Willingness of corneal donation and its associated factors among adult patients attending Gondar University Comprehensive and Specialized Hospital.

INTRODUCTION: Corneal transplantation is the only treatment option for corneal blindness to restore sight. However, there is a disproportionate imbalance between the demand and supply of corneal tissue in Ethiopia. This is because accessing corneal tissue is reliant on people who are willing to donate corneas after death. OBJECTIVE: This study aimed to assess the proportion of willingness to donate cornea and associated factors among adult patients attending at University of Gondar comprehensive and specialized hospital. METHOD: Institutional based cross-sectional study was conducted from July 13 to July 28, 2020, through a face-to-face interview. A total of 451 samples were selected using systematic random sampling. The data were entered into Epidemiological information version 7 and exported to statistical package for social science version 20 for formal analysis. Variables with a P-value of < 0.20 in a bi-variable logistic regression were entered into the multivariable logistic regression and those variables with a p-value of < 0.05 were taken as statistically significant. The strength of association was shown using the odds ratio with a 95% confidence interval. RESULT: A total of 408 adults participated in this study with a response rate of 90% and the proportion of willingness to donate cornea was 179(43.90%). Participants who had a religious belief in Christianity (AOR = 3.23 (95% CI: 1.09-9.57)) and good knowledge about corneal donation (AOR = 5.45(95%CI: 2.69-11.18)) were positively associated with the willingness of corneal donation. On the other side, the age group above 43 years (AOR = 0.31(95% CI: 0.11-0.89) was negatively associated with the willingness of corneal donation. CONCLUSION: The proportion of willingness to donate cornea 43.9% among participants attending Gondar University Comprehensive and Specialized Hospital. Age group greater than 43 years, religion of Christianity and good knowledge were associated with the willingness of corneal donation.

Ethics in Eye Banking: Understanding Professional Attitudes Toward Industry Changes.

PURPOSE: To describe the ethical attitudes of corneal surgeons and eye bank leadership toward for-profit entities in corneal donation, processing, and distribution. METHODS: Fifty postfellowship corneal surgeons practicing in the United States and 25 eye bank leaders (eg, eye bank directors, CEOs, or presidents) for the Eye Bank Association of America-accredited eye banks completed a 22-question interview, focusing on corneal donation industry changes, including the entry of for-profit institutions. RESULTS: Most participants in both study groups agreed that they have concerns with the entry of for-profit businesses into eye banking (62% corneal surgeons, 68% eye bank leadership), although physicians partnered with a for-profit corneal processor were significantly more likely to have no concerns with the entry of for-profits into eye banking than corneal surgeons partnered with a nonprofit processor (P = 0.04). The most frequently identified concerns with the entry of for-profit businesses into corneal banking were the hypothetical loss of donor trust (56% corneal surgeons, 64% eye bank leadership, P = 0.04) and the potential exploitation of donor generosity (72% corneal surgeons, 60% eye bank leadership). Qualitative theme analysis suggests that both study groups may view increased research/innovation as a potential benefit (64% corneal surgeons, 66% eye bank leadership) of for-profits in eye banking. CONCLUSIONS: Key stakeholders in eye banking do hold relevant ethical beliefs toward recent industry changes, and these attitudes should be considered in the future creation of the ethical corneal donation policy. Further research is needed to assess the attitudes of potential donors and donor families.

Current Global Bioethical Dilemmas in Corneal Transplantation.

PURPOSE: To analyze some of the bioethical dilemmas that may arise during the process required for corneal transplantation. METHODS: We conducted a narrative review based on the available literature and the experience of cornea specialists from 3 different countries. RESULTS: Bioethical dilemmas related to informed consent for organ and tissue donation, allocation of corneal tissues, transplant tourism, corneal tissue exportation and importation, and for-profit eye banking were analyzed and discussed. CONCLUSIONS: Around the world, the number of required corneal transplants exceeds the number of donated corneas that are available and suitable for transplantation. This shortage of corneal tissue has led to the emergence of practices that may put the 4 basic principles of bioethics at risk: autonomy, beneficence, nonmaleficence, and justice. Therefore, it has been necessary to create ethical guidelines such as the Barcelona Principles and the World Health Organization Principles of Transplantation that attempt to regulate these practices.

The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation.

To develop an international consensus regarding the appropriate conditions for undertaking clinical trials in xenocorneal transplantation, here we review specific ethical, logistical, scientific, and regulatory issues regarding xenocorneal transplantation, and propose guidelines for conduct of clinical xenocorneal transplantation trials. These proposed guidelines are modeled on the published consensus statement of the International Xenotransplantation Association regarding recommended guidelines for conduct of clinical islet xenotransplantation. It is expected that this initial consensus statement will be revised over time in response to scientific advances in the field, and changes in the regulatory framework based on accumulating clinical experience.

Understanding selective refusal of eye donation. Identity, beauty, and interpersonal relationships.

Corneal transplantation is the most common form of organ transplantation performed globally. However, of all organs, eyes have the highest rate of refusal of donation. This study explored the reasons why individuals decide whether or not to donate corneas. Twenty-one individuals were interviewed who had made a donation decision (13 refused corneal donation and eight consented). Analysis was performed using Grounded Theory. Refusal of corneal donation was related to concerns about disfigurement and the role of eyes in memory and communication. The request for donation therefore raised concerns about a potential adverse change in the ongoing relationship with the deceased, even in death. For those who refused donation, these concerns overshadowed awareness of need or benefit of transplantation. Adjusting the donation message to be more congruent with the real, lived experience of corneal donation may to some extent "prepare" individuals when the donation question is raised.

Ethical and regulatory guidelines in clinical trials of xenocorneal transplantation in Korea; the Korean xenocorneal transplantation consensus statement.

BACKGROUND: To establish the consensus about the conditions for undertaking clinical trials in xenocorneal transplantation in Korea, specific issues regarding the xenocorneal transplantation on ethical and regulatory aspects are addressed, and the guidelines to conduct clinical trial of the xenocorneal transplantation are proposed. METHOD AND RESULTS: Chapter 1 reviews the key ethical requirements and progress of a Korean regulatory framework for clinical trials of xenocorneal transplantation. Chapters 2-7 provide recommendations on source pigs, quality control of porcine corneal procurement, preclinical efficacy required to justify a clinical trial, strategies to prevent transmission of porcine endogenous retrovirus (PERV), patient selection for clinical trials, and informed consent in xenocorneal transplantation using either cellularized or decellularized porcine graft, which are essentially based on the International Xenotransplantation Association (IXA) islet xenotransplantation consensus statement. The consensus statement of the inclusion criteria for the patients' selection has been made by the executive board members in Korean External Eye Disease Society. CONCLUSIONS: This consensus statement will be a good initiative for Korean Food and Drug Administration to discuss final regulatory guidelines in conducting clinical trials of xenocorneal transplantation in Korea and for International Xenotransplantation Association to develop International Consensus Standards of Xenocorneal Transplantation.

Bioethics: a search for moral diversity.

The concept of global, Asian and Chinese bioethics are discussed in this paper and the difficulty in applying universal bioethics within different cultures and countries is addressed. The traditional beliefs and values in China are described with particular reference to medicine, and the implications for bioethics and research ethics within the country are considered.

Cornea donation: evaluation of a training session to obtain consent by telephone.

BACKGROUND: Obtaining consent from relatives is essential for cornea donation. When a face-to-face interview is not possible, telephone contact is used to obtain donation consent. We tried to evaluate the role of experience on the acceptance rate using this method. METHODS: This was a prospective study conducted over a 22-month period. Two nonmedical coordinators were evaluated. Telephone contact was conducted using a standardized procedure. We recorded for each coordinator the number of telephone contacts and the acceptance rate. RESULTS: Among 455 families contacted, the mean acceptance rate was 60%. Initial acceptance rate was below 30% for both coordinators, showing dramatic improvement with experience (acceptance rate >70% after 100 contacts). CONCLUSIONS: Telephone contact is an efficient method to obtain cornea donation consent. However, as with other new methods, a training period is necessary to increase effectiveness.