IRB and Ethics Application Template
Four 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.
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Requirement Checklist: Recruitment Materials
Two rows, same document, different grade
| 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.
What's in the pack
Application Narrative doc
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.
Consent Form doc
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.
Recruitment Materials doc
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.
Data Management Plan doc
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.
Requirement Checklist sheet
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.
Amendment Register sheet
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 continuing review date is a computed row, not a memory
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.
How to use it
- 1
Open in River, or download it
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.
- 2
Send the study design, not the finished paperwork
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.
- 3
Run the checklist before every submission
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.
- 4
Keep the continuing review date live after approval
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.
Frequently asked questions
Is this template free?
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.
What format are the downloaded files?
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.
Does this replace my institution's own IRB or ethics board?
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.
Why do recruitment materials and the data plan need the most rework?
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.
What happens if continuing review is missed?
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.
Does this cover what happens after the study ends?
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.
Get ethics approval without three rounds of revision
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