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Record W2287020562

Protecting Human Research Subjects: A Jurisdictional Analysis

2003· article· en· W2287020562 on OpenAlexaffabout
Jennifer Llewellyn, Jocelyn Downie, R. Holmes

Bibliographic record

VenueeYLS (Yale Law School) · 2003
Typearticle
Languageen
FieldMedicine
TopicEthics in Clinical Research
Canadian institutionsDalhousie University
Fundersnot available
KeywordsPledgeGovernment (linguistics)Public administrationJurisdictionPolitical scienceFederalismFederal jurisdictionCorporate governanceScope (computer science)CLARITYNegotiationPublic relationsBusinessLawPolitics
DOInot available

Abstract

fetched live from OpenAlex

The most recent speech from the throne contained a pledge from the federal government to "work with provinces to implement a national system for the governance of research involving humans, including national research ethics and standards." This commitment signals a desire on the part of the federal government to address concerns about the inadequacies of the current governance of health research involving humans (RIH). To this end, Health Canada's Ethics Division is currently exploring the ways in which such a national governance system for RIH might be implemented. It is important for the federal government, as it moves toward making good on its Throne Speech pledge, to have clarity concerning the jurisdictional authority to legislate with regard to RIH. Specifically, it needs to be clear about whether the constitutional jurisdiction over RIH rests with the federal government, the provinces or whether it is divided or shared between them. The answer to this jurisdictional question will shape the federal government's approach to any negotiations with the provinces concerning the creation and implementation of a national system of governance for RIH. Addressing the jurisdictional issues is an important precursor to any negotiation process for two reasons. First, the scope of federal and provincial power over RIH is key both to the design and implementation of a comprehensive national system of regulation over RIH. It is necessary to determine which sphere of government has the power to do what before deciding how to go about creating a national governance system. Second, knowing the extent and the scope of federal jurisdiction with respect to RIH might strengthen the negotiating position of the federal government vis a vis the provinces. It will provide clarity as to what the federal government could do in terms of regulating RIH if the provinces are unwilling to cooperate. In short, it will make clear whether, and to what extent, the federal government needs provincial agreement to regulate RIH and what options are available to the federal government if such agreement is not attained.

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)0.382
metaresearch head score (Gemma)0.280
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Qualitative · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.618
Threshold uncertainty score0.762

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.3820.280
Meta-epidemiology (narrow)0.0010.002
Meta-epidemiology (broad)0.0020.003
Bibliometrics0.0080.007
Science and technology studies0.0170.072
Scholarly communication0.0210.027
Open science0.0070.016
Research integrity0.0200.023
Insufficient payload (model declined to judge)0.0050.001

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 head0.285
GPT teacher head0.520
Teacher spread0.235 · 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 designQualitative
DomainMethods
GenreEmpirical

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

Citations1
Published2003
Admission routes2
Has abstractyes

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