Table 13 Key ethical and legal considerations in iPSC research

Intellectual Property Rights

Refers to the legal ownership and control over the intellectual property (IP) generated from iPSC research. This consideration involves issues such as patenting iPSC technologies, ownership of cell lines, licensing agreements, and potential conflicts over IP rights between researchers, institutions, and commercial entities

[733, 774]

Regulations

Refers to the regulatory frameworks and guidelines that govern iPSC research. This consideration involves compliance with applicable laws, regulations, and ethical guidelines at the national, regional, and institutional levels. It includes obtaining appropriate research approvals, informed consent from donors of biological materials, and adherence to ethical standards in research involving human subjects

[535, 775]

International Consensus

Refers to the need for a global agreement or consensus on ethical and legal standards in iPSC research. This consideration involves addressing differences in regulations and ethical frameworks across countries and fostering collaboration and sharing of data, resources, and knowledge while respecting cultural, legal, and social diversity

[611]

Privacy and Confidentiality

Refers to protecting the privacy and confidentiality of individuals who contribute biological materials for iPSC research. This consideration involves implementing measures to ensure that personal information and data are handled securely, anonymized when necessary, and used only for authorized purposes while complying with applicable privacy laws and regulations

[532]

Informed Consent

Refers to obtaining voluntary, informed, and documented consent from individuals who provide biological materials for iPSC research. This consideration involves ensuring that potential donors are adequately informed about the nature, purpose, risks, and benefits of the research and that their consent is obtained without coercion or undue influence

[593]

Ethical Use of iPSCs in Research

Refers to conducting iPSC research in an ethically responsible manner. This consideration involves adhering to ethical principles, such as respect for autonomy, beneficence, non-maleficence, and justice. It includes considering the potential ethical implications of iPSC research, such as the creation and destruction of embryos, the use of human-animal chimeras, and potential social implications

[38]

Equity and Access to iPSC Technologies

Refers to ensuring equitable access to iPSC technologies, benefits, and potential therapies. This consideration involves addressing issues of fairness, affordability, and accessibility, particularly in the context of healthcare disparities and global health challenges. It includes promoting the inclusion of diverse populations and addressing barriers to access for underserved communities

[15, 776]

Data Sharing and Collaboration

Refers to the sharing of research data, resources, and knowledge among researchers and institutions involved in iPSC research. This consideration involves promoting open science principles, facilitating data sharing while respecting privacy and confidentiality, and fostering collaboration to accelerate scientific progress and maximize the benefits of iPSC research

[45]

Ethical and Responsible Conduct of Research

Refers to upholding high ethical standards and responsible conduct in all aspects of iPSC research. This consideration involves ensuring integrity, transparency, and accountability in research practices, including study design, data collection, analysis, publication, and dissemination. It includes promoting research integrity and addressing conflicts of interest or misconduct

[46]

Genetic Privacy and Discrimination

Refers to protecting the privacy of an individual's genetic information obtained through iPSC research and preventing potential discrimination based on genetic data. This consideration involves implementing safeguards to ensure that genetic information is not misused, disclosed without consent, or used to discriminate against individuals in areas such as employment, insurance, or social services

[47]

Research on Vulnerable Populations

Refers to conducting iPSC research involving vulnerable populations, such as minors, individuals with cognitive impairments, or individuals lacking decision-making capacity. This consideration involves implementing additional safeguards to protect the rights and welfare of these individuals, including obtaining informed consent from legally authorized representatives and ensuring the research benefits outweigh the potential risks

[48]

Benefit-Sharing and Return of Results

Refers to addressing the equitable sharing of benefits and returning research results to participants or communities involved in iPSC research. This consideration involves establishing mechanisms and policies to ensure that the benefits derived from iPSC research, such as potential therapies or commercial products, are shared fairly and that research findings are communicated back to participants in an understandable manner

[49]

Animal Welfare in iPSC Research

Refers to considering and minimizing potential harm or suffering experienced by animals used in iPSC research, particularly in experiments involving human-animal chimeras. This consideration involves following ethical guidelines for animal welfare, implementing appropriate animal care and use protocols, and exploring alternative methods to reduce or replace animal models when feasible

[50]

Research Transparency and Reproducibility

Refers to promoting transparency and reproducibility in iPSC research. This consideration involves sharing research protocols, methods, and data openly, making research findings accessible for scrutiny and replication, and adhering to best practices in research design, statistical analysis, and reporting to ensure the reliability and validity of scientific findings

[51]

Commercialization and Accessibility

Refers to the balance between commercial interests and ensuring accessibility of iPSC technologies and therapies. This consideration involves addressing issues related to affordability, affordability, and fair pricing of iPSC-based products, as well as implementing measures to ensure that essential iPSC research tools and technologies are widely available for scientific advancement

[52]

Governance and Oversight

Refers to establishing appropriate governance and oversight mechanisms for iPSC research. This consideration involves defining responsible conduct guidelines, establishing research ethics committees or institutional review boards, and monitoring compliance with ethical and legal standards to ensure the responsible and accountable conduct of iPSC research

[53]

Social and Cultural Considerations

Refers to recognizing and addressing social and cultural factors in iPSC research. This consideration involves engaging with diverse stakeholders, including communities affected by the research, to understand and address potential cultural, social, or value-based concerns. It includes respecting cultural practices, beliefs, and societal norms in the design, implementation, and dissemination of iPSC research

[45]