Backed by Y CombinatorFour documents and two sheets that grade every section against a stated requirement before a reviewer has to, and keep your continuing review date live afterward.
Free download · No account needed
What you get
Pack of 6 files: 4 documents, 2 spreadsheets
IRB and Ethics Application TemplateRequirement Checklist: Recruitment Materials
| Requirement | Status |
|---|---|
| Names the research team and institution conducting the study | Ready |
| Distributed through a channel independent of the participant's own supervisor | Needs Revision |
The second row is the one a general read-through misses: the email reads fine until you ask who it's actually from.
Two sections account for most of the revision requests on a human-subjects application, and neither fails for a reason a general read-through reliably catches. Recruitment materials read as coercive once they travel through an authority a subject might feel unable to refuse, since federal regulation requires that consent be sought only under circumstances that minimize the possibility of coercion or undue influence. A data management plan that promises confidentiality without naming a method, an access list and a retention period fails the same specific criterion every time, just described differently.
The pack is four documents, two sheets, and one rule. Application Narrative, Consent Form, Recruitment Materials and Data Management Plan draft from the same study design, so a fact stated in one, a retention period or a described risk, has to match what the others say about it. Requirement Checklist grades every section against its own stated requirement rather than a general impression. Amendment Register keeps the continuing review date as a computed row with a lookahead flag, since federal guidance gives a lapsed approval no grace period.
In one worked example, a field study on a four-day compressed workweek, recruiting through the partner employer's HR office, is checked against 27 requirements before its first submission. Seven come back Needs Revision: three of five in Recruitment Materials, since the recruitment email comes from each employee's supervisor with no separate channel offered. Three of six are in Data Management Plan, since it names no de-identification method, access list or retention period. Application Narrative grades zero, and the same discipline runs before every amendment, the one a grant's own commitment register runs against a budget.
Application Narrative8 of 8 requirements Ready on first submission. Two shown here.
| Requirement | Status |
|---|---|
| Procedures separate research-only activity from data the firm already collects | Ready |
| Risk-benefit justification stated as a comparison, not an assertion | Ready |
Zero Needs Revision rows here. The narrative is not where this application loses time.
Consent Form7 of 8 requirements Ready. The eighth is the one a reviewer sends back.
| Requirement | Status |
|---|---|
| States that participation is voluntary with no penalty for withdrawing | Ready |
| Gives contact information for questions about the study and about participant rights | Needs Revision |
Names the department and the IRB, but gives no phone number or email for either.
Recruitment Materials3 of 5 requirements Needs Revision, the section with the most rework almost every time.
| Requirement | Status |
|---|---|
| States plainly that declining has no effect on employment or pay | Needs Revision |
| Distributed through a channel independent of the participant's own supervisor | Needs Revision |
| Names the research team and institution conducting the study | Ready |
Both failing rows trace to one cause: the office manager, the person each employee reports to, is the one sending the email.
Data Management Plan3 of 6 requirements Needs Revision, the same count as Recruitment Materials.
| Requirement | Status |
|---|---|
| Names a specific de-identification method, not a confidentiality assertion | Needs Revision |
| States a retention period as a specific duration or triggering event | Needs Revision |
| Names specific storage and security safeguards | Ready |
"As long as necessary to complete the analysis" is the exact phrasing this checklist is built to catch.
Amendment RegisterThree amendments since approval, and the row that matters most today.
| Date | Type | What changed or is due | Days left |
|---|---|---|---|
| 2026-06-02 | Amendment | Removed a free-text field flagged as a re-identification risk | |
| 2026-09-18 | Amendment | Extended the comparison offices' survey window by two weeks | |
| 2027-01-20 | Continuing Review | Annual review due, computed from the 2026-01-20 approval date | 18 |
18 days out, computed, not remembered. Federal guidance gives this row no grace period once it passes.
Background and rationale, built the way a literature review synthesis builds one, plus specific aims, study design, subject population, procedures split into research-only activity, risks, benefits, and a risk-benefit justification stated as a comparison rather than an assertion.
Drafted against the fixed list of eight required elements in order, not a persuasive narrative checked afterward for whether each one appears somewhere in it.
Every email, flyer and script checked for who is actually distributing it and what authority they hold over the person receiving it, not only for what the text says.
A named de-identification method, a named access list, and a stated retention period for the same fields a variable-level codebook will organize once collection actually starts, each checked against the same promise in Consent Form the day either one changes.
Every section graded Ready, Needs Revision or Not Started against a specific requirement, with the exact gap named in the reason column rather than a general note to revise.
Every change logged the day it is submitted, and the continuing review date kept as a computed row with a lookahead flag rather than a fact filed in an approval letter.
The standing space rule every prompt reads first: the date recomputes the moment the approval date or the review period changes, since a lapsed approval gets no grace period at all.
Open the pack in River and the agent drafts all four documents from your study design, or download the four Word documents and two CSV sheets instantly, filled in with the worked example.
Who you would recruit and through what channel, what you would collect directly, and whether any other dataset gets linked to it. Narrative, consent form, recruitment materials and data plan draft from that same answer.
Every row graded Ready, Needs Revision or Not Started against the current draft, with the specific gap named rather than a general note to revise, before the initial submission and every amendment after it.
Amendment Register logs every change the day it is submitted and recomputes the continuing review row the moment the approval date or review period changes, so the date is watched rather than filed.
Yes. Download the whole pack as Word documents and CSV sheets with no signup and no credit card. Edit with AI is a separate, optional path that has the agent draft your application from your own study design. The template library holds every other pack this research catalog ships.
Word documents for Application Narrative, Consent Form, Recruitment Materials and Data Management Plan, and CSV for Requirement Checklist and Amendment Register, in one zip. They open in Word, Pages, Google Docs, Excel, Numbers and Sheets with nothing to convert.
No. The board makes the actual determination, and nothing here approves anything. Requirement Checklist grades a draft against the same specific requirements a board applies, so what comes back is a judgment call the board actually has to make, not a gap the checklist already knew was missing.
Because both fail on specific, checkable criteria that a general read-through does not surface reliably. Recruitment routed through a supervisor or another authority reads as coercive regardless of its wording. A data plan that says data will stay confidential without naming a method, an access list and a retention period fails the same way every time.
All research activity involving human subjects stops the day approval lapses, with no grace period, unless the board determines that continuing already-enrolled subjects is in their own best interest. Amendment Register's continuing review row is built to be checked well before that date, not after it.
Only the ethics side: closing the study with the board once data collection finishes. Planning what each dataset can actually be shared as, analyzing what was collected, and responding to a journal's decision letter once a manuscript comes back are separate jobs this pack hands off to.
Written by
Co-founder & CEO, River
Chandler has spent the last six years working in AI, building tools for millions of users and Fortune 100 companies. In 2025, he co-founded River to build a new kind of operating system for AI agents.
Send the study design, however rough. The pack drafts all four documents and grades every section against a stated requirement before a reviewer has to say so.
Edit with AI