Governance
Research governance
Analyses of vaccine and drug safety data can be bent toward any conclusion by choosing the outcome, window, comparator or background rate after seeing the data. These are the commitments that make the site's analyses checkable, and their current status.
1. Pre-specified protocols
| Analysis | Protocol | Status |
|---|---|---|
| Observed vs expected (VAERS AESIs) | oe-protocol v1.0 — pairs, MedDRA terms, risk windows, background sources, decision rules; SHA-256 of the analysis code at fixing | published 2026-10-09, before counts |
| VAERS signal detection (phase 1) | protocols/phase1_vaers_signal_detection.md | in repository |
| External registration of both | OSF Registries (requires the foundation's OSF account) | prepared, not yet deposited |
Rule: once a protocol is published, any change to pairs, windows, comparators or decision rules is recorded in a dated Deviations section of that protocol, never by silent edit.
2. Versioned, citable data
Every analysis writes a public JSON file under /data/science/ or /openpv/data/. A release bundle (data files, analysis code, CITATION.cff and Zenodo metadata) is assembled at release/vdn-science-2026-10.zip for deposit on Zenodo, which assigns a DOI so that every page can cite a frozen version. prepared, not yet deposited
| Dataset | File |
|---|---|
| Observed vs expected | observed_vs_expected.json |
| Controlled-study results | active_surveillance_results.json |
| Background incidence rates | background_rates.json |
| Disease complication risks | disease_risks.json |
| GRADE ratings | grade_ratings.json |
| Brighton documentation screen | brighton_proxy.json |
| Reporting rates | vaers_reporting_rates.json |
| COVID-19 lot standardization | covid_lot_standardized.json |
| OpenPV method validation | method_validation.json |
| WHO coverage and burden (31 countries) | who_country_epi.json |
3. External scientific review
Charter. Two to three pharmacoepidemiologists or biostatisticians with no financial relationship to vaccine or drug manufacturers, litigants or advocacy organisations on either side are invited to review the methods once a year. Reviewers receive the protocols, code and data releases; their written comments are published unedited next to the changelog, with the site's response and any resulting changes. Reviewers are not asked to endorse conclusions, only to judge whether methods and caveats are sound.
Status: charter published; reviewers not yet appointed. Suggestions of reviewers are welcome through corrections.
4. Conflicts of interest and funding
The site is published by the Open Source Medicine Foundation. It accepts no funding from vaccine or drug manufacturers or from parties to vaccine or drug litigation. Pages are reviewed by Matthew Thomas J Halma (Founder, Open Source Medicine Foundation), whose published work includes the DARE-SAFE framework cited on vaccine pages; that relationship is disclosed wherever it is cited. Individual readers can contribute to the foundation's open-source medical infrastructure fund; donations are not tied to any analysis or conclusion.
5. Corrections
Anyone can report an error through corrections. Accepted corrections are logged with a date in the changelog. Analyses that turn out to be wrong are corrected in place with a note, not removed; for example, the October 2026 lot pages that ranked lots by raw report count were replaced, and the change is recorded.
Updated 2026-10-09.