Time to obtain ethics approval and sites authorization for research in the Cohort in Primary Care (COPRI)
Bibliographic record
Abstract
Context: The Cohort in Primary Care (COPRI) is ongoing in 29 Family Medicine Groups (FMG) across Québec. The research ethics approval process must follow the 2016 Québec Ministry of Health framework for multicentric projects which specifies that Evaluating Research Ethics Board (EREB) must respond to evaluation requests within 5 days and evaluate the project within 30 days. Once ethics approval is obtained by the EREB, institutional feasibility approval and authorization to conduct research is required for each site. Objective: The objective of this analysis is to measure the time required currently to obtain authorization for research in a multicentric project in Québec. Study design and analysis: Time between each step of the submission process were measured in days and descriptive results will be presented with tables and figures. Population studied: COPRI is recruiting adults followed at FMGs, but the unit of measurement are here the FMGs. Outcome measures: Data collected consists of date of submissions and approvals for ethics and authorization for research, obtained through Nagano. Results: We submitted the COPRI protocol 1.0 (McGill GMFs only) for multicentric ethics approval to the selected EREB on 2022-FEB-18. The EREB accepted 4 days later and reviewed the project 94 days after accepting. The EREB final ethics approval was obtained 186 days after submission. The authorization to conduct research at the 7 McGill sites then took 1, 115, 164 (3 sites covered), 171 and 392 days. COPRI protocol version 2.0 included the expansion of the study to clinics affiliated with other universities, adding 21 GMFs. The amendment to the protocol took 111 days to be approved by the EREB, the new questionnaires and recruiting material took 80 days, and the request to add new sites took 11-23 days. The authorization to conduct research was obtained after 52 days for one site and remains pending for the others. Conclusions: It takes a minimum of 6 to 19 months to obtain authorization to conduct research at GMFs for a non-interventional observational study in primary care in Québec. The delays observed exceed the recommended delays by the provincial framework. These create challenges to conduct research in primary care. Recognizing these delays can justify initiatives to improve the efficacy of the process and help plan realistic timelines with funding agencies.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot 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.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.098 | 0.162 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.007 | 0.002 |
| Scholarly communication | 0.006 | 0.003 |
| Open science | 0.003 | 0.005 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.145 | 0.054 |
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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".