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Record W231553816

Challenges to Ethics Review in Health Research

2009· article· en· W231553816 on OpenAlex
Bartha Maria Knoppers

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

venuePublished in a venue whose home country is Canada.
aboutThe title or abstract carries a Canadian signal from the geographic lexicon.
no affNo Canadian affiliation: this work is invisible to an affiliation-only frame.
No Canadian affiliation. An affiliation-only frame, the usual design, would never have seen this work. It is one of the works that make the case for inverting the frame.

Bibliographic record

VenueHealth law review · 2009
Typearticle
Languageen
FieldMedicine
TopicEthics in Clinical Research
Canadian institutionsnot available
Fundersnot available
KeywordsResearch ethicsPolitical scienceMandateLegislationEthical codeInclusion (mineral)Public relationsEngineering ethicsSociologyLawSocial science
DOInot available

Abstract

fetched live from OpenAlex

Whereas Parliament believes that health research should ... take into consideration issues .... (1) The legislation creating the Canadian Institutes of Health Research (CIHR) in 2000 specifically mentioned ethics in the preamble (as noted above). This historic legislation first led the inclusion of an ethics member in boards across the Institutes and the creation of an Ethics Office within CIHR. Prior the creation of the CIHR, the Medical Research Council of Canada (MRC) had mandated ethics review and provided guidelines researchers since 1978. (2) Indeed, it was the MRC that provided the initial leadership in the creation of a Tri-Council committee prepare the 1998 Policy Statement on Ethical Conduct for Research Involving Humans. (3) This Statement is unique in that all ethics review of research involving human beings, whether in the social sciences, the humanities, engineering or the pure sciences, were regrouped together. While well-intended, logical and unifying, this approach has had unintended consequences in the social sciences and the humanities. (4) The National Council on Ethics in Human Research created in 1989 has as its mandate to provide leadership in advancing the knowledge and practice of the conduct of research involving humans through advice, guidance and education stakeholders. (5) Yet, in spite of all this guidance in health research ethics, there are problems concerning the need share and access data as exemplified by the report of the CIHR's task force on privacy. (6) The other federal initiative that came fruition after a decade of discussion and a Royal Commission is the law on assisted human reproduction and related research. (7) Again, the principles underscoring this legislation mention Parliament's ethical concerns as justifying certain prohibitions. (8) This legislation has far-reaching potential, well-beyond the prohibited criminal activities. Indeed, the federal regulatory powers extend the Agency created by the Act, which has amongst its objectives identify issues (s. 18(1)) and foster the application of principles (s. 22). (9) It is against this background, and that of further provincial legislative and overlay for biomedical research, that Canada's health research community attempts fulfill its desire advance research and yet protect participants through ethics review. Moreover, increasingly international norms also come into play as the Canadian research community becomes part of consortia that cross borders and share data and research tools. This latter and very recent phenomenon is not without influence on the nature and impact of ethics in health research. Indeed, it may well be time examine the role of ethics review in Canada as research becomes increasingly international and collaborative in terms of the research teams themselves and the data and tissue samples they seek share. Furthermore, as we will see, the principles underlying international projects particularly in population genomics research (while not denying the importance of autonomy and privacy), center on the values of solidarity and equity (10) and consider international databases as global public goods. (11) This paper will focus first on a discussion of the literature on the nature and role of ethics review generally and in Canada (i) and second, on the confounding factor of the international nature of modern health research on the underlying principles that have governed review until now (ii). (i) Nature & Role of Ethics Review Since the revision of the Declaration of Helsinki (12) in 2004, increasing attention has surrounded the discussion on the role of commercialization, the use of placebos, the return of research (as opposed clinical research) results and on the biobanking of tissues and DNA, especially at the level of populations. The latter topic in particular, where confined sampling in defined and identifiable populations such as aboriginal peoples, has resulted in the CIHR adopting guidelines specific this population. …

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.

Direct model labels (unvalidated)

Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.

Model armCategoriesStudy designConfidence
gemmaResearch integrity
Domain: not available · Genre: Empirical
About the Canadian research system: no · About a Canadian topic: no
Theoretical or conceptuallow
gptno category
Domain: not available · Genre: Other
About the Canadian research system: no · About a Canadian topic: no
Other designlow
models splitAgreement compares identical category sets and study designs across arms.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.171
metaresearch head score (Gemma)0.072
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Research integrity, Insufficient payload (model declined to judge)
Consensus categoriesMetaresearch
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Systematic review · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.600
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.1710.072
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.000
Bibliometrics0.0000.002
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0010.000
Research integrity0.0000.011
Insufficient payload (model declined to judge)0.0000.001

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 head0.957
GPT teacher head0.791
Teacher spread0.166 · 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