quality of others’ lives are often motivated by emotive connections/relations. For this reason, Barbara Prainsack and Alena Buyx define solidarity as “a practice by which people accept some form of financial, practical, or emotional cost to support others to whom they consider themselves connected in some relevant respect.”[8] Although this description has been critiqued, the critics[9] do not deny that sympathy and understanding are the bases for “standing up beside” or relating to others. Political solidarity is a “response to injustice, oppression, or social vulnerability”[10] and it entails a commitment to the betterment of the group. “Rational self-interest” describes when parties behave in ways that make both parties better off.[11] They may be partly motivated by their own economic outcome. It may be that when some regions or groups act solidaristically, they are also motivated by shared economic goals.[12] Rational self-interest is not always opposed to the commitment to collectively work for the group’s good. Rational self-interest can intersect with collective action when parties behave in ways that make both parties better off. For example, one study found that individuals are willing to bear the burden of higher taxes in favor of good education policies that significantly increase their opportunities to have a good life.[13] Rationally self-interested persons may be partly motivated by their own economic outcome. It may be that when some regions or groups act solidaristically, they are also motivated by shared economic goals.[14] Specifically, individuals, organizations, and governments are driven to positively identify with or aid others because they feel connected to them, share the same interest, or would benefit from the same action. Cooperating with others on this basis guarantees their interests. Individuals will be less likely to help those with whom they do not feel connected. Respect, loyalty, and trust among solidary partners are equally grounded in this belief. “[S]olidarity involves commitment, and work as well as the recognition that even if we do not have the same feeling, or the same lives, or the same bodies, we do live on common grounds.”[15] Although individuals are more likely to exhibit solidarity with those to whom they feel connected, their lives and interests are still different. Some African philosophers describe solidarity as entailing reciprocal relations and collective responsibility.[16] The bases for positively acting to benefit others are communal relations and individual flourishing, similar to solidarity as it is described in the global literature. Common motifs and maxims typify this belief: the West African motifs like the Siamese Crocodile and the African maxims like “the right arm washes the left hand and the left arm washes the right arm”, and the Shona phrases “Kukura Kurerwa” and “Chirere chichazo kurerawo” ­– both meaning the group’s development is vital for the individual’s development.[17] As a reciprocal relation, solidaristic actions are instrumentalized for one’s self-affirmation or self-emergence. This view underlies practices in Africa like letsema, which is an agricultural practice where individuals assist each other in harvesting their farm produce. It is also the animating force underlying a favorable disposition towards joint ventures like the ajo (an African contributing saving scheme whereby savings are shared among contributors by rotation).[18] Furthermore, as entailing collective ownership, solidaristic actions become ways of affirming each other’s destiny because it is in one’s best interest to cooperate with them this way or help others realize their life goals given the interconnectedness of lives. One advantage of forming solidary union that reaches out to others is that they possess qualities and skills that one lacks. This application of solidarity is more localized than solidarity among countries or global institutions. Furthermore, solidarity also entails altruism, an idea that is particularly common in the philosophical literature of low-income countries. On this account, solidarity implies a voluntary decision to behave in ways that make individuals better off for their own sake. Here, it matters only that some have thought about solidarity this way. Moreover, this belief informs pro-social behaviors – altruism is acting solely for the good of others.[19] Altruistic behaviors are motivated by empathy, which is an acknowledgement of individuals who require aid, and sensitivity, which is a thoughtful response to individuals in need of help. Solidarity can seem to be a call to help strangers rather than a genuine feeling of uniting with people for a common cause. Altruism and solidarity appear similar although they are distinct in that solidarity is not merely helping others. It is helping others out of a feeling of unity. In some cultures in Africa, an indifference to the needs of others or a failure to act solely in ways that benefit others or society are often considered an exhibition of ill will.[20] Precisely, the phrases “Kukura Kurerwa” and “Chirere chichazo kurerawo” among the Shona people in Southern Africa morally compel one to play an active role in the growth and improvement of others. “The core of improving others’ well-being,” as explained, “is a matter of meeting their needs, not merely basic ones but also those relevant to higher levels of flourishing, e.g. being creative, athletic, theoretical.”[21] On this basis, self-withdrawal, self-isolation, and unilateralism, would be failures to be solidaristic. II. COVID-19 Vaccine Distribution Disparity And The Imperative To Reach Out The strength and benefits of cooperation are well documented. COVID-19 vaccine distribution did not reflect solidarity despite the use of rhetoric suggesting it. COVID-19 vaccine distribution disparity exemplifies how solidarity requires individuals to make sacrifices that they will refuse under challenging circumstances. Solidaristic rhetoric was not uncommon during the COVID-19 pandemic. This was expressed through maxims like “Stronger together”, “No one is safe until everyone is safe”, “We are all in this together”, and “Flatten the curve”, as well as cemented through actions like physical distancing, mask-wearing, travel restrictions, and limits on social gatherings. Before the pandemic, solidarity rhetoric informed alliances like the Black Health Alliance that was created to enable Black people in Canada to access health resources. This rhetoric and the global recognition of the vital importance of exhibiting solidarity had little if any impact on preventing vaccine distribution disparity. Notably, the World Health Organization set a goal of global vaccination coverage of 70 percent. The 70 percent figure was recognized as key for ending the pandemic, preventing the emergence of new variants, and facilitating global economic recovery.[22] The solidaristic rhetoric that no country was safe until all countries were safe did not result in enough vaccine distribution. Nor did the rational self-interest of common economic goals. The economic impact of the pandemic has been huge for most nations, costing the global community more than $2 trillion.[23] Vaccine distribution disparity across countries and regions undermined international efforts to end the COVID-19 pandemic. The disparity revealed that self-interested persons, organizations, and countries reached inward, prioritized their needs, and acted to realize their own self-interest. Empirical studies confirmed the disparity at the macro and micro levels. Some of the findings are worth highlighting. The number of vaccine doses injected in high-income countries was 69 times higher than that in low-income countries.[24] In fact, the UK had doubly vaccinated about 75 percent of its adult population by February 2022, while more than 80 percent of African nations had not received a single dose of the vaccine.[25] Precisely, the national uptake of vaccines in Uganda (which is a low-income economy without COVID-19 production capacity) was “6 percent by September 2021 and 63 percent by June 2022. The vaccination coverage in the country was 2 percent by September 2021 and 42 percent by June 2022. Yet both the national COVID-19 vaccination uptake and coverage were far below WHO targets for these dates.[26] Although a report which assessed the impact of COVID-19 vaccines in the first of year of vaccination showed that about 19 million COVID-19-related deaths were averted, they were mainly in the high-income countries rather than in countries that failed to reach the vaccine coverage threshold for preventing the emergence of new variants.[27] There were more than 250,000 COVID-related deaths in African countries.[28] Though this figure is significantly lower than reported COVID-19 deaths in North America (1.6 million), the report and other studies confirm that many of the deaths in Africa could have been prevented if the vaccines had been widely distributed in the region. [29] Still at the macro level, whereas 78 percent of individuals in high-income countries were vaccinated by February 15, 2022, only 11 percent of persons in low-income countries were vaccinated by the same date.[30] By February 15, 2022, high-income countries like Lithuania and Gibraltar (a UK territory) had more than 300 percent of doses required for vaccinating their population, while low-income countries in Africa had only managed to secure about 10 percent of the necessary vaccine doses for their people. Burundi had vaccinated less than 1 percent of its population by December 2022. The disparity between countries of similar income levels was also evident. For example, among 75 low- and middle-income countries, only about 14 countries reported vaccinating at least 50 percent of their population. And, while high-income countries like Qatar had secured more than 105 percent of doses for their people, other high-income countries like Liechtenstein had only managed about 67 percent vaccination coverage by December 2022.[31] Within countries, vaccination coverage gaps were also evident between urban and rural areas, with the former having higher vaccination coverage than the latter.[32] There were many tangible solidaristic efforts to cooperate or reach out through schemes like the COVID-19 Vaccines Global Access (COVAX), African Vaccine Acquisition Trust (AVAT) and Technology Access Pool (C-TAP). Notably, the schemes were testaments of the global recognition to lift others as we rise and not leave anyone behind. Both high-income and low- and middle-income countries supported the programs as an expression of solidarity. Indeed, many low- and middle-income countries secured about 800 million doses through these schemes by the end of December 2021. Nonetheless, this was still far below these countries’ two-billion-dose target by the same date. The wealthier countries’ rhetoric of support did not lead to delivery of enough vaccines. The support by high-income countries seems disingenuous. While high-income countries at first allocated vaccines carefully and faced shortages, they had plentiful supplies before many countries had enough for their most vulnerable people. Thus, these schemes did very little to ensure the well-being of people in low- and middle-income countries that relied on them. These schemes had many shortcomings. For example, COVAX relied on donations and philanthropy to meet its delivery targets. In addition, despite their support for these schemes, many high-income countries hardly relied on them for their COVID-19 vaccine procurement. Instead, these high-income countries made their own private arrangements. In fact, high-income countries relied on multilateral agreements and direct purchases to secure about 91 percent of their vaccines.[33] These solidaristic underfunded schemes had to compete to procure vaccines with the more highly resourced countries. Arguably, many factors were responsible for the uneven distribution of COVID-19 vaccines. For example, vaccine production sites facilitated vaccine nationalism whereby countries prioritized their needs and enabled host states like the UK to stockpile vaccines quickly. Regions without production hubs, like many places in Africa, experienced supply insecurity.[34] The J & J-Aspen Pharmacare deal under which a South African facility would produce the J&J COVID vaccine did not improve the local supply.[35] Companies sold vaccines at higher than the cost of production despite pledges by many companies to sell COVID-19 vaccines at production cost. AstraZeneca was the only company reported to have initially sold vaccines at cost until it replaced this with tiered pricing in late 2021.[36] Moderna estimated a $19 billion net profit from COVID-19 vaccine sales by the end of 2021. Pricing practices undermined solidaristic schemes designed to help low-income countries access the doses required for their populations.[37] The unwillingness of Western pharmaceutical companies like Johnson and Johnson, Pfizer-BioNTech, and Moderna to temporarily relinquish intellectual property rights or transfer technology that would have eased vaccine production in low-income countries that lacked production capabilities even when taxpayers’ money or public funding accelerated about 97 percent of vaccine discovery is another example of acting without solidarity. South Africa and India proposed the transfer of essential technological information about COVID-19 vaccines to them to increase local production.[38] The EU, UK, and Germany, which host many of these pharmaceutical companies, opposed the technology transfers.[39] Corporations protected their intellectual property and technology for profits. There were many other factors, like vaccine hoarding. Although the solidaristic rhetoric suggested a global community united to help distribute the vaccine, COVID-19 vaccine distribution demonstrates that individuals, institutions, regions, or states will prioritize their needs and interests. This leads to the question, “What sort of behaviors can reasonably be expected of individuals in difficult situations? In what ways can solidarity be re-imagined to accommodate such behaviors? Ought solidarity be re-imagined to accommodate such actions? III. COVID-19 Vaccine Disparity: Lessons For Solidarity Literature COVID-19 vaccine distribution disparity has been described as inequitable and immoral.[40] One justification for the negative depiction is that it is irresponsible of individual states or nations to prioritize their own needs over the global good, especially when realizing the global interest is necessary for ensuring individual good. Although such contributions to the ethical discourse on COVID-19 vaccine disparity are essential, they could also distract attention from vital conversations concerning how and why current solidarity conceptions can better reflect core human dispositions. To clarify, the contestation is not that solidaristic acts of reaching out to others are morally unrealistic or non-realizable. There are historical examples of solidarity, particularly to end a common affliction or marginalization. An example is the LGBT support of HIV/AIDS-infected persons based on their shared identities to confront and end the stigma, apathy, and homophobia that accompanied the early years of the crisis.[41] Equally, during the apartheid years in South Africa, Black students formed solidarity groups as a crucial racial response to racism and oppression by the predominantly White government.[42] Additionally, the World Health Organization’s (WHO) director, Tedros Ghebreyesus cited solidarity and its rhetoric as the reason for the resilience of societies that safely and efficiently implemented restrictive policies that limited COVID-19 transmission. To improve its relevance to emergencies, solidarity ought to be reconceptualized considering COVID-19 vaccine distribution. As demonstrated by the COVID-19 vaccine distribution disparity, individuals find it difficult to help others in emergencies and share resources given their internal pressing needs. Moreover, humans have a natural tendency to take care of those with whom they identify. That may be by country or region, race, ethnicity, socioeconomic status, type of employment, or other grouping. By extension, the morality that arises from the tendency towards “the tribe” is sometimes loyalty to one’s broader group. Evidence from human evolutionary history, political science, and psychology yields the claim that “tribal [morality] is a natural and nearly ineradicable feature of human cognition, and that no group—not even one’s own—is immune.”[43] Tribal morality influences mantras like America First, South Africans Above Others, or (arguably) Brexit. These conflict with solidarity. As another global example, climate change concerns are not a priority of carbon’s worst emitters like the US, China, and Russia. In fact, in 2017, the US pulled out of the Paris Agreement, a tangible effort to rectify the climate crisis.[44] Droughts experienced by indigenous people in Turkana, the melting ice experienced by the Inuit, the burning bush experienced by the aboriginal Australians, and the rise in ocean levels that remain a constant threat to the Guna are examples of the harm of the changing climate. In the case of climate action, it appears that governments prioritize their self-interests or the interests of their people, over cooperation with governments of places negatively impacted. In the instance of COVID-19 vaccine distribution disparity, loyalty to the group was evident as states and countries kept vaccines for their own residents. Solidarity has a focus on shared interests and purpose, but in its current conceptions it ignores human nature’s loyalty to groups. In emergencies that involve scarcity, solidarity needs to be redefined to address the impulse to keep vaccines for one’s own country’s population and the choice to sell vaccines to the highest bidder. For solidarity to be normatively relevant in difficult and emergency circumstances, solidarity scholars ought to leverage the knowledge of human natural tendency to prioritize one’s own group to rethink this concept. IV. Rethinking Solidarity For Challenging Circumstances In the globalized world, exhibiting solidarity with one another remains intrinsically valuable. It makes the world better off. But the challenge remains ensuring that individuals can exhibit solidarity in ways that align with their natural instincts. Rather than helping those seen as other, or behaving altruistically without solidarity, people, governments, and organizations should engage in solidarity to help others and themselves as part of the global community. A rational self-interest approach to solidarity is similar, while altruism is distinguishable. Solidarity can be expanded to apply when the human race as a whole is threatened and common interests prevail, sometimes called nonexclusive solidarity.[45] That is distinguished from altruism as solidarity involves seeing each other as having shared interests and goals – the success of others would lead to the success of all. For example, cleaner air or limiting the drivers of human-made climate change would benefit all. Warning the public, implementing social distancing and masking, and restricting travel are examples of global goals that required solidaristic actions to benefit the human race.[46] Arguably, this conception of solidarity could apply to a scarce resource, like the COVID-19 vaccine. Notably, the solidarity rhetoric that this gives rise to is that COVID-19 vaccine equitable distribution is a fight for the human race. Solidarity has been applied to scarcity and used to overcome deprivation due to scarcity. In the case AIDS/HIV, there were many arguments and then programs to reduce drug prices and to allocate and condoms to countries where the epidemic was more pronounced and continuing to infect people. Similarly, a solidarity-inspired effort led to treatments for resistant tuberculosis.[47] Summarily, I suggest that we cannot tackle global health problems without exhibiting solidarity with one another. Humans can exhibit solidarity in ways that align with their natural instincts. To do this, nonexclusive solidarity described in this section, is required. Although the nonexclusive solidarity recognizes difference, it avoids the “logic of competition that makes difference toxic.”[48] Without necessarily requiring every country's leaders to prioritize global citizens equally, the nonexclusive solidarity at least, prohibits forms of competition that undermine initiatives like COVAX from securing the required vaccines to reach the vaccine coverage target. CONCLUSION COVID-19 vaccine distribution disparity does not create a new problem. Instead, it reveals an existing concern. This is the disconnect between dominant human psychological makeup and the sort of solidarity expounded in current literature or solidaristic actions. Notably, it reveals a failure of current solidarity conceptions to reflect the natural human tendency to prioritize the interests of one’s own group. As such, the disparity requires rethinking or reconceptualization of solidarity in ways that align with the dominant human tendency. As conceptualized currently, solidarity enjoins a form of morality that many found very difficult to adhere to during the COVID-19 pandemic. Notably, they perceived solidarity as a call to help strangers. Humans are linked by something that is far more important than a relationship between strangers. The unbreakable bond among humans that this idea gives rise to would necessitate genuine concern for each other’s well-being since we are implicated in one another's lives. The exact ways a conception of solidarity that applies to the global community can inform guidelines and policies in emergencies and difficult situations when individuals are expected to be solidaristic is a recommended task for future studies. - [1] Ingmar Persson & Julian Savulescu 2019. The Duty to be Morally Enhanced. Topoi, 38, 7-14. [2] M. Inouye 2023. On Solidarity, Cambridge, MA, Boston Review. [3] Barbara Prainsack & Alena Buyx 2011. Solidarity. Reflections on an Emerging Concept in Bioethics. Summary. 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