Core elements of consent documentation for clinical research in Canada: guidance for policy
Bibliographic record
Abstract
BACKGROUND: Consent forms have become too long and often do little to help people understand the risk elements of their participation in research, instead focusing on risk reduction for research institutions. Under the auspices of the Canadian Institutes of Health Research and the Canadian Critical Care Trials Group, we identified a core set of elements for participant consent documents to be used in clinical research and present these as a template consent form. METHODS: Our guideline core team comprised experts in the legal and ethical aspects of research, and a clinical trialist-scientist. We conducted a directed review to compile a list of applicable regulatory, policy, and guidance requirements for the documentation of informed consent for research conducted with human participants in Canada. We used a gap analysis to identify the elements required in a research consent form, based on these documents and in comparison with 10 existing research ethics board (REB) informed-consent form templates. The guideline, as well as a fillable template for the form, was created with input from a pan-Canadian advisory group, interested parties, and broad public input. We tested the template with a small group of studies across several research domains. Our process for managing competing interests adhered to Guidelines International Network principles. RECOMMENDATIONS: From our gap analysis, we identified 75 core elements for participant consent forms in clinical research, which we have grouped under 6 main categories (i.e., information for potential participants about participating in research in general and in the particular study; harms and benefits of participation; protection of participant data; points of contact; and giving consent) in a fillable consent template. Because studies vary, specific elements should be included in a study consent form only if relevant to the type of research being conducted and the corresponding compliance requirements, as identified in our gap analysis. INTERPRETATION: The template with the core set of required elements is intended to be used by any researcher applying for REB approval to document participant consent and, when applied with consideration of our associated guidance, is sufficient to meet regulatory requirements for research in Canada. Identifying the required elements for consent forms is intended to streamline consent documents across the country, facilitate multi-site projects, and simplify the approval process for all those involved.
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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 | 0.382 | 0.531 |
| Meta-epidemiology (narrow) | 0.002 | 0.005 |
| Meta-epidemiology (broad) | 0.003 | 0.005 |
| Bibliometrics | 0.015 | 0.018 |
| Science and technology studies | 0.020 | 0.017 |
| Scholarly communication | 0.025 | 0.019 |
| Open science | 0.012 | 0.013 |
| Research integrity | 0.030 | 0.021 |
| Insufficient payload (model declined to judge) | 0.022 | 0.013 |
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; the direct Gemma label and the distilled Codex classifier 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".