Bibliographic record
Abstract
Organoids are cell aggregates made by reprocessing stem cells through a three-dimensional culture method and are expected to revolutionize biomedical research and clinical treatment.However, organoid regulation is unclear and has ethical issues that remain unresolved.We performed to systematically reviewed the regulation of organoids internationally, detailing the definition of organoids, and their regulation in ethical and technical aspects.In this cross-sectional study, we systematically searched the official websites of regulatory authorities in the European Union, United Kingdom, United States, Canada, Japan, South Korea, Switzerland, Germany, China, Netherlands, and International Society for Stem Cell Research (ISSCR) up to May 2023.However, if no organoid regulations are published on the official worldwide website, regulations are looked into in the stem cell and embryo domains.Organoid regulations were extracted that covered informed consent, chimeras and gastruloids, germ cells, and comparisons were made between countries.The only ISS-CR has standard, formal definitions for organoids, there was no document describing the definition of organoid in any other legislation or regulations.In organoid regulations on ethics, several national laws restrict organoid research.Also, replacing organoids with animal testing has been overall positive in the investigated countries.Research on organoids is advancing rapidly.To build science-based research ethics and laws, organoid regulations call for the creation of convergence grounds, it is crucial to keep moving toward the goal of broad convergence in the field of common research ethics.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.015 | 0.025 |
| Meta-epidemiology (narrow) | 0.000 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.008 | 0.012 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".