research articles about organ donation

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• v.128(4); Jul-Aug 2013

The Power of Organ Donation to Save Lives Through Transplantation

Organ and tissue donation is more important than many of us realize—for society and for the individuals it directly affects. Today, there are nearly 118,000 individuals waiting for an organ transplant to live healthier, more productive lives (Unpublished data, Organ Procurement and Transplantation Network [OPTN], April 2013). For some people with end-stage organ failure, it is truly a matter of life and death. Add to these the thousands more whose lives will be improved through tissue and cornea donation and transplants that can help them move better, see better, and live better.

Donation affects more than the donors and recipients. It also affects the families, friends, colleagues, and acquaintances who love and support those in need of transplantation, and who benefit from their renewed life and improved health after transplant. For my part, I have experienced not once, but twice how donation and transplantation affects individuals.

Twenty years ago, my wife, Donna Lee Jones, died in a severe automobile accident. Her death was a shock, and my family did not know what to make of our tragedy. Then we were offered the opportunity to donate her organs and tissues for transplantation. While it did not lessen the pain of her loss, it brought comfort to us knowing that out of our tragedy, some good would come, and others could receive the gift of life. Because of her donation, several people received a new lease on life: a man in Tampa, Florida, received her heart; a teenage boy in Washington, D.C., received a kidney and pancreas; a hospital custodian received her other kidney; a woman in Pennsylvania received her liver; and her corneas went to a young woman in Baltimore, Maryland, and a government worker.

Four years later, my 20-year-old daughter, Vikki Lianne, was struck by a car and died. Losing a spouse was tragic enough, but the pain of losing a child cannot be expressed. Falling back on our previous experience, we decided to donate Vikki's organs and tissues for transplantation. Again, several individuals benefited from her gift: a mother of five children from Upstate New York received her heart; a widow with four children received her lung; a 59-year-old man from Washington, D.C., who was active with a local charity, received her liver; a widower with one daughter received her kidney; a working father received the other kidney; and her corneas went to a 26-year-old man in Florida and a 60-year-old woman in Pennsylvania. And we, her family, took comfort in the idea that Vikki's legacy was one of life and giving.

Organ donation provides a life-giving, life-enhancing opportunity to those who are at the end of the line for hope. And the need for organ donors is growing. When Donna Lee died in 1992, there were 27,000 people on the transplant wait list. When Vikki died just four years later, that number had grown to 47,000 (Unpublished data, OPTN, January 2010). As of April 5, 2013, there were 117,812 people waiting, with hope, for an organ to become available (Unpublished data, OPTN, April 2013).

One way to expand the number of organs available for transplantation is to expand the number of donors, through carefully and safely considering individuals who in the past were not included. The guideline in this special issue of Public Health Reports provides a scientific, evidence-based process to assure a balance between organ safety and availability for each individual on the transplant wait list. As our knowledge and scientific capabilities regarding safety and availability grow and evolve, donors who in the past would not have been considered as donors are now able to provide the gift of life to others.

This guideline will help improve organ transplant outcomes, leading to more individuals being able to live healthier and longer lives. The science and evidence are clear and will improve the safety of organs, balanced with a clear and conscious regard for donors and recipients. It is the human aspect of donation and transplantation—helping people. It is the right thing to do.

Rear Admiral (Ret.) Kenneth Moritsugu is a former Acting Surgeon General of the United States.

This article was supported in part by Health Resources and Services Administration contract #234-2005-370011C. The content of this article is the responsibility of the author alone and does not necessarily reflect the views or policies of the Department of Health and Human Services.

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Organ Donor Research : Overcoming Challenges, Increasing Opportunities

• 1 University of Virginia, Charlottesville

A substantial gap exists between the need for organ transplants and the number of transplants performed each year in the United States. In 2016, 27 630 organs were transplanted from 9971 deceased donors and 5980 additional organs from living donors, but as of September 29, 2017, a total of 116 602 individuals were included on the nation’s organ transplant wait lists. 1 This gap remains despite increases in the number of both donated organs and organ transplants in recent years. In 2015, close to 5000 organs from deceased donors were discarded because they were deemed unsuitable for transplantation. 1

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Childress JF. Organ Donor Research : Overcoming Challenges, Increasing Opportunities . JAMA. 2017;318(22):2177–2178. doi:10.1001/jama.2017.16442

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• Published: 27 May 2020

Knowledge, attitude and willingness to donate organ among medical students of Jimma University, Jimma Ethiopia: cross-sectional study

• Fantu Kerga Dibaba   ORCID: orcid.org/0000-0003-4331-3907 1 ,
• Kabaye Kumela Goro 1 ,
• Amare Desalegn Wolide 2 ,
• Fanta Gashe Fufa 1 ,
• Aster Wakjira Garedow 1 ,
• Birtukan Edilu Tufa 3 &
• Eshetu Mulisa Bobasa 1  

BMC Public Health volume  20 , Article number:  799 ( 2020 ) Cite this article

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The lack of organ donors has become a limiting factor for the development of organ transplantation programs. Many countries are currently facing a severe shortage of organs for transplantation. Medical students, as future doctors can engage in the role of promoting organ donation by creating awareness and motivating the community to donate their organs besides their voluntary organ donation. The aim of this study is to assess the knowledge, attitude and willingness of undergraduate medical students’ towards organ donation at Jimma University.

A cross-sectional study was conducted among 320 medical students from year I to internship using questionnaire in order to assess their knowledge, attitude and willingness regarding organ donation. Data collected was entered using epidata and analyzed using Statistical Package for Social Sciences (SPSS) software version 20.

Mean (±SD = standard deviation) age of participants was 23.48 ± 17.025 years. 57.8% of the study subjects were male. There was a statistically significant interaction effect between gender and year of study on the combined knowledge questions (dependent variables) F(25,062) = 1.755, P  = 0.014, Wilk’s Λ  = .033. Variables which were related to a positive attitude towards organ donation were: being of the male sex (Odds Ratio = 1.156); having awareness about organ donation (Odds Ratio = 2.602); not having a belief on the importance of burying intact body (Odds Ratio = 5.434); willingness to donate blood (Odds Ratio = 4.813); and willingness to donate organ (Odds Ratio = 19.424).

High level of knowledge but low level of positive attitude and willingness was noticed among the study participants toward organ donation.

Peer Review reports

The need for organ donation has increased globally in the past years due to an increase in organ failure [ 1 ]. Every day in the United States of America (USA), 21 people die waiting for an organ and more than 120,048 men, women, and children await life-saving organ transplants [ 2 ]. Accor-ding to a survey In India every year about 5 lakh (500,000) people die because of non-availability of organs and 1.5 lakh(150,000) people await a kidney transplant but only 5000 get among them [ 3 ]. Recently published report has found that approximately 3 million people in sub-Saharan Africa diagnosed with end-stage kidney disease (ESKD) die each year due to renal failure [ 4 ]. In Kenya, the kidney transplant queue at Kenyatta National Hospital in Nairobi stretches all the way to 2018, despite the hospital performing the procedure on a weekly basis [ 5 ]. In Ethiopia, between 130 and 150 corneas are collected yearly. However, there are more than 300,000 blind people waiting for corneal transplantation [ 6 ].

There are no sufficient facilities which provide maintenance and transplantation therapy for failed organs in Ethiopia. Currently there are only cornea and living related kidney transplant programs established in the nation’s capital Addis Ababa [ 6 ]. Facilities which provide maintenance dialysis has been in existence in the country starting from 2001. Hemodialysis has become on hand in private institutions, mostly in Addis Ababa the capital city of the country, and more recently in a few other urban and semi-urban regions. Currently, there are 30 hemodialysis centers with a total of 186 hemodialysis chairs and approximately 800 patients on hemodialysis. Among patients on maintenance dialysis, only about one-third receives treatment 3× per year because the cost of hemodialysis is unaffordable for the majority of patients [ 7 ].

Organ transplantation is one of the great advances in modern medicine and is the best option for failed organ. Transplantation is defined as the transfer of human cells, tissues or organs from a donor to recipient with an aim of restoring normal physiology in the body [ 8 ]. In Ethiopia, up to 2018, 1336 corneal and 90 living donor kidney transplants have been performed. Currently the kidney transplant program accepts candidates only at the age of 14 and above [ 7 , 9 ].

Some studies found out that the issue of organ donation is multifactorial. In developed countries relational ties, religious beliefs, cultural influences, family influences, body integrity, and previous interactions with the health-care system were reported as the potential factors for organ donation [ 10 ]. However, there are limited studies regarding organ donation and the factors that influence it in developing countries for instance, in Kenya there are peoples who believe a person’s body should be intact when buried this belief and other sociocultural and legal factors hinder the harvest of organ from patients who have been medically declared to be in a “state of dying” [ 5 ].

Among 100,000 of people died each year are believed to be potential donors; however, only less than 200 actually become donors [ 11 ]. This indicates that a lot should be done on awareness creation towards organ donation. As a new approach in solving the organ shortage, it has been suggested that awareness about organ donation to be made a part of school education [ 12 ]. In Ethiopia we suggest to use religious leaders besides to incorporating the issue in school education, because Ethiopia is religious country. Our country has close ties with all three major Abrahamic religions, and it was the first in the region to officially adopt Christianity in the fourth century. Christians account for 63% of the country’s population, with 43.5% belonging to the Ethiopian Orthodox Church, 18.5% Protestant and 0.7% Catholic. Ethiopia has the first Hijra in Islamic history and the oldest Muslim settlement on the continent. Muslims account for 34% of the population, traditional 2.7% and other 0.6% [ 13 ].

In Ethiopia there are no data on public perception of organ donation and transplantation Therefore, the present study was designed to assess the knowledge, attitude and willingness of organ donation among medical students. Medical students, as future doctors can take up the role of promoting organ donation by educating and motivating the public to initiate them donate their organs besides their voluntary organ donation. Therefore, assessing medical student’s knowledge, attitude and willingness to donate organ is very important to decrease the shortage of organ in the future.

Study setting and subjects

A cross sectional study was carried out for 3 months from May to July 2019among under graduate medical students in Jimma University after obtaining Institutional Ethical Clearance from institutional review board (IRB) of Jimma University. The University is located in Jimma town which is 352 km from Addis Ababa, the capital city of Ethiopia. Jimma University is one of the most distinguished centers of excellence in medical education in the country.

Sample size

All medical students (from first to internship) registered in the year 2018/2019 were the source population. Based on their training background, medical students in Jimma University were divided into two groups: PRE-CLINICAL and CLINICAL. PRECLINICAL is subdivided in to two groups: Year I (PC-I) and Year II (PC-II) and CLINICAL in to three subgroups Year III(C-I), Year IV(C-II) and internship. The sample size was calculated by using simple proportion formula assuming a prevalence of 50% for knowledge, attitudes and willingness of organ donation, a 95% confidence interval and a sample error of 5%. This was adjusted for 10% non-response rate; bringing the total sample size to 320.There were about 1200 students studying in Jimma University medical school.

The questionnaire was distributed to undergraduate medical students during lecture hours in the classroom and in ward during attachment. They were instructed not to discuss the questions among themselves. The importance of the study was explained and confidentiality regarding the participant response for the questions was ensured.

A 20-item self-administered questionnaire was developed. The first part of the questionnaire gathered the demographic details from the students, which included age, gender, year of study and religion. The second, third and fourth sections assessed the levels of knowledge (Q1–7), attitude (Q8–16) and willingness (Q17–20) to donate organ, respectively.

The students were grouped as those who do have adequate and inadequate knowledge based on their score.

Adequate knowledge is when 4–6 questions were answered correctly and inadequate when less than 4 questions answered correctly out of 6 knowledge questions.

Attitude was assessed by using 9 attitude statements and respondents were categorized as those who do have positive attitude and negative if they agree to 6–9 and less than 6 attitude statements respectively.

Statistical analysis

Data was entered to EPI data and exported to SPSS version 20 for analysis. Descriptive statistics like percentage and mean and standard deviation were used to present socio-demography, knowledge, attitude and willingness response of the participants. Multivariate analysis was used in order to relate those factors that gave a significant result: One way Multivariate analysis of variance (MANOVA) was used to see a significant relationship between one independent variable and dependent variables and two ways MANOVA was considered to know if there was an interaction between two independent variables on the dependent variables. One way Analysis of Variance (ANOVA) was used for comparing means of variables to know among which groups were the differences. Finally, Odds ratio analysis was used to find out variables which were related to a positive attitude towards organ donation.

Out of 320 participants 57.8% were male. Mean (±SD = standard deviation) age of participants was 23.48 ± 17.025 years. Majority of the participants were orthodox (49%.7) and the least percentage being others constituting wakeefeta, apostolic, humanity, atheist and Seventh Day Adventist (SDA) (2.8%) (Table  1 ).

96.9% of the students had awareness about organ donation. Only 25% had knowledge that there was no age limit for organ donation (Table  2 ).

There was a statistically significant difference in level of knowledge between study groups as demonstrated by one-way ANOVA(F (4,315) =7.6, p  = 0.001). Based on the post hoc test the significant difference was between PC-I and C-II( p  = 0.001), PC-I and intern( p  = 0.001), PC-II and C-I( P  = 0.022) and PC-II and intern( p  = 0.010). The mean for PC-I, PC-II, C-I, C-II and intern is 1.37, 1.27, 1.20, 1.08 and 1.05 respectively. Therefore, PC=I had significantly higher level of knowledge when compared to the rest year of study (Table  3 ).

74.1% of the participants agreed to support family members if they wish to become an organ donor. Majority of the study subjects (91.9%) felt that awareness about organ donation should be made a part of school education (Table  4 ).

According to our finding, males were 1.156 (Odds Ratio = 1.156) times likely to have positive attitude towards to organ donation as compared to female. Students who had an awareness about organ donation were 2.602 (Odds Ratio = 2.602) times likely to have positive attitude towards to organ donation as compared to those who were unaware. The other variables which were related to a positive attitude towards organ donation were: not having a belief on the importance of burying intact body (Odds Ratio = 5.434); knowing definition of brain death (Odds Ratio = 1.257); not having a belief that there is a danger of misuse, abuse or misappropriation of donated organ (Odds Ratio = 2.777); willingness to donate blood (Odds Ratio = 4.813); and willingness to donate organ (Odds Ratio = 19.424).

58.1% of the study participants were willing to donate their organs and allow organ donation after the death of a family member. Majority of the study subjects (88.4%) did not like to take money for organ donation. 90.3% of the study subjects were willing to donate blood and 58.1% were willing to donate their organ (Table  5 ) (Fig.  1 ).

Distribution of study subjects according to the source of information about organ donations. i.e. Note: No of respondents may be greater than sample size as multiple options were allowed. Most common source of information about organ donation was found to be internet (61%) television (50%) followed by, Movies and health care providers 46 and 45% respectively

There were an association between willingness and attitude. Willingness to donate organ was significantly higher among those who do have positive attitude (88.2%) as compared to those with negative attitude (11.8%) (Table  6 ).

There was a statistically significant difference on belief of burying intact body between religions as demonstrated by one-way ANOVA(F (3,316) =4.5, p  = .004). Based on the post hoc test the significant difference was between Protestant and Muslim ( p  = .007). The mean for protestant is 1.83 and Muslim 1.56.Therefore, Protestant had significantly higher belief on the importance of burying intact body when compared to Muslim (Table  7 ).

There was a statistically significant difference between males and females when knowledge questions considered jointly Wilk’s Λ  = .96, F (6,312) = 2.247, P  = 0.039, multivariate ƞ 2  = 0.041 and attitude statements consider jointly Wilk’s Λ  = .94, F (9,310) = 2.301, P  = 0.016, multivariate ƞ 2  = 0.063.

When year of study is considered, there was a statistically significant difference among year of studies when knowledge questions considered jointly Wilk’s Λ  = .75, F (25,079) = 3.966, P  < 0.001, multivariate ƞ 2  = .071, attitude statements considered jointly Wilk’s Λ  = .77, F (37,152) = .766, P  < 0.001, multivariate ƞ 2  = .065 and willingness questions considered jointly Wilk’s Λ  = .93, F (12,828) = 2.072, P  = 0.017, multivariate ƞ 2  = .026.

Two way MANOVA was considered to know if there was an interaction between two independent variables on the dependent variables. There was a statistically significant interaction effect between gender and year of study on the combined knowledge questions (dependent variables) F (25,062) = 1.755, P  = 0.014, Wilk’s Λ  = .033.

Knowledge of the participant

Organ failure and shortage of donated organs are global problem. Among 100,000 of people died each year are believed to be potential donors; however, only less than 200 actually become donors [ 9 ]. The widespread shortage of donated organs indicates that there is low donor rate worldwide; In Ethiopia there is no data on rate of organ donation. In 2017 Spain had the highest donor rate in the world at 46.9 per million people, followed by Portugal (34.0 per million), Belgium (33.6 per million), Croatia (33.0 per million) and the US (32.0 per million) [ 14 ]. Donated organs are the major pre-requisite for consistency of organ transplantation program; one of the solutions to increase organ supply is to assess public knowledge, attitude and willingness towards organ donation and taking an action based on the data. In our country there is no study done on people’s perception towards organ donation this background pledges us to conduct this study.

In our study 96.9% of the participants heard about organ donation which is similar to study done by Annadurai et al and Jothula et al. [ 15 , 16 ] both reported that 100% of the participants were aware about organ donation.74.1% of the participants were aware about the meaning of organ donation which is relatively higher than the study done by Annadurai et al. [ 15 ]. In the present study, level of knowledge was significantly higher among PC=I (year I) students as compared to the other year of study this finding was similar to study done among undergraduate dental students of Panineeya Institute of Dental Sciences and Hospital, which showed higher average knowledge among first-year students [ 17 ]. In this study, only 82.5%of medical students had adequate knowledge about organ donation which is relatively higher than the study done on final semester medical students by Karini et al. which showed that only 56% of them were having adequate knowledge [ 18 ].

In the present study the main sources of information about organ donation was found to be internet (61%) and television (50%).This was similar to study conducted in USA and Australia [ 19 , 20 ]. However; Similar findings were observed by Sindhu et al. and Jothula KY et al. [ 16 , 21 ]. The third source of information about organ donation in our study are health care providers (45%) which is relatively higher than the study done by Annadurai et al. [ 15 ] which reported 34.1%. this finding showed that health care providers are playing undeniable role in creating awareness towards organ donation in Ethiopia.

206(64.4%) of our study participants had identified all the organs that can be donated. This finding was higher than the study done by Annadurai et al. [ 15 ] and Karini et al. [ 18 ] which reported 16.1 and 26% respectively. In the present study 80(25%) of the students knew that there is no age limit for organ donation which is approximate to Sucharitha et al. and lower than Jothula KY et al. [ 16 , 22 ].

Attitude of medical students regarding organ donation

201(62.8%) of our study subjects have a positive attitude towards organ donation which is lower than the study in Spain and India which found 80 and 71.3% respectively [ 23 , 24 ]. 91.9% of this study subjects, felt that awareness about organ donation should be included in school curriculum which is similar to Adithyan et al. reported that 91.2% of the subjects felt the need for revision of medical curriculum on organ donation [ 25 ] Our study found out that 251(78.4%) of the study subjects would like to motivate others for organ donation which is lower than to the Vinay et al [ 26 ].

77(24.1%) of our study subjects belief that person’s body should be intact when buried A study in USA reported that 8% of participants strongly agree and 11.7% agree to this statement which is almost similar to our finding [ 19 ]. In our study being of the male sex (Odds Ratio = 1.156) was related to a favorable attitude towards to organ donation; in contrast, a study done in Spain reported that being of females sex (Odds Ratio = 1.739) was related to a favorable attitude [ 23 ]. In our study not having a belief on the importance of burying intact body (Odds Ratio = Ratio = 5.434) was one of the variables which affect positive attitude towards to organ donation which was similar to a study in USA [ 19 ]. A study done in Spain reported being a blood donor (OR = 2.824) as a variable related to a positive attitude towards to organ donation similarly in our study we found out willingness to donate blood (Odds Ratio = 4.813) as a variable to a favorable attitude.

Willingness of medical students to donate organ

In this study 186(58.1%) of the study participants were willing to donate their organ which is similar to a study done in USA [ 20 ] and lower than Payghan et al. and Vinay et al revealed that almost 90% of study participants were willing to donate their organs [ 26 , 27 ]. The present study found out that there is a significant association between attitude regarding organ donation and willingness to donate organs which is different from the finding by Ali et al. and by Dasgupta et al. [ 28 , 29 ] which reported that there was a significant association between attitude and knowledge acquired. Though taking money for organ donation is unethical 11.6% of our study participants would like to take money for organ donation which was higher than study by Jothula KY et al. [ 16 ].

Though most of the students had adequate knowledge, still gaps exist in their attitude and willingness. This implies the need for an intensified and sustained education to raise attitude and willingness of the students towards organ donation.

Recommendations

Most of the students (91.9%) felt that awareness about organ donation should be made a part of school education; until it included in school curriculum, we recommend the students to acquire an adequate knowledge by themselves; In our study the most common source of information about organ donation was internet; so, they can browse more to acquire additional knowledge and make informed decision.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Abbreviations

Analysis of variance

Clinical-II

End-stage kidney disease

Institutional Review Board

Jimma University Medical College

Multivariate analysis of variance

Pre-clinical-I

Pre-clinical-II

Seventh Day Adventist

Statistical Package for Social Sciences

United States of America

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The study was funded with the support of Jimma University; Faculty of Health Science. The funding body has no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.

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Fantu Kerga Dibaba, Kabaye Kumela Goro, Fanta Gashe Fufa, Aster Wakjira Garedow & Eshetu Mulisa Bobasa

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Dibaba, F.K., Goro, K.K., Wolide, A.D. et al. Knowledge, attitude and willingness to donate organ among medical students of Jimma University, Jimma Ethiopia: cross-sectional study. BMC Public Health 20 , 799 (2020). https://doi.org/10.1186/s12889-020-08931-y

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Organ and tissue donation in clinical settings: a systematic review of the impact of interventions aimed at health professionals

• Frédéric Douville 1 ,
• Gaston Godin 2 &
• Lydi-Anne Vézina-Im 2  

Transplantation Research volume  3 , Article number:  8 ( 2014 ) Cite this article

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In countries where presumed consent for organ donation does not apply, health professionals (HP) are key players for identifying donors and obtaining their consent. This systematic review was designed to verify the efficacy of interventions aimed at HPs to promote organ and tissue donation in clinical settings. CINAHL (1982 to 2012), COCHRANE LIBRARY, EMBASE (1974 to 2012), MEDLINE (1966 to 2012), PsycINFO (1960 to 2012), and ProQuest Dissertations and Theses were searched for papers published in French or English until September 2012. Studies were considered if they met the following criteria: aimed at improving HPs’ practices regarding the donation process or at increasing donation rates; HPs working in clinical settings; and interventions with a control group or pre-post assessments. Intervention behavioral change techniques were analyzed using a validated taxonomy. A risk ratio was computed for each study having a control group. A total of 15 studies were identified, of which only 5 had a control group. Interventions were either educational, organizational or a combination of both, and had a weak theoretical basis. The most common behavior change technique was providing instruction. Two sets of interventions showed a significant risk ratio. However, most studies did not report the information needed to compute their efficacy. Therefore, interventions aimed at improving the donation process or at increasing donation rates should be based on sound theoretical frameworks. They would benefit from more rigorous evaluation methods to ensure good knowledge translation and appropriate organizational decisions to improve professional practices.

The number of patients awaiting organ or tissue transplantation continues to grow throughout the world [ 1 – 4 ]. The shortage of organ and tissue donors is widely studied and several factors explaining why individuals accept or refuse to consent to organ and tissue donation are reported in the literature [ 5 ]. Simpkin et al . [ 6 ] conducted a review of modifiable factors that influence relatives’ decisions to allow organ donation. This review suggests that the skills of individuals making the request to donate may have a significant impact on consent rates. Based on this information, evaluating the efficacy of interventions among HPs to increase donation seems relevant.

The donation process depends on potential donor identification and on HPs approaching families for donation consent. Since HPs are responsible for this approach to families, they are the gatekeepers for organ and tissue donor notification.

Consent to organ and tissue donation is the end point resulting from many actions undertaken by HPs (from identifying potential donors to referring donors to an organ and tissue procurement representative). In fact, many of these actions can be viewed as professional practices and as forms of human behavior. Thus, interventions should take advantage of behavioral theories and behavior change strategies in their design [ 7 – 11 ]. Past studies have demonstrated the importance of developing theory-based interventions in order to enhance their potential success in changing behavior [ 12 , 13 ]. The absence of theoretical bases for interventions and the selection of appropriate behavioral change techniques are two of the main problems in behavior change research projects [ 14 – 17 ]. Grimshaw et al . [ 15 ] suggest exploring the applicability of behavioral theories to the understanding of behavior change among HPs.

Several systematic reviews on organ donation have been published. These systematic reviews have cover different aspects of organ donation including the factors influencing families consent to donation [ 6 ], the attitude of the public towards living donors [ 18 ], the educational interventions offered in high schools [ 19 ], the management of donor brain death [ 20 ] and professional’s attitude regarding the heart-beating donors [ 21 ]. However, there is no systematic review on the efficacy of interventions among HPs to encourage them to approach families for consent or increasing donation rates. This is an important aspect of organ donation because donor identification and obtaining the consent of family are necessary conditions to the donation process.

This systematic review was designed to identify and analyze the impact of interventions aimed at HPs to improve donation-promoting professional practices in clinical settings. Secondary outcomes consisted of verifying whether such interventions were effective in improving donation rates and exploring associated behavior change strategies and the underlying theoretical framework.

Search strategy

The most relevant electronic databases covering the field of behavior change among HPs are those in health and psychology. CINAHL (1982–2012), COCHRANE LIBRARY (Cochrane Reviews, Other Reviews, Trials, Methods Studies, Technology Assessments, Economic Evaluations, Cochrane Groups), EMBASE (1974–2012), MEDLINE (1966–2012), PsycINFO (1960–2012), and ProQuest Dissertations and Theses were searched for papers published in French or English until September 2012.

The search strategy included the following concepts: 1) health professionals; 2) organ and tissue donation; and 3) interventions or strategies. This search strategy was adapted according to the terminology of the various databases. Moreover, bibliographies of potential studies were analyzed manually to find other key words relevant to the search strategy and studies not identified with the main search strategy. Only French and English papers were considered for review for practical reasons. The complete search strategy for each database is presented in Additional file 1 .

Study eligibility criteria

To be eligible for inclusion, studies had to adopt an experimental or quasi-experimental design reporting interventions aimed at HPs in clinical settings in order to improve their practices regarding the donation process or to increase the donation rates. They also had to report behavioral measures of the donation process or impact on organ and tissue donation rates as the study outcome.

In this study, HPs refer to professionals with medical training whose jobs require them to be in contact with patients and who are in a position to ask for donor consent. The concept of HP includes family physicians, specialist physicians, nurses or any other allied HPs who meet families in their daily practice. It also includes physicians in training (residents or interns), but excludes healthcare students and administrators not in contact with patients.

Also, the interventions had to be offered to HPs with the intention of modifying their practice regarding the donation process or at increasing donation rates. Such interventions could take the form of educational (for example, flyers, workshop, or lecture) [ 22 , 23 ], organizational (for example, hospital personnel structure change, or guidelines) [ 24 ], or regulatory strategies. These interventions or strategies were retained insofar as they were aimed at HPs caring for patients.

From a methodological point of view, the studies had to include a control group. However, to ensure that the study would not overlook relevant interventions that might have been effective, intervention studies without a control group, but with a pre-post analysis, were considered in a separate analysis.

Finally, to be included in the review, the intervention outcome had to be reported as a behavioral measure of the donation process (objective or self-reported), based on Kirkpatrick’s third level of program evaluation [ 25 ], or as the impact on organ and tissue donation rates. Behavioral measures could be a specific action (behavior) in the donation process, such as identifying a potential donor, approaching families to initiate discussion, obtaining signed consent for a donation or referring a potential donor to an organ and tissue donor representative. Articles reporting the impact on organ and tissue donation rates were considered even if the study did not assess behavioral outcomes to ensure comprehensiveness of the interventions reported in this review.

Studies that did not include HPs were excluded, as were those not directly aimed at changing HPs’ behavior, such as the implementation of an Organ Procurement Organization (OPO) coordinator in a hospital. Although one of the OPO’s duties involves identifying potential donors and approaching families to initiate donation discussion, their implementation could not be considered as an intervention intended for HPs (nurses and physicians) to modify their practices regarding the donation process; the latter would still have to notify the OPO and procurement organizations of potential organ and tissue donors.

Finally, studies concerning HPs’ reactions following an intervention or their level of knowledge following the intervention [ 25 ] were not considered if the assessed outcomes did not include the HPs’ behavior or donation rate.

Sorting of the studies by their titles and abstracts was first carried out by FD in order to select the articles meeting the inclusion criteria. Thereafter, the full text articles that met the inclusion criteria were screened independently by FD and LAVI, and decisions were compared.

Study quality assessment

Quality assessment of the studies was performed using criteria inspired by Morrison [ 26 ] and Reed [ 27 ], who recommend questions for appraising reports of medical education interventions.

Three criteria were selected to assess the population (randomized sample; justification of sample size and existence of a control group). Two criteria evaluated the intervention (allocation concealment and theory underlying the intervention). Two criteria appraised the assessment tool (validity and reliability). Finally, two criteria assessed the statistical approach used (intention-to-treat) and the level of attrition at follow-up.

No assessment for the risk of bias across studies was performed because the interventions had different objectives, populations and outcomes, making it impossible to obtain cumulative evidence.

Data extraction

A first coding was carried out on one study to verify if there was agreement on the extraction of data and to confirm the quality of the coding sheet. In case of disagreement between the two reviewers, the final decision was taken after discussion with a third reviewer (GG).

The following data were extracted from the selected studies: authors, year of publication, population under study and sample size. The study data were extracted according to the recommendations for evaluating educational interventions [ 26 , 27 ]. Thus, the reported variables were: objective of the study; intervention type (educational or organizational) and strategy; duration of follow-up; behavior change techniques; and study methodology, outcomes and results. The theory underlying each intervention was also extracted.

To help classify HPs’ strategies and relate those to the most recognized and effective theory-based strategies, behavior change techniques were analyzed using the taxonomy developed by Abraham and Michie as reference [ 11 ]. This taxonomy contains 26 behavior change techniques used in interventions based on behavior change theories such as the theory of reasoned action [ 28 ], the theory of planned behavior [ 29 ], the social cognitive theory [ 30 ], the information-motivation-behavioral skills models [ 31 ] and other behavior change theories.

Data analyses

Based on the studies retained, a descriptive analysis of selected studies (study objective; intervention type (educational or organizational) and strategy adopted; duration of the follow-up; behavior change techniques used; and study methodology, outcomes and results) was completed prior to identifying effective interventions. Interventions with a control group and interventions with a pre-post analysis are described separately.

A risk ratio was calculated for each outcome among the studies with a control group. The risk ratio was determined based on the number of participants in each group (experimental and control) and on the frequency of HPs’ behavior adoption. Thus, the analysis allowed the identification of significant differences between the two groups following the implementation of an intervention.

Review statistics

A total of 15 studies assessing interventions among HPs in clinical settings aimed at improving professional practices regarding the donation process or increasing donation rates were identified. The results of the search strategy are presented in Figure  1 . All studies included used educational, organizational or a combination of both types of interventions to promote professional practices regarding the donation process. These took the form of in-service meetings, workshops, conferences, print documents, examples provided of situations associated with the organ and tissue donation process and identification of donation criteria or information on how to approach a potential donor [ 23 , 32 , 33 ].

Flow chart diagram.

The 15 studies were assessed regarding population and the intervention assessment tool. In general, study quality was low. No study used a randomized population or justified their sample size. Only five studies used a control group. Allocation concealment of the intervention was neither relevant nor mentioned for all the studies included, and 14 of the 15 studies did not use a theory-based intervention. Where relevant, the validity and reliability of the assessment tools were not mentioned. Among the studies with a control group, there was no intention-to-treat analysis. Finally, the attrition rate was appropriately mentioned when required. The results of the quality assessment for the studies of the present review are available in Table  1 .

Efficacy of the interventions

Intervention studies with comparison groups.

Among the 15 studies included, only five had a comparison group (Table  2 ) [ 23 , 32 – 35 ]. The specific populations in these studies were nurses [ 32 – 34 ], physicians [ 23 , 33 , 34 ] and residents in medicine [ 35 ]. In addition to HPs, three studies also included other allied HPs such as chaplains or administrators [ 32 – 34 ]. All the studies used educational interventions to increase donation and one also used an organizational strategy. None of these interventions were based on a theoretical framework. According to the list of behavior change techniques [ 11 ], the majority of the strategies provided instruction on the donation process, the HPs’ role or how to cope with families’ reactions.

Relative risks (risk ratios) were computed to determine how likely participants were to adopt a behavior related to organ and tissue donation following an intervention, compared with those not exposed to the intervention (Table  3 ). Due to a high level of heterogeneity, the relative risks were calculated independently for each study and not pooled together.

The intervention studies of Nelson et al . [ 33 ] and Riker and White [ 23 ] showed significant relative risks for the following: approaching families [ 23 , 33 ], referring potential donors [ 33 ] and increasing donation rates [ 23 ]. However, the interventions of Dettle et al . [ 32 ], Light [ 35 ] and Riker and White [ 23 ] did not result in a significant increase in the number of signed consents for donation. No relative risk could be computed for the interventions of Kittur et al . [ 34 ], since the results were presented in absolute numbers instead of percentages, and there were no data on the total size of the groups.

Intervention studies without a comparison group (pre-post assessments)

The remaining ten studies used pre-post assessments (Table  4 ) [ 36 – 45 ]. These studies evaluated behavior change toward donation among HPs or the impact of their intervention on donation rates. The participants targeted in these interventions were mainly nurses and physicians. However, six of these studies involved hospital staff, without specifying which types of HPs were targeted [ 36 , 38 , 40 , 42 , 44 , 45 ]. Also, in six of the ten studies, the number of participants was not provided [ 36 , 37 , 41 – 44 ].

All the studies used educational strategies or a combination of organizational and educational strategies to promote donation behavior among HPs. In the study of Taylor et al . [ 41 ], there were references to the concept of change theory in the development of their intervention, but none of the other studies used a theoretical framework to guide the development of their intervention. The most common technique was to provide instruction on the donation process, the identification of donor criteria, the HPs’ role in the donation process and how to approach family members to initiate discussion.

This systematic review summarized the studies assessing educational and/or organizational interventions aimed at HPs to improve professional practices regarding the donation process or increase donation rates in clinical settings. A total of 15 studies were identified, among which only five had a comparison group. No study referred to a theoretical framework, either for the development of the interventions or their assessment. The behavior change technique most often used consisted of providing instruction on the donation process, including criteria and the role of HPs (how to approach family members, to initiate discussion or how to cope with families’ reactions).

Based on our review, the selected interventions aimed at changing HP practices regarding donation were developed, for the most part, more than a decade ago. Recent developments in donation emphasized the introduction of OPO representatives [ 46 , 47 ] and the regulation ensuring donation after death (such as presumed consent) [ 1 ]. If organ donation rates increased following the introduction of OPOs in clinical settings [ 46 , 47 ] or following a change in regulations [ 1 ], HPs still have to notify procurement organizations of any potential donors, leaving place for more research and interventions to help HPs in the donation process.

Impact on donation-promoting professional practices

Although there are many interventions aimed at changing HPs’ behavior toward the organ and tissue donation process in clinical settings, only a few were carried out exclusively among HPs whose job position requires them to be in contact with patients and who are in a position to ask for donation consent [ 23 , 32 ]. Indeed, most of the interventions also targeted hospital administrators, clerical staff and chaplains [ 32 – 34 , 37 ]. As such, it is difficult to isolate the impact of these interventions on nurses’ and physicians’ behavior.

The lack of studies assessing the behavior changes or health outcomes in this literature review is consistent with a recent publication that reviewed the evaluation of inter-professional education programs. According to Kirkpatrick’s levels, [ 25 ] only 9.7% of program evaluations assessed changes in behavior, 0.004% examined organizational practice changes and no items addressed benefits to patients [ 48 ]. Similar results were obtained in continuing nursing education programs [ 49 ].

Impact on donation rates

Interestingly, more than half of the studies included used an objective measure of the impact of the intervention on donation rates. This was achieved by extracting the information from medical records to evaluate the number of deaths (potential donors) and the number of actual donors [ 23 , 39 , 44 ]. This type of measure is obviously better than using self-reported behavior and provides more confidence in the observed effects.

Behavior change strategies and underlying theoretical framework

Surprisingly, in spite of the HPs’ role of gatekeeper in the donation process, there is a lack of sound theoretical interventions aimed at improving professional practices regarding the donation process or at increasing donation rates. None of the interventions were developed with reference to a behavior change theory, except the study by Taylor, Young and Kneteman [ 41 ], which mentioned the use of the concept of change theory, but without explaining how it was applied.

The fact that the interventions included in the present review had a poor theoretical basis and an inappropriate evaluation of their impact has important clinical implications. OPOs and donation stakeholders seem to apply nontheory-based intervention strategies without being sure of their efficacy. These interventions have an important cost for the healthcare system without resulting in significant changes (for example, increases in donation rates).

Quality of reviewed studies

The interventions presented several weaknesses in their evaluation designs. For instance, only five of the 15 studies identified used a comparison group to ensure that the intervention effects could be attributed to the implemented change strategy [ 23 , 32 – 35 ]. In addition, significant methodological flaws (for example, vague definition of the intervention, absence of a theoretical framework, lack of explanations on the study design, unjustified sample size) were noted.

Many of the studies included showed nonsignificant improvements in the detection of potential donors, approaching families and achieving consent or increasing donation rates in clinical settings [ 32 , 35 ]. Yet, some studies have proven that providing instruction on the donation process can significantly change HPs’ behavior over a period of 6 to 24 months [ 23 , 33 ]. However, it was not possible to establish whether an intervention was efficient due to methodological flaws, poorly described population or the lack of details on the content of the interventions and evaluation. Moreover, it was not possible to determine the efficacy of studies only using a pre-post evaluation because of the lack of a control group.

Limitations of the systematic review

The present review has some limitations. Only a small number of studies could be included in the analysis because most did not use a control group to compute a relative risk. Not all interventions reported the required information to compute relative risk (that is, number of participants in the experimental and the control groups). Moreover, the variability of the intervention strategies and the different HP practices on donation prevented the computation of some comparisons and the pooling of relative risks.

Conclusions

Despite the large number of publications on interventions to improve HPs’ practices regarding the donation process or increase donation rates, few of these interventions have been evaluated, or the associated assessments have methodological flaws that make it difficult to draw clear conclusions regarding their efficacy. Therefore, interventions aimed at improving the donation process or increasing donation rates should be based on sound theoretical frameworks and would benefit from more rigorous evaluation methods to ensure good knowledge translation and appropriate organizational decisions to improve professional practices.

Authors’ information

FD is a PhD candidate at the Faculty of Nursing at Laval University (Quebec City, Canada) and a clinical nurse specialist at the Institut de cardiologie et de pneumologie de Québec. GG is a professor at the Faculty of Nursing at Laval University. LAVI is a research professional at the Faculty of Nursing at Laval University.

Abbreviations

• health professional

organ procurement organization.

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Douville, F., Godin, G. & Vézina-Im, LA. Organ and tissue donation in clinical settings: a systematic review of the impact of interventions aimed at health professionals. Transplant Res 3 , 8 (2014). https://doi.org/10.1186/2047-1440-3-8

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Organ Donation for Social Change: A Systematic Review

• First Online: 07 January 2020

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• Amani Alsalem 2 ,
• Park Thaichon 2 &
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This chapter presents a critical review of the existing organ donation literature. The objective of this chapter is to identify the main gaps in the current body of literature on the organ donation context and the marketing discipline. This chapter initially discusses social marketing within the context of organ donation for social change. Following on, this chapter provides a systematic quantitative literature review of the existing organ donation studies from the period of 1985–2019. Then, this chapter details and discusses the review method. The literature review findings include the geographical distribution of 262 peer-reviewed organ donation studies around the world; the frequency of published articles over the period 1985–2019; the disciplinary scope of these studies; the sample characteristics; and the key theories and models used to inform organ donation studies. Finally, this chapter concludes with a discussion of the main limitations of existing organ donation studies.

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Alsalem, A., Thaichon, P., Weaven, S. (2020). Organ Donation for Social Change: A Systematic Review. In: Ratten, V. (eds) Entrepreneurship and Organizational Change. Contributions to Management Science. Springer, Cham. https://doi.org/10.1007/978-3-030-35415-2_6

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Organ donation after extracorporeal cardiopulmonary resuscitation: a nationwide retrospective cohort study

• Tetsuya Yumoto 1 ,
• Kohei Tsukahara 1 ,
• Takafumi Obara 1 ,
• Takashi Hongo 1 ,
• Tsuyoshi Nojima 1 ,
• Hiromichi Naito 1 &
• Atsunori Nakao 1  

Critical Care volume  28 , Article number:  160 ( 2024 ) Cite this article

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Limited data are available on organ donation practices and recipient outcomes, particularly when comparing donors who experienced cardiac arrest and received extracorporeal cardiopulmonary resuscitation (ECPR) followed by veno-arterial extracorporeal membrane oxygenation (ECMO) decannulation, versus those who experienced cardiac arrest without receiving ECPR. This study aims to explore organ donation practices and outcomes post-ECPR to enhance our understanding of the donation potential after cardiac arrest.

We conducted a nationwide retrospective cohort study using data from the Japan Organ Transplant Network database, covering all deceased organ donors between July 17, 2010, and August 31, 2022. We included donors who experienced at least one episode of cardiac arrest. During the study period, patients undergoing ECMO treatment were not eligible for a legal diagnosis of brain death. We compared the timeframes associated with each donor’s management and the long-term graft outcomes of recipients between ECPR and non-ECPR groups.

Among 370 brain death donors with an episode of cardiac arrest, 26 (7.0%) received ECPR and 344 (93.0%) did not; the majority were due to out-of-hospital cardiac arrests. The median duration of veno-arterial ECMO support after ECPR was 3 days. Patients in the ECPR group had significantly longer intervals from admission to organ procurement compared to those not receiving ECPR (13 vs. 9 days, P  = 0.005). Lung graft survival rates were significantly lower in the ECPR group (log-rank test P  = 0.009), with no significant differences in other organ graft survival rates. Of 160 circulatory death donors with an episode of cardiac arrest, 27 (16.9%) received ECPR and 133 (83.1%) did not. Time intervals from admission to organ procurement following circulatory death and graft survival showed no significant differences between ECPR and non-ECPR groups. The number of organs donated was similar between the ECPR and non-ECPR groups, regardless of brain or circulatory death.

Conclusions

This nationwide study reveals that lung graft survival was lower in recipients from ECPR-treated donors, highlighting the need for targeted research and protocol adjustments in post-ECPR organ donation.

A worldwide crisis in organ shortage is intensifying as the need for transplantations spikes; however, the supply of available organs falls short of meeting this escalating demand, further widening the gap between those in need and the organs available [ 1 ]. In response, the significance of comprehensive screening for brain death in the intensive care unit (ICU), particularly following cardiac arrest, to identify potential organ donors has been increasingly emphasized [ 2 , 3 ].

Extracorporeal cardiopulmonary resuscitation (ECPR) for out-of-hospital cardiac arrest (OHCA) has been increasingly employed as an emerging rescue treatment strategy [ 4 , 5 ]. However, the implementation of ECPR introduces complex ethical challenges, primarily because it frequently results in patients being placed on mechanical support with minimal prospects of neurological recovery [ 6 ]. Previous research has indicated that patients resuscitated with ECPR exhibit a markedly higher rate of brain death compared to those who undergo conventional CPR [ 2 ]. Indeed, a large retrospective study of ECPR in Japan, a leading country in the field of ECPR, revealed that decisions to withhold or withdraw life-sustaining therapy were most frequently made on the first day, with a median decision time of 2 days following admission to the ICU. Importantly, the perceived unfavorable neurological prognosis was the primary reason for the withhold or withdraw life-sustaining therapy decision [ 7 ]. In Japan, the legal diagnosis of brain death while on extracorporeal membrane oxygenation (ECMO) was not allowed until recent guideline amendments [ 8 ]. Further, the actual practice patterns and prevalence of organ donation following ECMO discontinuation have not been thoroughly investigated. A registry study from Europe suggests that organ donation rates are higher in patients undergoing ECPR than those receiving conventional CPR, indicating a potential for increasing organ donations through ECPR [ 9 , 10 ].

This situation highlights the need for a comprehensive investigation into the practices of organ donation following ECPR, encompassing donor characteristics and the impact on recipients. To date, there has been a lack of research focused on the outcomes for recipients of organs from donors who have undergone ECPR, as well as those who have not. This study aims to fill this gap by examining the current practices and outcomes of organ donation post-ECPR, thereby enhancing our understanding of the potential for organ donation following cardiac arrest.

Study design and ethics

This was a nationwide retrospective cohort study in Japan using the Japan Organ Transplant Network database, covering the entire cohort of deceased organ donors of any ages, from July 17, 2010 through August 31, 2022. The Japan Organ Transplant Network prospectively collects data, including basic patient information and the clinical course details. These are recorded in a paper-based format by a transplant coordinator, based upon the patient’s medical records. This study was approved by the Ethics Committee of the Japan Organ Transplant Network (Approved Number: 15) and the Ethics Committee of Okayama University Hospital (Approved Number: K2303-030). Informed consent from the patient's family or legal representative was waived in this study.

Organ donation policy in Japan

The history and details of organ donation policy and the surrounding system are elaborated on elsewhere [ 11 , 12 ]. To summarize, Japan's organ donation policy after brain death underwent significant revision with the implementation of the revised Organ Transplant Law on July 17, 2010. This revision introduced two major changes: firstly, it established a system permitting organ donation with only the family's consent when the preferences of the deceased are unknown; and secondly, it authorized the transplantation of organs from children under 15 years of age. Prior to these changes, organ donation after brain death was permitted only if the patient had formally documented their wish to donate their organs. As a direct consequence of these policy revisions, the number of organ transplants from brain-dead donors saw a substantial increase, from 86 cases recorded between 1997 and 2010 to 413 cases between 2010 and 2017. In Japan, the donor's family has the right to choose which organs can be procured for recipients.

Protocol for organ donation following brain death

The timing of presenting organ donation as a potential end-of-life care option is entirely at the discretion of the attending physician or according to hospital policy. Per the Japan Organ Transplant Network procedures, this option is typically presented after the clinical confirmation of brain death. However, if a patient is considered a potential organ donor due to devastating brain damage, the presentation of this option can proceed before the confirmation of brain death. Upon family consent, the process requires two distinct legal confirmations of brain death, conducted at least 6 h apart (or 24 h for children under 6 years old), through comprehensive neurological tests, an apnea test, and electroencephalography, leading to the eventual retrieval of organs. Previously, during the study period, individuals undergoing ECMO treatment were not eligible for a legal diagnosis of brain death until the guidelines were updated on January 1, 2024. Therefore, during our study, brain death could only be diagnosed post-decannulation of veno-arterial (VA) ECMO, when possible. In Japan, the transfer of potential organ donors between hospitals for the purpose of donation is prohibited.

Protocol for organ donation following circulatory death

In Japan, controlled donation after circulatory death programs, particularly those using VA ECMO perfusion for organ preservation, have not been widely introduced [ 13 ]. Consequently, only kidneys and pancreases are typically donated after circulatory death under the scenario of unexpected circulatory demise. Accordingly, all donors after circulatory death have been categorized as IIb or VI, in accordance with the modified Maastricht classification [ 14 ]. The placement of a catheter for organ perfusion and the administration of heparin are permitted only after a diagnosis of brain death has been confirmed and the donor's family has consented to preoperative procedures. This allows for the placement of a catheter before cardiac arrest and the administration of heparin.

Study population and data extraction

The data source for this study was the Japan Organ Transplant Network database. We included all deceased organ donors from whom at least one organ was recovered and subsequently transplanted. From this cohort, we specifically selected those individuals who had experienced at least one episode of cardiac arrest either before or after hospital arrival were selected. This selection was based on the free text comments that summarized the clinical course from admission to the legal determination of brain death. We received the anonymized data as follows: whether the donation was after brain death or circulatory death, age, sex, primary disease or injury, the modified Maastricht classification for donation after circulatory death (either IIb or VI as mentioned above), time intervals from admission to brain death confirmation, presentation of the option for organ donation, legal determination of brain death, organ procurement, the number of organs donated, and, if applicable, the duration of VA ECMO use in patients who received ECPR. The matched data from donors and recipients, provided by the Japan Organ Transplant Network using identifiable numbers, were used to observe graft survival rates over the longest follow-up period.

The primary outcome was timeframe for the organ donation process, spanning from admission to organ procurement. Secondary outcomes included the number of organs donated and their graft survival rates.

Statistical analysis

Continuous data were expressed as medians with interquartile range (IQR), and categorical data as counts and percentages. Patients were stratified based on whether they underwent ECPR and the type of donation (either after brain death or circulatory death) for comparative analyses. Comparisons between the two groups employed the Mann–Whitney U test for continuous variables and the Chi-square test for categorical variables. Graft survival curves were generated using the Kaplan–Meier method and were compared with the log-rank test. Graft survival is defined as the graft still functioning and not having been rejected by the recipient's body at a specified time post-transplantation. This excludes cases where the patient has been relisted for transplantation. Specifically for kidney transplants, graft survival also includes the period until the patient becomes dependent on dialysis again. Donor and recipient characteristics were not matched between groups. In an exploratory analysis, as ECMO technology and management have developed over last years, graft survival rates except for small intestine were compared between the periods from 2010 to 2017 and 2018 to 2022. Missing data were removed during the analysis whenever comparisons were made. All tests were two-tailed, and a P value of < 0.05 was considered statistically significant. Analyses were conducted using Prism 10.0.3 (GraphPad, San Diego, CA) and IBM SPSS Statistics 26 (IBM SPSS, Chicago, IL).

During the study period, there were 370 donors after brain death with an episode of cardiac arrest, of which 26 (7.0%) patients received ECPR and 344 (93.0%) did not receive ECPR. Additionally, there were 160 donors after circulatory death, among whom 27 (16.9%) patients received ECPR and 133 (83.1%) did not.

Donation after brain death

Table 1 shows the demographic and clinical characteristics of donors after brain death with an episode of cardiac arrest, revealing similar basic demographics between groups. However, the majority of cases in the ECPR group were of cardiac origin. The median duration of VA ECMO support in the ECPR group was 3 days (IQR, 1 to 4). Compared to those not receiving ECPR, patients in the ECPR group experienced significantly longer intervals from admission to the presentation of the organ donation option to their families (5 vs. 3 days, P  = 0.012), to the clinical confirmation of brain death (9 vs. 5 days, P  = 0.001), and to organ procurement (13 vs. 9 days, P  = 0.005).

Table 2 presents the number and distribution of organs donated, comparing the ECPR and non-ECPR groups. The median number of organs donated was similar between the groups (5 vs. 5, P  = 0.294). The proportion of heart donations was significantly lower in the ECPR group compared to the non-ECPR group (50% vs. 80%, P  < 0.001). However, the donation rates for other organs were comparable between the two groups.

Figure  1 illustrates the graft survival curves for each organ. The lung graft survival rates were significantly lower in the ECPR group compared to the non-ECPR group (log-rank test P  = 0.009). Graft survival rates for both unilateral (single) and bilateral (double) lung grafts among recipients from brain-dead organ donors were generally lower in the ECPR group. This reduction was statistically significant for unilateral lung grafts, as detailed in Additional file 1 . No significant differences were observed in the graft survival rates of other organs.

The Kaplan–Meier curve of graft survival for each organ among recipients from brain-dead organ donors, comparing those who had received ECPR with those who had not. The P values obtained from the log-rank test for heart, lung, liver, pancreas, kidney, and small intestine were 0.072, 0.009, 0.950, 0.902, 0.577, and 0.519, respectively. The median observation periods for grafts from donors who experienced cardiac arrest and received ECPR versus those from non-ECPR donors, respectively, were as follows: for heart grafts, 1203 days (IQR: 542 to 2278) and 1690 days (IQR: 908 to 2610); for lung grafts, 777 days (IQR: 573 to 1816) and 1323 days (IQR: 596 to 2211); for liver grafts, 1816 days (IQR: 671 to 2438) and 1551 days (IQR: 738 to 2466); for pancreas grafts, 1083 days (IQR: 442 to 2118) and 1708 days (IQR: 677 to 2673); for kidney grafts from brain-dead donors, 1787 days (IQR: 736 to 2429) and 1690 days (IQR: 987 to 2576); and for small intestine grafts, 2446 days (IQR: 2446 to 2446) and 703 days (IQR: 404 to 1217); ECPR: extracorporeal cardiopulmonary resuscitation

Donation after circulatory death

Table 3 outlines the demographic and clinical characteristics of donors post-circulatory death, highlighting a higher prevalence of male donors in the ECPR group compared to the non-ECPR group. Regarding the primary disease or injury, cardiac diseases were notably more common among ECPR patients, mirroring the trend observed in brain-dead organ donors. The reporting of the duration of VA ECMO support was limited by extensive missing data. Additionally, the intervals from admission to offering the option of organ donation to the family and proceeding to organ procurement showed no significant differences between the two groups.

Table 4 reports the number and distribution of organs donated, comparing the ECPR and non-ECPR groups. The pancreas was not donated in either group. High kidney donation rates were noted in both groups. Left kidney donation was lower in the ECPR group compared to non-ECPR group (85 vs. 96%, P  = 0.023).

Figure  2 shows the graft survival curve for kidneys, indicating no significant differences between the ECPR and non-ECPR groups.

The Kaplan–Meier curve of graft survival for kidney among recipients from circulatory-dead organ donors, comparing those who had received ECPR with those who had not. The P values obtained from the log-rank test were 0.363. The median observation periods for grafts from donors who experienced cardiac arrest and received ECPR versus those from non-ECPR donors were 2071 days (IQR: 1004 to 3110) and 2160 days (IQR: 1175 to 3535), respectively. ECPR: extracorporeal cardiopulmonary resuscitation

Exploratory analysis

Lung graft survival rates for ECPR patients from the periods 2010–2017 and 2018–2022 showed no significant difference, as indicated in Additional file 2 (log-rank test P  = 0.827). Similarly, liver graft survival rates for the same periods did not differ significantly within the ECPR group; however, liver graft survival rates from ECPR patients were significantly lower compared to those from non-ECPR patients in 2018–2022 (log-rank test P  = 0.023). Comparable patterns were observed in graft survival for other organs.

In this nationwide cohort study conducted in Japan, we found that time intervals from admission to organ procurement after brain death were significantly longer for ECPR patients compared to non-ECPR patients. However, these intervals were similar following circulatory death. The number of organs donated after either brain death or circulatory death was comparable between the ECPR and non-ECPR groups. Despite similar proportions of lung donations between groups, lung graft survival was significantly lower in recipients from brain-dead organ donors who received ECPR compared to those without ECPR.

Our findings indicate that the time from admission to organ procurement in Japan is longer than that reported in other countries [ 15 , 16 ]. This variation may be attributed to the extensive discussions required around end-of-life care options, including organ donation, which are further complicated by the cultural emphasis on family involvement in medical decision-making processes [ 17 ]. Moreover, we noted that donors who underwent ECPR experienced longer delays to organ procurement compared to those who did not receive ECPR. This delay is likely due to legal constraints preventing the determination of brain death until after the decannulation of VA ECMO, highlighting a unique challenge in the organ donation process in Japan. Notably, guidelines were updated on January 1, 2024, allowing the diagnosis of brain death while on ECMO.

The influence of a donor’s ICU stay duration on recipient outcomes remains underexplored. A study from Germany indicated that the ICU stay duration of donors did not significantly impact the survival rates or outcomes following heart transplantation [ 18 ]. Similarly, another study concluded that the duration of a donor's ICU stay had no significant effect on patient and graft survival rates after pediatric liver transplantation [ 19 ]. These insights suggest that the ICU stay duration may not critically affect transplantation outcomes, consistent with our observations, with the possible exception of lung transplants. Meanwhile, there is limited data on donors who are brain dead with ongoing ECMO support. Among the available studies, the largest, conducted in France, focused predominantly on donors who received VA ECMO. It revealed that kidneys procured and transplanted from these donors did not exhibit differences in survival and functional outcomes compared to those from donors who were brain dead without ECMO support [ 20 ].

ECPR is typically administered to patients with a potential or presumed cardiac origin [ 4 , 5 ]. Consequently, even after the successful decannulation of VA ECMO, we observed a significantly lower rate of heart donations in the ECPR group compared to the non-ECPR group. Meanwhile, despite similar lung donation rates between groups, lung graft survival was significantly lower in ECPR recipients from brain-dead donors than in those without ECPR. This trend was consistent across both time periods, from 2010 to 2017 and from 2018 to 2022. This phenomenon may be attributable to “ECMO lung”, a condition characterized by lung injury induced by VA ECMO, resulting from inflammatory injury or pulmonary congestion [ 21 ]. Meanwhile, we observed that liver graft survival rates from ECPR patients were significantly lower compared to those from non-ECPR patients in 2018–2022. Although we could not fully explain the reasons, this might be partly due to severe cardiovascular condition affecting liver function through mechanisms such as cardiac hepatopathy, which includes impaired arterial perfusion and passive congestion from elevated venous pressure, often exacerbated by the hemodynamic instability and changes in liver perfusion associated with ECMO support [ 22 ].

According to the study using Japanese Diagnosis Procedure Combination Database, the prevalence of ECPR for OHCA from July 2010 to March 2017 was 2.6% (5612/212,295) [ 23 ]. Over the past 12 years, despite the lack of legal permission of brain death diagnosis during ECMO support, our study identified 53 deceased organ donors who had undergone VA ECMO due to at least one episode of cardiac arrest, with the vast majority experiencing OHCA. The exact number of brain death cases among patients who received ECPR for OHCA in the prior study is unknown; however, considering a meta-analysis indicating a 27.9% prevalence of brain death following ECPR [ 6 ], it can be speculated that the majority may have died without the opportunity for organ donation.

This study has several limitations. First, regarding donor characteristics, the study did not capture donors' comorbidities, the detailed processes involved in organ donation, or outcomes focused on the donors' families. Second, the analysis was limited by the absence of specific data, particularly the duration of VA ECMO support. These missing data restricted our ability to analyze and adjust graft survival outcomes in relation to the duration of ECMO support. Third, from the perspective of recipients, essential characteristics, including factors known to influence graft survival such as human leukocyte antigen mismatches and primary or underlying diseases, were unavailable. As a result, these variables were not adjusted for in our analysis [ 24 , 25 , 26 ]. Lastly, detailed recipient data was not available, and the small sample size precluded matching between groups, further constraining our analysis.

Despite these limitations, our research provides crucial insights into the patterns of organ donation and long-term graft survival after ECPR, based on extensive nationwide data. Although diagnosing brain death while on ECMO is now permitted in Japan, scenarios in which brain death is diagnosed after successful decannulation of ECMO are expected to increase as the use of ECPR as a strategy for OHCA expands worldwide. While the primary goal of ECPR should not be organ donation, our findings underline the necessity for additional research to develop thorough guidelines for end-of-life care and the organ donation process in such scenarios. Additionally, our study suggests that lung transplantation from donors who underwent ECPR may result in worse graft survival compared to those who did not receive ECPR. This aspect, as well as the impact on other organs, warrants further investigation in future research.

In this nationwide study from Japan, we discovered that lung graft survival was lower in recipients from ECPR-treated donors. These results emphasize the influence of ECPR on organ donation and underscore the need for further research to refine end-of-life care and organ donation protocols, particularly concerning lung graft survival and its effects on other organs following ECPR.

Availability of data and materials

Data not available due to ethical restrictions.

Abbreviations

• Extracorporeal membrane oxygenation

Extracorporeal cardiopulmonary resuscitation

Interquartile range

• Out-of-hospital cardiac arrest

Veno-arterial

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Acknowledgements

We would like to thank the Japan Organ Transplant Network for providing data and supporting this project.

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Department of Emergency, Critical Care, and Disaster Medicine, Faculty of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

Tetsuya Yumoto, Kohei Tsukahara, Takafumi Obara, Takashi Hongo, Tsuyoshi Nojima, Hiromichi Naito & Atsunori Nakao

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TY, KT, TO, TH, TN, HN, and AN designed the concept of the study. TY retrieved the data and prepared the manuscript. KT, TO, TH, HN, TN, and AN made substantial revisions and edits. All authors read and approved the final manuscript.

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Correspondence to Tetsuya Yumoto .

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This study was approved by the Ethics Committee of the Japan Organ Transplant Network (Approved Number: 15) and the Ethics Committee of Okayama University Hospital (Approved Number: K2303-030). Informed consent from the patient's family or legal representative was waived in this study.

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Supplementary Information

Additional file 1.

. The Kaplan–Meier curves comparing survival of unilateral (single) and bilateral (double) lung grafts among recipients from brain-dead organ donors, categorized by whether they received ECPR or not. The P values from the log-rank test for unilateral and bilateral lung graft survival were 0.049 and 0.104, respectively. The median observation periods for grafts from donors who experienced cardiac arrest and received ECPR versus those from non-ECPR donors, respectively, were as follows: for unilateral lung, 817 days (IQR: 553 to 1816) and 1311 days (IQR: 582 to 2196); and for bilateral lung, 707 days (IQR: 535 to 2174) and 1374 days (IQR: 695 to 2261). ECPR: extracorporeal cardiopulmonary resuscitation.

Additional file 2

. The Kaplan–Meier curves comparing survival of heart, lung, liver, pancreas, and kidney (both from donation after brain death and donation after circulatory death) grafts, according to two periods: 2010–2017 and 2018–2022. The left set of curves represents comparisons between ECPR and non-ECPR groups from 2010 to 2017. The middle set of curves shows comparisons between ECPR and non-ECPR groups from 2018 to 2022. The right set of curves compares the two time periods among patients who received ECPR. ECPR: extracorporeal cardiopulmonary resuscitation, DBD: donation after brain death, DCD: donation after circulatory death.

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Yumoto, T., Tsukahara, K., Obara, T. et al. Organ donation after extracorporeal cardiopulmonary resuscitation: a nationwide retrospective cohort study. Crit Care 28 , 160 (2024). https://doi.org/10.1186/s13054-024-04949-5

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Research Reports

2019 national survey of organ donation attitudes and practices.

The 2019 National Survey of Organ Donation Attitudes and Practices measured public opinion about organ donation and transplantation. This survey was completed by 10,000 U.S. adults. Key findings include:

• People’s support for organ donation.
• If they have signed up to be an organ donor and where.
• Talking to family members about organ donation and their wish.
• Beliefs about organ donation and transplantation.
• If they want their organs used locally or wherever they are needed most.
• Where they got their information on organ donation in the past year.

View and download the 2019 National Survey report (PDF - 3 MB) .

Supplemental Tables

• Binary Response Tables (XLSX - 459 KB)  – Frequency tables with data bars/color coding in the 2019 National Survey report.  
• Supplemental Tables (XLSX - 196 KB)   – Non-frequency tables in the 2019 National Survey report. 
• Full Response Tables (XLSX - 510 KB)  – Proportions and confidence intervals for every response option for all 86 key survey questions.  

Listen to/watch a webinar recording on key findings of the survey. Slides from the webinar (PDF - 697 KB)  are also available.

Note: If you are using assistive technology, you may not be able to fully see all of the information in this PDF file. The Excel file with it has the same information for the National Survey of Organ Donation Attitudes and Practices, 2019: Report of Findings. For help, please email  [email protected]  or call 301-443-3300.

2012 National Survey of Organ Donation Attitudes and Behaviors

This report details the findings of the 2012 survey of the American public’s attitudes and behaviors about organ donation.

View and download the  2012 National Survey of Organ Donation Attitudes and Behaviors (PDF - 1 MB)  report.

How pigs became the 'beacon of hope' to solve human organ donation shortages

When surgeons in the United States transplanted a kidney from a genetically modified pig into a living human in March, it was seen as a major milestone in the quest to solve organ shortages across the world.

The lead surgeon was optimistic, saying he believed the kidney could survive for two years. 

But nearly two months after he underwent the procedure,  62-year-old Richard "Rick" Slayman has died.

The Massachusetts General Hospital surgical team released a statement this week saying there was "no indication that it was the result of his recent transplant".

And leaders in xenotransplantation — the transplant of animal organs into humans — remain hopeful that pigs, in particular, are the answer. 

So how did pigs become the focus of future organ donation?

Desperate need for non-human alternatives 

As of May 1, about 1,400 Australians were waiting for a kidney transplant, the most in-demand organ in the country.

In the US, there are more than 96,500 patients on waitlists.

People are given transplants when their kidney is no longer working and they have been living on dialysis.

Studies show that people with kidney transplants live longer than those who stay on dialysis, according to the National Kidney Foundation. 

Wayne Hawthorne, professor of transplantation, and immediate past president of the International Xenotransplantation Association, said it's not possible for donation rates to meet demands.

At the Westmead National Pancreas and Islet Transplant unit, they have 10 times more patients on the waitlist than they can ever offer a transplant, he said. 

"We have been trying for decades to develop, and improve on organ donation from human to human," Professor Hawthorne told the ABC.

But even with changes to hospital systems and improvements to organ donor rates, organs such as kidneys and hearts remain in short supply as they need to come from "brain-dead donors".

And these aren't easy to come across. 

"Once your heart stops, you stop breathing and your circulation stops, and your organs are no good," Professor Hawthorne said. 

"That's the problem, you have to have this circulation. 

"So it means we have very, very few organ donors ... we're talking only a few 100 donors per year in Australia, compared to many thousands of patients."

For decades, researchers have been exploring the use of transplanted animal organs and tissues in humans.

In 1984, "Baby Fae" became the first infant to undergo a xenotransplant procedure, receiving the heart of a baboon.

The 14-day-old baby from California survived for 21 days.

But although non-human primate organs would be the best match, Professor Hawthorne says there are issues around ethics and supply.

"People don't like these sorts of animals being used in research, let alone as donors to humans," he said.

"The other big problem is trying to breed them ... like humans, they take a very long time to generate and have single offspring, usually.

"So they're very, very difficult to generate as organ donors."

Pig parts are already widely used in human medicine, for things like diabetes insulin and tissue for heart valves.

And, given they have similar organ sizes, it makes pigs the next ideal option.

Gene editing a 'beacon of hope'

Entire organ transplants have failed over the decades due to people's immune systems attacking the foreign tissue.

But researchers are now utilising advancements in gene editing to better match animal organs to human bodies.

Mr Slayman became the first living person to receive a modified pig kidney after his human transplant in 2018 failed. 

Kidneys from similarly edited pigs had successfully been transplanted into monkeys that were kept alive for an average of 176 days, and in one case for more than two years,  researchers reported  in October in the journal Nature.

Tatsuo Kawai, who helped lead the transplant team for the procedure, described the pig organ as "truly the most beautiful kidney I have ever seen".

"The success of this transplant is the culmination of efforts by thousands of scientists and physicians over several decades," Dr Kawai said in March.

"Our hope is that this transplant approach will offer a lifeline to millions of patients worldwide who are suffering from kidney failure."

The surgical team is not yet linking Mr Slayman's death to the transplant and still sees the  procedure as "a beacon of hope".

And Mr Slayman's family said they are grateful he was given the opportunity for a second chance.

"We felt – and still feel – comforted by the optimism he provided patients desperately waiting for a transplant," the family said in a statement.  

When he was discharged from hospital in early April, Mr Slayman said he was "leaving the hospital today with one of the cleanest bills of health I've had in a long time ... one I wished would come for many years".

Toby Coates, the director of transplantation at the Royal Adelaide Hospital, said Mr Slayman's death is a tragedy, but by no means a setback for xenotransplantation.

"It's an absolute tragedy, but this has moved the field forward," he told the ABC. 

"It's quite extraordinary, really, that there's now been three of these done and this will be the the beginning of a whole lot more."

Lessons from pig heart transplants 

Two men from the US have received genetically-edited pig heart transplants since early 2022. 

Fifty-seven-year-old David Bennett was the first person in the world to undergo the procedure. He survived for two months.

While 58-year-old Lawrence Faucette died nearly six weeks after his transplant.

Both men had underlying health issues, but Mr Bennett was found to have a pig-derived infection, which may have contributed to transplant complications.

"Transplant recipients regularly die after a transplant, they're just so unwell," Professor Hawthorne said.

"These people were not suitable for human transplants, which means they were even sicker than people that get human transplants."

Professor Coates said his "gut feeling" is that the poor health of patients before the xenotransplant procedures was a main factor in their deaths. 

He added that the use of medications, which lower the body's ability to reject transplants, can also weaken immune systems.

In all cases, the men were able to live longer than they would have otherwise.

And Professor Hawthorne expects the outcomes to significantly improve over time.

"We didn't just magically have people surviving with human kidneys for years ... The first human kidneys only survived weeks," he said. 

"We've been building on the science and the medicine for a long time to get it right, and are very, very slowly, systematically and safely implementing it into patients."

Where is Australia at?

Australia is leading the world in islet cell transplantation and has been working in parallel with researchers in the US and Europe to enhance xenotransplantation.

But Australia faces restrictions getting the pigs needed for trials into the country, because "we didn't just start with this magic pig," Professor Hawthorne said. 

And developing local porcine colonies for xenotransplantation would require large financial backing.

"We have spent decades developing our own transgenic pigs for clinical transplants here in Australia and require more support to take these to the clinic," Professor Hawthorne said. 

They have also been working closely with the World Health Organization to ensure strict guidance and ethics.

"The reason we haven't done these transplants earlier is not just because we didn't have the transgenic pig," he said.

"We didn't want to make any mistakes ... we wanted to get the ethics and all of our background research right to the point where we can provide safe and efficacious xenotransplants."

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Gender Disparities In Organ Donation And Transplantation In India: A Call For Equality

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The 2021 statistics report of the National Organ and Tissue Transplant Organisation (NOTTO) of India has brought attention to a significant gender disparity: 80% of organ recipients were male, while, 75% of organ donors were female. This phenomenon has become entangled in the complex existing web of intersectional discrimination in India, which deviates from the principles of justice and equality enshrined in Articles 14 and 15 of the Indian Constitution. Moreover, the gender inequality in organ donation and transplantation in India reflects discriminatory practices and is a manifestation of patriarchal ideologies that marginalize women’s accessibility to healthcare facilities. This gender imbalance constitutes a violation of women’s right to health and medical care, which were recognized as essential aspects of the right to life under Article 21 of the Indian Constitution in the landmark case of Francies Coralie Mullin v Union Territory of Delhi.

Female organ donors are influenced by sociocultural factors and financial dependency. Financial independence may reduce their inclination to donate. Additionally, one of the psychological factors contributing to the gender gap in organ donation is women’s prior experiences, like childbirth, which enhance their trust in the medical system. Mothers are the primary organ donors among parents accounting for 73% of donations, while wives contribute 91% of donations in married couples. Regarding this gender inequality, Dr Pranjali Modi, the convenor of the State Organ and Tissue Transplant Organisation (SOTTO), has emphasized that patriarchal beliefs play a significant role in the general reluctance to accept organ donations from men, who are often considered to be the primary breadwinners in families. Moreover, when men donate organs, financial difficulties might arise during the evaluation, surgery, and recovery phases, which can result in the coercion of women to undergo organ donation surgery.

Relatedly, there is a subconscious prioritization of men over women for life-saving treatments, such as organ transplantation, based on the perceived economic importance of their roles. These biases are also apparent within medical institutions and professions, potentially affecting doctor-patient interactions and resulting in gender inequalities in organ transplant procedures. However, a notable scientific reason for the gender disparity in organ transplantation is that pregnancy sensitizes women’s immune systems, potentially diminishing the compatibility of their organs with those of their blood relatives, which are those individuals who are most inclined to donate organs. Further, women waiting to receive organ donations, due to their typically smaller stature, encounter a greater likelihood of being declined organ offers, leading to a higher risk of death or removal from the waitlist compared to small-stature men. This inherent bias in healthcare exacerbates gender inequalities in organ transplantation access for women. These factors, altogether, contribute to unequal access to organ transplantation, a critical healthcare intervention, as evidenced by a longitudinal study spanning 15 years which revealed that a mere 15% of female individuals were organ recipients in the nation.

This healthcare outcome contradicts the stipulations outlined in Article 12 of the International Covenant on Economic, Social and Cultural Rights (“ICESCR”), which acknowledges the entitlement of every individual to achieve “ the highest attainable standard of physical and mental health .” Additionally, the importance of guaranteeing equitable allocation of health facilities, goods and services among both men and women has been underscored in the remarkable case of Karukola Simhachalam vs Union of India and Ors (WP PIL No 164 of 2019). The case further emphasized the necessity of counteracting any hindrances to the full realisation of the right to health and eradicate discriminatory practices for all people. Nevertheless, any practice embedded in gender bias not only perpetuates disparities for women but also undermines the very bedrock of equality principles. This practice is vulnerable to legal scrutiny under the Universal Declaration of Human Rights , which accentuates the significance of legal egalitarianism, the right to health, and well-being.

It is imperative to confront gender imbalances to foster a society characterised by equality, inclusivity and the protection of women’s rights. Although the Transplantation of Human Organs Act, of 1994 ostensibly maintains a gender-neutral stance, the actual implementation unveils a fabric intricately woven with evident gender disparities and prejudices. The dissonance between legal intent and application of the legislation in practice underscores the need to erase gender stereotypes and inequalities within the organ transplantation and donation domain.

Addressing the issue of gender disparities in organ transplantation necessitates raising awareness as a foundational step. To mitigate disparities among disadvantaged groups, it is crucial to implement transplant centers and community initiatives targeting rural and marginalized areas and establish transplant centers in those places as well. The pre-transplant assessment should encompass psychosocial and economic dimensions to identify any potential negative motivations for donation, such as underlying abuse, coercion, threats and violence. Conducting research studies and collecting accurate statistics at the grassroots level is also imperative for developing policies that promote equality and fair access to organ transplantation. Additionally, overcoming biological barriers in transplantation procedures requires the implementation of science-backed policies.

Lastly, providing medical assistance to organ donors for the transplantation process and offering medical support to organ recipients from vulnerable communities are essential steps that Indian government should take. However, addressing gender imbalance requires more than just focusing on education and poverty alleviation. It necessitates a deeper examination of traditional gender roles and the roles of women within their families. Policies must be implemented to ensure that women receive equitable access to transplantation services, regardless of their societal status or financial standing within the family.

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Cultural Relativity and Acceptance of Embryonic Stem Cell Research

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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.

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]

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.

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[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.

Mifrah Hayath

SM Candidate Harvard Medical School, MS Biotechnology Johns Hopkins University

Olivia Bowers

MS Bioethics Columbia University (Disclosure: affiliated with Voices in Bioethics)

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