RECORDREFERENCE OUTLINE

IRB Submission Package

Submission inventory built to survive validation rather than stall on it: every document with a version and date including every recruitment item, the risk determination with its justification, a vulnerable-population table answered row by row including the exclusions, recruitment and compensation, and continuing-review obligations diarised with owners. Maps to 21 CFR Part 56.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
21 CFR Part 56
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

An institutional review board decides whether risks are reasonable against anticipated benefits, whether participant selection is equitable, and whether the consent process is adequate. Submissions stall for procedural reasons far more often than ethical ones — a missing version number, a recruitment flyer nobody submitted, a continuing-review date that quietly lapsed. This package is an inventory built to survive that administrative review, not a substitute for the board’s judgement.

What's Inside

✓Submission inventory carrying a version and date on every document, including every recruitment item
✓Risk determination with the anticipated benefits and the reasoning that connects the two
✓Equitable selection statement explaining who is included, who is excluded, and on what grounds
✓Vulnerable-population table answered row by row, including the populations deliberately ruled out
✓Recruitment and compensation description, with the participant-facing wording attached exactly as submitted
✓Consent process description covering who consents, where, when, and how comprehension is checked
✓Continuing review and reporting commitments with named owners and diarised dates against them

How to Use It

1Inventory every document with a version and date before writing anything else; you cannot later evidence which text was approved
2Include every recruitment item — flyer, social post, screening script — because the first thing a participant sees should not be unreviewed
3State the risks and the anticipated benefits separately, then write the reasoning between them rather than asserting the balance
4Answer every vulnerable-population row, including the ones ruled out; an unaddressed population reads as an unconsidered population
5Describe the consent process as it will actually run, including who is available to answer questions and when
6Diarise the continuing review date with an owner — approval that lapses mid-enrolment cannot be cured retrospectively
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Submission Inventory
2Risk Determination
3Equitable Selection and Vulnerable Populations
4Recruitment, Compensation and Consent Process
5Continuing Review and Reporting Commitments
REGULATORY CONTEXT

21 CFR Part 56 governs institutional review boards — their composition and records, the criteria they apply in approving research, and the continuing review that keeps an approval alive. It sets what the board must consider; it does not tell you how to assemble a submission, and no regulation requires the inventory structure used here. That structure is SPEQ practitioner synthesis, built around the procedural failures that stall submissions. The board’s determination remains the board’s, and nothing in this package anticipates it.

MAPPED STANDARDS
21 CFR Part 56
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