Unified IRB Submission Checklist for Startups: Key Components and Approval Criteria for Human Subjects Research

You are spinning up a new research study involving human subjects. You have already confirmed that you need IRB approval, and you want to do a one-and-done submission with the IRB. Great plan. The fastest path is to package your submission so any IRB can check off all approval criteria without hunting or a bunch of back-and-forths. Whether your work aligns with the Common Rule for federally funded studies or FDA regulations for clinical investigations of products, the requirements share significant overlap. To streamline this, we've created two practical tables below: one for what to include in your submission package, and another for what the IRB must determine to grant approval. Think of this like a product spec for reviewers

What to Include in Your IRB Submission Package

This table outlines the essential documents and components to submit. It combines expectations from Common Rule and FDA guidance, using the more detailed elements where they strengthen protections.

Document or Component	What the IRB Expects to See
Protocol	A clear description of objectives, methods, procedures, participant involvement, visit or interaction schedule, recruitment approach, timeline, and tools. Distinguish routine care or product use from research procedures.
Informed Consent Documents	Plain-language forms or scripts that explain procedures, risks, benefits, alternatives, participant rights, and voluntariness. No exculpatory language, and a copy is provided to participants.
Risk Assessment and Minimization Plan (include in protocol)	A concise analysis of foreseeable risks, how you reduce them, and why remaining risks are reasonable in light of benefits or knowledge gained.
Participant Selection Criteria (include in protocol)	Inclusion and exclusion standards, recruitment sources, and how selection is fair. Call out safeguards for vulnerable groups (e.g., children, pregnant women, sponsor employees) if relevant.
Privacy and Confidentiality Plan (include in protocol)	Data map from collection to storage, access controls, retention and destruction, coding or de-identification, and any sharing.
Data Monitoring Plan (include in protocol)	Ongoing safety checks, who reviews what and how often, stopping rules, and prompt reporting pathways (to the IRB, and where relevant, to the FDA) for significant issues.
Investigator Qualifications	CVs or short bios for key study personnel, human subjects or Good Clinical Practice training certificates (e.g., from PHRP or CITI or equivalent), roles and oversight, plus conflicts management if applicable.
Consent Process Documentation (include in protocol)	Who obtains consent, when and where it happens, language access, comprehension checks, and how documentation works, including information about eConsent audit trails if used.
Records and Reporting Commitments (include in protocol)	How you maintain records and how you will promptly report changes, unanticipated problems, or noncompliance to the IRB.
Funding and Additional Protections (include in protocol and/or consent form)	Funding sources and any extra protections, like assent and parental permission if minors are involved.

What the IRB Must Find to Approve Your Study

Before approval, the IRB reviews your submission against core criteria to confirm the study is compliant with the relevant regulations. This table lists those criteria in plain language and points to primary regulations.

IRB Needs to Decide That	How to Show the IRB This	Relevant Regulations
Risks to participants are minimized	In your protocol and risk plan, show sound design, avoid unnecessary procedures, and specify concrete mitigations.	45 CFR 46.111(a)(1), 21 CFR 56.111(a)(1) (eCFR)
Risks are reasonable in relation to anticipated benefits	Provide a balanced benefit-risk analysis and realistic alternatives to participation (even if the alternative is “to not participate”).	45 CFR 46.111(a)(2), 21 CFR 56.111(a)(2) (eCFR)
Selection of subjects is equitable	Explain your inclusion and exclusion criteria, recruitment setting, and fairness for the population.	45 CFR 46.111(a)(3), 21 CFR 56.111(a)(3) (eCFR)
Informed consent will be appropriately sought and documented	Include process details and finalized consent materials. Ensure required content, understandable language, and proper documentation, including eConsent where used.	45 CFR 46.111(a)(4)-(5), 45 CFR 46.116, 45 CFR 46.117, 21 CFR 56.111(a)(4)-(5), 21 CFR 50.20, 21 CFR 50.25, 21 CFR 50.27 (eCFR, Legal Information Institute)
There are adequate provisions for monitoring study data to ensure safety	Spell out what is reviewed, by whom, how often, and what triggers pausing or stopping.	45 CFR 46.111(a)(6), 21 CFR 56.111(a)(6) (eCFR)
There are adequate provisions to protect privacy and maintain data confidentiality	Provide a data flow diagram, access controls, retention plan, and de-identification or coding strategy.	45 CFR 46.111(a)(7), 21 CFR 56.111(a)(7) (eCFR)
When appropriate, there are additional safeguards for vulnerable participants	If applicable, include assent and permission plans and any population-specific protections.	45 CFR 46.111(b), 21 CFR 56.111(b) (eCFR)

Common pitfalls to avoid

• Benefits that read like marketing copy. Keep benefit claims modest and aligned with the protocol.
• Consent materials that are readable to you but not to participants. Test with a non-expert and trim jargon - see Tempus IRB’s consent form template as an example.
• Vague “we’ll secure the data” language. Show specific controls, retention, and who has access.

Uncertain about your submission? Tempus IRB would be happy to talk to you about your protocol and identify gaps that need to be filled before submission. Schedule a call with us today!

This post is for informational purposes only and does not constitute legal advice.