IRB Consent Form Template
The study
Consent form
Study title and investigator (study title not set) (principal investigator not set) Purpose You are invited to take part in a research study. (say why the study is being done, in one or two sentences.) What participation involves If you agree to take part, you will be asked to: (describe each task, in the order it happens.) Time required Taking part will take about (state the total time, including any follow-up.). Risks (State the risks. If there are none beyond everyday life, say the risk is no more than minimal and name anything a participant might find uncomfortable.) Benefits (State the benefits to the participant or to others; do not promise an outcome.) Confidentiality Your responses will be seen only by the research team. Records will be kept for 5 years and then destroyed. Voluntary participation and withdrawal Taking part is voluntary. You may stop at any time and may decline any question, without giving a reason and with no penalty. Withdrawing will not affect any service you receive. Contacts (Give two contacts: the researcher's email or phone, and the review board's, so a participant has somewhere to go that is not the researcher.) Signature block I have read the information above, or it has been read to me. I have had the chance to ask questions, and my questions have been answered. I voluntarily agree to take part in this study. Name of participant: ______________________________ Date: ______________ Signature of participant: _________________________ Name of person taking consent: ______________________ Date: ______________
Checks
No study title: the title has to match the protocol exactly, because it is what the reviewer searches for.
No principal investigator named.
The purpose is missing or under ten words; state why the study is being done in plain language.
The procedures are missing; list each task in the order a participant will meet it.
No time stated; participants weigh a study by what it will cost them in minutes.
The risk section is empty. Minimal-risk studies still state it: say the risk is no more than minimal.
No benefits stated; say what the participant or others gain, without promising an outcome.
The contact section has no email address or phone number a participant can actually use.
1 sentence runs past 25 words; consent forms are read once and quickly, so split them.
Scope and limits
The element list follows the Common Rule's basic and additional elements of informed consent (45 CFR 46.116) as published: purpose, procedures, duration, risks, benefits, confidentiality, voluntary participation, withdrawal, contacts and the signature block.
This is a drafting aid, not IRB review and not legal advice. Exemptions, waivers and the wording your board requires are decided by your board, and its template overrides this one.
The IRB consent form template assembles the published elements of informed consent from your study's own answers and flags the ones that are missing, overstated or written past a comfortable reading length.
What is IRB Consent Form Template?
The irb consent form template builds the document from the published elements of informed consent rather than from a blank page. Those elements are the ones a review board checks in order: the study title and investigator, the purpose, what participation involves, the time required, the risks, the benefits, confidentiality, voluntary participation and withdrawal, the contacts, and the signature block. Each element is assembled from what you write, and an element that is empty is named rather than quietly omitted.
The drafting checks are the ones reviewers apply to the prose. A missing risk section is flagged even for minimal-risk studies, because the required statement is that the risk is no more than minimal, not that the study has none. A risk section that says there are no risks at all is flagged for the same reason: the phrase a review board accepts is a specific one, and using it is not a formality. Benefits that promise an outcome — guaranteed, will cure, assured — are flagged because the document may describe benefits but must not guarantee them.
Withdrawal gets its own attention, since it is the element participants actually rely on. The template always includes the voluntary statement, and when you describe payment it checks whether withdrawal is addressed: a study that pays twenty dollars per session should say how payment is prorated if someone stops early, because the alternative is a participant who feels fined for leaving. The contact check looks for an email address or phone number, on the reasoning that a participant with only a name has nowhere to go. Long sentences are counted as well — a consent form is read once, quickly, by someone who did not choose the wording.
The additional elements are switches. Audio or video recording adds the transcription and identifier-removal language, future use of de-identified data adds the paragraph that lets a participant ask for removal before that point, vulnerable populations add the representative signature line and the assent language, and a waiver of documentation replaces the signature block with the verbal-consent statement.
What the template cannot do is decide whether your study is exempt, whether a waiver is approvable, or what your particular board requires. Those are the board's decisions, and its own template overrides this one. Treat the page as a drafting aid that makes sure no element is silently absent, and bring the result to your board rather than past it.
The order of the elements is not arbitrary. Purpose, procedures and duration tell a participant what they are being asked to do. Risks, benefits and confidentiality tell them what it may cost and how it will be handled. Voluntary participation and withdrawal tell them they can leave. Contacts and the signature block make the agreement verifiable. A form that opens with confidentiality and never states the purpose is out of the order a participant reads in, even when every element is present. Reading your draft aloud in this order is the fastest way to find the element that is technically there but functionally buried.
How to use IRB Consent Form Template
- Fill in the study identity, purpose, procedures and time first.
- Write the risk and benefit sections in the review board's own language.
- Set the switches for recording, future use, vulnerable populations or a waiver.
- Clear the checks, paying attention to payment and contact details.
- Copy or download the form and attach it to your protocol submission.
When to use IRB Consent Form Template vs related tools
Use the irb consent form template when a protocol is being assembled and the consent document has to be drafted. It is most useful before submission, because the checks catch the missing element or the overstated benefit while there is still time to change the protocol wording that produced it. For the study around the form, the Peer Review Checklist covers the paper's own sections, and the Technical Report Template assembles the report a funder or committee will read alongside the protocol.
Privacy & Security
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