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Ethics and Uncertainty: Considerations for the Design and Review of Translational Trials Involving Stem Cells

2010· book-chapter· en· W980054348 on OpenAlexaff
James A. Anderson, Jonathan Kimmelman

Bibliographic record

VenueStem cell biology and regenerative medicine · 2010
Typebook-chapter
Languageen
FieldMedicine
TopicBiomedical Ethics and Regulation
Canadian institutionsMcGill University
Fundersnot available
KeywordsNormativeEngineering ethicsContext (archaeology)Informed consentStem cellTranslational researchTranslational scienceClinical trialSet (abstract data type)Research ethicsPolitical scienceRisk analysis (engineering)MedicinePsychologyAlternative medicineComputer scienceEngineeringLawPathologyBiology

Abstract

fetched live from OpenAlex

Once we set aside issues related to the ontological status of the human embryo, many of the ethical issues presented by translational stem cell trials resemble those presented by other areas of clinical research. Does the trial present a favorable balance of risks and benefits? Will the selection of subjects be fair? Will the consent of participants be informed and voluntary? The familiarity of these questions, however, belies difficulties faced by researchers and regulators involved in the design and review of translational stem cell trials. In this context, issues are problematized by high degrees of uncertainty concerning the nature and probability of study risks, the absence of accepted normative standards or frameworks for risk assessment, and the limited expertise concerning stem cell science on most institutional review committees.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.230
metaresearch head score (Gemma)0.221
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: Theoretical or conceptual
GenreCandidate signal: Methods · Consensus signal: none
Teacher disagreement score0.770
Threshold uncertainty score0.950

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.2300.221
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0020.001
Bibliometrics0.0020.002
Science and technology studies0.0030.030
Scholarly communication0.0160.016
Open science0.0040.005
Research integrity0.0150.019
Insufficient payload (model declined to judge)0.0030.002

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.

Opus teacher head0.203
GPT teacher head0.374
Teacher spread0.171 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designTheoretical or conceptual
DomainMethods
GenreMethods

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".

Quick stats

Citations5
Published2010
Admission routes1
Has abstractyes

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