Ottawa Statement does not impede randomised evaluation of government health programmes
Bibliographic record
Abstract
In this issue of JME , Watson et al call for research evaluation of government health programmes and identify ethical guidance, including the Ottawa Statement on the ethical design and conduct of cluster randomised trials, as a hindrance. While cluster randomised trials of health programmes as a whole should be evaluated by research ethics committees (RECs), Watson et al argue that the health programme per se is not within the researcher’s control or responsibility and, thus, is out of scope for ethics review. We argue that this view is wrong. The scope of research ethics review is not defined by researcher control or responsibility, but rather by the protection of research participants. And the randomised evaluation of health programmes impacts the liberty and welfare interests of participants insofar as they may be exposed to a harmful programme or denied access to a beneficial one. Further, Watson et al ’s claim that ‘study programmes … would occur whether or not there were any … research activities’ is incorrect in the case of cluster randomised designs. In a cluster randomised trial, the government does not implement a programme as usual. Rather, researchers collaborate with the government to randomise clusters to intervention or control conditions in order to rigorously evaluate the programme. As a result, equipoise issues are triggered that must be addressed by the REC.
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 distilled prediction
Teacher imitationNot 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.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.076 | 0.010 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.006 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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; both teacher heads agree on what is shown here.
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".