This qualitative study aims to elucidate the ethical challenges associated with umbilical cord blood stem cell banks. The principal themes emerging from interviews with both specialists and families encompass the presentation of information, interpersonal relationships among stakeholders, respect for human dignity, adherence to rules and regulations, and the use of tissue samples.
The data gathered from participants indicate the necessity for families to be comprehensively informed about umbilical cord blood banks and storage processes prior to providing their informed consent. Concerns were raised about the absence of clear procedures for obtaining informed consent for blood donation and the lack of dedicated authorities to address this issue. Corresponding to these findings, the challenge of securing informed consent for donating or storing umbilical cord blood was also highlighted in the study by Ozturk Turkmen and Arda (
20). Furthermore, Rao et al. emphasized the importance of individuals being informed about the processes involved in the collection and use of donated blood, either for themselves or for others, and providing their explicit consent for these procedures (
21).
The practice of securing individuals’ consent and informing them about their participation has been longstanding (
22). Within the framework of laws regulating the tissue economy, the contractual agreement (inclusive of an informed consent clause) should encompass a broad spectrum of scenarios, ranging from tissue donation to storage for personal use (
23).
Another significant ethical concern involves ensuring equitable access to the services offered by these banks (
24). Ethically, it is imperative that individuals can readily utilize these banks' services when necessary. However, in reality, many people face challenges in storing their samples in private banks due to various reasons, including financial constraints. Additionally, there may be lengthy waiting lists for accessing the services of public blood banks, potentially posing a threat to life (
25). The interviews highlighted challenges such as the high costs associated with transplants, particularly travel expenses for those residing outside the capital. Umeh and Feeley found that individuals with limited financial resources and no insurance are more vulnerable to diseases and often prioritize spending on essentials like food and shelter over healthcare, leading to reduced access to medical services, which contradicts ethical principles (
26). The establishment of private umbilical cord blood stem cell banks aims to offer superior services to those who can afford them (
27). Health policymakers are tasked with not only facilitating quicker access to services for those willing to pay but also improving the availability and conditions of public umbilical cord blood bank services for the broader population (
28).
The issue of umbilical cord blood ownership and determining who holds authority over it presents another challenge. The current study highlights a lack of consensus regarding the ownership of umbilical cord blood. Opinions vary, with some advocating for maternal ownership, others for paternal ownership, and still others believing that both parents share ownership. Mendes-Takao et al. and Chima and Mamdoo supported the view that the mother has ownership rights over the umbilical cord blood as it is considered a product of birth (
22,
29). Conversely, research by Pinch, Warwick and Fehily, and Childress suggests that ownership should reside with the parents, while some argue that the child should make decisions regarding their stored blood upon reaching puberty. Furthermore, findings indicate that the storage of samples in private umbilical cord blood banks is initiated upon request by the applicant and funded through payment, making the applicant or contract party the owner of the sample (
24,
30,
31). Childress noted that in public umbilical cord blood banks, samples are donated by families, storage is offered free of charge, and any ownership rights are held by the public bank (
24).
Several studies propose that in private banks, parents hold ownership of the umbilical cord blood until the child reaches 18 years of age. Ownership then passes to the child on the condition they continue paying for storage. Failure to cover these costs results in the loss of ownership rights for the child (
23). Consequently, some U.S. laws associate ownership with the capacity to sustain payment obligations.
According to some legal experts, umbilical cord blood and its components are the property of the mother, and any use of it requires her consent. Conversely, others argue that the blood is not solely the mother's but is shared with the infant. They assert that the infant's ownership, similar to their other financial assets, is established through legal guardianship (
32).
Another major challenge facing umbilical cord blood banks is the existence and enforcement of ethical rules and guidelines within different countries. Evidence from various parts of the world indicates a widespread failure to adhere to medical ethics, highlighting the need for stringent ethical regulations and oversight of umbilical cord blood banks (
33,
34).
Advertising has also emerged as a significant challenge in this study. It is essential for advertisements to accurately communicate the potential benefits of private umbilical cord blood banks to clients and to make it clear that the likelihood of using the stored sample for autologous purposes is slim, and that certain future treatments may be inaccessible. Local authorities should regulate advertising practices (
23).
Reviews of findings by Warwick and Fehily indicate that all advertising for umbilical cord blood banks should be prohibited. Blood banks must not present themselves as commercial entities or engage in practices that mislead individuals or incite fear through unscientific methods (
31). The public deserves accurate information regarding the pros and cons of umbilical cord blood banks. The content of advertisements or information provided to families must be precise, and informed consent must be secured from them before storing their infant's umbilical cord blood (
35).
Financial issues and commercialization represent another challenge discussed in this study, particularly regarding the extent to which these cells can be utilized. A significant ethical concern raised during the interviews and reflected in the study findings pertains to cloning. In line with the studies reviewed, there was considerable apprehension among families and specialists regarding the cloning, commercialization, and trading of umbilical cord blood (
19,
29,
36).
International laws underscore that biological materials should not result in financial profit (
37). Mendes-Takao et al. highlighted the insufficient oversight of bank procedures in their research (
29). Numerous critics, including Panagouli et al., have associated the utilization of stem cells and umbilical cord blood with religious concerns, arguing that using these cells contravenes religious teachings. Additionally, these critics contend that the use of these cells should be highly restricted and that rigorous monitoring and legislation are necessary for their broader application (
36).
The issues of confidentiality, privacy, and discretion, particularly whether the identities of donors and recipients should be revealed, especially in public umbilical cord blood stem cell banks, present another challenge identified in this study. This finding aligns with those of other research; for instance, Petrini asserted that service providers at these banks should endeavor to maintain the anonymity of users. However, the question remains as to whether donors of umbilical cord blood can be informed about the identities of the recipients (
38). Ballen, and Mendes-Takao et al. stressed the importance of protecting personal information in these banks and noted that the decision to reveal or conceal this information at the donor's request has sparked considerable debate among proponents and critics of this practice. Despite differing views, there is a general agreement that umbilical cord blood banks must safeguard this information as private and confidential (
29,
39).
The application of stem cells derived from umbilical cord blood in research holds the promise of addressing a multitude of previously untreatable conditions and alleviating human suffering. However, without adequate quality control, there is a risk that the medical commitment to “do no harm" could be compromised (
23).
The Declaration of Helsinki strictly forbids exploiting individuals for research purposes and underscores the necessity of respecting individuals by safeguarding their autonomy through the process of obtaining informed consent. The practice of securing informed consent serves as a cornerstone of bioethics. While this principle alone does not safeguard individuals, it empowers them to exercise their fundamental right to decide on the utilization of their body, body parts, and related products, particularly in research contexts (
37).
5.1. Conclusions
In contemporary medicine, evidence-based clinical practices and technological advancements have opened new avenues for treating numerous diseases previously deemed incurable. The rapid evolution in stem cell transplantation exemplifies such progress. The findings from this study highlight that the operation of umbilical cord blood stem cell banks brings forth specific ethical challenges and concerns across various nations. Given the critical importance of healthcare activities and their impact on life quality and human dignity, it is imperative to confront and address the ethical dilemmas associated with these practices, encompassing prevention, diagnosis, and treatment. Consequently, health policymakers worldwide must prioritize identifying and addressing these ethical challenges before establishing umbilical cord blood banks.
5.2. Recommendations
In light of the findings from this research and acknowledging the existing umbilical cord blood banks in Iran, the formulation of ethical guidelines on this matter would be beneficial for health decision-makers. Furthermore, the inclusion of ethical experts in these centers would be advantageous, as they would offer necessary ethical advice, monitoring, and assessment.