IRB submission template — section on open-source platform considerations (good first issue)

[dblizinski]

What this is

A reusable 1–2 page section that researchers can drop into their IRB submission when proposing a study that uses the Openwater open-source platform. Most IRBs have never reviewed a protocol built on an open-source medical device. This template anticipates and answers the questions a committee is likely to ask.

Why this matters

IRB friction is among the top reasons researchers stall on a first deployment. Every site invents its own justifications from scratch, often poorly, because no one has provided the framing language. A reusable, partner-reviewed template directly compresses time-to-first-protocol.

What to do

1. Comment to claim.
2. Read the linked regulatory context (Openwater's regulatory pathway, AGPL/Apache licensing transition, partner-institution example protocols if available).
3. Draft a template section covering:
   • Code provenance: how the platform is developed, where the source lives, how versions are tagged
   • Version control and reproducibility: how researchers pin a specific commit for their study
   • Validation: how the platform has been validated to date (cite published work)
   • Safety data sharing: how community pooling works and what protections are in place
   • What happens if Openwater changes the platform: how an active study handles upstream changes
   • Vendor lock-in (or absence of): the open-source advantage on long-term institutional control
4. Use neutral, IRB-appropriate language — no marketing voice, no superlatives.
5. Submit as a PR to the wiki under "IRB Resources."
6. Request review by a clinical contact from a partner institution (MIT, UCLA, UPenn, Brown, U of Arizona, or ETH Zurich) before merging the lane lead, which will help connect you.

Definition of done

• Template covers all six question areas above.
• Language is IRB-appropriate (formal, neutral, evidence-anchored).
• Cites at least three peer-reviewed sources or partner publications.
• Reviewed by a partner-institution clinical contact before merge.

Skills

• IRB familiarity (or willingness to read sample submissions)
• Clear, formal writing
• Comfort with regulatory framing

Scope estimate

6–10 hours.

Helpful starting points

• Openwater regulatory page: https://www.openwater.health/clinical
• Sample IRB submissions on open-source platforms (PubMed Central often has these as supplementary materials)
• The Frontiers in Psychiatry April 2025 paper (cites the IRB approach used at the University of Arizona)

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How to claim this issue

1. Comment "I'd like to work on this." We'll assign it to you.
2. Open a draft PR within ~3 weeks of being assigned.
3. Ask any scoping questions on this issue or in our Discord #contributing channel.

Contact: community@openwater.health

By contributing, you agree to our Contributor License Agreement. (If the CLA isn't yet live when you start, we'll handle it once the flow is up.)