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Record W2134021542 · doi:10.1002/tera.10038

Ethical framework for observational studies of medicinal drug exposure in pregnancy

2002· article· en· W2134021542 on OpenAlexaff
Gideon Koren

Bibliographic record

VenueTeratology · 2002
Typearticle
Languageen
FieldMedicine
TopicPregnancy and Medication Impact
Canadian institutionsSickKids FoundationUniversity of Toronto
Fundersnot available
KeywordsObservational studyPregnancyDrugMedicinePharmacologyBiologyInternal medicineGenetics

Abstract

fetched live from OpenAlex

BACKGROUND: The conduct of human research in the teratogenicity of drugs, chemicals, radiation and infections is needed in order to close critical gaps in knowledge. METHODS: We reviewed the various aspects of the ethics of conducting prospective human research in teratogenicity. RESULTS: Such research should respect the confidentiality of pregnant women and their families. Because this research is observational, interpretation of results is difficult, and the study design should strive to meet the highest possible scientific standards attainable in the particular research conditions. It should also be acknowledged that confidentiality cannot be always adhered to (e.g., if the interview reveals risks to minors). CONCLUSIONS: In general, the benefit risk ratio in this type of research is very favorable, although in specific cases the research follow-up may induce fears (e.g., drugs of abuse) in the woman being interviewed.

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)0.646
metaresearch head score (Gemma)0.623
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Research integrity
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: Methods
Study designCandidate signal: Theoretical or conceptual · Consensus signal: Theoretical or conceptual
GenreCandidate signal: Methods · Consensus signal: Methods
Teacher disagreement score0.982
Threshold uncertainty score0.436

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.6460.623
Meta-epidemiology (narrow)0.0020.002
Meta-epidemiology (broad)0.0040.003
Bibliometrics0.0060.004
Science and technology studies0.0090.036
Scholarly communication0.0090.006
Open science0.0070.009
Research integrity0.0180.018
Insufficient payload (model declined to judge)0.0020.001

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.

Opus teacher head0.194
GPT teacher head0.423
Teacher spread0.230 · 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

Citations20
Published2002
Admission routes1
Has abstractyes

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