Organoids

Table Of Contents

Overview #

Organoids are advanced three-dimensional (3D) cell culture systems that reproduce key structural and functional characteristics of human organs, offering more physiologically relevant models than conventional two-dimensional cell cultures. Organoids are increasingly used to study human development, disease mechanisms, drug responses, and regenerative medicine.

Because organoids are derived from human biological material and increasingly integrated into clinical research, biobanking, and precision medicine, they also raise important ethical, legal and social issues. These include questions relating to informed consent, ownership of biological materials, donor participation, privacy, governance, regulation, and the moral status of certain organoid models, particularly brain organoids and human-animal chimeras.

Notion of organoids #

Organoids are advanced three-dimensional cell culture systems designed to reproduce essential characteristics of human organs. Unlike conventional laboratory models, organoids contain multiple interacting cell types organised into structures that closely resemble those found in vivo.

Their development addresses an important limitation of traditional biomedical research. Human tissues and blood samples are limited in quantity and cannot fully reproduce the complexity of whole organs or the interactions occurring within the human body. Organoids therefore provide more representative models for studying both normal physiology and disease.

Organoids are generated from stem cells, including:

  • embryonic pluripotent stem cells;
  • induced pluripotent stem cells (iPSCs);
  • adult stem cells;
  • tissue-specific stem cells, including cancer stem cells.

The development of induced pluripotent stem cells (iPSCs) represented a major scientific advance because they provide pluripotent cells without requiring the destruction of human embryos, thereby addressing one of the principal ethical concerns associated with embryonic stem cell research.

Current research is expanding toward:

  • organoid-on-chip technologies, where multiple organoids are interconnected through microfluidic systems that transport nutrients, drugs and signalling molecules;
  • human-animal chimeras, where organoids are integrated into animal models to better reproduce physiological interactions.

Applications #

Current and future applications include:

  • basic biomedical research;
  • modelling human development;
  • disease modelling;
  • drug screening and personalised medicine;
  • regenerative medicine;
  • development of bioartificial organs;
  • precision oncology;
  • organoid biobanking to create repositories accessible for future research.

Legal and regulatory aspects #

  • Lack of a harmonised international framework. A clear international framework is lacking on this topic. Instead, regulation has developed ad hoc, often in response to scientific advances rather than through comprehensive policy planning. Examples discussed include:
    • Italy, where certain embryo-related research remains highly restricted.
    • The Netherlands, where research involving in vitro-created embryos is permitted under a strict licensing regime.
    • Portugal and Greece, where research using surplus embryos is permitted up to the fourteenth day of in vitro development.

These differing approaches contribute to regulatory fragmentation and legal uncertainty.

Organoid research occupies an evolving legal space in which regulations governing human biological materials; embryos; research ethics; data protection; biobanking; clinical research often overlap. Many existing regulatory frameworks were not designed specifically for organoid technologies.

Consequently, some jurisdictions are perceived as overregulated, limiting research flexibility; others present regulatory gaps, particularly regarding emerging stem cell technologies.

  • Privacy: Organoid research extends traditional privacy concerns beyond conventional biobanking. Relevant dimensions include informational privacy; decisional privacy; bodily privacy; intellectual privacy.

Ethical issues #

Organoid research raises numerous ethical questions throughout the research lifecycle.

  • Moral status of different organoid models and acceptability of Stem cell sources. One of the earliest ethical debates concerns the source of stem cells. The use of embryonic stem cells raises concerns because embryo destruction is required. The development of induced pluripotent stem cells has significantly reduced, but not entirely eliminated, these ethical concerns.
  • Informed consent. Traditional project-specific informed consent is often insufficient for organoid research because future research applications cannot always be anticipated. Dynamic consent, allowing ongoing communication between researchers and donors, is increasingly viewed as a promising model because it enables participants to monitor how their samples are used over time. Nevertheless, important questions remain regarding: duration of consent;  re-contact procedures;  future uses; donor preferences; withdrawal of consent. Withdrawal becomes particularly complex once samples have undergone processing; organoids have been established; organoids have been distributed to multiple researchers. Researchers generally recognise that withdrawal may become impossible beyond certain stages of processing.
  • Governance. Several contributors suggested complementing consent with broader governance mechanisms. Potential approaches include: governance bodies involving patient representatives; public oversight mechanisms; transparent governance structures for organoid biobanks; continuous donor engagement.
  • Research ethics committees: Research ethics committees face new responsibilities in reviewing organoid research. Important questions include: whether committees possess sufficient scientific expertise; whether existing ethical review frameworks remain adequate; whether additional guidance or specialised regulations are needed.

Social implications #

Organoid research has significant implications for relationships between researchers, donors and society.

  • Donor engagement: Many donors continue to perceive organoids as connected to their own bodies and therefore wish to know how their cells are used; who is using them; what research outcomes result from their contribution. This suggests that participation extends beyond a single act of donation.
  • Bodily integrity: Organoid research raises broader questions regarding the right to bodily integrity and ongoing control over biological materials. Consent represents one mechanism for exercising control, but participants may expect additional forms of involvement throughout the research process.
  • Beyond consent: Governance should move beyond traditional consent models toward more participatory approaches, including continuous communication; patient representation; transparency.
  • Reciprocity and benefit sharing: Participants may reasonably expect reciprocal benefits, including information about research and fair benefit sharing.  
  • Public trust: Maintaining public trust requires transparency; responsible governance; stakeholder engagement and clear communication regarding the aims and limitations of organoid research.

Legal and ethical EU and international sources #

BBMRI-ERIC resources #

Publications #

    • Ortega E, Berdasco M, Guerra C, Goisauf M, Martín-Arribas MC (2022). “Organoides Humanos. Aspectos Éticos, Legales y Sociales.” ANCEI V (4). https://ancei.es/wp-content/uploads/2023/02/4-BOLETIN-ANCEI-2022.pdf

    Webinars #

    External resources #

    Relevant literature #

    • Clevers H. Modeling Development and Disease with Organoids. Cell. 2016 Jun 16;165(7):1586-1597. doi: 10.1016/j.cell.2016.05.082. PMID: 27315476.
    • Fatehullah A, Tan SH, Barker N. Organoids as an in vitro model of human development and disease. Nat Cell Biol. 2016 Mar;18(3):246-54. doi: 10.1038/ncb3312. PMID: 26911908.
    • Insoo Hyun, Stem cell ethics and policy: What’s old is new again, Med, Volume 3, Issue 12, 2022, Pages 820-823, ISSN 2666-6340, https://doi.org/10.1016/j.medj.2022.11.008
    • de Jongh D, Massey EK; VANGUARD consortium; Bunnik EM. Organoids: a systematic review of ethical issues. Stem Cell Res Ther. 2022 Jul 23;13(1):337. doi: 10.1186/s13287-022-02950-9. PMID: 35870991; PMCID: PMC9308907.
    • Gaillard M, Pence CH, Botbol-Baum M. Organoid Ethical Typology: varieties of three-dimensional stem cell constructs and the many issues they raise in bioethics. Biol Cell. 2025 Jan;117(1):e2400093. doi: 10.1111/boc.202400093. PMID: 39853801; PMCID: PMC11758490.
    • Boers SN, Bredenoord AL. Consent for governance in the ethical use of organoids. Nat Cell Biol. 2018 Jun;20(6):642-645. doi: 10.1038/s41556-018-0112-5. PMID: 29784910.
    • Pichl A, Ranisch R, Altinok OA, Antonakaki M, Barnhart AJ, Bassil K, Boyd JL, Chinaia AA, Diner S, Gaillard M, Greely HT, Jowitt J, Kreitmair K, Lawrence D, Lee TN, McKeown A, Sachdev V, Schicktanz S, Sugarman J, Trettenbach K, Wiese L, Wolff H, Árnason G. Ethical, legal and social aspects of human cerebral organoids and their governance in Germany, the United Kingdom and the United States. Front Cell Dev Biol. 2023 Nov 13;11:1194706. doi: 10.3389/fcell.2023.1194706. PMID: 38020890; PMCID: PMC10679683.
    • Masanori Kataoka, Takuya Niikawa, Naoya Nagaishi, Tsung-Ling Lee, Alexandre Erler, Julian Savulescu, Tsutomu Sawai, Beyond consciousness: Ethical, legal, and social issues in human brain organoid research and application, European Journal of Cell Biology, Volume 104, Issue 1, 2025, 151470, ISSN 0171-9335, https://doi.org/10.1016/j.ejcb.2024.151470
    • Yang S, Hu H, Kung H, Zou R, Dai Y, Hu Y, Wang T, Lv T, Yu J, Li F. Organoids: The current status and biomedical applications. MedComm (2020). 2023 May 17;4(3):e274. doi: 10.1002/mco2.274. PMID: 37215622; PMCID: PMC10192887.

    ELSI, organoids
    Updated on 20 August, 2026